Quality Assurance

SOP for recording of temperature, relative humidity (RH) & Pressure differential

Production

               The purpose of this SOP is to lay down the procedure for recording of temperature, relative humidity (RH) & Pressure differential of a particular area from digital thermo hygrometer / data logger & calibrated Magnehelic gauge. SCOPE:                This SOP shall be applicable for recording of temperature, relative humidity (RH) & Pressure differential through …

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FDA WARNING LETTER – Shilpa Medicare Limited

FDA Warning Letter

Shilpa Medicare Limited FDA Warning Letter 2020 Delivery Method:VIA UPSProduct:Drugs Recipient:Mr. Vishnukant Chaturbhuj BhutadaManaging DirectorShilpa Medicare Limited #12-6-214/A1 Hyderabad RoadRaichur 584135 KarnatakaIndiaIssuing Office:Center for Drug Evaluation and Research | CDER United States Warning Letter 320-21-01 October 9, 2020 Dear Mr. Bhutada: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility at Shilpa Medicare Limited, …

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Cleaning Validation Protocol Format

Quality Assurance

A cleaning validation protocol format shall be developed for the ‘worst case’ product selected for cleaning validation programme. Following information (but not limited to) the following included in the cleaning validation protocol. Numbering of protocol shall done through of respective SOP of Cleaning Validation Protocol Numbering. Cleaning Validation Protocol Format – Objective: A brief description …

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SOP For Vendor Management

Quality Assurance

The manufacturer or supplier who is supplying the material in routine and registered for the supply of specific material after the approval process considered as an approved vendor. Vendor management consists of the Identification, Qualification, Requalification, management of changes at the vendor site, Vendor Audit, Technical Agreement, Deregistration Process, etc. Vendor Management   PURPOSE: The …

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SOP for BMR & BPR Review

Quality Assurance

Standard Operating Procedure (SOP) for Review of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) in the pharmaceutical manufacturing plant. A detailed checklist for review of BMR and BPR for Draft Copy as well as  Filled Copy of Batch Manufacturing/Packing Records.  Procedure for BMR & BPR Review 1.0       PURPOSE: The purpose of …

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SOP For Handling of Power Failure in Plant

Quality Assurance

Standard Operating Procedure (SOP) for Handling Power Failure situations in different areas like Production, Quality Control, Microbiology, Utility, Stores, etc at the pharmaceutical drug manufacturing plant. Procedure for Handling of Power Failure in Pharma 1.0   Purpose: To lay down a procedure for handling power failure situations. 2.0   Scope:This procedure is applicable to handling power failure …

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SOP For Batch Release of Finished Product

Quality Control

Standard Operating Procedure (SOP) for approval and release of Finished Product Batch for moving from the manufacturing site to supply chain/distributors or C&F warehouses.  Procedure for Finished Product Batch Release1.0   PURPOSE: To lay down the procedure for approval and release of the finished product batch. 2.0   SCOPE: This Standard Operating Procedure is applicable for all …

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