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