Year: 2020

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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Sterility Testing in Pharmaceutical Product as per USFDA Guideline

Sterility Testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Sterility testing is very important for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms. A. Method Suitability Test For all product types, follow current USP …

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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 on Site Master File (SMF) Preparation

Standard Operating Procedure (SOP) and Guideline for preparation, approval, and revision of Site Master File (SMF). The Site Master File (SMF) Document shall contain specific information about the quality management policies, activities of the site, the production and/or quality control, pharmaceutical manufacturing operations, and any closely integrated operations at adjacent and nearby buildings. Guideline for …

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WARNING LETTER

Pfizer Healthcare India Private Limited Warning Letter 2020 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Pfizer Healthcare India Private Limited, FEI 3008316085, at Plots 116-117-118-119-111-123 (part), Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam, Andhra Pradesh, India, from August 29 to September 6, 2019. This warning letter summarizes significant violations of current …

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Checklist for Microbiological Analytical Data and Reports

Checklist for review of microbiology data generated during the different tests of microbiology i.e. Antibiotic Assays, Particulate matter test, BET test, Preservative effectiveness testing ( Antimicrobial effectiveness testing), Microbial limit test (MLT), sterility, water analysis, and preservative effectiveness testing, Sterility testing. etc. Checklist for Microbiological Analytical Data and Reports Followings are the checkpoints during the …

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SOP For Microbial Culture Management

A microbial culture (microbiological culture) is a procedure of growing microbial organisms (reproduction) by allowing them to breed in programmed culture medium under controlled laboratory conditions. Microbial cultures are initial and basic diagnostic methods used as a research tool in molecular biology. Microbial Culture Management Standard Operating Procedure (SOP) PURPOSE: To lay down the procedure …

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