Procedure for Preparing and Reviewing Standard Operating Procedures

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for preparing, reviewing, approving, and maintaining SOPs within pharmaceutical manufacturing. SOPs ensure standardization of processes, regulatory compliance, and effective training of personnel.

2. Scope

This SOP applies to personnel in the Quality Assurance (QA), Quality Control (QC), Production, and other relevant departments responsible for drafting, reviewing, and maintaining SOPs.

3. Responsibilities

• Departmental Heads: Identify the need for new or revised SOPs and assign authors.
• SOP Author: Drafts the SOP following standard templates and guidelines.
• QA Officer: Reviews the SOP for compliance and clarity.
• QA Manager: Approves the final SOP for implementation.
• Training Coordinator: Ensures that relevant staff members are trained on new or revised SOPs.

4. Accountability

The QA Manager is accountable for ensuring that all SOPs are properly prepared, reviewed, and maintained in compliance with GMP, FDA, ICH, and WHO regulations.

5. Procedure

5.1 SOP Format and Structure

All SOPs must follow a standard format, which includes:

• Title: Clearly defines the purpose of the SOP.
• Version Number: Specifies the revision history.
• Scope: Defines the applicability of the SOP.
• Responsibilities: Identifies personnel responsible for execution.
• Procedure: Provides a step-by-step guide for performing the process.
• References: Lists regulatory and internal guidelines followed.
• Annexures: Includes templates, logs, or additional reference documents.

5.2 SOP Preparation

• The SOP author must draft the SOP using the **standard template**.
• Each SOP must be assigned a **unique identification number**.
• All procedures must be described in **clear and concise language**.
• The draft SOP must be **submitted to the department head for initial review**.

5.3 SOP Review and Approval Process

• The **QA team** must review the SOP for:
  • Compliance with GMP and regulatory standards.
  • Accuracy and completeness of instructions.
  • Consistency with existing procedures.
• The **QA Manager** must approve the SOP before implementation.
• The approved SOP must be:
  • Signed and dated by all relevant stakeholders.
  • Uploaded to the **document management system (DMS).**
  • Distributed to all applicable departments.

5.4 SOP Implementation and Training

• All employees affected by the SOP must receive **formal training**.
• A **Training Record** must be maintained for each employee trained.
• The training coordinator must conduct **assessments** to ensure comprehension.

5.5 SOP Revision and Control

• SOPs must be reviewed **every two years** or when regulatory updates occur.
• Any revision must be documented in the **SOP Revision History Log.**
• Obsolete SOPs must be marked as **”Superseded”** and archived.

5.6 Archiving and Retention of SOPs

• All approved SOPs must be stored in a **secured archive.**
• Retention period:
  • Active SOPs – **Minimum 5 years.**
  • Superseded SOPs – **Minimum 10 years.**

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• DMS – Document Management System
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• SOP Preparation Checklist (Annexure-1)
• SOP Revision History Log (Annexure-2)

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO Guidelines on SOP Management
• US FDA Guidance on Document Control

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: SOP Preparation Checklist

Annexure-2: SOP Revision History Log

12. Revision History

Procedure for Archiving Ointment Manufacturing Records

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for archiving ointment manufacturing records. Proper archiving ensures compliance with Good Manufacturing Practices (GMP), facilitates audits, and maintains traceability of batch production records, test reports, and regulatory documents.

2. Scope

This SOP applies to personnel in the Quality Assurance (QA), Quality Control (QC), and Production departments responsible for maintaining, reviewing, and archiving ointment manufacturing records in both physical and electronic formats.

3. Responsibilities

• Production Officer: Ensures manufacturing records are compiled and submitted for archiving.
• QC Analyst: Provides laboratory test reports and analytical data for archiving.
• QA Officer: Reviews records for completeness and compliance before archiving.
• QA Manager: Approves the archiving of records and ensures compliance with regulatory retention policies.

4. Accountability

The QA and Production Managers are accountable for ensuring that all ointment manufacturing records are properly archived and maintained for the required retention period.

