Oral Liquid Formulations
The oral liquids are homogenous liquid preparations, which contain an emulsion, solution or suspension of one or more active ingredients that are suitable as liquid…
Tag: Production
Why Up-Skilling is required in Pharma Industry?
It’s an old saying “Change or DIE” but it holds true in every sense & in all times. Darwin clearly says that Survival of the…
SOP for User Requirement Specification in Pharmaceutical Industry
ObjectiveTo lay down a procedure for User requirement specification (URS). ScopeThis is applicable mainly to production equipment and utility systems. It shall also be applicable…
SOP for Cleaning and Sterilization of Bulk Storage Tank
1. Objective: To lay down a procedure for cleaning and sterilization of bulk storage tank during batch to batch and product to product cleaning. Scope: This…
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 Failure Investigation in Pharmaceutical Industry
Objective: To lay down a procedure for failure investigation. Scope: This procedure is applicable for investigation of process or system failure having impact on…
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…
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…
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