Tablet manufacturing SOPs – SOP Guide for Pharma

Tablets: SOP for Dissolution Method Development for Sustained Release Tablets – V 2.0

Wed, 26 Feb 2025 23:32:00 +0000

Tablets: SOP for Dissolution Method Development for Sustained Release Tablets – V 2.0

Standard Operating Procedure for Dissolution Method Development for Sustained Release Tablets

Department	Quality Control
SOP No.	SOP/TAB/102/2025
Supersedes	SOP/TAB/102/2022
Page No.	Page 1 of 7
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for developing dissolution testing methods for sustained release tablets, ensuring that the release of the active pharmaceutical ingredient (API) is consistent and reproducible.

2. Scope

This SOP applies to the development of dissolution methods specifically for sustained release tablet formulations. It covers method selection, validation, and optimization to ensure proper release of the API under simulated physiological conditions.

3. Responsibilities

Quality Control (QC): Responsible for developing and optimizing the dissolution testing method for sustained release tablets and ensuring that the method meets the necessary specifications and regulatory requirements.
Quality Assurance (QA): Reviews and approves the dissolution method development process to ensure compliance with regulatory standards and company policies.
Laboratory Personnel: Responsible for carrying out the dissolution method development, performing tests, recording results, and ensuring that all necessary equipment is calibrated and functioning properly.

4. Accountability

The QC Manager is accountable for ensuring the accurate execution and development of the dissolution method for sustained release tablets. The QA Manager is responsible for reviewing and approving the developed methods.

5. Procedure

5.1 Method Selection

Select the appropriate dissolution method based on the formulation characteristics of the sustained release tablets. Consider factors such as API solubility, release mechanism, and the intended therapeutic use of the tablet.
Choose the dissolution medium, based on the pH and ionic strength that simulates the physiological conditions in the gastrointestinal tract (e.g., pH 1.2, 4.5, or 6.8 depending on the type of sustained release tablet).
Determine the appropriate dissolution apparatus, such as USP Apparatus 1 (baskets) or USP Apparatus 2 (paddles), based on the tablet characteristics.

5.2 Method Development

Optimize the dissolution method by testing various parameters, including the dissolution medium, paddle speed, and temperature. Ensure that the dissolution test conditions mimic the tablet’s intended release profile.
Perform dissolution tests using a minimum of 6 tablets to ensure representative results, ensuring the integrity and uniformity of the sustained release mechanism.
Record the time points at which the dissolution samples will be collected (e.g., 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr) and analyze the release profiles accordingly.

5.3 Method Validation

Validate the dissolution method by performing multiple tests with tablets from different batches, ensuring the reproducibility and accuracy of the dissolution profiles across all batches.
Ensure that the dissolution method meets the acceptance criteria for sustained release tablets, such as the percentage of API released within a specified time range (e.g., 80% API released in 12 hours or as specified).
Perform method robustness testing by varying the dissolution test parameters (e.g., temperature, paddle speed) and observing any changes in dissolution results.
Compare the dissolution profiles with the drug release specifications to ensure they meet the target release profile.

5.4 Data Recording and Calculation

Record the dissolution results, including the amount of API released at each time point, in the batch record (Annexure-1).
Calculate the cumulative percentage of the API released at each time point and compare it to the target dissolution profile.
Document the dissolution results, including the time points, apparatus settings, and any deviations or anomalies during the test process.

5.5 Acceptance Criteria

Ensure that the sustained release tablets meet the dissolution specifications defined in the product development report or regulatory guidelines (e.g., 80% drug release in 12 hours, or as specified).
If the dissolution results do not meet the specified release criteria, investigate and document the findings in the deviation report (Annexure-2). Consider adjusting the formulation or method as necessary and perform re-testing.

5.6 Documentation and Record-Keeping

Document all dissolution test results, including the setup parameters, time points, and calculated release profiles in the batch record (Annexure-1).
Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
Maintain raw data, test results, and supporting documentation for regulatory compliance and future reference.

5.7 Post-Test Cleanup

Clean all equipment used in the dissolution testing, including dissolution vessels, paddles, and collection vials, according to the cleaning SOP.
Ensure that all equipment is properly maintained and calibrated for future use in dissolution tests.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient
HPLC: High-Performance Liquid Chromatography
USP: United States Pharmacopeia

7. Documents

Batch Record (Annexure-1)
Deviation Report (Annexure-2)

8. References

USP <711> – Dissolution Testing of Tablets
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
European Pharmacopoeia (EP) – Dissolution Testing Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number	Tablet Sample	Dissolution Method	API Released at 1 Hour (%)	API Released at 12 Hours (%)	Result
Batch 001	Tablet Sample	Apparatus 2	25%	80%	Pass

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Release profile did not meet specifications	Optimized formulation and re-tested	John Doe

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated Dissolution Method	Refined dissolution testing for sustained release	QA Head

Tablets: SOP for Cleaning Validation Swab Analysis in Quality Control – V 2.0

Wed, 26 Feb 2025 10:12:00 +0000

Tablets: SOP for Cleaning Validation Swab Analysis in Quality Control – V 2.0

Standard Operating Procedure for Cleaning Validation Swab Analysis in Quality Control

Department	Quality Control
SOP No.	SOP/TAB/101/2025
Supersedes	SOP/TAB/101/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for performing cleaning validation swab analysis in the quality control laboratory, ensuring that equipment and surfaces are free from residual contaminants that could affect product quality.

2. Scope

This SOP applies to cleaning validation testing of equipment used in tablet manufacturing. It ensures that cleaning methods effectively remove residues of active pharmaceutical ingredients (API) and excipients.

