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
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
What is CFR 21 PART 11 compliance
What is HEPA filter
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies