Two directives laying down principles and guidelines of GMP for medicinal products were adopted by the European Commission. Directive 2003/94/EC applies to medicinal products for human use and Directive 91/412/EEC for veterinary use. Detailed guidelines in accordance with those principles are published in the Guide to Good Manufacturing Practice, which will be used in assessing applications for manufacturing authorisations and as a basis for inspection of manufacturers of medicinal products.
The Guide is presented in three parts and supplemented by a series of annexes. Part I covers GMP principles for the manufacture of medicinal products. Part II covers GMP for active substances used as starting materials. Part III contains GMP related documents, which clarify regulatory expectations.a The quality of pharmaceuticals has been a concern of the World Health Organization (WHO) since its inception. The setting of global standards is requested in Article 2 of the WHO Constitution, which cites as one of the Organization’s functions that it should “develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products.”
The first GMP text published by WHO was developed during 1967-69 upon request by WHO’s Member States and was revised in 1975.
Revised and expanded GMP guidelines were prepared during 1989-90, approved by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in late 1990 and subsequently published by WHO. At that time, Part One of these revised and expanded guidelines set out the philosophy and essential elements of GMP; Part Two dealt with good practices in production and quality control. These two parts together represented the “core” of the GMP guidelines published by WHO.
The alert reader can easily detect that the EU and WHO guidelines are based on the same principles but differ in detail.
This study is supposed to compare the EU and WHO GMP guidelines and work out the differences, especially with regard to the question which GMP guideline contains the stricter and more expensive requirements and in which sections. The statement that the EU GMP guidelines are supposed to be more expensive with regard to the adaption and implementation of the requirements but lead to a hiqher quality shall be herewith reviewed.
Furthermore, it shall be stated exemplary where the critical and consuming requirements of the WHO with regard to the implementation of GMP can be seen, bearing in mind that especially developing countries adhere to WHO GMP guidelines. For this purpose, polls have to be executed with pharmaceutical producers in Africa and, for ease of reference, smaller manufacturers in Europe.
Finally, this study should inform, in how far the adaption of WHO GMP guidelines can be sensible or a harmonisation of requirements is unavoidable. Especially with regard to the compliance of requests developing countries are facing, a risk- Orientated sensitivity is necessary, i.e. minimising requirements which are unnecessary and too expensive but implemented voluntarily in Europe / USA.