The pharmaceutical industry is a complex sector due to the many regulations and laws governing it, as well as the varied roles that it fulfils. There is a need for strict regulations over the manufacturing, researching and distribution of the medicines and medicinal devices that are produced by the industry so that any risk posed to the general public is effectively reduced.
Good Manufacturing Practices have been brought into place and they cover clinical trials, laboratory experiments, the manufacturing processes and the distribution of medicinal products. In the UK the ‘orange guide’ outlines GMP regulations governing domestic businesses however there are general GMP guidelines covering the entire EU, a separate set for the US and many more for other countries around the world.
One of the most effective ways in which a company can ensure that their processes comply with the Good Manufacturing Practices regulations is to provide their staff with regular, up-to-date GMP training.
Training sessions can take place at the manufacturing base or at an independent location. Both ways seem to provide effective results with employees learning how their individual and collective actions affect the quality and safety of the products which they manufacture. The consultants who take the training sessions are qualified professionals often with years of experience in the pharmaceutical industry behind them.
They make it their business to keep up to date with any new laws or regulations that are coming into effect and keep an ear to the ground for any industry news which could affect future cGMP guidelines.
Individual departments within a company might go on separate training sessions. The scientists and researchers who are involved with drug development and clinical trials, either on humans or animal subjects will need training on different issues than the employees who are responsible for packaging and distribution. The same goes for the staff who deal with APIs and those that handle the finished product.
Because there are so many sectors within the pharmaceutical industry it is important that every member of staff has the general knowledge on GMP regulations and the specific information for their individual role.
Only when a company invests in employee development and training do they have any hope of passing the annual and biannual inspections completed by the governing institutions of GMP. It should be seen as an investment rather than an unnecessary expenditure as there can be serious financial and brand damage when a company fails to comply with GMP.