3. Responsibilities

Quality Control (QC): Responsible for performing the cleaning validation swab analysis, ensuring that all equipment surfaces meet residue limits specified in the cleaning validation protocol.
Quality Assurance (QA): Ensures that the cleaning validation testing procedure is followed and reviews the results for compliance with regulatory and internal requirements.
Cleaning Personnel: Responsible for carrying out the cleaning of equipment, ensuring it is properly cleaned according to the validated procedures.

4. Accountability

The QC Manager is accountable for ensuring that cleaning validation swab testing is conducted accurately and consistently. The QA Manager is responsible for reviewing and approving the results.

5. Procedure

5.1 Sample Collection

Collect swab samples from equipment surfaces after cleaning, as specified in the cleaning validation protocol (typically, from high-contact surfaces such as product contact areas).
Ensure that the swabs are properly labeled to maintain traceability to the specific equipment, batch, and cleaning procedure.
Collect at least two swabs from each equipment surface, depending on the validation protocol and the surface area.

5.2 Swab Preparation

Prepare the swab by moistening it with an appropriate solvent (e.g., water for injection, 70% ethanol) as per the cleaning validation protocol.
Ensure that the swab is fully wetted to efficiently collect any residual contaminants from the equipment surface.

5.3 Performing the Swab Analysis

Analyze the swab samples using an appropriate analytical method (e.g., High-Performance Liquid Chromatography (HPLC), UV spectrophotometry, or other methods as specified in the protocol) to detect residues of the API or excipients.
Ensure that the method is validated for the specific residues being tested, and use a sensitivity level that ensures detection of the contaminants within acceptable limits (e.g., ≤ 10 ppm).
Perform the analysis in triplicate to ensure reliable and reproducible results.

5.4 Data Recording and Calculation

Record the results of the swab analysis, including the quantity of the contaminant detected, in the batch record (Annexure-1).
Calculate the residue concentration based on the swab sample results, using the following formula:
- Residue Concentration = (Sample Concentration / Swab Area) × Swab Recovery
Ensure that the residue concentration is below the predetermined acceptance criteria, typically ≤ 10 ppm for the API and excipients combined, or as specified by regulatory guidelines.

5.5 Acceptance Criteria

Ensure that the residue levels in the swab sample are within the acceptable limits defined in the cleaning validation protocol. Typically, this will be ≤ 10 ppm of the API and excipients combined, or as per the product specifications.
If the residue level exceeds the allowable limit, document the deviation in the deviation report (Annexure-2) and initiate a thorough investigation.
Take corrective actions as necessary and repeat the cleaning and testing process if required to meet the acceptance criteria.

5.6 Documentation and Record-Keeping

Document the results of the cleaning validation swab analysis, including the test method, swab samples, and results, in the batch record (Annexure-1).
Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
Maintain raw data, test results, and supporting documentation for regulatory compliance and future reference.

5.7 Post-Test Cleanup

Clean all equipment used for cleaning validation swab testing, including sample containers, HPLC instruments, and any other analysis apparatus, according to the cleaning SOP.
Ensure that all equipment is properly maintained and calibrated for future use.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
API: Active Pharmaceutical Ingredient
HPLC: High-Performance Liquid Chromatography
ppm: Parts Per Million
QA: Quality Assurance

7. Documents

Batch Record (Annexure-1)
Deviation Report (Annexure-2)

8. References

USP <1223> – Validation of Cleaning Processes
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
European Pharmacopoeia (EP) – Cleaning Validation and Residue Testing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number	Swab Sample	Residue Detected (ppm)	Result
Batch 001	Surface A	0.2	Pass

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Residue exceeded limit	Re-clean and re-test the equipment	John Doe

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated Sampling Method	Refined residue detection procedure	QA Head

Tablets: SOP for Accelerated Stability Testing of Tablets – V 2.0

Tue, 25 Feb 2025 20:52:00 +0000

Tablets: SOP for Accelerated Stability Testing of Tablets – V 2.0

Standard Operating Procedure for Accelerated Stability Testing of Tablets

Department	Quality Control
SOP No.	SOP/TAB/100/2025
Supersedes	SOP/TAB/100/2022
Page No.	Page 1 of 7
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for performing accelerated stability testing on tablet formulations, ensuring that the tablets maintain their quality, efficacy, and safety under accelerated storage conditions.

2. Scope

This SOP applies to the accelerated stability testing of tablet products, ensuring that the tablets are stored under controlled conditions to simulate the effects of long-term storage in a shorter time frame.

3. Responsibilities

Quality Control (QC): Responsible for conducting the accelerated stability testing, including sample preparation, testing, and recording results accurately.
Quality Assurance (QA): Ensures that the accelerated stability testing procedure is followed and reviews the results for compliance with regulatory standards.
Laboratory Personnel: Responsible for the preparation of samples, calibration of instruments, and execution of stability tests under the specified conditions.

4. Accountability

The QC Manager is accountable for ensuring that the accelerated stability testing is performed accurately and consistently. The QA Manager is responsible for reviewing the stability test results and approving the batch for release based on the data obtained.

5. Procedure

5.1 Sample Collection

Collect a representative sample of tablets from the batch, as specified in the batch record or pharmacopeial guidelines (usually a minimum of 6 tablets or as specified).
Ensure that the tablets are free from defects such as cracks, chips, or discoloration that could affect the stability testing results.
Label the sample appropriately for identification during testing.

5.2 Preparation of Testing Apparatus

Ensure that all laboratory equipment, such as stability chambers, temperature/humidity controllers, and test instruments, are calibrated and functioning properly.
Set up the stability chamber to the required temperature and humidity conditions as per the accelerated stability test specifications (e.g., 40°C and 75% relative humidity).
Ensure that the chamber is operating correctly, with continuous monitoring of temperature and humidity levels during the test period.

