CAPA Management: A well-defined CAPA system ensures product safety and regulatory compliance and drives continuous improvement. 🟢CAPA Workflow: →Identification: Detect...
What is change control A Process which ensures that changes to procedures, materials, methods, equipment, and software are properly documented, approved, validated and traceable. CHANGE CONTROL...
What is QM? The quality manual is a statement of the Company’s Quality Policy and Quality Objectives of the organization. Which Guideline follow for preparation of QM? US FDA 21 CFR Parts 210...
Title: Raw Material Test Method Material Name: Vitamin E Acetate 50 % Dry PowderGeneric Name ...
A Quality by Design (QbD) approach to understanding tablet compression failures and preventing them through proper material, machine, and process controlTablet Compression Under QbD: What Regulators...
Current Good Manufacturing Practices (cGMP) Regulatory Framework for Pharmaceutical Manufacturing Excellence Introduction to cGMP ...
HPLC Method Development Analytical method development is a critical process in pharmaceuticals. The variety of columns, operating parameters, mobile phase compositions, and pH values...
Worst-Case Media Fill Design | Sterile Production ...
Clinical Pharmacy Process Clinical Pharmacy Process Reference Book: Clinical Pharmacy and Therapeutics Authors: D. G. Webb, J. G. Davies and D....