September 2017 ARTICLE LIST >>
PharmaTutor (September - 2017)
ISSN: 2347 - 7881
(Volume 5, Issue 9)
Received On: 04/05/2017; Accepted On: 01/06/2017; Published On: 01/09/2017
AUTHORS:
Suleman S. khoja * 1, Sohil S. khoja 1, Karim R. Panjwani1, Jagdish Ray 1, Parthkumar H. chauhan 2
1Resource person in Pharmaceutical Quality Assurance,
Audit and Compliance, Vapi, Gujarat, India.
2 Resource person in Quality Assurance, Navsari, Gujarat, India
* premukhoja@gmail.com
ABSTRACT:
It has been always International Regulatory concern on Role and Responsibility of Pharmaceutical Higher Management in this review article we have taken some of the concern and how responsible leadership should ensure the support and commitment of staff at all levels and sites within the organization to the Pharmaceutical Quality System ,management review , Quality committee and to make a platform for leadership engagement, awareness and decision making around quality and process performance.Implement new controls as per GMP Guidelines to check impact and management tool for identification and reduction of human Errors in pharmaceuticals Industry.
How to cite this article: Khoja SS, Khoja SS, Panjwani KR, Ray J, Chauhan PH;A review on International Regulatory concern on Role and Responsibility of Pharmaceutical Higher Management; PharmaTutor; 2017; 5(9);7-9
[ABSTRACT WITH CITATION] [VIEW AS HTML]
REFERENCES:
1. ICH Harmonised Tripartite Guideline, Pharmaceutical quality systems Q10, in: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2008.
2. Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Chapter 1 Pharmaceutical Quality System.
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/vol4-chap1_2013-01_en.pdf.
3. Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Chapter 4 Documentation. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/chapter4_01-2011_en.pdf.
4. Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Chapter 8 Complain, quality defect and Product Recall. https://ec.europa.eu/health/sites/health/files/files/eudraex/vol-4/2014-08_gmp_chap8.pdf.
5. Khoja SS, Khoja S, Chauhan PH, Khoja FS; A review on USFDA warning letter and violation observed in Pharmaceutical Industry; PharmaTutor; 2016; 4(12); 33-36.
6. Khoja SS, Khoja S, Khoja FS, Khoja S, Pirani N; Impact and management tool for identification and reduction of human Errors in pharmaceuticals Industry; PharmaTutor; 2017; 5(2); 7-13.
7. 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
8. ICH Harmonised Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7. in: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2000.
9. 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.
10. ICH Harmonised Tripartite Guideline, Quality risk management Q9, in: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2005.
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