Manufacturers of therapeutic goods (TG) intended for supply in Australia are required to comply with Good Manufacturing Practice (GMP) appropriate to the class of goods supplied. For medicines this is the Pharmaceutical Inspection Convention “Guide To GMP for Medicinal Products” (commonly but erroneously referred to as the “Code of GMP”), which requires that the environment in which medicines are manufactured be monitored, and out of specification (OOS) results be investigated. Two OOS investigations involving manufacture of sterile TGs are discussed, used root cause analysis based on Professor Kaoru Ishikawa’s use of cause and effect diagrams (also called the "Ishikawa" or "fishbone" diagram).
The standards for some special environments (cleanrooms) are covered in the ISO 14644 intended to serve as a standard for a wide range of industries with different needs, such as the electronic, and TG industries. ISO14644 is in 10 parts or more, some in draft. For example, part 1 covers “Classification of Air Cleanliness”, part 2 “Testing for Continued Compliance”, and so on. This presentation will cover some of the major changes recently published or in draft which could have some impact or conflicts with the requirements to comply with the Code of GMP.