Quality Assurance

SOP For Sampling of Swab/Rinse

 OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for sampling of Rinse / Swab during manufacturing of different products. SCOPE: This SOP is applicable for sampling of Rinse / Swab during manufacturing of different types of products at manufacturing facility. RESPONSIBILITY: Authorized designee of QA shall prepare the

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SOP For Recording Pressure Difference in Manufacturing Area

OBJECTIVE: The purpose of this SOP is to provide a procedure for recording pressure difference in cubicle with respect to adjacent area. SCOPE: This SOP is applicable to checking of pressure difference in cubicles with respect to adjacent area at manufacturing facility.    RESPONSIBILITY: Authorized designee of user department shall be responsible for recording of differential

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SOP For Label Control

OBJECTIVE: The purpose of this SOP is to lay down the procedure for handling of different type of labels ( Label Control) in production department. SCOPE: This SOP is applicable for handling of different type of labelsat manufacturing facility. RESPONSIBILITY: Authorized designee of user department is responsible to maintain thestatus label in department. Head- user

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

               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

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

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

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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