1. Необходимость внедрения GMP

2. Ответственность за внедрение и поддержание GMP

3. Контроль качества

4. Обучение персонала базовым принципам GMP

5. Соблюдение требований гигиены

6. Ведение производственных записей

1. All aspects of pharmaceutical manufacture must comply with the most rigorous standards to ensure consistent production of a safe, effective product. The principles underlining such standards are summarized in publications which detail good manufacturing practice (GMP). Pharmaceutical manufacturers must be familiar with the principles laid down in these publications and they are legally obliged to ensure adoption of these principles to their specific manufacturing process. Regulatory authority personnel will assess compliance of the manufacturer with these principles.

2. Most of the principles outlined in such guides to GMP are equally as applicable to the manufacture of traditional pharmaceuticals as to the newer biopharmaceutical preparations. However, the regulatory authorities have found it necessary to publish additional guidelines relating to many of the newer biotechnology-based biopharmaceuticals. Examples include the ‘Points to Consider’ series, which contain guidelines relating to safe production, e.g. of recombinant biopharmaceuticals produced by genetic engineering.

3. Appropriate design and layout of the pharmaceutical facility is an issue central to the production of safe, effective medicines. In common with many other manufacturing facilities, pharmaceutical facilities contain specific production, quality control (QC) and storage areas, etc. However, certain aspects of facility design and operation are unique to this industry, in particular with regard to manufacturers of parenteral products. Incorporation of these features is rendered mandatory by guides to pharmaceutical GMP.

4. Validation can be defined as ‘the act of proving that any procedure, process, equipment, material, activity or system leads to the expected results’. Routine and adequate validation studies form a core principle of GMP as applied to biopharmaceutical manufacture, as such studies help assure the overall safety of the finished product . All validation procedures must be carefully designed and fully documented in written format. The results of all validation studies undertaken must also be documented, and retained in the plant files.

5. Although separate guides to pharmaceutical GMP are published in different world regions the principles outlined in them all are largely similar. In Europe, for example, the European Union (EU) publishes the EU Guide to Good Manufacturing Practice for Medicinal Products. This guide consists of a number of chapters, each of which is concerned with a specific aspect of pharmaceutical manufacture. The principles therein often appear little more than common-sense guidelines.

6. The manufacture of pharmaceutical substances is one of the most highly regulated and rigorously controlled manufacturing processes known. In order to gain a manufacturing licence, the producer must prove to the regulatory authorities that not only is the product itself safe and effective, but that all aspects of the proposed manufacturing process comply to the highest safety and quality standards. Various elements contribute to the safe manufacture of quality pharmaceutical products.