5.3 Performing Accelerated Stability Test

Place the tablet samples in the stability chamber for the prescribed period (e.g., 6 months, typically accelerated to 3 months), ensuring that the sample containers are properly sealed and labeled.
Monitor the storage conditions throughout the test period, making sure the temperature and humidity levels remain within the specified range.
Remove the tablets from the chamber at the specified time points (e.g., 0, 1, 2, and 3 months) for testing.
Perform the required quality control tests at each time point, which may include:
- Appearance testing
- Hardness testing
- Disintegration testing
- Dissolution testing
- Content uniformity or assay testing

5.4 Data Recording and Calculation

Record all results from the stability tests, including appearance, hardness, dissolution, and any observed changes in the tablet characteristics (Annexure-1).
Compare the results at each time point to the initial results to evaluate any changes or degradation in the tablet’s quality and stability.
Calculate the percentage change in tablet characteristics, such as dissolution rate or assay, and document whether the tablets meet the stability acceptance criteria.

5.5 Acceptance Criteria

The tablets must meet the specified quality criteria at each time point, including:
- Appearance: No significant color changes or discoloration
- Hardness: Should remain within the established range
- Disintegration: Tablets must disintegrate as per the specifications
- Dissolution: Dissolution profiles should remain within the established limits
- Assay: No significant loss in active pharmaceutical ingredient (API) content
If any of the criteria are not met, investigate and document the findings in the deviation report (Annexure-2), and determine whether corrective action is required.

5.6 Documentation and Record-Keeping

Document all stability testing results, including test methods, time points, and any deviations, in the batch record (Annexure-1).
Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
Maintain raw data, test results, and supporting documentation for future reference and regulatory compliance.

5.7 Post-Test Cleanup

Clean all equipment used for stability testing, including the stability chamber, test instruments, and sample containers, according to the cleaning SOP to prevent cross-contamination between tests.
Ensure that all testing equipment is properly maintained and calibrated for future use.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient
RH: Relative Humidity
HPLC: High-Performance Liquid Chromatography

7. Documents

Batch Record (Annexure-1)
Deviation Report (Annexure-2)

8. References

USP <1116> – Stability Testing of Drug Substances and Drug Products
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
European Pharmacopoeia (EP) – Stability Testing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number	Tablet Sample	Test Method	Initial Hardness (kg)	Hardness After 3 Months (kg)	Result
Batch 001	Tablet Sample	Dissolution	6.5	6.4	Pass

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Tablet hardness decreased below specification	Adjusted formulation and re-tested	Jane Doe

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated Testing Methodology	Refined stability testing protocols	QA Head

Tablets: SOP for Compression Force Impact Analysis on Tablet Hardness – V 2.0

Tue, 25 Feb 2025 07:32:00 +0000

Tablets: SOP for Compression Force Impact Analysis on Tablet Hardness – V 2.0

Standard Operating Procedure for Compression Force Impact Analysis on Tablet Hardness

Department	Tablet
SOP No.	SOP/TAB/099/2025
Supersedes	SOP/TAB/099/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for analyzing the impact of compression force on tablet hardness, ensuring that tablets meet the required hardness specifications for product quality and performance.

2. Scope

This SOP applies to the compression force impact analysis on tablets during manufacturing, ensuring that the compression process does not adversely affect the tablet hardness, which is critical for handling, storage, and dissolution.

3. Responsibilities

Manufacturing Personnel: Responsible for adjusting compression force during the tablet compression process and ensuring that the tablet hardness meets the specified criteria.
Quality Control (QC): Responsible for conducting the compression force impact analysis, testing tablet hardness, and ensuring that the tablets comply with hardness specifications.
Quality Assurance (QA): Ensures that the compression force impact analysis procedure is followed, reviews the test results, and approves the batch for release based on the tablet hardness data.

4. Accountability

The QC Manager is accountable for ensuring the proper execution of compression force impact analysis. The QA Manager is responsible for reviewing and approving the batch release based on hardness test results.

5. Procedure

5.1 Sample Collection

Collect a representative sample of tablets from the batch, as specified in the batch record or pharmacopeial guidelines (usually a minimum of 10 tablets or as specified).
Ensure that the tablets are free from defects such as cracks, chips, or discoloration that could affect the analysis.
Label the sample appropriately for identification during testing.

5.2 Preparation of Compression Force Testing Apparatus

Ensure that all testing equipment, such as hardness testers, compression machines, and load cells, are calibrated and functioning properly.
Set up the compression machine to the specified compression force ranges, based on the tablet formulation and the batch record specifications.
Verify that the testing environment (e.g., temperature and humidity) meets the specifications for the compression force impact test.

5.3 Performing Compression Force Impact Test

Set the compression machine to a predetermined compression force based on the tablet formulation and product specifications.
Compress a set of tablets at varying compression forces to evaluate the relationship between the compression force and tablet hardness.
Measure the tablet hardness using an appropriate hardness tester (e.g., Pfizer hardness tester, or a similar device) at each compression force setting.
Record the tablet hardness values for each compression force level (Annexure-1).

5.4 Data Recording and Calculation

Record the compression force and corresponding tablet hardness values in the batch record (Annexure-1).
Analyze the data to determine the correlation between compression force and tablet hardness. The goal is to identify the optimal compression force that results in the desired tablet hardness without causing any defects.
Calculate the average tablet hardness for each compression force setting and identify the optimum force range that meets the product specifications for hardness.

5.5 Acceptance Criteria

The tablet hardness must fall within the specified range outlined in the batch record or product specifications, which is typically in the range of 4–8 kg (or as specified).
If the tablet hardness falls outside the specified range, investigate and document the findings in the deviation report (Annexure-2).
Adjust the compression force settings and perform re-testing if necessary to meet the acceptance criteria.

