Factory and Hospital Hygiene

There are many definitions of quality (see Sharp, 2000). For the purpose of pharmaceutical products the term quality is usually taken to mean fitness for purpose. Not only must the product have the desired therapeutic properties; it must also be safe for administration by the route intended. Some products such as injections must be sterile, while others such as oral drugs need not be sterile, but must be free from pathogens that can be contracted via the oral route (British Pharmacopoeia, 2003). A great deal more space in the literature is dedicated to quality of sterile products, but this reflects the additional quality assurance required compared with that for non-sterile products (Sharp, 2000).

Manufacturing is carried out in both industry and hospitals. In the latter, batches tend to be much smaller, sometimes only one item, and the products are stored for much less time, usually less than 24 hours (Beaney, 2001).

The difficulty in demonstrating quality is that the tests carried out are designed to detect its absence.

For example, the test for sterility involves taking samples at random and testing for microorganisms. The absence of microorganisms only allows an estimate of the statistical probability that the batch is sterile. Therefore it is important hat a product be manufactured in a suitable environment by a procedure that minimizes the possibility of contamination occurring. At the end of this process the tests can be performed as an additional measure.

The UK Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers and Distributors, 2002) emphasizes the fundamental point that the manufacture of sterile products: must strictly follow carefully established and validated methods of preparation and procedure. Sole reliance for sterility or other quality aspects must not be placed on any terminal process or finished product test. 

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