Training is a key focus of regulatory agencies, mentioned in Code of Federal Regulations Title 21 Part 211; International Conference for Harmonisation Q10, Pharmaceutical Quality Systems; and US Food and Drug Administration’s Guide to Inspections of Pharmaceutical Quality Control Laboratories, and, thus, is a key aspect of compliance. Furthermore, robust training will minimize rework, improve quality of data, and ensure thorough data review. All personnel should be properly trained on good documentation practices, the company data maintenance policy, and the inter-connected quality systems. On closer investigation, there are six components of good manufacturing practice (GMP) training for laboratory personnel.
Editor's Note: The following was adapted from Alice Krumenaker's presentation given at IVT's Method Validation and Development conference.
1. Management Training
Management must be trained on company procedures regarding laboratory operations. Depending on their role, management should have data interpretation skills that will enable them to detect issues the analyst may have missed; this requires basic knowledge of data acquisition software and laboratory instruments.
2. Analyst Training
Analysts must be knowledgeable of instrument operation and laboratory software, including data acquisition, instrument operation, software used for calculation, and validated computer/software systems.
Analysts should also frequently review in-house method/procedures, use of compendia and other references, and significant figures and rounding rules.
Utilizing written evaluations for laboratory training is acceptable for basic procedures. Written evaluations are easy to add to individual training files; however, it should be noted that they might not provide accurate assessment.
Training evaluations should consist of observing the analyst performing the technique and providing appropriate feedback. The analyst needs to obtain an acceptable result on the trial method before working in the laboratory.
However, before training evaluations can be implemented as part of a training plan, criteria needs to be established for passing evaluations. Analysts should see the results of their training; those who do not meet the criteria should be provided an explanation and be retrained according to a predetermined procedure.
4. Re-Training Schedule
There is no uniform re-training schedule for each sector; each department will have a different program that is dependent on individual needs. However, there are some universals that apply to all situations of laboratory re-training. These include annual refreshers for GxP elements, training all departments upon procedure revisions, and periodic reviews of laboratory techniques—based on analyst experience or amount of laboratory investigations.
5. Internal and External Training
GXP training may be performed by either in-house or external trainers. In-house trainers are most beneficial for routine training, especially training related to internal procedures. New or complex topics can be taught by external trainers or via webcasts, which are low-cost alternatives.
6. Site, Department, and Groups
The details of the training will depend on whether it is aimed tothe entire site, a specific department, or an individual/group.
Site training will include a review of general topics and, potentially, a written evaluation as follow-up. If necessary and applicable, participants will receive correct results or retraining.
Department training will include both updates to department-specific procedures and overviews of new equipment/software operation. Evaluations should also occur on an as-needed basis.
Individual and group training will involve detailed instructions of instrument and software operation. These lessons also require technique training (e.g., correct use of electronic pipetting devices, manual titrations). Post-training, appropriate evaluations should follow to ensure effectiveness. Furthermore, individuals and groups should be re-trained following any laboratory investigations