Audit and Guideline

GLOSSARY – Validation of Analytical Procedures 1. Analytical Procedure: The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of …

VALIDATION AND QUALIFICATION OF WATER PURIFICATION Validation Requirement:  Establishing reliability of pharmaceutical water purification, storage, and distribution systems requires demonstrating control of the process through an appropriate period of monitoring and observation. Finished water is typically continuously produced and used, while product and process attributes may only be periodically assessed. The quality …

ANALYTICAL INSTRUMENT QUALIFICATION A large variety of laboratory equipment, instruments, and computerized analytical systems  are used in the pharmaceutical industry to acquire data to help ensure that products are suitable for their intended use. An analyst’s objective is to consistently obtain reliable and valid data suitable for the intended purpose. Depending on the …

Analytical Instrument Categories Users are  establishing the level of qualification needed for an instrument. On the basis of the level needed, it is to categorize instruments into three groups: A, B, and C, as  for detail defined below. Examples of instruments in each group are provided. Note that the list of instruments …

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USFDA WARNING LETTER 2016 (Finished Pharmaceuticals) in Pharma Noven Pharmaceuticals, Inc. 8/5/16 Huzhou Aupower Sanitary Commodity 8/10/16 Frontida BioPharm Inc 8/15/16 College Pharmacy Incorporated 8/15/16 Ajes Pharmaceuticals LLC 9/9/16 Mappel Industria de Embalagens S.A. 9/12/16 Cheng Fong Chemical Co., Ltd. 9/15/16 Yangzhou Hengyuan Daily Chemical Plastic Co Ltd 9/26/16 Laboratoire …

USFDA WARNING LETTER 2014 (Finished Pharmaceuticals) in Pharma Usv Limited 2/6/14 SmithKline Beecham (Cork) Ltd. 3/18/14 Sun Pharmaceutical Industries Limited – Karkhadi 5/7/14 Apotex Pharmachem India Pvt Ltd. 6/16/14 M.D. Science Lab 7/15/14 Zions Rx Formulations Services LLC dba Rx Formuations Serv. 8/15/14 Wells Pharmacy Network LLC 11/10/14 Pharmagen Laboratories, …