Purpose

The purpose of this SOP is to outline the procedures for conducting density testing during the liquid oral manufacturing process to ensure the proper formulation and quality of the product.

Scope

This SOP applies to all personnel involved in liquid oral manufacturing, specifically those responsible for density testing.

Responsibilities

• Quality Control Analysts: Conducting density testing according to this SOP.
• Production Department: Providing samples for testing and cooperating with quality control personnel.
• Quality Assurance Department: Ensuring compliance with regulatory standards and guidelines.

Procedure

1. Calibrate the density meter using standard calibration solutions.
2. Take the liquid oral sample and ensure it is at the specified temperature.
3. Fill the density meter with the sample and record the density reading.
4. Repeat the process for each sample as per the testing plan.
5. Compare the density values against acceptance criteria.
6. Document all testing procedures, observations, and results accurately and comprehensively.
7. Review and approve the test results by authorized personnel.
8. Initiate corrective actions if deviations from acceptance criteria are identified.

Abbreviations Used

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

Documents

• Density Testing Protocol
• Standard Operating Procedures Manual
• Batch Records
• Quality Control Reports
• Deviation Reports

Reference

No specific references are cited for this SOP.

SOP Version

Version 1.0

Purpose

The purpose of this SOP is to define the procedures for conducting hardness testing during the tablet manufacturing process to ensure the mechanical strength and integrity of capsules.

Scope

This SOP applies to all personnel involved in tablet manufacturing, specifically those responsible for conducting hardness testing.

Responsibilities

• Quality Control Analysts: Responsible for conducting hardness testing according to this SOP.
• Production Department: Providing tablets for testing and cooperating with quality control personnel.
• Quality Assurance Department: Ensuring compliance with regulatory standards and guidelines.

Procedure

1. Select a representative sample of tablets according to predefined sampling procedures.
2. Place each tablet individually between the anvils of the hardness tester.
3. Apply increasing force until the tablet fractures or deforms.
4. Record the force required to fracture or deform the capsule.
5. Compare the hardness values against acceptance criteria.
6. Document all testing procedures, observations, and results accurately and comprehensively.
7. Review and approve the test results by authorized personnel.
8. Initiate corrective actions if deviations from acceptance criteria are identified.

Abbreviations Used

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

Documents

• Hardness Testing Protocol
• Standard Operating Procedures Manual
• Batch Records
• Quality Control Reports
• Deviation Reports

Reference

No specific references are cited for this SOP.

SOP Version

Version 1.0

Purpose

The purpose of this SOP is to define the procedures for determining granule size distribution during the tablet/ capsule manufacturing process to ensure product quality and consistency.

Scope

This SOP applies to all personnel involved in the tablet/ capsule manufacturing process, specifically those responsible for assessing granule size distribution.

Responsibilities

• Quality Control Analysts: Responsible for conducting granule size distribution analysis according to this SOP.
• Production Department: Providing granule samples for testing and cooperating with quality control personnel.
• Quality Assurance Department: Ensuring compliance with regulatory standards and guidelines.

Procedure

1. Collect representative samples of granules from the manufacturing process.
2. Prepare the samples for analysis by following established procedures for sample preparation.
3. Use appropriate analytical techniques such as sieve analysis or laser diffraction to determine granule size distribution.
4. Record and analyze the results obtained from the granule size distribution analysis.
5. Compare the results against predefined acceptance criteria.
6. Document all testing procedures, observations, and results accurately and comprehensively.
7. Review and approve the test results by authorized personnel.
8. Initiate corrective actions if deviations from acceptance criteria are identified.

Abbreviations Used

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

Documents

• Granule Size Distribution Testing Protocol
• Standard Operating Procedures Manual
• Batch Records
• Quality Control Reports
• Deviation Reports

Reference

No specific references are cited for this SOP.

SOP Version

Version 1.0

Purpose

The purpose of this SOP is to outline the procedures for conducting blend uniformity testing during the tablet/ capsule manufacturing process to ensure homogeneity and consistency of the blend.

Scope

This SOP applies to all personnel involved in the tablet/ capsule manufacturing process, specifically those responsible for conducting blend uniformity testing.

Responsibilities

• Quality Control Analysts: Responsible for conducting blend uniformity testing according to this SOP.
• Production Department: Providing samples for testing and cooperating with quality control personnel.
• Quality Assurance Department: Ensuring compliance with regulatory standards and guidelines.

