The Annual Product Quality Review (APQR) is a structured, yearly health checkup for manufactured pharmaceutical products.
ย It evaluates manufacturing, quality, and compliance data to verify process consistency, identify emerging risks, and ensure patient safety. It is also a mandatory legal requirement for maintaining a license to operate.
๐๐ก๐ฒ ๐ข๐ฌ ๐ข๐ญ ๐ข๐ฆ๐ฉ๐จ๐ซ๐ญ๐๐ง๐ญ ๐ญ๐จ ๐๐จ๐ง๐๐ฎ๐๐ญ ๐๐ง ๐๐ง๐ง๐ฎ๐๐ฅ ๐๐ซ๐จ๐๐ฎ๐๐ญ ๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒ ๐๐๐ฏ๐ข๐๐ฐ (๐๐๐๐) ๐ข๐ง ๐๐ก๐๐ซ๐ฆ๐?
Annual Product Quality Reviewย is not only aย legal requirementย but also allows the company to better understand the processes and take improvement actions toย ensure product quality.
In pharma, APQR / PQR determines the need for changes to the manufacturing process, in-process controls, and specifications. This involves identifying improvements to the product and manufacturing process based on trend analysis and risk assessment.
๐๐ก๐ ๐จ๐๐ฃ๐๐๐ญ๐ข๐ฏ๐๐ฌ ๐จ๐ ๐ญ๐ก๐ ๐๐๐ ๐ข๐ง๐๐ฅ๐ฎ๐๐:
- Verification of product performance.
- Consistency of the manufacturing process.
- Determination of the need for revalidation of manufacturing processes.
๐๐ก๐๐ญ ๐๐ซ๐ ๐ญ๐ก๐ ๐๐๐ง๐๐๐ข๐ญ๐ฌ ๐จ๐ ๐ ๐๐ซ๐จ๐๐ฎ๐๐ญ ๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒ ๐๐๐ฏ๐ข๐๐ฐ (๐๐๐)?
- Ensures Product Quality
- Facilitates the adjustment of process, raw material and excipient specifications
- Process improvement
- Helps identify areas of improvement to adjust processing and control procedures
- Reduction of quality defects
- Better understanding of production processes and identification of tendencies
- Identification of potential risks due to variations in processes and materials
- Compliance with regulatory authority requirements
- Generates a consistent, efficient and effective way of working
- Encourages a culture of prevention rather than reaction
- Better product knowledge
๐๐๐ง๐๐ซ๐๐ฅ ๐ฌ๐ญ๐๐ ๐๐ฌ ๐จ๐ ๐ญ๐ก๐ ๐๐ซ๐จ๐๐ฎ๐๐ญ ๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒ ๐๐๐ฏ๐ข๐๐ฐ ๐๐ซ๐จ๐๐๐ฌ๐ฌ ๐ข๐ง ๐๐ก๐๐ซ๐ฆ๐
- Data Collection
- Data Analysis & Trend Assessment
- Risk Assessment and Investigation
- Compilation of the PQR Report
- Management Review and Approval
๐๐ก๐จ ๐ข๐ฌ ๐ซ๐๐ฌ๐ฉ๐จ๐ง๐ฌ๐ข๐๐ฅ๐ ๐๐จ๐ซ ๐๐๐๐ ๐๐จ๐ฆ๐ฉ๐ฅ๐ข๐๐ง๐๐?
APQR ownership sits with Quality Assurance, supported by QC, Manufacturing, Engineering/Validation, and Regulatory Affairs.ย All these business functions collaborate to prepare a comprehensive APQR report with inputs from all the stakeholders. The report must be finally reviewed by a senior Quality Assurance person before it is submitted to the concerned regulatory agency.
๐๐ก๐๐ง ๐ฌ๐ก๐จ๐ฎ๐ฅ๐ ๐ฒ๐จ๐ฎ ๐ฌ๐ฎ๐๐ฆ๐ข๐ญ ๐ญ๐ก๐ ๐๐๐๐?
- Calendar year: JanuaryโDecember, with the APQR report issued by the end of Q1.
- Rolling 12-month period: Common for low-volume products or mid-year launches
Annual Product Quality Review brings together manufacturing, laboratory, stability, complaint, and investigation data to provide a complete picture of product quality.ย