Validation Lifecycle
Validation lifecycle approach is linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control…
Process For Vendor Audit
Audit Process: The process of managing the Vendor Audit Program is conducted in the following phases: Initiation Pre-audit & Audit Planning Preparation of Audit Audit…
MSDS Format
It is a document that contains information on the potential hazards (health, fire, reactivity and environmental) and how to work safely with the chemical product.(MSDS…
MSDS : Material Safety Data Sheet
What is a Material Safety Data Sheet (MSDS)? A material safety data sheet is a technical document, which provides detailed and comprehensive information on a…
Types of Impurities
Impurity is considered as any other inorganic or organic material, or residual solvents other than the drug substances, or ingredients, that arise out of synthesis or…
ETA : Event Tree Analysis
Introduction ETA has gained widespread acceptance as a mature methodology for dependability and risk analysis and is applied in diverse industry branches ranging from aviation…
COMPLIANCE: KEY TO BUSINESS REPUTATION
We are living in an era of increased regulation and renewed enforcement efforts, especially for public companies as well as private companies. Governmental regulation and…
Calibration of Reactor
1.Objective : To lay down the procedure for the calibration of reactor used in API manufacturing. 2. Scope : Applicable in API manufacturing industry. 3.…
FTA: Fault Tree Analysis
FTA is one of the important investigation tool. Introduction Fault tree analysis (FTA) is concerned with the identification and analysis of conditions and factors that…
APQR- Annual Product Quality Review
The Annual Product Quality review (APQR) is an effective quality improvement tool to enhance the consistency of the process and the overall quality of the…
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