Procedure

1. Collect a representative sample of the blend according to defined sampling procedures.
2. Weigh and subdivide the sample as per the specified testing protocol.
3. Prepare samples for analysis using appropriate techniques and equipment.
4. Perform blend uniformity testing using validated methods and instruments.
5. Analyze the results and compare them against established acceptance criteria.
6. Document all testing procedures, observations, and results accurately and legibly.
7. Review and approve the test results by authorized personnel.
8. Initiate appropriate corrective actions in case of deviations from acceptance criteria.

Abbreviations Used

SOP: Standard Operating Procedure
QC: Quality Control

Documents

The following documents are relevant to this SOP:

• Blend Uniformity Testing Protocol
• Standard Operating Procedures Manual
• Batch Records
• Quality Control Reports
• Deviation Reports

Reference

No specific references are cited for this SOP.

SOP Version

Version 1.0

Purpose

The purpose of this SOP is to outline the procedures for conducting pH testing during the tablet/ capsule manufacturing process to ensure the acidity or alkalinity of the tablets / capsule.

Scope

This SOP applies to all personnel involved in tablet manufacturing, specifically those responsible for pH testing.

Responsibilities

• Quality Control Analysts: Conducting pH testing according to this SOP.
• Production Department: Providing samples for testing and cooperating with quality control personnel.
• Quality Assurance Department: Ensuring compliance with regulatory standards and guidelines.

Procedure

1. Calibrate the pH meter using standard buffer solutions.
2. Take the tablet/ capsule sample and prepare a solution according to defined procedures.
3. Immerse the pH electrode into the capsule / tablet solution and allow time for stabilization.
4. Record the pH value displayed on the pH meter.
5. Repeat the process for each capsule/ tablet sample as per the testing plan.
6. Compare the pH values against acceptance criteria.
7. Document all testing procedures, observations, and results accurately and comprehensively.
8. Review and approve the test results by authorized personnel.
9. Initiate corrective actions if deviations from acceptance criteria are identified.

Abbreviations Used

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

Documents

• pH Testing Protocol
• Standard Operating Procedures Manual
• Batch Records
• Quality Control Reports
• Deviation Reports

Reference

No specific references are cited for this SOP.

SOP Version

Version 1.0

Purpose

The purpose of this SOP is to outline the procedures for conducting dissolution testing during the Capsule/ tablet manufacturing process to ensure proper release of the active pharmaceutical ingredient (API).

Scope

This SOP applies to all personnel involved in capsule/ tablet manufacturing, specifically those responsible for dissolution testing.

Responsibilities

• Quality Control Analysts: Conducting dissolution testing according to this SOP.
• Production Department: Providing samples for testing and cooperating with quality control personnel.
• Quality Assurance Department: Ensuring compliance with regulatory standards and guidelines.

Procedure

1. Prepare dissolution testing apparatus according to manufacturer instructions.
2. Fill dissolution vessels with specified dissolution medium at the specified temperature.
3. Place capsules/ tablets into individual dissolution vessels and start the apparatus.
4. Collect samples at specified time intervals.
5. Analyze samples using appropriate analytical techniques.
6. Calculate the percentage of API released at each time point.
7. Compare dissolution profiles against acceptance criteria.
8. Document all testing procedures, observations, and results accurately and comprehensively.
9. Review and approve the test results by authorized personnel.
10. Initiate corrective actions if deviations from acceptance criteria are identified.

Abbreviations Used

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

Documents

• Dissolution Testing Protocol
• Standard Operating Procedures Manual
• Batch Records
• Quality Control Reports
• Deviation Reports

Reference

No specific references are cited for this SOP.

SOP Version

Version 1.0

Purpose

The purpose of this SOP is to outline the procedures for conducting disintegration testing during the tablet manufacturing process to ensure proper breakdown and dissolution of tablets.

Scope

This SOP applies to all personnel involved in tablet manufacturing, specifically those responsible for disintegration testing.

Responsibilities

• Quality Control Analysts: Conducting disintegration testing according to this SOP.
• Production Department: Providing samples for testing and cooperating with quality control personnel.
• Quality Assurance Department: Ensuring compliance with regulatory standards and guidelines.

Procedure

1. Prepare disintegration testing apparatus according to manufacturer instructions.
2. Place a tablet in each of the testing tubes or baskets of the apparatus.
3. Immerse the tablets in the specified disintegration medium at the specified temperature.
4. Activate the apparatus and observe the tablets for disintegration.
5. Record the time taken for complete disintegration of each tablet.
6. Compare the disintegration times against acceptance criteria.
7. Document all testing procedures, observations, and results accurately and comprehensively.
8. Review and approve the test results by authorized personnel.
9. Initiate corrective actions if deviations from acceptance criteria are identified.

