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Friday, August 22, 2008

CHANGE CONTROL DOCUMENT CHANGE CONTROL IN PHARMACEUTICAL MANUFACTURING

CHANGE CONTROL DOCUMENT
Change control Document for a WHO GMP pharmaceutical manufacturing company
It is a very important document in pharmaceutical industry.
It is intended to controls any change in manufacturing
Process
It studies all aspects and effects of the proposed change on product quality.
Efficacy, and all aspects of Quality Assurance measures

To effectively control any change happening in pharmaceutical manufacturing change control management should consider following points



1.ORIGINATING DEPARTMENT:- From where the change is originated or recommended
ORIGINATOR :- what is the opinion of originator.

2.CHANGES PROPOSED :- what are the changes proposed.
3.COMMENTS OF ORIGINATING DEPARTMENT ON THE CHANGES
( Brief details of why change(s) is/are proposed and what is expected from changes)
4.COMMENTS FROM QA DEPARTMENT
5.COMMENT FROM THE PRODUCTION DEPARTMENT
6.COMMENT FROM THE PARTY IF ANY
Change control sample document

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

FDA guidelines

What is CFR 21 PART 11 compliance

What is HEPA filter

To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies

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