5. Procedure

5.1 Types of Ointment Manufacturing Records for Archiving

The following records must be archived:

• Batch Manufacturing Records (BMR): Contains details of batch processing, raw material usage, and in-process controls.
• Quality Control Test Reports: Includes analytical and microbial test results for raw materials, intermediates, and finished products.
• Cleaning and Sanitation Records: Documents cleaning schedules for equipment and manufacturing areas.
• Deviation and CAPA Reports: Contains information on any process deviations and corrective actions taken.
• Validation and Qualification Reports: Includes process validation, equipment qualification, and stability study reports.
• Regulatory Submission Documents: Includes regulatory approvals, compliance certificates, and audit reports.

5.2 Record Compilation and Review

• All manufacturing records must be compiled within **7 days** of batch completion.
• QA must review each record for:
  • Completeness of entries.
  • Signatures and authorizations.
  • Accuracy and compliance with GMP requirements.
• Any missing or incorrect entries must be corrected before archiving.

5.3 Record Categorization and Labeling

• Records must be categorized into **paper-based and electronic formats.**
• Each record must be labeled with:
  • Record type (e.g., BMR, QC Report, Validation Report).
  • Batch Number.
  • Retention Period.
  • Storage Location.

5.4 Physical Archiving of Paper Records

• Paper records must be stored in a **fireproof, humidity-controlled archive room**.
• Records must be stored in **labeled storage boxes** arranged systematically by:
  • Batch Number.
  • Year of Manufacture.
  • Record Type.
• Access to the archive must be **restricted** to authorized personnel only.
• A **record retrieval log** must be maintained to track document access.

5.5 Electronic Archiving of Records

• All electronic records must be stored in a **validated document management system (DMS).**
• Electronic records must be:
  • Scanned in **PDF format** for long-term preservation.
  • Digitally signed for authenticity.
  • Backed up on **secured servers** with controlled access.
• Audit trails must be enabled to track any modifications or access.
• Records must be periodically checked for **file integrity and readability.**

5.6 Retention Period and Disposal of Archived Records

• Retention periods must comply with **GMP and regulatory guidelines**:
• Batch Manufacturing Records – **Minimum 5 years**.
• QC Test Reports – **Minimum 7 years**.
• Validation Documents – **Minimum 10 years**.
• Regulatory Compliance Records – **Permanent Storage**.
• Records past the retention period must be **disposed of securely** following approval from QA.
• Record disposal must be documented in a **Record Destruction Log.**

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record
• CAPA – Corrective and Preventive Action
• DMS – Document Management System
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• Record Retrieval Log (Annexure-1)
• Record Destruction Log (Annexure-2)

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• WHO Guidelines on Document Retention
• US FDA Guidance on Archiving and Record Management

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Record Retrieval Log

Annexure-2: Record Destruction Log

12. Revision History

Procedure for Ensuring Data Integrity in Documentation

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for ensuring data integrity in pharmaceutical documentation. Data integrity is essential for maintaining compliance with Good Manufacturing Practices (GMP), regulatory requirements, and audit readiness.

2. Scope

This SOP applies to personnel in the Quality Assurance (QA), Quality Control (QC), Production, and IT departments responsible for maintaining, verifying, and reviewing electronic and paper-based documentation.

3. Responsibilities

• QA Officer: Ensures adherence to data integrity principles.
• QC Analyst: Verifies laboratory data for accuracy and completeness.
• Production Supervisor: Ensures real-time documentation of manufacturing processes.
• IT Department: Maintains security and audit trails for electronic records.
• QA Manager: Reviews and approves data integrity policies.

4. Accountability

The QA and IT Managers are accountable for ensuring data integrity compliance across all documentation and electronic systems.

5. Procedure

5.1 ALCOA+ Principles of Data Integrity

All data must adhere to the **ALCOA+ principles**, which ensure reliability and compliance:

• Attributable – Each entry must be linked to the person responsible.
• Legible – Data must be recorded clearly and permanently.
• Contemporaneous – Entries must be made in real-time.
• Original – Records must be the first recording (not transcribed or copied).
• Accurate – Data must be correct and free from manipulation.
• Permanent – Records must be durable and not altered.
• Available – Data must be accessible for review and audits.

5.2 Documentation Requirements

• Data must be recorded in **indelible ink** (for paper records) or **secure electronic systems**.
• All entries must include:
  • Full name and signature of the person making the entry.
  • Date and time of entry.
  • Reason for any data modifications.
• Corrections must follow **Good Documentation Practices (GDP)**:
  • Errors must be struck through with a single line.
  • Corrections must be initialed and dated.
  • Do not use correction fluid or erasers.