5.6 Documentation and Record-Keeping

Document all test results, including compression force, tablet hardness, and any deviations, in the batch record (Annexure-1).
Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
Maintain raw data, test results, and supporting documentation for future reference and regulatory compliance.

5.7 Post-Test Cleanup

Clean all equipment used for compression force testing, including the hardness tester, compression machine, and sample containers, according to the cleaning SOP to prevent cross-contamination between tests.
Ensure that all testing equipment is properly maintained and calibrated for future use.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient
Kg: Kilogram

7. Documents

Batch Record (Annexure-1)
Deviation Report (Annexure-2)

8. References

USP <1216> – Tablet Hardness Testing
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
European Pharmacopoeia (EP) – Tablet Hardness Standards

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number	Tablet Sample	Compression Force (kg)	Hardness (kg)	Result
Batch 001	Tablet Sample	5	6.2	Pass

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Tablet hardness outside specification	Adjusted compression force and re-tested	John Doe

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated Compression Force Ranges	Refined tablet compression process	QA Head

Tablets: SOP for Microbial Endotoxin Testing for Tablets – V 2.0

Mon, 24 Feb 2025 18:12:00 +0000

Tablets: SOP for Microbial Endotoxin Testing for Tablets – V 2.0

Standard Operating Procedure for Microbial Endotoxin Testing for Tablets

Department	Quality Control
SOP No.	SOP/TAB/098/2025
Supersedes	SOP/TAB/098/2022
Page No.	Page 1 of 7
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for microbial endotoxin testing of tablets, ensuring that endotoxin levels in the tablets meet the regulatory limits for product safety and efficacy.

2. Scope

This SOP applies to microbial endotoxin testing of finished tablet products to ensure that the endotoxin levels do not exceed the allowable limits defined by regulatory standards.

3. Responsibilities

Quality Control (QC): Responsible for performing the endotoxin testing, ensuring that the test is conducted according to established methods, and recording results accurately.
Quality Assurance (QA): Ensures that the microbial endotoxin testing procedure is followed and reviews the test results for compliance with regulatory standards.
Laboratory Personnel: Responsible for preparing the samples, performing the endotoxin test, and maintaining proper documentation throughout the testing process.

4. Accountability

The QC Manager is accountable for ensuring that microbial endotoxin testing is performed correctly according to this SOP. The QA Manager is responsible for reviewing the test results and approving the batch for release.

5. Procedure

5.1 Sample Collection

Collect a representative sample of tablets from the batch, as specified in the batch record or pharmacopeial guidelines (usually a minimum of 10 tablets or as specified).
Ensure that the tablets are free from visible defects, contamination, or external microbial contamination that may interfere with the testing process.
Label the sample appropriately for identification during testing.

5.2 Preparation of Test Solution

Crush the tablets into a fine powder using a clean mortar and pestle or tablet grinder.
Weigh the appropriate amount of the powdered tablet (usually 10–20 tablets) and dissolve it in a suitable solvent (e.g., pyrogen-free water, saline) to create a sample solution.
Ensure that the sample solution is homogeneous and filter it if necessary to remove any undissolved particles or impurities.
Prepare multiple sample solutions if required for testing, following the specified dilution factors.

5.3 Performing Endotoxin Test

For endotoxin testing, use the Limulus Amebocyte Lysate (LAL) assay or another suitable validated method, according to pharmacopeial guidelines or the batch record.
Prepare the LAL reagent and calibrator standards according to the manufacturer’s instructions.
Test the sample solution and controls by adding a specified amount of LAL reagent to each sample aliquot.
Incubate the samples and controls according to the method’s required conditions (e.g., temperature and time).
Measure the endotoxin levels using an appropriate endpoint detection method (e.g., turbidity, chromogenic, or fluorogenic assay). Record the results for each sample.

5.4 Data Recording and Calculation

Record the endotoxin concentration for each sample and control, including any observed discrepancies or deviations during testing (Annexure-1).
Calculate the endotoxin levels in the sample by comparing the results to the endotoxin standards and using the following formula:

Endotoxin Level (EU/mL) = (Sample Reading / Standard Reading) × Standard Concentration

Ensure that the endotoxin levels are within the acceptable limits specified in the batch record or regulatory guidelines (usually < 0.5 EU/tablet for parenteral tablets, but may vary).

5.5 Acceptance Criteria

Ensure that the endotoxin level in each tablet sample does not exceed the maximum allowable limit specified in the batch record or pharmacopeial guidelines (usually ≤ 0.5 EU/tablet for parenteral tablets).
If the endotoxin level exceeds the acceptable limit, document the deviation in the deviation report (Annexure-2) and investigate the cause of failure.
Take corrective actions as necessary and perform re-testing if required.

5.6 Documentation and Record-Keeping

Document all endotoxin test results, including the endotoxin levels, sample preparation details, and any deviations or corrective actions, in the batch record (Annexure-1).
Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
Maintain raw data, test results, and supporting documentation for future reference and regulatory compliance.

