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The retention period for Batch Manufacturing Records (BMRs) varies depending on regulatory requirements, industry standards, and company policies. Here are some general guidelines:
Regulatory Requirements:
1. FDA (US): 21 CFR 211.180 – 1 year after expiration date or 3 years from batch release, whichever is longer.
2. EU GMP: Annex 11 – 5 years from batch release.
3. ICH Q7: 5 years from batch release.
4. WHO GMP: 5 years from batch release.
Industry Standards:
1. Pharmaceutical: 5-10 years.
2. Biotechnology: 5-15 years.
3. Medical Devices: 5-10 years.
4. Food Processing: 2-5 years.
Company Policies:
1. Typically align with regulatory requirements.
2. May vary depending on company-specific needs.
Electronic BMR (eBMR) Retention:
1. Same retention period as paper-based BMRs.
2. Ensure electronic records are secure, backed up, and accessible.
Retention Period for Specific Documents:
1. Batch production records: 5-10 years.
2. Quality control records: 5-10 years.
3. Certificates of analysis: 5-10 years.
4. Deviation/CAPA records: 5-10 years.
Storage and Accessibility:
1. Store BMRs in a secure, climate-controlled environment.
2. Ensure easy accessibility for audits and inspections.
3. Consider digitizing paper-based records for easier storage and retrieval.
Destruction of BMRs:
1. Follow company policies and regulatory guidelines.
2. Ensure secure destruction methods (e.g., shredding, electronic wiping).
It’s essential to consult relevant regulations, industry standards, and company policies to determine the specific retention period for BMRs.
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