PowerPoint Presentation

[Audio] Annual Product Quality Review Annual Product Quality Review Section 19 contains guidance that only applies to the manufacture of APIs used in the production of investigational medicinal products although it should be noted that its application in this case, although recommended, is not required in PIC/S countries.

[Audio] Agenda General Overview of APQR 01 Live Demo 05 Process flow 04 Out of Specification 03 Stability study of substances 02.

[Audio] General Overview The Annual Product Review is an annual evaluation to ensure the quality of each drug product. It verifies process consistency, checks current specifications, and identifies trends, prompting adjustments to specifications, manufacturing processes, or control procedures as needed. APQR is the documented evidence provides review of product on annual basis for the quality purpose. It is a regulatory requirement for Pharma companies..

[Audio] Stability Study Prescribed storage conditions to maintain optimal product integrity and stability. Monitoring changes in drug quality over time due to temperature, humidity, and light exposure. Employing stress testing and controlled storage conditions to simulate environmental factors' effects. Defined re-test periods to periodically evaluate product quality and potency. Established shelf lives to guarantee safety, efficacy, and consistent quality throughout the product's lifespan. Critical assessment of product stability and shelf-life through environmental impact analysis.

[Audio] Out of Specifications Process Capability A process-capability study to assess the ability of a process to meet specifications. Occurrence Out of Specifications Manufacturing error Storage error/Stability Analytical error Sampling error A result or observation outside predetermined acceptance criteria for a process or product. Out of Trend Analyzing historical data, trends, and patterns for similar products or processes to identify potential issues contributing to OOS findings OOS/OOT can occur due to: Cp Cpk Pp & Ppk.

[Audio] Stability Study report and results Out of specifications for each conditions (real time/long term/ accelerated studies). Occurrence Out of Specifications Manufacturing error Storage error/Stability Analytical error Sampling error A result or observation outside predetermined acceptance criteria for a process or product. Out of Trend Analyzing historical data, trends, and patterns for similar products or processes to identify potential issues contributing to OOS findings OOS/OOT can occour due to:.

[Audio] Process Flow NO YES Identify and report Document Deviations Identification of Product Substances (API) Analyse trend charts Identify OOS Calculate CPK,PPK Analyze process capability Identify root causes Root Cause Analyses Stress testing Conduct degradation assay Storage Condition Test Stability Study.

[Audio] Gradient Customer Journey Map 05 03 01 Stability Study Stress testing Conduct degradation assay Storage Condition Test 02 Identify OOS 04 Root Cause Analyses Calculate CPK,PPK Analyze process capability Identify root causes 06 Identify and report Document Deviations Analyse trend charts Identification of Product Substances (API).

[Audio] Process Flow Conduct degradation assay Identification of Product Substances (API) Stability Study Stress testing Storage Condition Test Analyse trend charts Identify OOS Identify and report Stress testing Identify root causes Root Cause Analyses Calculate CPK,PPK Analyze process capability Document Deviations.

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[Audio] THANK YOU. THANK YOU.