On-site Good Manufacturing Practices (GMP) Training
The value of an employee training program is appreciated by organizations of all sizes and specialties. Training programs enhance the skills of employees and can bring personnel to a higher level with respect to expertise and knowledge. Specific training for employees involved in Good Manufacturing Practices (GMP) is a requirement for any Canadian business involved in the supply chain for drugs and natural health products.
The Where, Who, What and When of GMP training will be different for each organization. However, when consulting Part 2 of Health Canada’s Food & Drug Regulations (Regulation C.02.006) the requirements contained within can be used as a target:
C.02.006 Every lot or batch of a drug shall be fabricated, packaged/labelled, tested and stored under the supervision of personnel who, having regard to the duties and responsibilities involved, have had such technical, academic and other training as the Director considers satisfactory in the interests of the health of the consumer or purchaser.
This regulation reminds us that notwithstanding digital advancements people are still the most important element in any pharmaceutical operation. Without the proper personnel and adequate training, it is almost impossible to fabricate, package, label or import good quality drugs. Inadequate training of personnel often accounts for the failure of a product to meet required standards. Follow these basic suggestions to keep your staff trained and up to date on GMP practices.
Where: While there are many ways to attend GMP training such as workshops, on-line training and webinars, the ideal training is conducted at the facility in question. Some advantages of on-site GMP training:
– On-site training allows the trainer to engage with all staff and properly assess the current level of GMP compliance.
– Training programs are tailored to the specific activities of the building and avoid time wasted on unrelated areas.
– On-site training programs encourage face-to-face dialogue where questions are answered regarding past experiences and potential errors.
– The GMP trainer can perform a mock-audit on your behalf, inspecting facilities and reviewing your internal procedures which will put you in the highest state of readiness for a Health Canada inspection.
Who: Train any personnel who have job responsibilities associated with GMP principles. Don’t forget administrative staff and management where ever possible. Management are often involved in decision making for some important items including product recall and complaint management.
What: Health Canada requires GMP training to be conducted in accordance with a written program.
When: Many companies implement yearly training programs. There is no specific minimum or maximum frequency listed in the regulations. Training may be required more often in cases of mergers, staff changes or promotions. Training should be done prior to implementation of new or revised standard operating procedures (SOPs).