5.7 Post-Test Cleanup

Clean all equipment used for endotoxin testing, including the LAL reagents, sample containers, and testing instruments, according to the cleaning SOP to prevent cross-contamination between tests.
Ensure that all testing equipment is properly maintained and calibrated for future use.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient
LAL: Limulus Amebocyte Lysate
EU: Endotoxin Units

7. Documents

Batch Record (Annexure-1)
Deviation Report (Annexure-2)

8. References

USP <85> – Bacterial Endotoxins Test
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
European Pharmacopoeia (EP) – Microbial Endotoxin Testing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number	Tablet Sample	Endotoxin Level (EU/tablet)	Result
Batch 001	Tablet Sample	0.3	Pass

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
12/12/2025	Batch 001	Endotoxin level exceeded limit	Rework tablet formulation and retest	Jane Doe

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated Testing Methodology	Refined endotoxin testing protocols	QA Head

Tablets: SOP for Identification Testing of Active Ingredients in Tablets – V 2.0

Mon, 24 Feb 2025 04:52:00 +0000

Tablets: SOP for Identification Testing of Active Ingredients in Tablets – V 2.0

Standard Operating Procedure for Identification Testing of Active Ingredients in Tablets

Department	Tablet
SOP No.	SOP/TAB/097/2025
Supersedes	SOP/TAB/097/2022
Page No.	Page 1 of 7
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for identification testing of active ingredients in tablets, ensuring that the correct active pharmaceutical ingredient (API) is present in the tablets and that the drug is compliant with product specifications.

2. Scope

This SOP applies to the identification testing of active ingredients in tablet formulations, including the use of appropriate analytical methods such as UV spectrophotometry, HPLC, or FTIR to confirm the presence of the API.

3. Responsibilities

Quality Control (QC): Responsible for conducting the identification testing of active ingredients in tablets and ensuring that the results meet the required specifications.
Quality Assurance (QA): Responsible for reviewing and approving the identification test results to ensure compliance with regulatory requirements and product specifications.
Laboratory Personnel: Responsible for the preparation of samples, calibration of instruments, and execution of the identification test according to the established methods.

4. Accountability

The QC Manager is accountable for ensuring the accurate execution of identification testing in accordance with this SOP. The QA Manager is responsible for reviewing the test results and approving the batch for release.

5. Procedure

5.1 Sample Collection

Collect a representative sample of tablets from the batch, ensuring that the sample size meets the requirements specified in the batch record or pharmacopeial guidelines (usually a minimum of 6 tablets).
Ensure that the tablets are free from visible defects such as cracks, chips, or discoloration that could interfere with the testing process.
Label the sample appropriately for identification during testing.

5.2 Preparation of Testing Apparatus

Ensure that all laboratory equipment, such as balances, UV spectrophotometers, HPLC systems, or FTIR devices, are calibrated and functioning properly.
Prepare any reagents or solvents required for the identification test as per the test method outlined in the batch record or pharmacopeial guidelines.
Ensure that the test environment (e.g., temperature, humidity) is controlled as per the specifications for the chosen analytical method.

5.3 Performing Identification Test

For UV spectrophotometry: Dissolve a specified number of tablets in a suitable solvent, filter the solution if necessary, and measure the absorbance at the wavelength specific to the API.
For HPLC: Prepare a sample solution of the tablet, inject it into the HPLC system, and record the chromatogram. Compare the retention time and peak shape with those of a known standard of the API.
For FTIR: Prepare a sample of the tablet, dissolve it if necessary, and record the infrared spectrum. Compare the spectrum with the standard fingerprint of the API.
Ensure that the identification test confirms the presence of the API in the tablet and that the spectral or chromatographic characteristics match the expected values for the active ingredient.

5.4 Data Recording and Calculation

Record the test results, including any chromatograms, spectra, or absorbance data, in the batch record (Annexure-1).
Ensure that the identification test results comply with the specifications for the API, such as the correct retention time, absorption maxima, or spectral peaks.
If the test results match the expected identification criteria, consider the sample compliant. If the results do not match, investigate and document the findings in the deviation report (Annexure-2).

5.5 Acceptance Criteria

The identification test should confirm the presence of the API in the tablet. The results should match the expected values for the chosen analytical method (e.g., retention time, absorbance maxima, or spectral peaks).
If the identification test fails, investigate and document the findings. Additional tests or sample retesting may be required to resolve any discrepancies.

5.6 Documentation and Record-Keeping

Document all test results, including chromatograms, spectra, absorbance data, and calculations, in the batch record (Annexure-1).
Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
Maintain all raw data, test results, and supporting documentation for future reference and audits.

5.7 Post-Test Cleanup

Clean all equipment used for the identification test, including sample containers, balances, and instruments, according to the cleaning SOP to prevent contamination between tests.
Ensure that all testing equipment is properly maintained and calibrated for future use.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient
HPLC: High-Performance Liquid Chromatography
UV: Ultraviolet
FTIR: Fourier Transform Infrared Spectroscopy

7. Documents

Batch Record (Annexure-1)
Deviation Report (Annexure-2)

8. References

USP <711> – Dissolution Testing
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
European Pharmacopoeia (EP) – Identification Testing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number	Tablet Sample	Test Method	Result	Remarks
Batch 001	Tablet Sample	HPLC	Pass	API identified correctly

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
12/12/2025	Batch 001	API not identified	Resample and retest using alternate method	John Doe

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated Test Methods	Refined testing procedure	QA Head

Tablets: SOP for Analytical Standards Preparation for Quality Control – V 2.0

Sun, 23 Feb 2025 15:32:00 +0000

Tablets: SOP for Analytical Standards Preparation for Quality Control – V 2.0

Standard Operating Procedure for Analytical Standards Preparation for Quality Control

Department	Quality Control
SOP No.	SOP/TAB/096/2025
Supersedes	SOP/TAB/096/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for preparing analytical standards for use in quality control testing, ensuring the accuracy, precision, and reliability of testing methods for raw materials and finished products.

2. Scope

This SOP applies to the preparation of all analytical standards used in the quality control laboratory for testing raw materials, intermediates, and finished products in accordance with specified methods.

