Course Overview:
The Annual Product Quality Review (APQR) is a cornerstone of GMP compliance, providing ongoing assurance that processes remain in control, specifications remain appropriate, and products continue to meet quality, safety, and efficacy standards.
Yet many organisations still struggle with incomplete PQRs, poor data integrity, inadequate trending, unclear responsibilities, or ineffective use of statistics — all of which have been highlighted repeatedly in global regulatory findings.
This training programme provides a practical, end-to-end understanding of APQR requirements under PIC/S PE009-17, TGA interpretations, FDA expectations, and international best practices. Using real examples and cases from regulatory inspections, participants will learn how to plan, conduct, analyse, document, and defend an APQR that withstands regulatory scrutiny.
Course Outline:
DAY 1 — Foundations & Requirements
Regulatory Basics
- PIC/S requirements
- API requirements
- Regulatory expectations & common findings
Planning the APQR
- Scope, grouping, schedule
- Roles & responsibilities (QA/QC/RA/Production)
- Compliance obligations & MA variations
Data Inputs & Integrity
- Ensuring complete, accurate data
- Mapping data sources & consolidation
Qualitative Review
- Deviations, CAPA, complaints
- Change controls, stability trends
- Supplier/API traceability
- Equipment/utility qualification
DAY 2 — Analysis, Trending & Reporting (Short Version)
Quantitative Analysis Qualitative Interpretation
- Trending CQAs & CPPs
- SPC basics: charts & rules- Capability (Cp/Cpk/Pp/Ppk)
- Identifying drift & need for revalidation
- Cross-functional trends, CAPA effectiveness
- Systemic vs isolated issues
Grouping & Frequency
- Scientific grouping criteria
- Review-by-exception
- FDA APR differences
APQR Reporting
- Required sections & structure, Writing conclusions & trends clearly
- CAPA recommendations
Participants:
This course is suitable for both participants new to Product Quality Reviews and experienced professionals involved in GMP compliance. It is particularly valuable for those responsible for compiling, reviewing, or interpreting PQR data across quality, manufacturing, QC, regulatory, or technical functions, equipping them with the skills needed to manage product and process risks effectively through robust annual reviews.