Pharmaceuticals CAPA Management Overview
Corrective Action: Reacting to existing problems, complaints, or nonconformities and fixing them.
Preventive Action: Detecting potential problems/non ...
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Quality Assurance
Quality Control
HPLC Basics - Comprehensive Study Note
HPLC is an abbreviation for High Performance Liquid Chromatography (previously referred to as High Pressure LC).
Key difference from LC: In principle ...
Job Preparation
HPLC Interview Question and Answer for Pharmaceutical Job Preparation
HPLC (High Performance Liquid Chromatography) is an analytical technique used to separate, identify, and quantify components in a mixture. In pharmace ...
Quality Control
Pharmaceuticals Cleaning Validation
Cleaning validation is documented evidence that an approved cleaning procedure will reproducibly remove the previous product or cleaning agents used i ...
Production
Isolators and RABS Technology for Pharmaceuticals Aseptic Processing
Restricted Access Barrier Systems (RABS) are intermediate technology between traditional cleanrooms and full isolators. RABS provide a physical barrie ...
Production
Pharmaceuticals Sterile Dosage Forms and Aseptic Processing
Sterile products can be manufactured by two primary methods: 1) Terminal sterilization (product sterilized in final container) and 2) Aseptic processi ...
Production
Pharmaceuticals Solid Dosage Manufacturing Facility Design
Solid dosage forms, primarily tablets and capsules, represent the largest category of pharmaceutical products by volume. The design of facilities for ...
Engineering
Pharmaceuticals Cleanroom Features and Construction Materials
All cleanroom surfaces must be non-porous, non-shedding, easily cleanable, and resistant to the cleaning agents and disinfectants used. Joints and sea ...
Engineering
GMP Requirements for Pharmaceutical Facility Design
Pharmaceutical facilities must be designed, constructed, and maintained to ensure that products are consistently manufactured to the required quality ...
Production
PIC/S Classification System for Pharmaceutical Sterile Products
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international organization between pharmaceut ...