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…
Category: Pharma Manufacturing
SOP for Validation/Qualification Policy in Pharmaceutical Industry
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:…
EudraLex Volume 4 – Good manufacturing Practice (GMP) guidelines
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…
SOP for Repacking of Products in Pharmaceutical Industry
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…
SOP for Incident Handling in Pharmaceutical Industry: PharmaState
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…
SOP on Calibration Management in Pharmaceutical Industry
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…
SOP for finished product Inspection and Release in Pharmaceuticals
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:…
FRIABILITY TEST
(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…
Cleanroom Standards – ISO Guidelines
(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)…
Procedure for Cleaning and Monitoring of Clean Room Pass Boxes
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-…
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