5.3 Ensuring Data Integrity in Electronic Records

• Electronic records must be stored in **validated systems** with controlled access.
• Systems must generate **audit trails** that track:
  • User logins and modifications.
  • Time-stamped changes to records.
  • Reasons for data entry modifications.
• Electronic signatures must comply with **21 CFR Part 11** regulations.
• Data backups must be performed **daily** and stored in a secure location.

5.4 Reviewing and Verifying Data Integrity

• QA must conduct **monthly audits** of documentation for data integrity compliance.
• QC must verify laboratory data before final approval.
• Production records must be reviewed **before batch release**.

5.5 Handling Data Integrity Violations

• Suspected data integrity issues must be **reported to QA immediately**.
• An **investigation** must be conducted to determine:
  • Root cause of the violation.
  • Extent of data falsification or errors.
  • Impact on product quality and regulatory compliance.
• Corrective actions may include:
  • Retraining employees on data integrity policies.
  • Implementing stricter access controls.
  • Revalidating affected systems.

5.6 Retention and Archiving of Records

• All paper records must be archived in a **fireproof storage area**.
• Electronic records must be stored with **secure encryption**.
• Retention periods:
  • Manufacturing records – **Minimum 5 years**.
  • QC test records – **Minimum 7 years**.
  • Audit trails – **Minimum 10 years**.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• GDP – Good Documentation Practices
• CFR – Code of Federal Regulations
• IT – Information Technology

7. Documents

• Data Integrity Compliance Checklist (Annexure-1)
• Audit Trail Review Log (Annexure-2)

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• WHO Guidelines on Data Integrity
• US FDA Guidance on Data Integrity

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Data Integrity Compliance Checklist

Annexure-2: Audit Trail Review Log

12. Revision History

Procedure for Maintaining QA Approval Logs

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for maintaining Quality Assurance (QA) approval logs in pharmaceutical manufacturing. These logs provide traceability and ensure regulatory compliance for batch approvals, document verifications, deviation authorizations, and other QA-related activities.

2. Scope

This SOP applies to personnel in the Quality Assurance (QA), Quality Control (QC), and Production departments responsible for recording, reviewing, and maintaining QA approval logs for manufacturing, validation, deviation approvals, and batch releases.

3. Responsibilities

• QA Officer: Updates QA approval logs with relevant details.
• QC Analyst: Provides verification data to support QA approvals.
• Production Supervisor: Ensures batch documents are submitted for QA approval.
• QA Manager: Reviews and approves QA logs for compliance.

4. Accountability

The QA Manager is accountable for ensuring that all QA approval logs are maintained in compliance with GMP, FDA, ICH, and WHO regulations.

5. Procedure

5.1 Types of QA Approval Logs

The following types of QA approval logs must be maintained:

• Batch Manufacturing Record (BMR) Approval Log: Documents approvals for batch processing.
• Deviation and CAPA Approval Log: Records QA approvals for deviations and corrective actions.
• Validation Approval Log: Maintains records of validation study approvals.
• Change Control Approval Log: Documents QA approvals for process or document changes.
• Vendor and Material Approval Log: Tracks approval of raw materials and vendor qualifications.

5.2 Recording QA Approvals

• QA approvals must be recorded in **real-time** to ensure traceability.
• The following details must be recorded for each approval:
  • Approval date and time.
  • Document reference number (Batch No., Deviation No., Validation No.).
  • Nature of approval (batch release, deviation clearance, validation sign-off).
  • QA Officer’s name and signature.
  • QA Manager’s authorization.
• Electronic logs must be maintained in a **validated document control system** with controlled access.

5.3 Review and Verification of QA Approval Logs

• QA must review approval logs **weekly** for completeness.
• Any discrepancies in approval logs must be investigated and corrected.
• QA logs must be **cross-verified with batch records, deviation reports, and validation documents**.

