CONDUCTING TRAINING NEEDS ASSESSMENTS
Introduction
The purpose of this needs assessment is to provide your company with information about the current status of training systems which are required by the Code of Federal Regulations Title 21, Part 211, Sections 211.25(a) and 211.25(b) of the Good Manufacturing Practice Regulation. The purpose is also to provide conclusions from the assessment in the areas of GMP, SOP and OJT training, and provide any recommendations to assure that your company meets regulatory requirements.
The Process
An in-depth tour of the facility will be provided, and data collection will be accomplished via two methods:
1) a review of all SOP’s pertaining to GMP (Good Manufacturing Practice), SOP (Standard Operating Procedures) and OJT (on the job training), and all training records;
2) conducting of interviews with managers, supervisors, technicians (operators),
laboratory analysts in Quality Assurance, Quality Control and Manufacturing.
Regulatory Requirements
211.25(a) states that each person engaged in the manufacture, processing, packing, or holding of a drug products shall have the education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee’s functions. Training the current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them.
211.25(b) states that each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the proper education, training, and experience, or any combination thereof, to perform assigned functions.
SUMMARY: 211.25 requires training in the areas of SOP’s, GMP’s and OJT, and the training needs to be on a continuing basis.