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.

1. QA- Analyzing and reporting the summary
2. Production-Review of batch yields
3. 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.

ALSO READ: SOP for Preparation and Issuance of Data Sheet

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.

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.

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

Nil

ALSO READ: SOP for Job Responsibility of Quality Assurance Personnel