BMRs, batch packaging records (BPRs), deviation records, change controls, CAPAs, validation reports, SOP acknowledgment logs, and any other GMP-related documents generated in the API manufacturing site.

3. Responsibilities

• QA Documentation Cell: Responsible for document collection, review, indexing, secure storage, retrieval, and archival log maintenance.
• QA Officer/Executive: Reviews documents for completeness and compliance before archival.
• Department Heads: Ensure timely submission of completed and approved documents to QA for archival.
• IT (if electronic systems are used): Ensures backup, retrieval, and security of electronic QA records.

4. Accountability

The QA Head is accountable for maintaining an effective archival system that supports inspection readiness and ensures secure preservation of GMP records throughout their retention period.

5. Procedure

5.1 Document Categories for Archival

1. Documents eligible for archival include:
   • Completed and approved Batch Manufacturing Records (BMRs)
   • Batch Packaging Records (BPRs)
   • Analytical test reports and CoAs
   • Deviation and Incident Reports
   • CAPA reports
   • Change Control records
   • SOP training and acknowledgment records
   • Validation protocols and reports

5.2 Archival Preparation

1. Upon batch release, QA collects final signed copies of BMR/BPR and associated records.
2. Documents shall be verified against the QA Checklist (Annexure-1) for completeness, signatures, and accuracy.
3. Deficiencies found must be resolved before proceeding with archival.

5.3 Indexing and Labeling

1. Each record set shall be assigned a unique archival number and filed in a batch-wise manner.
2. Use Document Index Sheet (Annexure-2) for reference during retrieval.
3. Label files clearly with the following:
   • Batch Number
   • Product Name
   • Date of Manufacturing
   • Record Type (e.g., BMR, CAPA, Deviation)
   • Archive Box Number

5.4 Archival Storage

1. Documents must be stored in a locked, fire-resistant, humidity-controlled archive room accessible only to authorized QA personnel.
2. Storage racks and boxes should be sequentially numbered and recorded in the Archival Logbook (Annexure-3).
3. Conditions:
   • Temperature: 20–25°C
   • Humidity: NMT 60%

5.5 Retention Period

1. Retention periods are as follows (unless local regulations specify otherwise):
   • BMR/BPR: Minimum 1 year after expiry of the batch
   • Validation documents: 5 years
   • Change Controls, CAPAs, Deviations: 5 years from closure
   • SOP acknowledgments: 5 years

5.6 Document Retrieval and Access

1. Only QA personnel may access archives with written request approval from QA Head.
2. Use Document Retrieval Request Form (Annexure-4).
3. Retrieved documents must be returned within 7 working days and re-filed with return acknowledgment.

5.7 Electronic Document Archiving

1. Electronic records shall be archived in validated document management systems with:
   • Access control and audit trail
   • Periodic backup (weekly at minimum)
   • Disaster recovery provision
2. Scanned copies of physical documents may be maintained electronically with signed approval pages.

5.8 Disposal of Expired Records

1. QA shall conduct an annual review of archived records and identify those past retention period.
2. Obsolete documents shall be destroyed by shredding or incineration in presence of QA and recorded in the Destruction Log (Annexure-5).

6. Abbreviations

• BMR: Batch Manufacturing Record
• BPR: Batch Packaging Record
• QA: Quality Assurance
• GMP: Good Manufacturing Practices
• CAPA: Corrective and Preventive Action

7. Documents

1. QA Checklist for Archival (Annexure-1)
2. Document Index Sheet (Annexure-2)
3. Archival Logbook (Annexure-3)
4. Document Retrieval Request Form (Annexure-4)
5. Document Destruction Log (Annexure-5)

8. References

• ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – Subpart J: Records and Reports
• EU GMP Chapter 4 – 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: QA Checklist for Archival

Document Type	Checked By	Comments	Status
BMR for API-X	Rajesh Kumar	Complete	Ready

Annexure-2: Document Index Sheet

Batch No.	Product	Date	Record Type	Archive Box No.
BA2025X01	API-X	01/03/2025	BMR	Box-12

Annexure-3: Archival Logbook

Box No.	Document Type	From Date	To Date	Location
Box-12	BMRs	01/02/2025	31/03/2025	Shelf-3A

Annexure-4: Document Retrieval Request Form

Requested By	Date	Document Type	Batch No.	Purpose
Sunita Reddy	10/04/2025	Deviation Report	BA2025X01	Audit

Annexure-5: Document Destruction Log

Document Type	Destruction Date	Method	Witnessed By
BMR 2020 Series	01/04/2025	Shredded	QA Officer

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
14/04/2025	2.0	Added electronic archival section and annexures	Updated for compliance	QA Head