SubscribeTraining courses in Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
GMP and GDP are firmly established as the essential foundations for the production and distribution of safe, efficacious and high quality pharmaceuticals. However, that simple statement disguises the fact that there are differences in the way that GMP and GDP can be interpreted by individuals, and most importantly by the regulatory authorities. Understanding and responding to these differences is important for companies to pass their inspections.
Risk Assessment and GMP
ICHQ8 and ICHQ10 prompt risk based approach to GMP
In recent years, the concept of GMP has been evolving towards a strategy based more on risk assessment. The publication of ICHQ8 and ICHQ10 have encouraged pharmaceutical professionals to question if following standard operating procedures (SOP’s) is sufficient to guarantee a safe product or if they need to consider broader ideas of how production might be compromised by unforeseen errors and individual mistakes.
In effect, this evolution is expanding the responsibility for quality assurance across everyone involved in the production process. Quality is no longer the sole preserve of Quality Assurance (QA) professionals, but needs to involve machinery operators, maintenance engineers, store-room staff, cleaners etc. A risk based approach understands that everyone working within a pharmaceutical plant has the potential to influence the quality of production, and needs to be aware of their responsibilities in this context.
GDP affects every aspect of production
There is a growing realisation that GDP is not the sole concern of pharmaceutical distributors, but is actually something that needs to be applied across the whole supply chain. The principles of GDP apply as much to the sourcing, receipt and handling of ingredients as it does to the sale and distribution of the finished product. As with GMP, the concepts of GDP need to be understood by everyone involved in the production and marketing of pharmaceuticals.
Training in GMP and GDP
The key to better implementation of GMP and GDP principles is the through the training of staff.
GMP training for QA, QC, engineers, and laboratory technicians
RSSL Pharma Training now offers a range of GMP courses to suit every level of the organisation, starting with a one day introductory course of general interest, rising to a three day course aimed primarily at key personnel working in QA, QC, production and engineering. There are also specialist GMP courses for engineers, laboratory personnel and for those involved in the design and production of packaging.
GDP Training for everyone
The GDP courses offered by RSSL Pharma Training are hugely popular and demonstrate the importance of GDP in delivering safe and efficacious products, as well as the key role that GDP can play in reducing the risk of counterfeit products entering the legitimate supply chain. The course exposes how the practice of parallel distribution and issues around retrieval and disposal of recalled product can leave pharmaceutical companies more vulnerable to counterfeiting.
Interactive and practical training courses
A common feature of all RSSL Pharma Training’s courses is their highly practical and interactive nature. This ensures that delegates leave with practical skills and knowledge that they can apply immediately to the workplace. As RSSL Pharma Training understands the industry’s needs, they are able to run all courses ‘in house’. This offers clients the chance to have a personally tailored course aimed at their specific needs. In either case, RSSL Pharma Training gives delegates a superb grounding in the topic and are sure to enthuse and encourage individuals to take more responsibility in ensuring the quality of production.