If the emerging changes in current good manufacturing practices (cGMP) worldwide are indications, the pharmaceutical industry is moving towards a complete global harmonization. Whether it is WHO, US FDA, ICH or even the revised Schedule M of the Indian Drugs & Cosmetics Act, certainly the stage is set for imminent world integration in the quality standards as far as the pharmaceutical production is concerned.

The two-day workshop on "Changing scenario of cGMP regulations" jointly organized by the Indian Pharmaceutical Association (IPA) with American Association of Pharmaceutical Scientists (AAPS) International Pharmaceutical Federation (IFP), which started today in Mumbai, has clearly stated this emerging trend in the international pharmaceutical arena.

Pharma industry that is significantly influenced by the discoveries and the advancements in science and technology is at present one of the highly regulated and knowledge based industries worldwide. As the safety and efficacy have been the primary concerns ever for the international drug regulatory agencies, the good manufacturing practices in this sector that help to ensure right quality products undergo change to meet increasing demands for regulatory compliance.

Emphasizing the need and the developments of significant revisions in the GMPs, Dr Vinod P Shah, sr research scientist, US FDA, Dr S Nagarsenkar of Aventis Pharma, Ajit Singh, CMD, ACG Worldwide, the eminent speakers in the opening session on the first day expressed their views that the innovative change in the GMP standards is an ongoing process and in the recent past it has been quite evident by the revisions in the USFDA guidelines, Schedule M requirements of CDSCO India and also in the ICH guideline.

While Dr Venkateswarlu, deputy drug controller, India, elaborated the current scenario in the Indian cGMP compliance level and the see change in the attitude of the industry in the country, Dr Vinod P Shah said that new risk based approach in the cGMP guidelines of US FDA is indication to advancements in the thought process within the world pharma sector.

The presentation made by Andre J Van Zyl from WHO, Geneva, on audit and inspection perspectives also stressed the importance of changing scenario in the cGMP that corroborated the industry views on global harmonization in quality norms.

Barry Fox, Mendel Company, USA, spoke about GMP compliance for pharmaceutical compliance and Mukund Yelvigi from Wyeth, USA made a presentation on process validation and the right concepts in the important sessions on the first day of the work shop.

The second day workshop, which will discuss various other GMP aspects in the chemical, biotechnology and plant/herb based pharma products will conclude on Tuesday.