A Review on Quality Agreement requirement in Pharmaceuticals by Regulatory Authority in Compliance to cGMP Guidelines

May 2017 ARTICLE LIST >>

PharmaTutor (May - 2017)

ISSN: 2347 - 7881
(Volume 5, Issue 5)

Received On: 14/01/2017; Accepted On: 27/01/2017; Published On: 01/05/2017

AUTHORS:
Suleman S khoja ¹, Sohil S khoja ¹, Farhad S Khoja ², Shamim S Khoja², Narmin A Pirani^2
1Resource person in Pharmaceutical Quality Assurance and Facility Audit,
Vapi, Gujarat, India.
² Registered Pharmacist,
Gujarat State Pharmacy Council, Gujarat.
* premukhoja@gmail.com
 

ABSTRACT:
A quality agreement is a comprehensive written agreement between parties involved in the contract manufacturing of drugs that defines and establishes each party’s manufacturing activities in terms of how each will comply with CGMP. Quality agreements may be reviewed during inspections. A quality agreement describes the owner’s and the contract facility’s roles and manufacturing activities under CGMP.

 

How to cite this article: Khoja SS,Khoja S, Khoja FS,Khoja S, Pirani NA; A Review on Quality Agreement requirement in Pharmaceuticals by Regulatory Authority in Compliance to cGMP Guidelines; PharmaTutor; 2017; 5(5); 24-28

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