In Pharmaceutical, an Annual product quality review (APQR) is of high importance to summarize the product quality for an improvement or to know the product trends.
APQR is also known as Annual Product Review (APR) and Product Quality Review (PQR).
What is Annual Product Quality Review (APQR)?
APQR is a regular, periodic review of all commercially licensed medicinal products conducted in order to verify the consistency of the existing processes, parameters, right specification for starting materials and finished products, deviations, change control, market complaints and product improvements, and providing feedback on the quality of products.
An annual report summarizes and records all manufacturing activities, including analytical and physical testing, stability, deviations, change controls, recalls, and market complaints. It provides a comprehensive overview of how well each drug product meets the quality standards.
Which guidelines talk about Annual Product Quality Review (APQR)?
Regulatory requirements APQR are EU-GMP part-I, Chapter – I, and in 21 CFR – Parts 210 and 211 Subpart – J (Records and Report) 211.180 (e), ICH Q7, and PIC/S.
When APQR is Prepared?
For the purpose of determining when the APQR has been completed, it is prepared annually for the calendar year (Jan. to Dec.) or the financial year (March to April) in the year designated as the cut off date for finalization of the APQR.
The APQR for each batch manufactured during the year must be prepared regardless of the number of batches produced.
What Annual Product Quality Review (APQR) Includes (But not Limited to)?
- It includes Product Name, Generic Name, Strength, Market, Label Claim, Storage environment, Shelf life, Primary packaging, and complete packaging information.
- Manufacturing date, batch size (kg, units), and expiration date.
- Active Pharmaceutical Ingredients (API), excipients, and packaging materials used for both primary and secondary packaging.
- The review of equipment and utilities such as compressed air, gas, and HVAC systems qualification
- The quality of the water used in the process will be reviewed, and data will be compiled for pH, conductivity, TOC, and microbial tests.
- Reviews of batch manufacturing and packing records, including, at a minimum, key process parameters (e.g., LOD during drying, weight variation, hardness, friability, disintegration test, and coating weight gain), critical process parameters (CPP), and critical quality attributes (CQA), Manufacturing and packing yield.
- Including in-process controls and finished product analyses, along with trends and graphs for Release Testing data.
- Review of stability studies of commercial batches and any out-of-specification or out-of-trend issues.
- Review of the specifications for raw materials, packaging materials, and drugs.
- Review of validation activities related to products and processes.
- Review of Change Controls and deviations, including their status, e.g., open or closed.
- A summary of Corrective and Preventive Actions (CAPAs) related to Processes and Drugs.
- Review of any Out Of Specification (OOS) or Out Of Trend results (OOT).
- Complaints review, including complaints received, the status of complaints (open and close), etc.
- Recalls and product alerts.
- Review of Returned Finished Goods.
- Review of elemental impurities.
- If any, review the previous annual product quality review.
- During the review of APQR, observations and findings should be included in the conclusion.
The conclusion of any annual product quality review (APQR) is extremely important, as it, in essence, reflects the quality of that product.
Note: If packing of the batch is not done or not completed in the manufacturing year, the details of packing and quality control parameters of the same batch should be included in the next year’s annual product quality review.
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