PIC/S: TRAINING THE REGULATORS TO REGULATE cGMP COMPLIANCE

  • Rajkumar Gupta

Abstract

PIC/S is an international Organization for implementing cGMP standards in its member countries. The basic objective of PIC/S is to improve and standardize cGMP compliance in member countries. Their aim is to enhance GMP intelligence via sharing of GMP inspection reports. Further it wants to reduce duplication of inspections to save the cost and time.


Their regulations are directed to promote harmony in GMP standards and to train national regulatory authorities for cGMP vigilance. They requires that every nation shall empower the legislation to inspect the facilities as per definite program, to issue notices for noncompliance, to impart regular training to all concerned employees.

Keywords: cGMP, GMP, PIC/S, OOS, Compliance, Inspection.

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References

1. The Pharmaceutical Inspection Cooperation Scheme - PIC/S [Internet]. 2014 [cited, 2014 March 3]; Available from:
www.picscheme.org
2. Wikipedia, the free encyclopedia. The Pharmaceutical Inspection Cooperation Scheme - PIC/S [Internet]. 2014 [cited, 2014 April 4]; Available from:
http://en.wikipedia.org/wiki/ wiki/PICS
3. The Pharmaceutical Inspection Cooperation Scheme - PIC/S. Wikipedia, the free encyclopedia [Internet]. 2014 [cited, 2014 April 15]; Available from:
www.picscheme.org/pics.php
4. The Pharmaceutical Inspection Cooperation Scheme - PIC/S. GMP Guidelines [Internet]. 2013 Jan [cited, 2014 April 21]; Available from:
http://www.picscheme.org/pdf/PE_009-10_GMP_Guide.zip
5. The Pharmaceutical Inspection Cooperation Scheme - PIC/S. PICS Convention [Internet]. 2011 Nov [cited, 2014 April 15]; Available from:
http://www.picscheme.org/pdf/05_pics-01-95-rev-5-pic-scheme.pdf
6. Standard Operating procedures for Team Inspections [Internet]. 2009 July [cited, 2014 April 15]; Available from:
http://www.picscheme.org/pdf/11_pi-031-1-sop-on-team-inspections.pdf
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How to Cite
Gupta, R. “PIC/S: TRAINING THE REGULATORS TO REGULATE CGMP COMPLIANCE”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 3, Feb. 2018, pp. 48-51, doi:10.22270/ijdra.v2i3.141.