intermediates, and APIs in the QC department.

3. Responsibilities

• QC Analyst: Submit complete analytical data with necessary documentation.
• QC Reviewer: Review all raw data and reports for completeness, accuracy, and regulatory compliance.
• QA Officer: Approve the archive status and perform periodic audits of the archival system.

4. Accountability

The QC Head is accountable for ensuring the integrity, security, and retrievability of archived analytical data and adherence to data retention policies.

5. Procedure

5.1 Submission and Preliminary Review

1. Analyst shall compile the analytical report, raw data, instrument printouts, system suitability results, calculations, and applicable logs.
2. Attach a checklist to verify completeness of:
   • STP reference and batch details
   • Chromatograms or instrument files
   • Log entries and balance calibration
   
   

   5.1 Submission and Preliminary Review (continued)

   • Ensure all observations and manual entries are legible, signed, and dated.
   • QC Reviewer verifies the completeness and correctness of the data and signs the Analytical Data Review Checklist (Annexure-1).

5.2 Review of Electronic and Instrument Data

1. Review the system-generated data (e.g., chromatograms, UV/IR spectra, balance logs).
2. Ensure data integrity principles (ALCOA+) are followed:
   • Attributable
   • Legible
   • Contemporaneous
   • Original
   • Accurate
   • + Complete, Consistent, Enduring, and Available
3. Verify any reprocessed data is properly justified and documented.

5.3 Compilation and Approval

1. Combine reviewed documents in a single file arranged as:
   • Cover page with checklist
   • Analytical test report
   • Raw data
   • Instrument data
   • Calculations
   • Supporting documents (calibration, reference standard data)
2. QA or assigned approver signs off the data packet for archiving.

5.4 Archiving Procedure

1. Each approved file is given a unique archive code and indexed in the Analytical Archive Register (Annexure-2).
2. Store physical records in a secure, temperature-controlled, access-restricted archive room with fireproof storage cabinets.
3. Label archive box with content list, date, department, and archive reference number.
4. For electronic data:
   • Ensure storage on validated, access-controlled servers with backups.
   • Use approved LIMS/EDMS for retrieval and tracking.

5.5 Retrieval and Audit Trail

1. Maintain a log of retrievals (Annexure-3) stating:
   • Date of retrieval
   • Reason (e.g., audit, investigation, trending)
   • Person responsible
2. Ensure that any temporary movement or duplication of documents is logged and reconciled.

5.6 Retention Period

1. Follow the regulatory retention requirement of minimum 5 years from date of batch release unless otherwise specified.
2. For registration/stability batches, retain until the end of product life or as per market requirement.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• LIMS: Laboratory Information Management System
• EDMS: Electronic Document Management System
• ALCOA+: Data Integrity Principles
• SOP: Standard Operating Procedure

7. Documents

1. Analytical Data Review Checklist (Annexure-1)
2. Analytical Archive Register (Annexure-2)
3. Data Retrieval Log (Annexure-3)

8. References

• ICH Q7 – GMP for APIs
• MHRA GXP Data Integrity Guidance
• WHO Technical Series on Documentation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Analytical Data Review Checklist

Parameter	Yes/No	Remarks
STP version verified	Yes	Correct
Raw data complete	Yes	Attached
Calculations accurate	Yes	Double-checked

Annexure-2: Analytical Archive Register

Archive Code	Report No.	Batch No.	Archived Date	Storage Location
ARC-2025-001	ATR-20250413-01	API-B001	13/04/2025	Cabinet A1

Annexure-3: Data Retrieval Log

Date	Archive Code	Requested By	Purpose	Returned Date
14/04/2025	ARC-2025-001	QA Auditor	Regulatory Audit	14/04/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	GMP Requirement	QA Head
13/04/2025	2.0	Inclusion of ALCOA+, Annexure Format	Audit Suggestion	QA Head