GMP and GDP Training
Volume 4 Good manufacturing practice (GMP) Guidelines Chapter 2 – Personnel: All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.
Regular GMP refresher training ensures that GMP remains in the forefront of your staffs minds. We can develop and/or deliver induction and ongoing GMP training in accordance with your requirements. This can be done in a systematic way by reinforcement of key requirements of the Orange Guide or a more targeted approach by reviewing your risk register, deviation and complaints metrics for recurring failure trends.
Regulators are starting to pay more attention to pharmaceutical wholesaling and distribution with the greater risks posed by counterfeiting and the increasing demands for cold chain shipment. Staff knowledge and understanding of their role and vigilance in anti counterfeit measures and the consequences of failure in cold chain supply through effective GDP training will help to avoid or detect issues that may arise. We have experience in delivering GDP training to staff and reviewing effectiveness of the training through post training knowledge assessments.
We at Paul Graham Pharma Consulting believe that a pharmaceutical facility should be in continuous compliance with GMP, the manufacturer’s licence conditions and individual Marketing Authorisations. We can help by conducting a gap analysis to identify areas for improvement. We can also offer training and mentoring of staff to enable them to conduct themselves well in front of the inspector to facilitate the inspection process.
We have experience in delivering risk assessment training using FMEA which includes training exercises on real life pharmaceutical scenarios to help staff to understand and use the risk assessment tools to deliver real benefit to your business.
If any of these training offerings are of use to your business or to find out more, then please contact us at email@example.com