5.4 Archiving and Retention of QA Logs

• All QA logs must be archived in a **secure, fire-resistant storage area**.
• Retention period for QA logs:
  • Batch approvals – **Minimum 5 years**.
  • Deviation approvals – **Minimum 3 years**.
  • Validation approvals – **Minimum 5 years**.
• Archived QA logs must be **retrievable for regulatory audits**.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record
• CAPA – Corrective and Preventive Action
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• QA Approval Log Template (Annexure-1)
• QA Review Checklist (Annexure-2)

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO Guidelines on QA Documentation
• US FDA Guidance on QA Oversight

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: QA Approval Log Template

Annexure-2: QA Review Checklist

12. Revision History

Procedure for Filing Validation Protocols

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for filing validation protocols in pharmaceutical manufacturing. Proper documentation of validation protocols ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and traceability for audits and inspections.

2. Scope

This SOP applies to personnel in the Quality Assurance (QA), Validation, Quality Control (QC), and Production departments responsible for preparing, reviewing, and filing validation protocols for processes, equipment, and systems.

3. Responsibilities

• Validation Officer: Prepares and reviews validation protocols for processes, equipment, and facilities.
• QA Officer: Ensures proper documentation and filing of validation protocols.
• QC Analyst: Verifies compliance with validation requirements.
• QA Manager: Approves and ensures compliance with validation protocols.

4. Accountability

The QA and Validation Managers are accountable for ensuring that validation protocols are prepared, filed, and maintained in compliance with GMP, FDA, ICH, and WHO regulations.

5. Procedure

5.1 Types of Validation Protocols

The following types of validation protocols must be maintained:

• Process Validation Protocol: Documents procedures to validate manufacturing processes.
• Equipment Qualification Protocol: Defines the qualification process for equipment (IQ, OQ, PQ).
• Cleaning Validation Protocol: Establishes procedures for verifying cleaning effectiveness.
• Analytical Method Validation Protocol: Ensures analytical methods provide reliable test results.
• Computer System Validation Protocol: Verifies compliance of computerized systems used in manufacturing.

5.2 Preparation of Validation Protocols

• The Validation Officer must draft validation protocols based on regulatory and organizational requirements.
• Protocols must include:
  • Objective and scope of validation.
  • Validation approach and acceptance criteria.
  • Equipment and materials required.
  • Execution plan and responsibilities.
  • Data collection methods and report format.
• Protocols must be reviewed and approved by the QA Manager before implementation.

5.3 Filing and Documentation of Validation Protocols

• Validation protocols must be assigned a unique identification number.
• Each protocol must be stored in a **Validation Master File (VMF).**
• Filing must be categorized based on validation type (Process, Equipment, Cleaning, Analytical, Computerized Systems).
• Electronic copies must be stored in a **secured document management system** with controlled access.

5.4 Implementation and Execution of Validation Protocols

• QA must ensure that validation protocols are followed during execution.
• All test results must be recorded in a **Validation Execution Report**.
• Any deviations or failures must be documented and investigated.

5.5 Review and Approval of Validation Reports

• QA must review validation execution reports for compliance.
• Final validation reports must be signed off by the QA Manager.
• Validation records must be **archived for a minimum of 5 years.**

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• VMF – Validation Master File
• IQ – Installation Qualification
• OQ – Operational Qualification
• PQ – Performance Qualification
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• Validation Protocol Template (Annexure-1)
• Validation Execution Report Template (Annexure-2)

8. References

• ICH Q2 – Validation of Analytical Procedures
• WHO Guidelines on Process Validation
• US FDA Guidance on Validation Principles

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Validation Protocol Template

Annexure-2: Validation Execution Report Template

12. Revision History

Procedure for Preparing Stability Study Reports

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for preparing Stability Study Reports in pharmaceutical manufacturing. Stability studies evaluate the effect of environmental factors such as temperature, humidity, and light on drug products to determine their shelf life and storage conditions.

2. Scope

This SOP applies to personnel in the Quality Assurance (QA), Quality Control (QC), and Research & Development (R&D) departments responsible for conducting stability studies, analyzing data, and preparing Stability Study Reports for regulatory compliance.

3. Responsibilities

• QC Analyst: Conducts stability tests and records analytical data.
• QA Officer: Reviews stability study reports for compliance.
• R&D Scientist: Designs and monitors stability studies.
• QA Manager: Approves final Stability Study Reports.

4. Accountability

The QA and R&D Managers are accountable for ensuring that Stability Study Reports comply with GMP, ICH, WHO, and FDA guidelines.

