EU Guidelines For Computerized System Part -1

PrincipleThis annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities.The application should be validated; IT infrastructure should be qualified.Where a computerised system replaces a manual operation, there should be no resultant decrease …

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Manufacture of Liquids, Creams and Ointments

PrincipleLiquids, creams and ointments may be particularly susceptible to microbial and othercontamination during manufacture. Therefore special measures must be taken to prevent any contamination. Premises and equipment The use of closed systems for processing and transfer is recommended in order to protect the product from contamination. Production areas where the products or open clean containers …

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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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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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