Classification of Impurities
Impurities can be classified into the following categories: Organic Impurities (Process And Drug-Related) Inorganic Impurities Residual Solvents Organic Impurities : Organic impurities can arise during…
Category: GMP & Guidelines
Concurrent Validation
Description: Concurrent Validation is one the approach of Process Validation where batches are released for marketing prior to approval of batches of complete validation package based on…
CEHT (Clean Equipment Hold Time Study)
Why is the CEHT important for the control of a cleaning process? Essentially the reason is that nothing stays clean forever. It should be realized…
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. Classification of Fire : There are six classes of fire…
MACO Calculation
Maximum Allowable Carryover (MACO) shall be calculated based upon theses three criteria. Using Health Based Data Based on Therapeutic Daily Dose (TDD) Based on LD50…
Personal Protective Equipment (PPEs)- Safety Guideline
What is PPE? PPE can include items such as safety helmets, gloves, eye protection, hazmat suits, high-visibility clothing, safety footwear, safety harnesses, ear plugs, ear…
Dealing With Industrial Emergency Conditions-Safety Guidelines
This covers basic steps to handle emergencies in the workplace. These emergencies include accidental releases of toxic gases, chemical spills, fires, explosions, and bodily harm…
USFDA New Data Integrity and Compliance Guideline
(published in Dec 2018) Background : The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (cGMP)…
Validation Master Plan for Pharmaceutical Industry
Author of the document Prepared by Designation: Signature Date: Reviewer of the document for correctness Reviewed by: Designation: Signature: Date: Approver of the document for…
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 Manual, Quality Policy, SOPs, forms and logs. Scope: This…
You must be logged in to post a comment.