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Friday, June 12, 2009

Site Master file of a pharmaceutical manufacturing unit requirements

As per the requirement of WHO GMP certification of a pharmaceuticals manufacturing company , a pharmaceuticals manufacturer has to submit detailed information about pharmaceuticals manufacturing facility for which he want to get WHO GMP certification.
This set of information about the pharmaceuticals manufacturing unit is called as Site master file
A site master file of a pharmaceutical manufacturing unit is a set of documents made by the manufacturer which contains precise and factual GMP information about the pharmaceutical production and its control procedures of pharmaceutical manufacturing operations being carried out at the manufacturing site as well as any other closely integrated operations at premises and nearby premises, suppose if some part of a pharmaceutical manufacturing operations are carried out at the the premises , the site master file should describe only those operations,like, analysis, packaging,storing, distribution etc
I am giving here a link for a guide of MHRA for your reference for making a site master so look for that on this page : Site master file for pharmaceuticals

Following are some of articles which;will be useful for you in further understanding of aspects of sterile dosage form manufacturing

Pharmaceutical Validation

Cleen Room Classification

Pharmaceutical Industry

Pharmaceutical Manufacturing

Clinical Trials

Media fill

Regulatory Affairs in Pharmaceutical Industry

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