The Pharmaceutical Inspection Convention (PIC) and  Pharmaceutical Inspection Co-Operation Scheme (PICS) has now issued a guide to good manufacturing practice (GMP) for medicinal products. The objective is to further facilitate the removal of trade barriers in medicinal products. It would also  promote uniformity in licensing decisions and to ensure maintaining of high standards of quality assurance in the development, manufacture and control of medicinal products.
 
The standards set out apply to medicines and similar products intended for human use. It is recommended, however, that the same kind of attention be given to the manufacture of veterinary products. Administrative measures of national health authorities should be directed towards the application of these standards in practice.

According to PICS, any new or amended national regulations for GMP should at least meet their level. The standards are also intended to serve manufacturers as a basis for the elaboration of specific rules adapted to their individual needs.
 
It is recognised that there are acceptable methods, other than those described in this guidance. These norms are not intended to place any restraint upon the development of new concepts, which have been validated and provide a level of Quality Assurance.
 
The guidance is divided into two parts with common annexes.  Part I covers GMP principles for the manufacture of medicinal products. Part II covers GMP for active substances. It also  provides details on specific areas of activity.
 
According to Kaushik Desai, pharma consultant, the PIC/S guidance is a step in the right direction  and in line with the current global requirements.
 
Originally, the PIC/S GMP Guide derives from the WHO GMP guide. It was further developed to comply with stringent manufacturing requirements in PIC/S countries, to cover new areas like biologicals, radiopharmaceuticals among others.  The aim of such improvements was to ensure that high quality medicines were produced in line with the PIC Convention and then the PIC Scheme.
 
In 1989, the  EU adopted its own GMP guide, which was equivalent to the PIC/S GMP. Since that time, the EU and the PIC/S GMP guides have been developed in parallel and whenever a change has been made to one, the other has been amended so that both Guides are practically identical.
 
There are, however, some differences between the EU and the PIC/S GMP. These differences are related to  the  expression ‘authorised person’ used in the PIC/S guide is referred to as ‘qualified person’ in the EU guide.  Since not all participating authorities under the PIC Scheme are parties to the European Pharmacopoeia Convention, the mention of European Pharmacopoeia in the guidance has been amended as European or other relevant Pharmacopoeia.
 
In  2001, the PIC/S committee adopted the GMP guide for Active Pharmaceutical Ingredients developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as a stand-alone guide. The first draft of this GMP guide for APIs was elaborated by PIC/S, before it was transferred to ICH.