3. Responsibilities

Quality Control (QC): Responsible for preparing and calibrating analytical standards, ensuring that they meet the required specifications and are properly labeled and stored.
Quality Assurance (QA): Ensures that the standards preparation process is followed correctly and reviews the documentation for compliance.
Laboratory Personnel: Responsible for the actual preparation and verification of analytical standards and ensuring that the standards are stored and handled appropriately.

4. Accountability

The QC Manager is accountable for ensuring the proper preparation and validation of analytical standards. The QA Manager is responsible for reviewing the preparation process and approving the use of the standards in testing.

5. Procedure

5.1 Standard Selection

Select the appropriate analytical standard based on the testing requirements (e.g., reference substance, working standard, or calibration standard).
Verify that the standard is sourced from an authorized and reputable supplier or produced in-house following established procedures.
Check the expiration date and ensure that the standard has been stored and handled correctly according to storage guidelines (e.g., temperature, humidity, light exposure).

5.2 Preparation of Analytical Standard

Weigh the appropriate quantity of the analytical standard using an analytical balance, ensuring accuracy within the specified tolerance limits.
Dissolve the standard in an appropriate solvent (e.g., water, methanol, acetonitrile) according to the method specified in the batch record or pharmacopeial guidelines.
If necessary, filter the solution to remove any insoluble particles or impurities that may interfere with testing.
Prepare a series of dilutions or standard solutions as required by the analytical method (e.g., calibration curve, assay, content uniformity testing).

5.3 Verification and Calibration

Verify the concentration of the prepared standard solution by comparing the measured value to the known concentration using an appropriate analytical method, such as HPLC, UV-Vis spectroscopy, or titration.
If preparing a calibration standard, prepare a calibration curve by analyzing multiple concentrations of the standard solution to establish a relationship between concentration and response.
Ensure that the calibration curve has a correlation coefficient (R²) of at least 0.99, as specified in the method.

5.4 Labeling and Documentation

Label the prepared standard solution with the following information:
- Standard name
- Concentration
- Preparation date
- Expiration date
- Lot/batch number
- Storage conditions
Record the preparation process, including the quantities used, solvents, and any observations, in the preparation log (Annexure-1).
Ensure all records are signed and dated by the person responsible for the preparation and verification of the standard.

5.5 Storage and Stability

Store the prepared analytical standard in a labeled container, ensuring that it is stored under the specified conditions (e.g., temperature, humidity, light exposure).
Ensure that the standard is stored in a manner that prevents contamination or degradation (e.g., in sealed containers, away from direct light).
Monitor the stability of the prepared standard over time, and ensure that it is used within the specified shelf life.

5.6 Documentation and Record-Keeping

Document the preparation of all analytical standards in the preparation log (Annexure-1) and ensure that all records are signed, dated, and stored in accordance with the company’s record retention policy.
Maintain records of the verification and calibration of the standards in the calibration log (Annexure-2).
Ensure that all records are available for review during audits and inspections.

5.7 Quality Control Testing

Conduct periodic testing of the prepared standards to ensure that they maintain their integrity and meet the specified quality criteria.
Retest the standard if it exceeds its shelf life or if any issues are identified during routine usage.
Document any deviations from the acceptance criteria and take corrective actions as necessary.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient
HPLC: High-Performance Liquid Chromatography

7. Documents

Preparation Log (Annexure-1)
Calibration Log (Annexure-2)

8. References

USP <811> – General Chapter on Reference Standards
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
European Pharmacopoeia (EP) – Analytical Method Validation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Preparation Log

Standard Name	Concentration	Preparation Date	Expiration Date	Lot/Batch Number	Storage Conditions
API Standard	100 mg/mL	01/03/2026	01/03/2027	Lot-12345	Store at 2-8°C

Annexure-2: Calibration Log

Standard Name	Calibration Method	Result	Calibration Date	Next Calibration Date
API Standard	HPLC Calibration	Pass	01/03/2026	01/03/2027

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated Standard Preparation Process	Refined standards preparation procedure	QA Head

Tablets: SOP for Acid Resistance Testing for Enteric-Coated Tablets – V 2.0

Sun, 23 Feb 2025 02:12:00 +0000

Tablets: SOP for Acid Resistance Testing for Enteric-Coated Tablets – V 2.0

Standard Operating Procedure for Acid Resistance Testing for Enteric-Coated Tablets

Department	Tablet
SOP No.	SOP/TAB/095/2025
Supersedes	SOP/TAB/095/2022
Page No.	Page 1 of 7
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for testing the acid resistance of enteric-coated tablets, ensuring that the coating remains intact and protects the active pharmaceutical ingredient (API) from stomach acid, as per regulatory standards and product specifications.

2. Scope

This SOP applies to the testing of enteric-coated tablets for acid resistance to ensure that the coating protects the API under acidic conditions in the stomach, allowing for controlled release in the intestinal environment.

3. Responsibilities

Manufacturing Personnel: Responsible for providing enteric-coated tablet samples for acid resistance testing and ensuring that the coating process adheres to the established SOP.
Quality Control (QC): Responsible for conducting the acid resistance test, recording results, and ensuring that the tablets meet the required specifications for acid resistance.
Quality Assurance (QA): Ensures that the acid resistance testing procedure is followed correctly and reviews the results for batch approval and regulatory compliance.

4. Accountability

The QC Manager is accountable for ensuring the acid resistance testing is conducted in compliance with this SOP. The QA Manager is responsible for reviewing the results and approving the batch for release.

5. Procedure

5.1 Sample Collection

Collect a representative sample of enteric-coated tablets from the batch, as specified in the batch record.
The sample should consist of a minimum of 6 tablets, or as specified in the batch record or pharmacopeial guidelines.
Ensure that the tablets are free from defects such as cracks, chips, or coating defects.
Label the sample appropriately for identification during testing.

