Annual Product Review

1.0 OBJECTIVE

To lay down a procedure for writing the annual product reviews for drug products.

2.0 SCOPE

This procedure is applicable to all the drug products manufactured at company Name.

3.0 RESPONSIBILITY

3.1 Preparation : Executive or Above -Quality Assurance

3.2 Review: Head-Quality Control & Head-Production

3.3 Approval: Head-Quality Assurance

4.0 PROCEDURE

4.1 Annual product review is also called as product review or Product quality review.

4.2 An organized and comprehensive summary shall be compiled with all Production, Analytical and Customer data associated with a pharmaceutical product.

4.3 APRs for all products shall be completed before 31st of January.

4.4 The contents of annual product review shall be as follows

4.4.1 Batch Selection

4.4.1.1 Select all the batches of production in the current year and perform the review.

4.4.1.2 Consider the previous period batches while writing the product review.

4.4.2 Frequency

4.4.2.1 Annual product reviews are prepared for all the products produced in the manufacturing plant on yearly basis. The year starts from 1st January to 31st December.

4.4.2.2 Review the above document on half yearly basis and write the review comments

4.4.3 Product Review Team

4.4.3.1 Form the Product review team with the following personnel.

4.4.3.1.1 QA- Analyzing and reporting the summary

4.4.3.1.2 Production-Review of batch yields

4.4.3.1.3 QC-Review of Key quality attributes

4.4.3.2 After review of data in the review meeting, incorporate the outcome of the meeting in the review comments.

4.4.4 Qualification of Equipment and Utilities

4.4.4.1 Summarize the qualification status of the all the equipments used in the manufacturing process of the drug under review.

4.4.5 Water System and HVAC Validation

4.4.5.1 Verify the Validation status of the water System and HVAC.

4.4.6 Validation Status of Drug products namely Process, cleaning and analytical methods.

4.4.6.1 Summarize all the validations such as process, analytical and cleaning validation for the product under review.

4.4.7 Starting Material and Primary Packing Materials

4.4.7.1 Review the starting materials and primary packing materials approval status and its trend data.

4.4.8 Production Batches and key Quality Attributes with Trend Analysis.

4.4.8.1 Write down the batch numbers and yields, perform the trend analysis and draw the graphs with controls charts.

4.4.8.2 Identify the Key quality attributes of in-process and finished products and tabulate them and perform the trend analysis and draw the trend charts.

4.4.9 Product Specifications, test methods and changes

4.4.9.1 List the raw materials, in-process and finished product specification and tabulate them with STP Number.

4.4.10 Out of Specifications

4.4.10.1 Summarize the Out of specifications record and tabulate them for the drug product under review.

4.4.11 Rejected Batches

4.4.11.1 Review the rejected materials record for any rejections related to the raw material and finished product and tabulate them.

4.4.12 Non Conformances Verification

4.4.12.1 Tabulate if there are any Non conformances in that year related to the drug product under review.

4.4.13 Corrective and Preventive Actions Verification

4.4.13.1 Summarize whether there are any corrective preventive actions performed against the Non conformances and any other.

4.4.14 Internal Audits

4.4.14.1 Summarize the internal audits done during the current year. The Non conformances raised during the internal audits shall be closed as per the time periods given within the stipulated time.

4.4.15Reserve or Retention samples

4.4.15.1 Review the records of retention samples of dispatched batches during the current year.

4.4.16 Stability Studies

4.4.16.1 Summarize stability data of the product under review and enclose the data with the product review.

4.4.17 Change Controls

4.4.17.1 Review the change controls and tabulate them which occurred during the current year.

4.4.18 Market Complaints

4.4.18.1 Review the Market complaints records and tabulate them if any

4.4.19 Product Recalls

4.4.19.1 Review the product recalls record and tabulate them if any

4.4.20 Product Returns

4.4.20.1 Review the product returns record and tabulate them if any

4.4.21 Vendor Approvals

4.4.21.1 Review the vendor approval for raw materials, packing materials used in the Drug Product under review.

4.4.22 Technical Agreements

4.4.22.1 Review the technical agreements and Enclose the Technical agreements if any

4.4.23 Marketing authorization, post marketing commitments, and technical agreements

4.4.23.1 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.

4.4.24 Regulatory Inspections and External Audits

4.4.24.1 Describe the customer audits and regulatory audits and its finding and corrective actions taken for the raised deviations

4.4.25 Changes in the Facility or Equipment

4.4.25.1 Summarize the changes in the facility and equipment if any.

4.5 Data Analysis

4.5.1 Data generated from the product shall be trended using statistical techniques.

4.5.2 The data should be analyzed to determine if a) process is in control and b) is that process is capable?

4.5.3 The data shall be analyzed using the following techniques

4.5.3.1 Controls Charts

4.5.3.1.1 Prepare the control charts and analyze the data and make sure that the data shall be within the control limits.

4.5.3.2 Process capability study

4.5.3.2.1 Cp and CpK values shall be at 1.33 or above