5. Procedure

5.1 Types of Stability Studies

Stability studies are classified into the following categories:

• Accelerated Stability Studies: Conducted at elevated temperature and humidity conditions to predict long-term stability.
• Long-Term Stability Studies: Conducted under normal storage conditions to determine real-time stability.
• Intermediate Stability Studies: Performed at conditions between long-term and accelerated studies.
• Photostability Studies: Evaluates the effect of light exposure on drug products.

5.2 Stability Study Protocol Development

• A Stability Study Protocol must be prepared before initiating stability testing.
• The protocol must include:
  • Purpose and scope of the study.
  • Batch details (Batch No., manufacturing and expiry date).
  • Storage conditions and test intervals.
  • Test parameters (e.g., assay, pH, viscosity, microbial limits).
  • Acceptance criteria and test methods.
• The Stability Study Protocol must be reviewed and approved by the QA Manager.

5.3 Sample Preparation and Storage

• Stability samples must be collected from representative batches.
• Samples must be labeled with:
  • Product name and batch number.
  • Storage condition and test interval.
  • Date of sample collection.
• Samples must be stored in **stability chambers** under defined conditions:
• Storage conditions:
  • Accelerated: **40°C ± 2°C / 75% RH ± 5% RH**
  • Long-Term: **25°C ± 2°C / 60% RH ± 5% RH**
  • Intermediate: **30°C ± 2°C / 65% RH ± 5% RH**
  • Photostability: **Light exposure per ICH guidelines**

5.4 Stability Testing and Data Recording

• QC must conduct tests at predefined intervals (e.g., 1 month, 3 months, 6 months, 12 months, 24 months).
• Tests include:
  • Physical tests (appearance, odor, color).
  • Chemical tests (assay, pH, degradation products).
  • Microbiological tests (total viable count, endotoxin levels).
• All test results must be recorded in the **Stability Testing Log.**

5.5 Preparation of Stability Study Reports

• The Stability Study Report must include:
  • Summary of stability testing results.
  • Trend analysis of critical parameters.
  • Degradation profile and extrapolated shelf life.
  • Recommendations on storage conditions and expiry period.
• The report must be reviewed by the **QA Manager** before submission.

5.6 Review and Approval of Stability Study Reports

• QA must review stability data monthly.
• Regulatory compliance must be ensured before final approval.
• Reports must be archived for **a minimum of 5 years.**

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• R&D – Research & Development
• RH – Relative Humidity
• ICH – International Council for Harmonisation

7. Documents

• Stability Study Protocol Template (Annexure-1)
• Stability Study Report Template (Annexure-2)

8. References

• ICH Q1A – Stability Testing of New Drug Substances
• WHO Guidelines on Stability Studies
• US FDA Guidance on Stability Testing

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Stability Study Protocol Template

Annexure-2: Stability Study Report Template

12. Revision History

Procedure for Recording Deviations and CAPA Reports

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the systematic approach for identifying, documenting, investigating, and addressing deviations in pharmaceutical manufacturing. It also outlines the Corrective and Preventive Action (CAPA) process to ensure continual improvement and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Quality Control (QC), and Production departments responsible for identifying deviations, recording them in deviation reports, and implementing CAPA procedures.

3. Responsibilities

• Production Supervisor: Identifies deviations and initiates deviation reports.
• QA Officer: Reviews deviations, conducts investigations, and proposes corrective actions.
• QC Analyst: Evaluates quality-related deviations and assesses potential product impact.
• CAPA Coordinator: Implements corrective and preventive actions.
• QA Manager: Approves deviation reports and CAPA plans.

4. Accountability

The QA and Production Managers are accountable for ensuring that all deviations are documented and addressed in compliance with GMP, FDA, ICH, and WHO regulations.

5. Procedure

5.1 Types of Deviations

Deviations are classified into three categories based on their impact on product quality and regulatory compliance:

• Critical Deviation: Any deviation that significantly impacts product quality, patient safety, or regulatory compliance (e.g., microbial contamination, incorrect formulation, equipment failure).
• Major Deviation: A deviation that does not directly impact product quality but may affect process efficiency (e.g., exceeding temperature limits, incomplete documentation).
• Minor Deviation: A minor procedural deviation with no significant effect on product quality (e.g., slight delay in record entry, minor errors in labeling).

