QMS

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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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 on Change Control

Quality Assurance, Uncategorized

SOP on Change control The purpose of this SOP is to lay down a procedure to “Change Control” to ensure that the proposed changes shall not affect the strength, identity, safety, purity and quality of the product. PROCEDURE: TYPES OF CHANGE CONTROL: DOCUMENT CHANGE CONTROL (DC) : Initiation of a document or modification of approved …

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