Guideline for batch record review of pharmaceuticals and medical devices
- Kazi
- Last modified: September 7, 2024
Establishing standard operating procedures (SOPs) that describe how the batch record review must be conducted is essential to standardizing manufacturing, packaging, and testing processes of pharmaceutical products and medical devices.
Quality assurance is responsible for the final review and approval of completed batch records and associated control records.
Key Takeaways
- A thorough and standardized batch record review is critical in ensuring the safety, quality, and compliance of pharmaceutical products and medical devices.
- The production team is responsible for reviewing, signing, and verifying the accuracy of the batch records before forwarding them to the quality assurance team for final review and approval.
- Developing a detailed checklist for reviewing batch records, including in-process tests, environmental monitoring, raw materials, and equipment preparation, is essential for ensuring completeness and accuracy.
- Any deviations found during the batch record review must be documented, investigated, and resolved according to standard procedures to ensure compliance with regulatory standards.
- The batch review process includes verifying proper documentation, calculation accuracy, conformance of in-process controls, and compliance with critical process parameters.
240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents included each month. All written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.
Regulatory requirements for batch review
USFDA CFR 211.186 Master production and control records say:
– To ensure uniformity from batch to batch, master production and control records for each drug product, including each batch size, shall be prepared, dated, and signed.
– The preparation of master production and control records shall be described in a written procedure, and such written procedure shall be followed.
– Master production and control records shall include – complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed.
PICS GMP Guide (Annexes) section 4.15 described the processing instructions should include:
– A statement of the processing location and the principal equipment to be used.
– The methods, or reference to the methods, to be used for preparing the critical equipment (e.g., cleaning, assembling, calibrating, sterilizing).
– Detailed stepwise processing instructions (e.g., checks on materials, pre-treatments, sequence for adding materials, mixing times, temperatures).
– The instructions for any in-process controls with their limits;
Standard practices for batch record review
For batch records requiring quality review, the site production team should be responsible for reviewing production batch records, assuring those records are complete and accurate, and signing the batch record, signifying the review was performed, and the production records are accurate and complete, before forwarding to the quality team for final review.
For device history records (DHR) requiring quality review, the production team should be responsible for reviewing them, assuring that they are complete and accurate, and signing and dating the DHR, signifying the review was performed.
The production records must be accurate and complete before being forwarded to the quality team for final review.
For API Steps or Intermediates where no quality review is required, the production team should be responsible for reviewing and approving the batch records to ensure they are complete before assigning a disposition to the batch.
The production team should inform the quality team of any deviations discovered during the production team batch record review.
Any deviations should be investigated and documented as described in the internal deviation procedure.
Disposition of batches and lots should be performed according to the requirements of the internal release procedure.
What items should be checked during batch review?
You should prepare a checklist or protocol that outlines the specific information and documents that must be reviewed and included in the batch record or DHR.
Batch records or DHR review should include a review of the following:
– Results of any in-process tests or inspections.
– Documentation of applicable environmental conditions (air classifications, temperature, relative humidity).
– Documentation of raw materials, starting materials, packaging materials, and components used, including specific identification & quantity.
– Documentation of equipment preparation (e.g., cleaning records, sterilization, filter integrity test records).
– Calculations are correct (significant figures).
– Sample of labeling used.
– Documentation of samples collected.
In addition, the following items should be reviewed for pharmaceutical products:
– An accurate reproduction of the master manufacturing instruction with documentation that each step was executed and documented.
– Yield calculation and accountability.
– Documentation of manufacturing line cleaning and clearance.
– Document packaging line cleaning and clearance.
– Records of final quantity manufactured and packaged.
Batch records review for active pharmaceutical ingredients should include:
– An accurate reproduction of the master manufacturing instruction with documentation that each step was executed and documented.
– Documentation of bulk product filled and packaged, including lot identification and quantity.
– Accountability and yield calculations.
Batch records review for medical devices should include the following:
– Batch has been produced following the approved and current device master record (DMR).
– Documentation of manufacturing line cleaning and clearance.
– Document packaging line cleaning and clearance.
– Records of final quantity manufactured and packaged.
240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents included each month. All written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.
Batch review for products transferred to third-party
For drug products, intermediates, and APIs shipped to third-party (non-affiliate) sites requiring review by the site quality team, should include verification of the following items:
– Required documentation is included in the records.
– Required data entries have been made.
– Batch has been produced following the approved and current master batch record.
– The production team has signed the record to signify that the production records have been reviewed and are complete and accurate.
– Production materials were approved before use in production and were still within the expiration date or re-evaluation date when used.
– Calculations should be verified as complete and accurate. However, no verification is necessary when a validated computerized system is used for calculations.
– Applicable environmental monitoring data are within specified limits.
– The batch was produced within Process Parameter ranges.
– Results from in-process controls (IPC) and finished product testing for compliance with regulatory specifications.
– Records for accountability and yield calculations.
– Batch was produced within critical process parameter ranges.
Batch record review for intermediates for further processing on-site or by other sites should include verification of the following items:
– Results from critical in-process controls (IPC); and
– Batch was produced within critical process parameter ranges.
Site Quality Team Review of a DHR for Medical Devices should include verification of, but not be limited to, the following items:
– Required documentation is included in the records.
– Required data entries have been made.
– Batch has been produced following approved and current DMR.
– The production team has signed the record to signify that the production records have been reviewed and are complete and accurate.
– Production materials and components were approved before use in production and were still within the expiration date or re-evaluation date when used.
– Calculations should be verified as complete and accurate. However, no verification is necessary when a validated computerized system is used for calculations.
– Applicable environmental monitoring data are within specified limits.
– Documentation of manufacturing line cleaning and clearance.
– Document packaging line cleaning and clearance.
– Records of final quantity manufactured and packaged.
Other items to consider during batch record review
If the quality control record, batch record, or DHR is not filled or is missing data, an explanation must be documented in the batch record or DHR. If no explanation is provided, a deviation investigation must be initiated.
Missing data for critical process parameters should be added to the batch record or DHR only after a deviation is initiated.
You must investigate the reason the batch record or DHR is missing the data, and there is independent documented evidence to support the information.
If the data are added, the person adding the data should sign and date the addition and reference the supporting documented evidence. The quality team should also review, sign, and date each verification step.
Conclusion
In conclusion, a robust batch record review process ensures the integrity and compliance with regulatory and internal requirements of pharmaceutical and medical devices manufactured on your site.
Standard operating procedures (SOPs) and batch review checklists can ensure that each step of production is properly documented, reviewed, and verified by both the production and quality assurance teams.
This structured approach helps identify and investigate manufacturing deviations before the batches are released, reducing the risk of product quality issues and non-compliance.
Effective batch record review conforms to accuracy, accountability, and traceability, ultimately supporting the quality of the final product.
Author: Kazi Hasan
Kazi is a seasoned pharmaceutical industry professional with over 20 years of experience specializing in production operations, quality management, and process validation.
Kazi has worked with several global pharmaceutical companies to streamline production processes, ensure product quality, and validate operations complying with international regulatory standards and best practices.
Kazi holds several pharmaceutical industry certifications including post-graduate degrees in Engineering Management and Business Administration.