SOP on Vendor Qualification/Approval in Pharmaceutical Industry
1. Objective: To lay down a procedure for vendor approval. Scope: This procedure is applicable for vendors supplying raw materials and packaging materials. Responsibility: Quality…
Category: Quality Control
Important SOPs for Quality Control Department (Chemical section) in Pharmaceutical Industry
Sampling of raw material, packaging material, bulk, intermediate and finished product Raw material, packaging material, bulk, intermediate and finished product analysis Cleaning and storage of…
SOP on Data Integrity in Pharmaceutical Industry
Objective: To lay down a procedure for data integrity as part of quality management system. Scope: This procedure is applicable for all the data associated…
Important SOPs for Quality Assurance in Pharmaceutical Industry
Preparation, review, approval and control of SOPs Training procedure Handling and control of documents Change control Handling of deviations SOP for line clearance Handling of…
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:…
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-…
Working Principles for Dynamic and Static Pass Boxes
(1) Dynamic Pass Box: Procedure on the working of Dynamic Pass Box. (A) Objective: This working principle is applicable for usage of Dynamic Pass Box in formulation…
Pharmaceutical Quality/Manufacturing Standards (CGMP)- US FDA
Below is a sortable listing of Pharmaceutical Quality/Manufacturing Standards (CGMP) Guidances CATEGORY TITLE Pharmaceutical Quality/Manufacturing Standards (CGMP) COMPRESSED MEDICAL GASES GUIDELINE Compliance; Pharmaceutical…
Pharma Regulations and Guidelines-India, Easy Access Links
(1). Regulations & Guidelines: CDSCO Central Drugs Standard Control Organization (CDSCO), under MOHFW (Ministry of Health & Family Welfare), Government of…
FROM ALCOA TO ALCOA PLUS- DATA INTEGRITY
ALCOA:- Coined By: – Stan Woollen in Early 1990s. 1999 FDA Guidance:- ALCOA- To be acceptable; the data from the Clinical Trials should meet…
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