Personnel performing work affecting the quality of excipients should have the appropriate combination of education, training and experience for their assigned tasks.
Consultants advising on the design, production, packaging, testing or storage of excipients should have sufficient education, training and experience or any combination thereof to advise on the subject for which they are retained. Records should be maintained listing the name, address and qualifications of consultants and the type of service they provide.
Competence, Awareness and Training The excipient manufacturer should establish and maintain procedures for identifying training needs and providing the necessary training to personnel performing activities affecting excipient quality. Appropriate records of training should be maintained. Training should address the particular operations that the employee performs and GMP as it relates to the employee’s functions. Qualified individuals should conduct GMP training with sufficient frequency to ensure that employees remain familiar with applicable GMP principles. Management should establish adequate and continued personal hygiene training for personnel who handle materials so that they understand the precautions necessary to prevent contamination of excipients.
The training program should ensure personnel understand that deviations from procedures may have an impact on the customer’s product quality.
Personnel Hygiene To protect excipients from contamination protective apparel such as head, face, hand and arm coverings should be worn as appropriate to the duties performed. Jewellery and other loose items, including those in pockets, should be removed or covered. Only authorised personnel should enter those areas of the buildings and facilities designated as limited access areas.
Personnel should practice good sanitation and health habits. Any person shown to have an apparent illness or open lesions (by either medical examination or supervisory observation) that may adversely affect the safety or quality of the excipient should be excluded from direct contact with raw materials, packaging components, intermediates and finished excipients until the condition is corrected or determined by competent personnel not to jeopardise the safety or quality of the excipient. Personnel should be instructed to report to supervisory personnel any health conditions that may have an adverse effect on excipients.
The storage and use of food, drink, personal medication, tobacco products or similar items should be restricted to certain designated locations separate from manufacturing areas.
The infrastructure should be managed, operated, cleaned and maintained in accordance with GMP principles to ensure excipient quality and to avoid contamination (including, where critical to excipient quality, control of particulate matter, microbiological control and control of water quality).
Copyright © 2006 The International Pharmaceutical Excipients Council and Copyright © 2006 Pharmaceutical Quality Group