Good Manufacturing Practice history

Sheinin, E.B., ICH guidelines. History, Present Status, Intent, presented at the International Good Manufacturing Practices Conference, Athens, GA, 1998. 

Good documentation constitutes an essential part of the quality assurance system. As claimed in the European Community (EC) Guide to Good Manufacturing Practice (GMP), Chapter 4 Clearly written documentation prevents errors from spoken communications and permits tracing of batch history. In general, the requirements for documentation related to manufacturing of pharmaceuticals, as set in the GMP... 

Class 1 materials remaining from production by the manufacturing or converting industry where their history is well known. These materials typically are always under the control of the processor. Provided that good manufacturing practice is followed and contamination can be excluded, this material is as suitable for direct contact with foodstuffs as new material. Class 1 material can be defined as post-industrial recycled polymers and corresponds to US FDA s primary recycling (pre-consumer scrap). 

Hooten, Fred W., A Brief History of FDA Good Manufacturing Practices, Medical Device and Diagnostics Industry, May 1996. 

The inspection or testing frequency has to be determined. Traditionally this has been based on manufacturer recommendations or on good engineering practice. A recent trend is to establish inspection intervals for individual types of equipment based on results of reliability analyses. Reliability data serve as necessary data inputs to such analyses. In order to establish a database on barrier reliabiUty, it is necessary to tag each piece of equipment and to record its inspection/test, repair and maintenance history. 

Complementary Medicines Evaluation Committee (CMEC). The CMEC was established in 1997 a Traditional Medicines Evaluation Committee (TMEC) had been established by the Minister to provide expertise for the evaluation of non-prescription traditional medicines and advice on their registration. Whereas ADEC and MEC had a long history prior to the enactment of the Therapeutic Goods Act, 1989, there was no committee to handle traditional and alternative medicines which came under regulation for the first time with this Act. Although the TMEC was not a statutory committee, its role was to advise on quality and manufacture of traditional and alternative medicines, their pharmacognosy and toxicology and their clinical use. In practice, the committee formed a broad advisory role rather than a substance-by-substance evaluation role. 

---