5.2 Preparation of Testing Apparatus

Ensure that all testing equipment (e.g., dissolution apparatus, pH meters, and temperature controls) is clean, calibrated, and ready for use.
Prepare the dissolution apparatus, ensuring that it is fitted with the proper baskets or paddles and that the temperature and pH control systems are functioning correctly.
Prepare a simulated gastric fluid (SGF) solution with a pH of 1.2, and ensure that it is at the required temperature (usually 37 ± 0.5°C).

5.3 Performing Acid Resistance Test

Place the tablets into the dissolution apparatus, ensuring that they are properly aligned in the basket or paddle.
Start the dissolution apparatus and monitor the tablet behavior in the SGF solution for up to 2 hours, as specified in the pharmacopeial guidelines or batch record.
Ensure that the tablets do not show any signs of coating rupture or API release during the first 2 hours in the acidic environment.
After 2 hours, transfer the tablets to a simulated intestinal fluid (SIF) solution with a pH of 6.8 for further testing, to simulate the transition from the stomach to the small intestine.

5.4 Data Recording and Calculation

Record any observations during the test, including whether the tablets remained intact in the acidic environment and whether any coating detachment occurred (Annexure-1).
Note the time at which the tablets were transferred from the SGF solution to the SIF solution.
Ensure that the tablets maintain their integrity under acidic conditions before being exposed to the neutralizing environment.

5.5 Acceptance Criteria

Ensure that the tablets meet the following acceptance criteria:
- No visible signs of coating rupture or API release during the first 2 hours in SGF.
- The coating must withstand acidic conditions without failure.
- Any tablets showing signs of coating failure during the test should be considered non-compliant.
If the test fails, investigate and document the findings in the deviation report (Annexure-2).
Take corrective actions as necessary and perform re-testing if required.

5.6 Documentation and Record-Keeping

Document all test results, including observations, timings, and any deviations from the acceptance criteria, in the batch record (Annexure-1).
Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
Maintain all raw data, test results, and any supporting documentation for future reference and audits.

5.7 Post-Test Cleanup

Clean all equipment used for acid resistance testing, including the dissolution apparatus, sampling baskets, and sample containers, according to the cleaning SOP to prevent contamination between tests.
Ensure that the testing equipment is properly maintained and calibrated for future use.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient
SGF: Simulated Gastric Fluid
SIF: Simulated Intestinal Fluid

7. Documents

Batch Record (Annexure-1)
Deviation Report (Annexure-2)

8. References

USP <711> – Dissolution Testing
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
European Pharmacopoeia (EP) – Acid Resistance Testing for Enteric-Coated Tablets

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number	Tablet Sample	SGF Time (hrs)	Coating Integrity	Result
Batch 001	Enteric-Coated Tablet	2	Intact	Pass

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Coating failure in SGF	Reworked coating process	Jane Doe

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated Testing Parameters	Refined acid resistance testing protocols	QA Head

Tablets: SOP for Coating Adhesion Testing for Film-Coated Tablets – V 2.0

Sat, 22 Feb 2025 12:52:00 +0000

Tablets: SOP for Coating Adhesion Testing for Film-Coated Tablets – V 2.0

Standard Operating Procedure for Coating Adhesion Testing for Film-Coated Tablets

Department	Tablet
SOP No.	SOP/TAB/094/2025
Supersedes	SOP/TAB/094/2022
Page No.	Page 1 of 7
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To outline the procedure for testing the adhesion of the film coating to tablets, ensuring that the coating adheres properly to the tablet surface without detaching or compromising the product quality during handling and storage.

2. Scope

This SOP applies to the testing of the coating adhesion for film-coated tablets to ensure the integrity and uniformity of the coating layer as per regulatory and product specifications.

3. Responsibilities

Manufacturing Personnel: Responsible for preparing film-coated tablets for adhesion testing and ensuring that the coating process adheres to the established SOP.
Quality Control (QC): Responsible for conducting the adhesion testing, recording results, and ensuring that the coating meets the required specifications.
Quality Assurance (QA): Ensures that the adhesion testing procedure is followed correctly and reviews the results to approve or reject the batch for release.

4. Accountability

The QC Manager is accountable for ensuring the coating adhesion testing is conducted in compliance with this SOP. The QA Manager is responsible for reviewing the results and approving the batch for release.

5. Procedure

5.1 Sample Collection

Collect a representative sample of film-coated tablets from the batch, as specified in the batch record.
The sample should consist of a minimum of 10 tablets or as specified in the batch record or pharmacopeial guidelines.
Ensure that the tablets are free from defects such as cracks, chips, or coating defects.
Label the sample appropriately for identification during testing.

5.2 Preparation of Testing Apparatus

Ensure that all testing equipment (e.g., adhesion tester, test equipment, weighing balance) is clean, calibrated, and ready for use.
Set up the adhesion tester according to the manufacturer’s instructions, ensuring the proper application of force and measurement units.
Ensure that the test environment (e.g., temperature, humidity) is controlled as per the batch record or pharmacopeial requirements.

5.3 Performing Adhesion Test

Place the tablets on the adhesion tester one by one, ensuring they are positioned according to the test apparatus specifications.
Apply the specified force to the tablet surface as per the test method described in the batch record or pharmacopeial guidelines.
Measure the force required to detach the coating from the tablet surface, ensuring that the test is conducted on both the tablet surface and the edges.
Record the adhesion strength values for each tablet tested (Annexure-1).

5.4 Data Recording and Calculation

Record the adhesion strength values and any other observations (e.g., cracks, partial detachment) in the batch record (Annexure-1).
Calculate the average adhesion strength across all samples and compare it with the specified acceptance criteria.
Ensure that the coating adhesion meets the required specifications, typically a minimum adhesion strength to prevent coating detachment under normal handling conditions.

