Open AccessPIC/S: TRAINING THE REGULATORS TO REGULATE cGMP COMPLIANCE
Author(s) -
Rajkumar Gupta
Publication year - 2018
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v2i3.141
Subject(s) - compliance (psychology) , legislation , business , harmony (color) , law , political science , psychology , social psychology , art , visual arts
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.