The main objective of a pharmaceutical plant is to produce finished products for patients’ use a combination of materials (starting and packaging).
Materials include starting materials, packaging materials, gases, solvents, process aids, reagents and labelling materials.
No materials used for operations such as cleaning, lubrication of equipment and pest control should come into direct contact with the product. Where possible, such materials should be of a suitable grade (e.g. food grade) to minimize health risks.
All incoming materials and finished products should be quarantined immediately after receipt or processing, until they are released for use or distribution.
All materials and products should be stored under the appropriate conditions established by the manufacturer, and in an orderly fashion, to permit batch segregation and stock rotation by a first-expire, first-out rule.
Water used in the manufacture of pharmaceutical products should be suitable for its intended use.
