19-09-2012, 05:01 PM
GMP Manufacturing
GMP.pptx (Size: 254.33 KB / Downloads: 29)
What is GMP?
DEFINITON:
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
U.S. GMP REGULATIONS
All drugs shall be manufactured , processed and packaged in accordance with CGMP
No distinction is drawn between the manufacture of drug product and the manufacture of API’S
The requirements for compliance to cGMP are lain down in the following code of federal regulations (21 CFR)
Part 210 : cGMP in manufacturing , processing , packing (or) holding of drug
Part 211 : cGMP for finishing pharmaceuticals
ORGANISATION AND PERSONNEL
A)Responsibilities of quality control unit:
QC unit having responsibility and authority to approve and reject all components, drug product containers, closers, in process materials, packing materials, labeling and drug product.
The authority to review production records to assure that no errors have occurred.
It approve are reject all materials, specifications and procedures.
It must be described in written procedures.
GMP.pptx (Size: 254.33 KB / Downloads: 29)
What is GMP?
DEFINITON:
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
U.S. GMP REGULATIONS
All drugs shall be manufactured , processed and packaged in accordance with CGMP
No distinction is drawn between the manufacture of drug product and the manufacture of API’S
The requirements for compliance to cGMP are lain down in the following code of federal regulations (21 CFR)
Part 210 : cGMP in manufacturing , processing , packing (or) holding of drug
Part 211 : cGMP for finishing pharmaceuticals
ORGANISATION AND PERSONNEL
A)Responsibilities of quality control unit:
QC unit having responsibility and authority to approve and reject all components, drug product containers, closers, in process materials, packing materials, labeling and drug product.
The authority to review production records to assure that no errors have occurred.
It approve are reject all materials, specifications and procedures.
It must be described in written procedures.