Friday, May 17, 2024

Protocol for  Validation of Sterilization Process using Steam Sterilizer (Bung Processor)

Protocol For Validation Of Sterilization Process Using Steam Sterilizer (Bung Processor) Equipment ID Aseptic Processing Area Location: Pharmaceutical Company Document No. Supersedes Effective Date No. of Pages   PROTOCOL CONTENTS Sr. No.            ...

Qualification of Water System

Qualification of Water System Earlier pharmaceutical industries used to rely on one time procedures that had a severe impact on the formulations resulting in product...

SOP on Handling of Non-Conformances

1.0 Objective To lay down a procedure for handling of non-conformances. 2.0 Scope This Standard Operating Procedure is applicable for handling of non-conformances associated with product (s)...

How to Write a Validation Protocol?

A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report and...

VMP (Validation Master Plan) Preparation Guideline in Pharmaceuticals

Validation Master Plan VMP is a roadmap of validation activity like facility qualification and also define system and area to be validated. VMP justifies the...

Testing of Primary Packaging Materials

1.0 Objective To lay down a procedure for Testing of Primary Packaging Materials. 2.0 Scope This Standard Operating Procedure is applicable pharmaceutical formulation plant. 3.0 Responsibility QC- officer...