5.2 Identifying and Documenting Deviations

• Any personnel identifying a deviation must report it to the **Production Supervisor or QA Officer** immediately.
• A **Deviation Report** must be initiated, capturing the following details:
  • Date and time of deviation occurrence.
  • Location and process step affected.
  • Detailed description of the deviation.
  • Immediate corrective actions taken.
  • Name of the person reporting the deviation.
• The deviation report must be submitted to QA within **24 hours** of detection.

5.3 Investigation of Deviations

• QA must initiate a **Root Cause Analysis (RCA)** within **48 hours** of receiving a deviation report.
• Investigation methods include:
  • Review of batch records and process logs.
  • Interviews with personnel involved.
  • Analysis of equipment calibration and environmental monitoring records.
• The investigation findings must be recorded in the **Deviation Investigation Report**.
• Critical deviations must be escalated to senior management.

5.4 Corrective and Preventive Action (CAPA) Process

• Based on the deviation investigation, a **CAPA Plan** must be developed.
• Corrective Actions:
  • Immediate steps to rectify the identified deviation.
  • Product recall or batch rejection if necessary.
  • Training of personnel if human error is identified.
• Preventive Actions:
  • Revising SOPs and work instructions.
  • Enhancing equipment calibration and maintenance schedules.
  • Implementing additional quality control checks.
• The CAPA plan must be reviewed and approved by the QA Manager.

5.5 Implementation and Monitoring of CAPA

• The CAPA Coordinator must track the implementation of corrective and preventive actions.
• A **CAPA Effectiveness Check** must be conducted **one month after implementation**.
• QA must verify that no recurrence of the deviation has been observed.

5.6 Review and Approval of Deviation Reports and CAPA

• QA must review all deviation reports monthly.
• CAPA reports must be reviewed quarterly for effectiveness.
• Deviation records and CAPA reports must be archived for a **minimum of 5 years**.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• CAPA – Corrective and Preventive Action
• RCA – Root Cause Analysis
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• Deviation Report Template (Annexure-1)
• CAPA Implementation Log (Annexure-2)

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO Guidelines on Deviation and CAPA Management
• US FDA Guidance on CAPA Implementation

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Deviation Report Template

Annexure-2: CAPA Implementation Log

12. Revision History

Procedure for Filing Raw Material Inspection Reports

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for filing raw material inspection reports in pharmaceutical manufacturing. Proper documentation of raw material inspections ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and traceability.

2. Scope

This SOP applies to personnel in the Quality Control (QC), Quality Assurance (QA), and Warehouse departments responsible for receiving, inspecting, and filing raw material inspection reports for all incoming materials used in production.

3. Responsibilities

• Warehouse Personnel: Initiates the raw material receiving process and records preliminary observations.
• Quality Control (QC) Analyst: Conducts physical, chemical, and microbiological testing of raw materials and records results.
• QA Officer: Reviews raw material inspection reports for completeness and compliance.
• QA Manager: Approves and ensures proper filing and archiving of inspection records.

4. Accountability

The QA and QC Managers are accountable for ensuring that all raw material inspection reports are filed and maintained in compliance with GMP, FDA, ICH, and WHO regulations.

5. Procedure

5.1 Types of Raw Material Inspection Reports

The following types of reports must be maintained:

• Raw Material Receiving Report: Contains information on material name, supplier details, batch number, and preliminary inspection findings.
• Raw Material Test Report: Includes results of physical, chemical, and microbiological tests conducted on the raw material.
• Certificate of Analysis (CoA): Provided by the supplier, detailing the material’s specifications and test results.
• Raw Material Acceptance/Rejection Report: Documents final decision on whether the material is approved for use or rejected.

5.2 Raw Material Receiving and Preliminary Inspection

• Upon arrival, warehouse personnel must check the material against the purchase order.
• The following parameters must be recorded:
  • Material name and description.
  • Supplier name and details.
  • Batch number and manufacturing/expiry date.
  • Quantity received and condition of packaging.
• All details must be documented in the **Raw Material Receiving Report**.
• Warehouse personnel must label the material as **”Quarantine”** until QC testing is completed.

