application of cGMP

Since there are fundamental distinctions between the production of bulk active pharmaceutical ingredients and the formulation of finished pharmaceutical products, the strict application of GMP as set forth in the main part of this guide is not always practical or necessary. The present supplementary guidelines outline procedures and practices that manufacturers should employ to ensure that the methods, facilities, and controls used for the production of active pharmaceutical ingredients are operated or managed so that such products have the quality and purity appropriate for their use in finished pharmaceutical products.
General considerations
In the manufacture of active pharmaceutical ingredients, overall control is essential to ensure high quality. Haphazard operations cannot be permitted in the manufacture of substances that may be used to save life or to restore or promote health.
Recommended practices for the manufacture of active pharmaceutical ingredients are set out below. Adherence to these practices, complementing the various control tests carried out from the beginning to the end of the production cycle, will contribute substantially to the production of consistently uniform batches of high-quality active pharmaceutical ingredients.
The manufacturer must assume responsibility for the quality of the active pharmaceutical ingredients produced. The manufacturer alone can avoid mis-takes and prevent mishaps by exercising adequate care in both production and control procedures. Full evidence of compliance with GMP should be given from the step from which the processes or the starting materials used have a critical influence on the quality of the active pharmaceutical ingredient. This step should be determined in each individual case by agreement between the competent authority and the manufacturer.
The good practices outlined below should be considered general guides; whenever necessary, they may be adapted to meet individual needs provided the established standards of quality of the active pharmaceutical ingredients are still achieved. The good practices are intended to apply to the manufacturing processes (including packaging and labelling) used in the production of active pharmaceutical ingredients.