Impurities can be classified into the following categories: Organic Impurities (Process And Drug-Related) Inorganic Impurities Residual…
Category: GMP & Guidelines
Concurrent Validation
Description : Concurrent Validation is one the approach of Process Validation where batches are released for marketing prior…
CEHT (Clean Equipment Hold Time Study)
Why is the CEHT important for the control of a cleaning process? Essentially the reason is…
Fire Extinguisher-Safety Guidelines
What is fire? Fire is the rapid oxidation of a material in the exothermic chemical process of combustion, releasing heat, light, and various reaction products.…
MACO Calculation
Maximum Allowable Carryover (MACO) shall be calculated based upon theses three criteria. Using Health Based Data…
Personal Protective Equipment (PPEs)- Safety Guideline
What is PPE? PPE can include items such as safety helmets, gloves, eye protection, hazmat suits,…
Dealing With Industrial Emergency Conditions-Safety Guidelines
This covers basic steps to handle emergencies in the workplace. These emergencies include accidental releases of…
Validation Master Plan for Pharmaceutical Industry
Author of the document Prepared by Designation: Signature Date: Reviewer of the…
SOP for Quality Management System (Documentation) in Pharmaceutical Industry
Objective: To lay down a procedure for origination and review of the Site Master File, Quality …