Quality Assurance

 USER REQUIREMENT SPECIFICATION                    STERILE API FACILITY 1.0 Introduction  1.1 Scope of the Project:                                                           The project envisages setting up of a Greenfield Sterile API manufacturing facility and...

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...

SMF (Site Master File) as the name indicates is a document that provides authentic information regarding the site of a pharmaceutical manufacturing plant. The...

1.0 Objective To establish the guidelines for destruction of drug products and its components. Scope: This sop shall be applicable for rejection, collecting, accounting & safe destruction...

1.0 Objective To lay down a procedure for issuance, preparation, storage, usage and disposal of disinfectant solution. 2.0 Scope This SOP is applicable for issuance, preparation, storage,...

Objective To lay down a procedure for code transfer of same material from one code to another and to carry out additional testing of APIs,...

1.0 Objective To lay down a procedure for the Corrective and Preventive Action so as to eliminate the causes of potential non-conformities and /or encountered...

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.            ...

1.0 Objective To lay down a procedure for electronic data backup management system. 2.0 Scope This standard operating procedure is applicable at IT department of pharmaceutical company. 3.0...

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...