Abbreviations Used

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

Documents

• Disintegration Testing Protocol
• Standard Operating Procedures Manual
• Batch Records
• Quality Control Reports
• Deviation Reports

Reference

No specific references are cited for this SOP.

SOP Version

Version 1.0

Purpose

The purpose of this SOP is to outline the procedures for conducting weight variation testing during the tablet/ capsule manufacturing process to ensure uniformity and consistency of capsule/ tablet weight.

Scope

This SOP applies to all personnel involved in capsule/ tablet manufacturing, specifically those responsible for weight variation testing.

Responsibilities

• Quality Control Analysts: Conducting weight variation testing according to this SOP.
• Production Department: Providing samples for testing and cooperating with quality control personnel.
• Quality Assurance Department: Ensuring compliance with regulatory standards and guidelines.

Procedure

1. Select a representative sample of capsules/ tablets according to predefined sampling procedures.
2. Weigh each tablet/ capsule individually using a calibrated balance.
3. Record the weight of each tablet/ capsule and calculate the average weight of the sample.
4. Compare the individual capsule/ tablet weights against the average weight to determine weight variation.
5. Calculate the percentage deviation from the average weight for each capsule/ tablet.
6. Compare the percentage deviation against acceptance criteria.
7. Document all testing procedures, observations, and results accurately and comprehensively.
8. Review and approve the test results by authorized personnel.
9. Initiate corrective actions if deviations from acceptance criteria are identified.

Abbreviations Used

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

Documents

• Weight Variation Testing Protocol
• Standard Operating Procedures Manual
• Batch Records
• Quality Control Reports
• Deviation Reports

Reference

No specific references are cited for this SOP.

SOP Version

Version 1.0

Purpose

The purpose of this SOP is to outline the procedures for conducting friability testing during the tablet manufacturing process to assess the durability and quality of tablets.

Scope

This SOP applies to all personnel involved in tablet manufacturing, specifically those responsible for friability testing.

Responsibilities

• Quality Control Analysts: Conducting friability testing according to this SOP.
• Production Department: Providing samples for testing and cooperating with quality control personnel.
• Quality Assurance Department: Ensuring compliance with regulatory standards and guidelines.

Procedure

1. Weigh a predetermined amount of tablets and place them in the friability testing apparatus.
2. Operate the apparatus according to manufacturer instructions to subject the tablets to mechanical stress.
3. After the test cycle, remove the tablets and gently remove any loose dust or debris.
4. Weigh the tablets again and calculate the percentage of weight loss.
5. Compare the percentage of weight loss against acceptance criteria.
6. Document all testing procedures, observations, and results accurately and thoroughly.
7. Review and approve the test results by authorized personnel.
8. Initiate corrective actions if deviations from acceptance criteria are identified.

Abbreviations Used

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

Documents

• Friability Testing Protocol
• Standard Operating Procedures Manual
• Batch Records
• Quality Control Reports
• Deviation Reports

Reference

No specific references are cited for this SOP.

SOP Version

Version 1.0

Purpose

The purpose of this SOP is to outline the procedures for determining moisture content during the tablet manufacturing process to ensure product quality, stability, and compliance with regulatory requirements.

Scope

This SOP applies to all personnel involved in the tablet manufacturing process, particularly those responsible for moisture content determination.

Responsibilities

• Quality Control Analysts: Responsible for conducting moisture content determination according to this SOP.
• Production Department: Providing samples for testing and cooperating with quality control personnel.
• Quality Assurance Department: Ensuring compliance with regulatory standards and guidelines.

Procedure

1. Collect representative samples of tablets from the manufacturing process.
2. Weigh and record the initial weight of the samples.
3. Dry the samples using a suitable method such as oven drying or Karl Fischer titration.
4. Weigh the dried samples and calculate the moisture content using the appropriate formula.
5. Compare the moisture content results with established acceptance criteria.
6. Document all testing procedures, observations, and results accurately and comprehensively.
7. Review and approve the test results by authorized personnel.
8. Take corrective actions if deviations from acceptance criteria are identified.

Abbreviations Used

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

Documents

• Moisture Content Determination Testing Protocol
• Standard Operating Procedures Manual
• Batch Records
• Quality Control Reports
• Deviation Reports

Reference

No specific references are cited for this SOP.

SOP Version

Version 1.0