PIC/S: TRAINING THE REGULATORS TO REGULATE cGMP COMPLIANCE
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.
Downloads
References
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
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM