QA & QC
Understanding Stratified Sampling in Pharmaceutical Industry
FDA recommends the necessity of statistically sound sampling plans [Intra-Location (within a single location) Variability and Inter-Location (between locations) Variability] and acceptance criteria [acceptable range of deviation from the mean content, the variability of measurements, and the percentage of units falling within predetermined limits is based on statistical principles] to ... Read More
Excellence in Change Management | Industry Best Practices for QMS
Change Management is a critical process within a Quality Management System (QMS) that ensures all modifications are systematically evaluated, implemented, and verified to maintain compliance, quality, and efficiency. Following are the critical stages or steps as a part of the Change Management process are: Raise a Change Request Cross Functional ... Read More
Verification of OOS Results | EDQM Guidelines
VERIFICATION OF INITIAL OUT-OF-SPECIFICATION RESULTS SCOPE The objective of this Annex is to describe the steps to follow for the management of out-of-specification (OOS) testing results. The failure investigation may also be triggered if validation criteria defined by the method or laboratory are not met, including out-of-trend (OOT) results. To ... Read More
CAPA Management in FDA Regulated Industry
A CAPA plan is a quality management strategy used in the manufacturing and production industries to identify and rectify defects to ensure they won’t repeat again in the future. Once a CAPA plan is implemented, it must illustrate ten objectives to meet the intent of the FDA 21 CFR 820.100 ... Read More
Product Quality and Performance Tests for the Microsphere Drug Products
Microparticulate systems such as microspheres, microcapsules, or any particle in a micrometer scale (usually of 1–1000 µm) are widely used as drug delivery systems, owing to their higher therapeutic and diagnostic performance compared to conventional drug delivery forms. These systems can be manufactured with many raw materials, especially polymers, most ... Read More
Difference Between OOS and Deviation
OOS (Out of Specification) and deviation are terms commonly used in the context of quality management, particularly in pharmaceuticals industries. Here’s a brief overview of each term: Out of Specification (OOS) Definition: An OOS result occurs when the test results of a sample fall outside the established acceptance criteria or ... Read More
Difference Between Quality Control (QC) and Quality Assurance (QA)
Quality control and quality assurance are two essential concepts that help ensure the safety and quality of the finished products. While both concepts share the same goal of maintaining high standards, they approach this goal in different ways. Quality control involves inspecting and testing products at various stages of production ... Read More
In-Process Control Procedure in Pharmaceutical Industry
IPC are checks that are carried out during manufacturing process running and/or before the manufacturing process is completed. The function of in-process controls is in-process monitoring in order to comply with the specifications. This may include control of equipment and environment too. In-process materials should be tested for identity, strength, ... Read More
CAPA Process Steps in Pharmaceutical Industry
Each pharmaceutical manufacturer shall establish and maintain procedures for implementing corrective and preventive action (CAPA). And the procedures must ensure all requirements of CAPA subsystem are met. CAPA Subsystem in Context CAPA Process CAPA Sources Internal Sources External Sources CAPA Process Steps 1. Analyze Data Ensure all quality data sources ... Read More
Difference Between Out of Specification (OOS) and Out of Trend (OOT)
OOS and OOT are two common terms in pharmaceutical quality control laboratory. In this article we mention the similarities and differences between Out of Specifications (OOS) and Out of Trend (OOT) Similarities between Out of Specifications (OOS) and Out of Trend (OOT) a. Both OOS and OOT are conducted in ... Read More