Objective: To lay down a procedure for validation/qualification policy for equipment, system and instruments. Scope: This procedure is applicable for production/engineering equipment, utilities and laboratory instruments. Responsibility:…
Summary of contents Part I- Basic Requirement for medicinal products Part I has following 9 chapters: Chapter 1: Pharmaceutical quality system Chapter 2: Personnel Chapter…
1. Objective: To lay down a procedure for repacking of finished products. Scope: This procedure is applicable for repacking activities of finished products to be…
1. Objective: To lay down a procedure for handling of incidents. Scope: This procedure is applicable for accidental and untoward events occurring in factory premises. Incidents…
Objective: To lay down a procedure for management of calibration procedure. Scope: This procedure is applicable for QC instruments, production equipment, utility service and all other…
Objective: To lay down a procedure for finished product inspection and release. Scope: This procedure is applicable for all type of finished pharmaceutical product. Responsibility:…
(A) Subjective: Procedure for performing Friability test on Tablets. (B) Purpose: This procedure is applicable for friability test on tablets and calibration of friabilator used…
(A) Background: Before global cleanroom classifications and standards were adopted by the International Standards Organization (ISO), the U.S. General Service Administration’s standards (known as FS209E)…
Cleaning of Clean- Room Pass Boxes: (A) Subject: Procedure for Cleaning of Class- Room Pass Boxes. (B) Purpose: This procedure is applicable for Cleaning of Clean-…
A Clean- Room is an environment in which several parameters (like Contamination, Pressurization, Temperature & Humidity and Personnel Access) are controlled, monitored and maintained. Basically…
Please confirm you want to block this member.
You will no longer be able to:
Please allow a few minutes for this process to complete.
You must be logged in to post a comment.