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Images of a pharmaceutial manufacturing facility
Welcome

Training Department
- - -
o Buildings and Facilities Office
o Manufacturing
o Packaging and Labeling
o Product Development Laboratory
o QC - Analytical Labs
o QC - Batch Release
o Quality Assurance
o Receiving and Shipping
o Regulatory Affairs
o Training Department
o Validation Department

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Caption below

Operator receives On-the-Job Training

GMPs require that personnel be trained in the tasks assigned to them as well as in the GMPs themselves. Training needs to be provided to all personnel directly and indirectly involved with GMP, including senior management, temporary, and contract staff.

Example of a GMP expectation that applies to Training

Personnel are trained in the GMP concepts and regulations that apply to what they do. Personnel are trained in the procedures and methods they use and in the tasks they perform.

Example of GMP requirements specific to this GMP expectation

U.S. flag  U.S.

  • Training shall be in the particular operations that the employee performs and in current good manufacturing practice as they relate to the employee's functions. [211.25(a)]

Canadian flag  Canada

  • All personnel are aware of the principles of GMP that affect them, and all personnel receive initial and continuing training relevant to their job descriptions.[C.02.006 # 5]

European Union flag  European Union

  • Besides the basic training on the theory and practice of Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. [EU # 2.9]
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