A Review on Creation and handling of data in accordance with cGMP requirements in Pharmaceuticals

May 2017 ARTICLE LIST >>

PharmaTutor (May - 2017)

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

Received On: 13/02/2017; Accepted On: 21/02/2017; Published On: 01/05/2017

AUTHORS:
Suleman S. khoja * 1, Sohil S khoja 1,Parthkumar H chauhan 2,Farhad S Khoja 3 ,Shamim S Khoja3.
1 Resource person in Pharmaceutical Quality Assurance, Audit and Compliance, Vapi -396191.
2 Resource person in Quality Assurance, Navsari
3 Registered Pharmacist ,Gujarat State Pharmacy council, Vapi -396191.
premukhoja@gmail.com
 

ABSTRACT:
Data integrity is fundamental in a pharmaceutical quality system which ensures the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA), Arrangements shall be in place within an organisation with respect to people, systems and facilities that shall be  designed, operated and where appropriate adapted to support a working environment and  organisational culture that ensures data is complete consistent and accurate in all its forms, i.e. paper  and electronic record.

 

How to cite this article: Khoja SS, Khoja S, Chauhan PH, Khoja FS, Khoja S; A Review on Creation and handling of data in accordance with cGMP requirements in Pharmaceuticals; PharmaTutor; 2017; 5(5);64-69

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