SOP for Annual Product Quality Review
OBJECTIVE
To lay down a procedure for writing the annual product reviews for drug products.
SCOPE
This procedure applies to all the drug products manufactured at PharmaInfo Company Limited.
RESPONSIBILITY
Preparation: Executive or Above -Quality Assurance
Review: Head-Quality Control & Head-Production
Approval: Head-Quality Assurance
PROCEDURE
- An annual product review is also called a product review or Product quality review.
- An organized and comprehensive summary shall be compiled with all Production, Analytical, and Customer data associated with a pharmaceutical product.
- APRs for all products shall be completed before the 31st of January.
- The contents of the annual product review shall be as follows
Batch Selection
- Select all the batches of production in the current year and perform the review.
- Consider the previous period batches while writing the product review.
ALSO READ: SOP for Vendor Qualification and Approval
Frequency
- Annual product reviews are prepared for all the products produced in the manufacturing plant on a yearly basis. The year starts from 1st January to 31st December.
- Review the above document on half yearly basis and write the review comments
Product Review Team
- Form the Product review team with the following personnel.
- QA- Analyzing and reporting the summary
- Production-Review of batch yields
- QC-Review of Key quality attributes
- After review of data in the review meeting, incorporate the outcome of the meeting in the review comments.
Qualification of Equipment and Utilities
- Summarize the qualification status of all the equipment used in the manufacturing process of the drug under review.
Water System and HVAC Validation
- Verify the Validation status of the water System and HVAC.
Validation Status of Drug products namely Process, cleaning and analytical methods
- Summarize all the validations such as process, analytical and cleaning validation for the product under review.
Starting Material and Primary Packing Materials
- Review the starting materials and primary packing materials approval status and its trend data.
Production Batches and key Quality Attributes with Trend Analysis
- Write down the batch numbers and yields, perform the trend analysis and draw the graphs with control charts.
- Identify the Key quality attributes of in-process and finished products and tabulate them and perform the trend analysis and draw the trend charts.
Product Specifications, test methods and changes
- List the raw materials, in-process and finished product specifications and tabulate them with STP Number.
Out of Specifications: Summarize the Out of Specifications record and tabulate them for the drug product under review.
Rejected Batches: Review the rejected materials record for any rejections related to the raw material and finished product and tabulate them.
Non-Conformances Verification: Tabulate if there are any Non non-conformances in that year related to the drug product under review.
Corrective and Preventive Actions Verification: Summarize whether there are any corrective preventive actions performed against the Non-conformances and any others.
Internal Audits: Summarize the internal audits done during the current year. The Non-conformances raised during the internal audits shall be closed as per the periods given within the stipulated time.
Reserve or Retention samples: Review the records of retention samples of dispatched batches during the current year.
Stability Studies: Summarize the stability data of the product under review and enclose the data with the product review.
Change Controls: Review the change controls and tabulate them that occurred during the current year.
Market Complaints: Review the Market complaints records and tabulate them if any
Product Recalls: Review the product recalls record and tabulate them if any
Product Returns: Review the product returns record and tabulate them if any
Vendor Approvals: Review the vendor approval for raw materials, and packing materials used in the Drug Product under review.
Technical Agreements: Review the technical agreements and Enclose the Technical agreements if any
Marketing authorization, post-marketing commitments, and technical agreements: Describe the market authorizations list in the current year for the product under review and write the post-marketing commitments and technical agreements and enclose if any.
Regulatory Inspections and External Audits: Describe the customer audits and regulatory audits and their findings and corrective actions taken for the raised deviations
Changes in the Facility or Equipment: Summarize the changes in the facility and equipment if any.
Rejected Batches: Review the rejected materials record for any rejections related to the raw material and finished product and tabulate them.
Non-Conformances Verification: Tabulate if there are any Non non-conformances in that year related to the drug product under review.
Corrective and Preventive Actions Verification: Summarize whether there are any corrective preventive actions performed against the Non-conformances and any others.
Internal Audits: Summarize the internal audits done during the current year. The Non-conformances raised during the internal audits shall be closed as per the periods given within the stipulated time.
Reserve or Retention samples: Review the records of retention samples of dispatched batches during the current year.
Stability Studies: Summarize the stability data of the product under review and enclose the data with the product review.
Change Controls: Review the change controls and tabulate them that occurred during the current year.
Market Complaints: Review the Market complaints records and tabulate them if any
Product Recalls: Review the product recalls record and tabulate them if any
Product Returns: Review the product returns record and tabulate them if any
Vendor Approvals: Review the vendor approval for raw materials, and packing materials used in the Drug Product under review.
Technical Agreements: Review the technical agreements and Enclose the Technical agreements if any
Marketing authorization, post-marketing commitments, and technical agreements: Describe the market authorizations list in the current year for the product under review and write the post-marketing commitments and technical agreements and enclose if any.
Regulatory Inspections and External Audits: Describe the customer audits and regulatory audits and their findings and corrective actions taken for the raised deviations
Changes in the Facility or Equipment: Summarize the changes in the facility and equipment if any.
Data Analysis
- Data generated from the product shall be trended using statistical techniques.
- The data should be analyzed to determine if a) the process is in control and b) is the process is capable?
- The data shall be analyzed using the following techniques
Controls Charts: Prepare the control charts and analyze the data and make sure that the data is within the control limits.
Process capability study: Cp and CpK values shall be at 1.33 or above
Conclusion: Write the conclusion report at the end of the product review.
Process capability study: Cp and CpK values shall be at 1.33 or above
Conclusion: Write the conclusion report at the end of the product review.
ABBREVIATIONS
APR: Annual Product Review
STP: Standard Testing Procedure
HVAC: Heating Ventilation and Air Conditioning.
QC: Quality Control
QA: Quality Assurance
STP: Standard testing Procedure
ANNEXURE
Annexure-1: Annual Product Review Format
REVISION HISTORY
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