Pharmaceutical Regulatory Affairs: Open Access

Regulatory Need: Harmonized PIC/S GMP, Its Overview and Comparison with WHO GMP

Abstract

Charmy Kothari and Rushvi Patel

Currently, it is necessary to increase harmonization efforts in setting regulatory requirements, inspecting and evaluating GMP compliance, licensing manufacturing sites, recalling defective batches and increasing the exchange of information due to the increased globalization regulatory authorities. PIC/S offers attractive and stable platform to respond such challenges of the globalization. PIC/S actively encourage networking by organizing a “PIC/S GMP Forum” which allow non-member authorities, professional and other organizations to meet informally with the PIC/S Committee. PIC/s has established harmonized guide on GMP requirements for inspectorate and industry. There is the complementarity co-operation between the PIC/S and other organization. PIC/S participating authority co-operates actively and avoids the duplication of his member’s efforts. Till date, 46 countries are the member of the PIC/S and 10 countries are under Accession and Pre-Accession Procedure. PIC/S provide the sharing of the inspection report between the member authorities which allow them to prove their GMP facility equivalent to PIC/S standard and resulting into the reduction of the number of inspection and duplication of the inspection. Joining to PIC/S will endorse the Indian pharmaceutical companies to be reliable exporters of quality medicines globally. While for Indian Pharma Companies to meet the PIC/S requirement would not be like cakewalk especially for MSME Pharma segment that needs to upgrade their GMP facilities. Thus it will be challenging for stake holders to join PIC/S but simultaneously there will be bigger hurdles of not joining the PIC/S. While approaching to PIC/S, a careful examination is needed by India during export as maintaining high quality standards for export markets. PIC/S is bringing a great revolution in the GMP standards to establish the high quality in the drug product and thus INDIA should become the member of PIC/S to raise its GMP standards as it is recognized as ‘power house’ of pharmaceutical manufacturing.