5.3 Raw Material Testing by Quality Control (QC)

• QC personnel must collect representative samples from each batch following the **sampling plan**.
• Tests must be conducted according to predefined specifications, including:
  • Physical properties (appearance, odor, color, density).
  • Chemical composition (pH, solubility, purity, assay).
  • Microbiological testing (bioburden, endotoxin levels, sterility).
• Test results must be recorded in the **Raw Material Test Report**.
• The QC analyst must compare results with the supplier’s Certificate of Analysis (CoA).
• If test results meet acceptance criteria, the material is **approved** and moved to the **Approved Storage Area**.
• If test results do not meet specifications, the material is **rejected** and moved to the **Rejection Area**.

5.4 Review and Approval of Inspection Reports

• QA personnel must review all reports for accuracy and completeness.
• The **Raw Material Acceptance/Rejection Report** must be completed and signed by the QA Manager.
• All reports must be cross-verified with the CoA and supplier documents.
• Any discrepancies or deviations must be investigated and documented.

5.5 Filing and Archiving of Raw Material Inspection Reports

• All raw material inspection reports must be stored in a designated filing system.
• Reports must be categorized by **material name, batch number, and supplier name**.
• Electronic copies of reports should be scanned and backed up in the document management system.
• Retention period:
  • Approved materials – **Minimum 5 years**.
  • Rejected materials – **Minimum 3 years**.
• QA must ensure records are readily available for audits and regulatory inspections.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• CoA – Certificate of Analysis
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• Raw Material Receiving Report Template (Annexure-1)
• Raw Material Test Report Template (Annexure-2)

8. References

• ICH Q7 – Good Manufacturing Practice Guide
• WHO Guidelines on Raw Material Testing
• US FDA Guidance on Raw Material Inspection

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Raw Material Receiving Report Template

Annexure-2: Raw Material Test Report Template

12. Revision History

Procedure for Preparing Cleaning Records

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for preparing cleaning records in pharmaceutical manufacturing. Cleaning records ensure proper documentation of cleaning procedures performed on equipment, production areas, and storage areas, which is essential for regulatory compliance, product quality, and cross-contamination prevention.

2. Scope

This SOP applies to personnel in the Production, Quality Assurance (QA), and Housekeeping departments responsible for recording, reviewing, and maintaining cleaning records for equipment, production areas, and storage areas.

3. Responsibilities

• Production Operators: Document cleaning activities for equipment and production areas.
• Housekeeping Staff: Record routine cleaning and sanitization of manufacturing areas.
• QA Officer: Cross-verifies records and ensures compliance with documentation standards.
• QA Manager: Reviews and approves cleaning records before archiving.

4. Accountability

The QA and Production Managers are accountable for ensuring that all cleaning records are maintained in compliance with GMP, FDA, ICH, and WHO regulations.

5. Procedure

5.1 Types of Cleaning Records

The following types of cleaning records must be maintained:

• Equipment Cleaning Log: Records details of equipment cleaning, including cleaning agents used, method, and personnel responsible.
• Area Cleaning Log: Documents cleaning activities for manufacturing areas, including floors, walls, ceilings, and workstations.
• Cleaning Validation Record: Maintains validation data confirming cleaning effectiveness.
• Cleaning Verification Record: Confirms compliance with pre-defined cleanliness standards.

5.2 General Guidelines for Maintaining Cleaning Records

• All cleaning records must be maintained at the respective cleaning location.
• Entries must be made in **real time** using indelible ink.
• Each entry must be signed and dated by the responsible personnel.
• Cleaning logs must be reviewed periodically by the Production Supervisor and QA team.
• Logbooks must be bound and paginated sequentially to prevent data tampering.

5.3 Equipment Cleaning Record Entry Procedure

• Before starting production, the operator must verify equipment cleanliness.
• After cleaning, the operator must enter the following details:
  • Date and time of cleaning.
  • Equipment name and identification number.
  • Cleaning method (e.g., wet cleaning, dry cleaning, CIP).
  • Cleaning agents and sanitizers used.
  • Operator’s name and signature.
• QA personnel must verify and approve the cleaning record before equipment is used.

5.4 Area Cleaning Record Entry Procedure

• Housekeeping staff must document cleaning activities daily.
• The following information must be recorded:
  • Date and time of cleaning.
  • Area cleaned (e.g., production floor, storage room, corridor).
  • Cleaning method used.
  • Cleaning agents and disinfectants applied.
  • Verification signature from QA.

5.5 Cleaning Validation Record Entry Procedure

• Validation must be performed at regular intervals.
• The following details must be recorded:
  • Date of validation test.
  • Equipment or area tested.
  • Validation method (e.g., swab test, rinse test).
  • Acceptance criteria and test results.
  • Verification signature from QA Manager.