5.5 Acceptance Criteria

Ensure that the average adhesion strength meets the acceptance criteria specified in the batch record or pharmacopeial guidelines.
If the adhesion strength does not meet the criteria, investigate and document the findings in the deviation report (Annexure-2).
Take corrective actions as necessary and perform re-testing if required.

5.6 Documentation and Record-Keeping

Document all test results, including adhesion strength values, observations, and any deviations from the acceptance criteria in the batch record (Annexure-1).
Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
Maintain all raw data, test results, and photographs (if applicable) for future reference and audits.

5.7 Post-Test Cleanup

Clean all equipment used for adhesion testing, including the adhesion tester and sample containers, according to the cleaning SOP to prevent contamination between tests.
Ensure that the testing equipment is properly maintained and calibrated for future use.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient
RSD: Relative Standard Deviation

7. Documents

Batch Record (Annexure-1)
Deviation Report (Annexure-2)

8. References

USP <601> – Film-Coated Tablets
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
European Pharmacopoeia (EP) – Coating Adhesion Testing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number	Tablet Sample	Adhesion Strength (N)	Result
Batch 001	Film-Coated Tablet	1.2	Pass

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Low coating adhesion strength	Adjusted coating solution and reworked process	John Doe

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated Testing Procedures	Refined adhesion testing protocols	QA Head

Tablets: SOP for Content Uniformity Testing of Immediate Release Tablets – V 2.0

Fri, 21 Feb 2025 23:32:00 +0000

Tablets: SOP for Content Uniformity Testing of Immediate Release Tablets – V 2.0

Standard Operating Procedure for Content Uniformity Testing of Immediate Release Tablets

Department	Tablet
SOP No.	SOP/TAB/093/2025
Supersedes	SOP/TAB/093/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for content uniformity testing of immediate release tablets, ensuring that the active pharmaceutical ingredient (API) is consistently distributed within each tablet and meets the required specifications.

2. Scope

This SOP applies to content uniformity testing for immediate release tablets, including the preparation of the sample, testing procedure, and acceptance criteria to ensure consistent API distribution across all tablets.

3. Responsibilities

Manufacturing Personnel: Responsible for providing tablet samples for content uniformity testing and ensuring proper handling and storage of the tablets.
Quality Control (QC): Responsible for conducting the content uniformity test, recording the results, and ensuring compliance with established specifications.
Quality Assurance (QA): Ensures the testing procedure is followed correctly and reviews the results for batch approval and regulatory compliance.

4. Accountability

The QC Manager is accountable for ensuring that the content uniformity testing is conducted in compliance with this SOP. The QA Manager is responsible for reviewing the results and approving the batch for release.

5. Procedure

5.1 Sample Collection

Collect a representative sample of tablets from the batch. The sample should consist of a minimum of 30 tablets, or as specified in the batch record or pharmacopeial guidelines.
Ensure that the tablets are free from defects such as cracks, chips, or contamination.
Label the sample appropriately for identification during testing.

5.2 Preparation of Sample

Weigh a specified number of tablets (usually 10 tablets) and crush them into a fine powder using a clean mortar and pestle or a tablet grinder.
Ensure that the tablet powder is homogeneous, with no visible clumps or aggregation.
Accurately weigh an appropriate amount of the powder for dissolution in a suitable solvent or dissolution medium, following the test method outlined in the batch record or pharmacopeial guidelines.

5.3 Performing Content Uniformity Test

Transfer the prepared sample into a suitable solvent or dissolution medium, ensuring complete dissolution of the tablet powder.
Perform the assay of the API using a suitable analytical method, such as HPLC, UV spectrophotometry, or titration, depending on the characteristics of the API.
Ensure that the sample is analyzed according to the pharmacopeial guidelines or internal testing protocols to determine the API content in each tablet.

5.4 Data Recording and Calculation

Record the assay results for each tablet, including the concentration of the API and the calculated amount in each tablet (Annexure-1).
Calculate the average API content of the tested tablets and the relative standard deviation (RSD) for the sample.
Ensure that the individual tablet content does not vary by more than ±15% from the label claim (for 90% of the tablets tested) and that the average content is within 85%-115% of the label claim.

5.5 Acceptance Criteria

Ensure that the content uniformity test results meet the following acceptance criteria:
- The content of 90% of the tablets must be within ±15% of the label claim.
- The average content of the tablets must be within 85%–115% of the label claim.
If any tablet fails to meet the acceptance criteria, investigate and document the findings in the deviation report (Annexure-2).
Take corrective actions as necessary and perform re-testing if required.

5.6 Documentation and Record-Keeping

Document all test results, including the assay results, calculations, and observations, in the batch record (Annexure-1).
Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
Maintain all chromatograms, raw data, and assay results for future reference and audits.

5.7 Post-Test Cleanup

Clean all equipment used for content uniformity testing, including sample containers, balances, and dissolution apparatus, according to the cleaning SOP to prevent contamination between tests.
Ensure the laboratory equipment is properly maintained and calibrated for future use.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient
RSD: Relative Standard Deviation

7. Documents

Batch Record (Annexure-1)
Deviation Report (Annexure-2)

8. References

USP <905> – Uniformity of Dosage Units
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
European Pharmacopoeia (EP) – Content Uniformity Testing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number	Tablet Sample	Sample Weight (g)	API Content (%)	Result
Batch 001	Tablet Sample	0.5	99.3%	Pass

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
12/12/2025	Batch 001	API content variation in tablet samples	Adjusted blending process and rechecked formulation	John Doe

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated Testing Parameters	Refined content uniformity protocols	QA Head