Pharmaceutical ingredients for both human and veterinary preparations.

Sometimes several firms cooperate in the production (including packaging and labelling) of an active pharmaceutical ingredient. It may also happen that a finished, packed, and labelled active pharmaceutical ingredient is repacked and/or relabelled and given a new designation. Since such procedures constitute part of a manufacturing operation, they should be subject to the relevant guidelines set out below.
The practices outlined below are intended to apply to active pharmaceutical ingredients for both human and veterinary preparations.
Personnel
Each firm should employ personnel with the necessary qualifications and competence for the production and quality control of active pharmaceutical ingredients. There should be an adequate number of staff with appropriate education, technical knowledge, and practical experience related to the job they perform.
The firm should have a defined organization represented in a chart. Individual responsibilities should be laid down in written instructions, to ensure that there are no gaps or overlaps. The responsibilities placed on any one individual should not be so extensive as to incur any risk to quality.
Staff at all levels should be adequately trained for the tasks and responsibilities assigned to them.
Measures should be taken to ensure that no person affected by a disease in a communicable form or having open lesions on the exposed surface of the body is engaged in any production step involving direct contact with the active pharmaceutical ingredients.
Premises
Premises, including areas containing open tanks, should be of suitable construction. They should provide a suitable environment for manufacturing operations and should be adequately adapted to and of a sufficient size for their intended use. The premises should not contribute to actual or potential mix-ups or contamination of the active pharmaceutical ingredients. The arrangement should provide for a logical work flow.
For special purposes, such as the production of sterile products and of certain antibiotics, hormones, and cytostatic substances, separate specifically designed enclosed areas with completely separate air-handling systems should be provided.
To maintain hygienic working conditions, the premises should include facilities for changing clothes, washing, and toilet purposes as well as for eating, drinking, and smoking.
Equipment
Manufacturing equipment should be designed, constructed, located, and maintained in such a way as to:
(a) be suitable for its intended use;
(b) facilitate thorough cleaning;
(c) minimize the risk of contamination of products and containers during production; and
(d) facilitate efficient and, if applicable, validated and reliable operation.