Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

GMP Relating to Medicinal Products - Quality Instrument or Regulatory Burden ***

Dr. Hans-Jürgen Mika (Abschlußjahr: 2002)

The role of GMP in the context of quality referring to medicinal products is described. The need for having a sophisticated quality assurance system established in drug product manufacturing is illustrated. A concise definition of quality, namely "fit for purpose" as a result of considering the meaning of quality in various fields of every day life is given. The basic principles of GMP are explained. The philosophy of having the entire manufacturing process devoted to the spirit of quality assurance instead of solely performing spot checks of the finished product at the stage of release testing is thoroughly illustrated. GMP being the globally well established approach of assuring quality of medicinal products is depicted as a powerful tool of quality assurance. In terms of quality assurance GMP goes further than the ISO 9000 series. Referring to the manufacturing of drug products ISO 9000 et seq. do not set extra standards which have not yet already been covered by GMP.

The embedding of GMP into the legal framework of Europe and the USA is explained. The differences of EU and US GMP are described, in particular the differences in the legal enforcement. The US GMP rules are statutory, given in 21CFR (Title 21 of the Code of Federal Regulation) and thus legally binding whereas the European rules are more flexible. Their essential principles are fixed by a binding directive, namely Directive 91/356/EEC and the more detailed rules are provided as guidelines like the EC Guide to Good Manufacturing Practice and the annexes thereof which are supplementary guidelines.

The role of WHO, PIC/S and ICH in the field of GMP regulations is outlined. The world-wide contributions of these supranational organisations have provided a widely consonant understanding of GMP and pharmaceutical quality. This in turn is promoting global harmonisation of quality standards and global trade of pharmaceutical products. Compliance to widely harmonised GMP standards is attractive from a business point of view, since it offers access to a multitude of market places.

GMP compliance is a mandatory prerequisite for drug product manufacturers for staying in business. GMP compliance is an inherent component of pharmaceutical manufacturing and in no way an add on at the discretion of the manufacturer. In the same way the costs caused by the pharmaceutical entrepreneur's efforts to meet GMP standards are inherent to drug manufacturing and in no way an "extra" burden. Since factual grounds clearly substantiate that GMP is the best suited approach for assuring the quality of pharmaceutical products, it is for these factual grounds that GMP rules have to be followed. The legal enforcement of GMP rules reflects the responsibility of governmental organisations for public health but does not indicate despotism of regulatory authorities.

GMP which is primarily aiming at the regular manufacturing of marketed medicinal products is now expanding its scope and will soon include the manufacture of investigational drug products, i.e. clinical trial supplies and the manufacture of drug substances (synonym: active pharmaceutical ingredients ? APIs). In view of that it is to be expected that the manufacturing of pharmaceutical excipients will become sooner or later a subject of GMP regulation too.

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