ABSTRACT:
Good Documentation Practice (GDP) is a term used in the pharmaceutical industry. Good Documentation is an integral part of good manufacturing practices. it is essential for the integrity of data collection and reporting for supporting development, registrations, commercialization, and life-cycle management of pharmaceutical products. Documents are a mirror to show actual image of any pharmaceutical Industry. Such measures that collectively and individually ensure documentation, whether paper or electronic, is attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate.
Cite this article:
Pravin D. Kolekar, Avinash Mahadeo Bhagwat. Good Documentation Practices: A Need of Pharmaceutical Industry. Asian Journal of Research in Chemistry. 2021; 14(5):368-4. doi: 10.52711/0974-4150.2021.00063
Cite(Electronic):
Pravin D. Kolekar, Avinash Mahadeo Bhagwat. Good Documentation Practices: A Need of Pharmaceutical Industry. Asian Journal of Research in Chemistry. 2021; 14(5):368-4. doi: 10.52711/0974-4150.2021.00063 Available on: https://ajrconline.org/AbstractView.aspx?PID=2021-14-5-12
REFERENCES:
1. Mehta Binny, Hemangini Makwana, Pinak Patel, Krunal Detholia. A Concise Review on "Good Documentation Practice". JPSBR .02 March 2019; ISSN NO. 2271-3681, Page No 24.
2. Sandle Tim. Good Documentation Practices. Journal of validation Technology. Oct 2014; Volume 20. Page No.1.
3. Brunei Darussalam and Lao PDR. Documentation ASEAN THMS Product Working Group. 30 November 2016; Page No. 4.
4. Choudhary Ankur. Requirements for Good Documentation Practices, Pharmaceutical Guidelines, 2014; Page No- 1.
5. Mehta Binny, Hemangini Makwana, Pinak Patel, Krunal Detholia. A Concise Review on "Good Documentation Practice". JPSBR .02 March 2019; ISSN NO. 2271-3681, Page No 24.
6. Choudhary Ankur. Requirements for Good Documentation Practices, Pharmaceutical Guidelines, 2014; Page No- 1.
7. Pharmaout team. White Paper: How to Implement Good Documentation Practices. February 2016; Page No. 2.
8. Kumar Krishan Good Documentation Practices in Pharmaceutica Industry, Journal of Analytical and Pharmaceutical Research, March 08, 2017; Volume 4 (Issue 2): Page No-1,2.
9. Bhattacharya Joymalya. Good Documentation Practice (Gap): Coordinate Regulatory Requirements in Pharmaceutical Manufacturing Industry. IOSK-JPBS. Sep-Oct 2014; Volume 9. Issue 5 Ver VI. Page No. 24.
10. Sandle Tim. Good Documentation Practices. Journal of validation Technology. Oct 2014; Volume 20. Page No. 2-3.
11. Indian Pharmaceutical Alliance. Good Documentation Practices Guidelines, IPA Innovation, Quality and global rech, February 2018 page No.9.
12. Bhattacharya Joymalya. Good Documentation Practice (Gap): Coordinate Regulatory Requirements in Pharmaceutical Manufacturing Industry. IOSK-JPBS. Sep-Oct 2014; Volume 9. Issue 5 Ver VI. Page No.25.
13. Sandle Tim. Good Documentation Practices. Journal of validation Technology. Oct 2014; Volume 20. Page No.2-6
14. European Commission: Good Documentation Practices Health and Consumers Directorates-General. Article 47 of Directive 2001/83/EC; Page No.4-5.
15. Arpad Ambrus, G. Suszter. Quality Control and Quality Assurance. Analysis of Pesticides in Food Environmental Samples, March 2019; Page No.2.
16. Bhattacharya Joymalya. Good Documentation Practice (Gap): Coordinate Regulatory Requirements in Pharmaceutical Manufacturing Industry. IOSK-JPBS. Sep-Oct 2014; Volume 9. Issue 5 Ver VI. Page No.24.