regulatory requirements for document retention and accessibility.

4. Accountability

The QA Manager is accountable for the overall management of document archiving within the Creams department. The Document Control Team is responsible for executing the archiving process, ensuring proper handling, storage, and retrieval of all QA documents and records.

5. Procedure

5.1 Document Identification and Categorization

1. All QA documents must be categorized based on their type (e.g., batch records, testing reports, validation documents) and assigned a unique identifier or reference number.
2. Documents will be categorized and stored according to the following:
   • Document type
   • Product or batch number
   • Date of creation or modification
   • Department or team responsible
3. The Document Control Team will maintain a document inventory list, which includes:
   • Document title
   • Document reference number
   • Document creation date
   • Document storage location

5.2 Storage of Physical Documents

1. Physical documents will be stored in secure filing cabinets or locked storage rooms to ensure their protection from unauthorized access, damage, or loss.
2. Documents will be organized in a way that allows easy retrieval, including the use of alphabetical or numerical systems based on document reference numbers.
3. Only authorized personnel will have access to stored physical documents. Access logs will be maintained to track who retrieves or returns documents.
4. Documents will be stored in a clean, dry, and safe environment to prevent damage from environmental factors (e.g., humidity, heat, or light). Temperature and humidity conditions will be monitored and controlled as required.

5.3 Storage of Electronic Documents

1. Electronic documents will be stored in a secure, password-protected digital repository, such as a document management system (DMS).
2. The Document Control Team will ensure that electronic documents are organized using file names that are clear and consistent, including:
   • Document type
   • Document reference number
   • Document date
3. Documents will be regularly backed up to prevent data loss. Backups will be stored in a secure location and retained according to the company’s data retention policy.
4. Only authorized personnel will have access to electronic documents. Access logs will be maintained to monitor who accesses or modifies the documents.

5.4 Document Retention

1. All QA documents will be retained for a minimum of five years or as required by regulatory authorities (whichever is longer), unless a shorter retention period is specified by law or regulation.
2. The Document Control Team will maintain a document retention schedule, which specifies the retention periods for different types of documents. This schedule will be reviewed annually or whenever regulatory requirements change.
3. After the retention period has expired, documents will be securely destroyed or archived according to company procedures. Physical documents will be shredded, and electronic documents will be permanently deleted from the system.

5.5 Document Retrieval

1. Documents must be easily retrievable, whether they are physical or electronic. The Document Control Team will maintain an up-to-date inventory and filing system to facilitate efficient document retrieval.
2. Requests for document retrieval must be submitted to the Document Control Team in writing, specifying the document type, reference number, and any other relevant details.
3. The Document Control Team will respond to retrieval requests promptly, ensuring that requested documents are provided within the required timeframe.

5.6 Document Audit and Review

1. The Document Control Team will conduct regular audits of archived documents to ensure that they are stored correctly and remain accessible.
2. QA personnel will review archived documents periodically to ensure that they comply with internal policies and regulatory requirements.
3. Any discrepancies or issues identified during audits will be reported to the QA Manager, and corrective actions will be implemented as necessary.

5.7 Security and Confidentiality

1. All QA documents, whether physical or electronic, will be treated as confidential and will only be accessed by authorized personnel.
2. Physical documents will be locked and stored in secure areas. Electronic documents will be protected by password encryption, firewalls, and other appropriate security measures.
3. Any unauthorized access or tampering with documents will be reported to the QA Manager and investigated promptly.

5.8 Archiving for Regulatory Inspections

1. All archived documents must be readily available for regulatory inspections or audits. The Document Control Team will ensure that requested documents are provided to regulatory authorities in a timely and organized manner.
2. Documents that are required for regulatory submissions will be identified and marked as “regulated” to ensure they are retained in compliance with applicable guidelines.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure
• DMS: Document Management System

7. Documents

1. Annexure-1: Document Retention Schedule
2. Annexure-2: Document Retrieval Request Form
3. Annexure-3: Document Disposal Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Records and Reports

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Document Retention Schedule

Document Type	Retention Period	Responsible Person	Location
Batch Records	5 years	QA Manager	QA Archives

Annexure-2: Document Retrieval Request Form

Requestor Name	Document Type	Document Reference Number	Reason for Retrieval	Request Date
John Doe	Batch Record	BR-12345	Audit	21/02/2026

Annexure-3: Document Disposal Log

Document Type	Disposal Date	Reason for Disposal	Authorized By
Batch Records	21/01/2026	Retention Period Expired	QA Manager

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head