Attachment No. 9
to the Rules of Good Manufacturing Practice
Содержимое (Table of Contents)
MANUFACTURE OF LIQUIDS, CREAMS AND OINTMENTS
1. Liquids, creams and ointments are particularly vulnerable to microbial and other contamination. For this reason special measures shall be taken to prevent any contamination.
2. (1) It is recommended to use closed systems to ensure protection from contamination when manufacturing and relocating products. Processing areas where open products or open clean packages are placed, as a rule, shall be effectively ventilated by filtered air.
3. (2) The design and arrangement of reactors, containers, pipelines and pumps shall allow easy cleaning and sanitary treatment, if necessary. In particular, the design of the equipment shall contain as less inaccessible areas or parts as possible for remains of products may stay there and create a medium for the growth of microorganisms.
4. (3) Parts of equipment touching the products shall be generally made of high-quality stainless steel.
5. (4) It is necessary to define and control the quality of used water in terms of chemical and microbiological cleanliness. To eliminate any risk of growth of microorganisms the maintenance of water treatment systems shall be properly organized. After any chemical and sanitary treatment of water treatment systems they shall be washed in accordance with a validated procedure that ensures complete removal of disinfectants.
6. (5) The quality of raw materials received in big containers shall be checked before the materials have been put into containers for storage.
7. (6) It is necessary to control the transportation of raw materials in pipelines to ensure their arrival at the right place.
8. (7) There shall be no materials losing fibres or spreading other contaminants (e.g. cardboard or wooden pallets) in rooms where open products or open clean packages are kept.
9. (8) During pre-packing it is necessary to ensure the homogeneity of mixtures, suspensions and other bulk products. The processes of mixing and pre-packing shall be validated. Special attention shall be paid to the homogeneity of mixtures at the beginning of the filling process, during pauses and when it is completed.
10. (9) If finished products are not packed immediately, it is required to set the maximum allowed period before their packaging, and define appropriate storage conditions that shall be strictly observed.