(2003; 148 pages)
6.3 WHO GMP: main principles for pharmaceutical products
The Committee was informed of the main changes that had been made in revising these GMP guidelines, to incorporate texts and recommendations published separately, and to bring the guidelines into line with current GMP requirements, particularly in relation to validation, authorized persons, documentation and definitions. Consultations in December 2000 and August 2001 had been arranged to consider comments made by interested parties. During these consultations, all comments received were carefully examined.
The Committee discussed the difficulty of implementing cleaning validation in some countries and the apparent lack of guidelines on this subject to assist GMP inspectors. Examples of guidelines currently available were brought to the attention of the Committee. It was recommended that WHO should start work soon on the preparation of additional guidance documents for key areas of GMP such as validation and aerosol manufacture.
The Committee adopted the revised guidelines “Good Manufacturing Practices for pharmaceutical products: main principles” (Annex 4) and noted that they should be discussed at the next meeting of the Expert Committee to take account of any comments made in the interim.