5.6 Review and Approval of Cleaning Records

• Production Supervisors must review cleaning records weekly.
• QA must verify logs monthly to ensure compliance.
• Cleaning validation records must be reviewed quarterly.
• Cleaning records must be archived securely for at least five years.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• Equipment Cleaning Log Template (Annexure-1)
• Area Cleaning Log Template (Annexure-2)

8. References

• ICH Q7 – Good Manufacturing Practice Guide
• WHO Guidelines on Equipment and Facility Cleaning
• US FDA Guidance on Cleaning Validation

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Equipment Cleaning Log Template

Annexure-2: Area Cleaning Log Template

12. Revision History

Procedure for Maintaining Equipment Logbooks

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic process for maintaining equipment logbooks in pharmaceutical manufacturing. Equipment logbooks ensure proper documentation of equipment usage, cleaning, maintenance, and calibration, which is critical for regulatory compliance, traceability, and adherence to Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel in the Production, Quality Assurance (QA), and Engineering departments responsible for updating, verifying, and archiving equipment logbooks for manufacturing, cleaning, and utility systems.

3. Responsibilities

• Machine Operator: Records equipment usage, cleaning, and maintenance activities.
• Production Supervisor: Reviews logbook entries for completeness and accuracy.
• Engineering Team: Updates calibration and maintenance records.
• QA Officer: Ensures compliance with logbook documentation standards.
• QA Manager: Reviews and approves logbook records.

4. Accountability

The QA and Engineering Managers are accountable for ensuring that all equipment logbooks are maintained in compliance with GMP, FDA, ICH, and WHO regulations.

5. Procedure

5.1 Types of Equipment Logbooks

The following types of logbooks must be maintained:

• Equipment Usage Log: Records details of equipment operation, including date, time, batch number, and operator name.
• Cleaning and Sanitation Log: Documents cleaning and sanitization activities, including cleaning agents used, cleaning time, and operator signature.
• Maintenance and Repair Log: Records preventive and corrective maintenance activities performed by the engineering team.
• Calibration Log: Includes records of calibration activities, reference standards used, and results.
• Breakdown and Downtime Log: Documents unplanned downtime, cause of breakdown, and corrective actions taken.

5.2 General Guidelines for Maintaining Logbooks

• All logbooks must be maintained at the respective equipment location.
• Entries must be made in **real time** using indelible ink.
• Each entry must be signed and dated by the responsible personnel.
• Logbooks must be reviewed periodically by the Production Supervisor and QA team.
• Logbooks must be bound and paginated sequentially to prevent data tampering.

5.3 Equipment Usage Log Entry Procedure

• Before operating the equipment, the machine operator must enter the following details:
  • Date and time of use.
  • Batch number associated with the equipment operation.
  • Equipment ID and name.
  • Start and end time of the operation.
  • Operator’s name and signature.
• After completion of batch processing, the log must be verified by the Production Supervisor.

5.4 Equipment Cleaning and Sanitation Log Entry Procedure

• Cleaning logs must be filled after every cleaning cycle.
• The following information must be recorded:
  • Date and time of cleaning.
  • Cleaning method and cleaning agents used.
  • Operator name and signature.
  • QA verification signature.

5.5 Equipment Maintenance and Calibration Log Entry Procedure

• The engineering team must update the logbook with the following details:
  • Date of maintenance or calibration.
  • Type of maintenance (preventive/corrective).
  • Parts replaced, if any.
  • Reference standards used for calibration.
  • Results of calibration.
  • Technician name and signature.

5.6 Review and Approval of Logbooks

• Production Supervisors must review logbooks weekly for completeness.
• QA must verify logbooks monthly for compliance.
• Engineering must review calibration logs quarterly.
• Logbooks must be archived securely for at least five years.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• Equipment Usage Log Template (Annexure-1)
• Equipment Maintenance and Calibration Log Template (Annexure-2)

8. References

• ICH Q7 – Good Manufacturing Practice Guide
• WHO Guidelines on Equipment Maintenance
• US FDA Guidance on Equipment Documentation

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Equipment Usage Log Template

Annexure-2: Equipment Maintenance and Calibration Log Template

12. Revision History