Guide to Good Manufacturing Practice

Lack of GMP compliance is no joke. D&MD's Guide to Good Manufacturing Practice provides pharmaceutical and biological companies with assistance in compliance with the GMP rules laid down by the USA, Canada and Japan, the EC and WHO. It is addressed particularly to smaller companies, perhaps those with their first new drug, facing this extra challenge to their capabilities. This guide includes the full text of the most up-to-date regulations, along with the most relevant 'guidelines' issued by the various authorities intended to assist in the interpretation and application of the regulations. The contents of these documents are compared in easy-to-read tables. A full set of forms for performing internal inspections or audits to GMP standards is also provided. Specialist guides published by the FDA to assist its inspectors in the confirmation of GMP compliance are also included or referenced, as well as references to support organizations, consultants, useful books and informative Web sites. The cost of non-compliance may be huge - one US company recently paid a $100 million fine and another agreed to a payment of $30 million in a consent decree and to have outside experts audit their entire GMP set-up. Products may be recalled, facilities closed, company officers fined or even sent to jail. All FDA warning letters state that companies under warning for non-compliance cannot participate in public contracts - a serious loss of business for some. Overseas companies have been banned from importing their products into the USA until all faults have been corrected. In just the last 12 months, there have been over 160 warning letters issued for serious GMP non-compliance in drug manufacturing. Failure to comply with GMP will eventually be revealed, by product problems or by inspectors' reports. Prevention is a more economically viable option than having to face the cost of correcting non-compliance after the event.