Month: October 2020

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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