gmp checklist of all requirements and needed certifications and documents
Documentation Requirements
- Draft SOPs for each process.
- Ensure clear, concise language.
- Include version control and approval dates.
- Distribute to relevant staff.
- Review and update regularly.
- Outline quality policies and objectives.
- Define roles and responsibilities.
- Include compliance requirements.
- Review annually for accuracy.
- Ensure accessibility to all staff.
- Document every production batch.
- Include raw material sources and quantities.
- Record equipment used and operating conditions.
- Sign off by responsible personnel.
- Store securely for traceability.
- Track all maintenance activities.
- Document dates, tasks performed, and personnel.
- Include calibration and repairs.
- Ensure logs are accessible for audits.
- Review for patterns needing attention.
- Maintain individual training files.
- Record all training sessions attended.
- Include competency assessments.
- Update regularly with new training.
- Ensure compliance with regulatory requirements.
- Document all changes to processes or products.
- Include rationale, assessment, and approval.
- Track implementation and verification.
- Review for potential impacts on quality.
- Retain for audit purposes.
- Record any deviation from established protocols.
- Include investigation findings and actions taken.
- Document corrective actions implemented.
- Review trends for potential improvements.
- Ensure timely reporting and resolution.
- Perform regular internal audits.
- Document findings and non-conformities.
- Include corrective action plans.
- Review with management for follow-up.
- Retain for compliance and improvement.
- Develop and document validation plans.
- Include equipment specifications and intended use.
- Execute validation activities and record results.
- Review for compliance with regulatory standards.
- Maintain reports for future reference.
- Assess suppliers based on quality criteria.
- Document qualification process and outcomes.
- Monitor supplier performance regularly.
- Maintain records of supplier audits.
- Ensure compliance with GMP standards.
- Establish monitoring protocols for environment.
- Document sampling methods and results.
- Include actions taken for out-of-spec results.
- Review data for trends over time.
- Retain for compliance verification.
- Develop detailed product specifications.
- Document test methods and acceptance criteria.
- Ensure methods are validated and approved.
- Review specifications regularly for updates.
- Maintain for traceability and audits.
- Design stability studies per product requirements.
- Document study protocols and results.
- Include storage conditions and timeframes.
- Review data for shelf-life determination.
- Ensure compliance with regulatory guidelines.
- Conduct risk assessments for processes and products.
- Document identified risks and mitigation strategies.
- Review and update assessments regularly.
- Involve cross-functional teams in assessments.
- Maintain records for compliance.
- Document all customer complaints received.
- Investigate and record findings and actions taken.
- Track trends for potential systemic issues.
- Ensure timely follow-up with complainants.
- Review for process improvements.
- Identify potential allergens in products.
- Document allergen control measures in place.
- Review supply chain for allergen risks.
- Train staff on allergen handling procedures.
- Maintain records for audit purposes.
- Schedule routine calibration for all equipment.
- Document calibration results and adjustments made.
- Track calibration history for each device.
- Ensure compliance with industry standards.
- Retain records for audits and inspections.
- Track all inventory movements accurately.
- Document quantities, locations, and batch numbers.
- Perform regular inventory reconciliations.
- Ensure proper storage conditions are maintained.
- Review for discrepancies and adjust records.
- Document all testing performed on materials.
- Include test results and acceptance criteria.
- Sign off by authorized personnel upon release.
- Maintain records for traceability.
- Review data regularly for trends.
- Implement tracking systems for materials.
- Document source and usage of all components.
- Ensure easy access to traceability records.
- Review systems for effectiveness.
- Maintain records for compliance.
- Document all identified issues and investigations.
- Include actions taken to rectify problems.
- Track effectiveness of preventive measures.
- Review regularly for improvements.
- Maintain records for compliance audits.
- Conduct annual reviews of product performance.
- Document changes in production and quality.
- Include customer feedback and complaint summaries.
- Review for compliance with regulatory requirements.
- Maintain records for audit purposes.
- Document all findings from external audits.
- Include corrective actions planned and implemented.
- Track follow-up activities and timelines.
- Review audits for compliance improvements.
- Maintain records for future reference.
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