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...
What is VMP Brief information about Qualification, Validation and calibration of Equipment, Instrument and System. A document providing information on the company’s validation work programme. ...
What is SMF? Site Master File is Full information about the site. Site Master file is a document that summarises the firm’s overall philosophy, intentions and approach to be used for...
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 ...
TABLE OF CONTENTS Sl. No. Description 01METHOD OF ANALYSIS ...