GMP 2002

							GMP 2002

PERSONNEL REGULATION

With reference to personnel, the regulation provides guidelines and standards for
the employees working the manufacturing industry. I defines that the personnel
should possess technical training and must also have an academic background. As
the customer priority is the main subject, therefore it is the responsibility of
either the HR or the Manager concerned to ensure that the personnel working
have adequate training. If not they should provide such training necessary for the
interest of the consumer. These trained workers will then be eligible to conduct
testing, packaging and fabricating the product.

Personnel working in the drug industry are in the most critical situation. It is
almost impossible to produce quality products without proper trained people,
even to store them takes good expertise. The tolerance limits in the drug industry
is highly narrow and high skills are required to maintain standards.




INTERPRETATION

The personnel working in the manufacturing department specifically fabricators,
packagers/labellers/testers should possess some basic requirements e.g.,
university degree or a diploma and they should have completed this education in
a technical institute in science related to health Canada.

Similarly for personnel which are distributers, importers and wholesalers, they
should also be qualified and attained academic training and have adequate
experience.

The standard also emphasizes upon workload. The manager or the person in
charge (supervisor) should not put extra or too much work load on the person
working so that he can do his work with accuracy. There may be a risk involved in
quality when undue production or maintenance pressures are imposed upon the
personnel working in manufacturing (food or pharmaceutical) environment.

The guide also talks about clear duties of the employees working. Their duties
should be written down and stored in such place where it is accessible to the
employee himself. In this way he can be accounted for all the acts mentioned in
his job description.

Lastly, the training should be mandatory and should be imparted to every
employee on regular basis. All trainings imparted should be properly documented
and the training should be provided by qualified individuals.

At the end, the performance of all the employees should be reviewed and
accordingly appraised.