Personnel Training in Pharmaceutical Manufacturing

Katherine V. Domenick, Training and Communications Group, Inc., Berwyn, Pennsylvania, Personnel Training in Pharmaceutical Manufacturing... 

The cGMPs require manufacturers to have adequately equipped manufacturing facilities, adequately trained personnel, precisely controlled manufacturing processes, appropriate laboratory controls, complete and accurate records and reports, appropriate finished product examination, and so on. Current GMPs are not best practices rather, they establish threshold or minimum standards which must be satisfied in order for a pharmaceutical manufacturing operation to be compliant. 

The training requirements for personnel working in a pharmaceutical manufacturing environment are specified in (21 CFR) 211.25 [1] ... 

In summary, the Code of Federal Regulations states that pharmaceutical manufacturing personnel must be trained as follows ... 

In essence, the code specifies that pharmaceutical manufacturing companies must train their employees using qualified trainers it also states that supervisors must have the same training as qualified personnel. What the regulations do not say is how to conduct this training. 

The pharmaceutical manufacturer must ensure that personnel are trained to an appropriate level in GMP and validation planning and requirements to enable them to adequately perform their function. This applies to any resource used in connection with GMP compliance and validation life-cycle activities and documentation. A training program should be in place and individual training records maintained. The records and suitability of external resources used by suppliers or contractors should also be examined. 

It should be recognized that qualification activities need to be undertaken to detailed test procedures that provide comprehensive test records, with all documentation formally reviewed and approved by a designated level of management from the pharmaceutical manufacturer. With this in mind, suitably trained qualification test personnel will be required. 

To maximize the life and effectiveness of the facility, it must be maintainable. The facility should be designed to permit ongoing day-to-day preventive maintenance of the mechanical systems and, should a failure occur, permit needed repairs to be made in an expeditious manner. Perhaps of equal importance is the janitorial maintenance required to keep the facility suitable for pharmaceutical manufacturing. Proper janitorial maintenance begins with the design of the facility and evolves into an operational protocol, personnel training, and effective implementation. 

Personnel should be restricted from all areas of pharmaceutical manufacture to those who are necessary. Protection from contamination from personnel is by training in hygiene, enforcement of hygiene rules, and provision of protective clothing. Hair is the major source of contamination from personnel, and street clothes is the second most significant source. Hair-covers should beprovided and worn properly in all areas of sterile manufacture beards, moustaches, and other excessive facial hair should be covered. Overall sleeves should extend to the wrist and be elasticated or studded to provide a neat fit. Because dogs are still allowed to soil the streets, protective footwear or shoe covers should be provided to all personnel allowed to enter pharmaceutical manufacturing areas. 

The importance of personnel training and behavior cannot be overemphasized in the maintenance of an acceptable environment for the manufacture of sterile ophthalmic products or sterile pharmaceutical agents in general. Personnel must be trained in the... 

Akers, M. J., Good Aseptic Practices Education and Training of Personnel Involved in Aseptic Processing, Aseptic Pharmaceutical Manufacturing II, (M. J. Groves and R. Murty, eds.), Interpharm Press, Buffalo Grove, IL, pp. 181-222 (1995)... 

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