- FDA and WHO regulations on training
- The consequences of inefficient process management
- Digitising training within a single Quality System
In the pharmaceutical sector, training is a key activity to ensure the quality of processes, the company, and products. In spite of its strategic importance, however, it is often considered a waste of time, rather than an opportunity to increase competitiveness, quality and company know-how.
The inspection bodies have drawn up guidelines to be followed to train qualified personnel to carry out a specific task and operate in a specific area.
FDA discusses the qualification of personnel, internal and external, in 21CFR 211.25 and 211.34, highlighting several points:
- Each person involved in the manufacture, process, packaging or handling of a drug must be educated, trained and experienced to perform the assigned task. In addition to the activities performed, the training must include cGMP
- Training must be conducted by qualified persons and with sufficient frequency to ensure that employees remain aware of the cGMP requirements applicable to them
- There must be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packaging or holding of each pharmaceutical product
- Each person responsible for the supervision, manufacture, processing, packaging, or holding of a pharmaceutical product shall have the education, training, and experience to perform assigned functions in a manner that ensures the safety, identity, strength, quality and the purity of the product
- Persons who perform consultation on the manufacture, processing, packaging or holding of pharmaceutical products must have sufficient education, training and experience to give advice on the subject which they are involved with. This must be recorded and kept, indicating the names and qualifications of all consultants and the type of service they provide.
Annex 3 and WHO
The guidelines of Annex 3 WHO “Good manufacturing practices for pharmaceutical products: main principles”, add some other aspects:
- The manufacturing company should carry out training according to a written programme for all personnel working in the production areas or control laboratories (including technical, maintenance and cleaning personnel), as well as for other personnel if necessary.
- The basic training will cover the cGMP, in addition there will be specific training for the job performed
- Continuous training should be provided and its practical effectiveness periodically evaluated. Approved training programmes should be available. Training records should be kept and available for consultation
- The concept of quality assurance and all the measures to ensure its implementation should be addressed in each training course
- People who do not have specific training to be and work in a certain area (production and quality control areas) should not be there, and if necessary, they should first be informed, in particular, about hygiene rules, and supervised
- Consultants and external staff should be qualified to carry out the service. Evidence should be provided in the training records
The consequences of poor training
The consequences of poor, incomplete, incorrectly recorded training fall on the company’s entire quality system, impacting not only on the product, but also productivity in the face of errors and shortcomings by staff.
Non-compliance with regulations may also have legal consequences, fines, loss of licences, authorisations. An example is the FDA Warning Letter received by a pharmaceutical company in 2015 (WL: 320-16-01), where training was expressly referred to among the cGMP violations:
“Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions, and that training in current good manufacturing practice is conducted by qualified individuals (21 CFR 211.25(a))”.
Digitising training within a single Quality System
The perception that training is a “waste of time” and a duty to comply with regulations is very often due to the fact that it is disconnected from the business objectives and the impact it has on company productivity is underestimated. Think, for example, with effective and up-to-date training, how many deviations could be avoided, how many hours and costs could be saved from investigations, creating documentation, reworking batches or even throwing them away.
Another cause of negative perception is the cumbersome processes for planning, executing and maintaining training activities. Training is very often managed in a haphazard way and not centralised between departments, recorded on paper or in files that clutter network folders, which makes it difficult to retrieve when required. Many training courses are also not linked to the reference SOPs, which are present in other systems, and this leads to management difficulties and huge time losses each time a new SOP or version is issued.
A solution to simplify training and transform it into an opportunity for improvement is to digitalise the process within a single Quality System capable of automating operations, centralise data, track changes, send alerts, facilitate planning, execute and maintain activities. Training can also be linked to other processes, such as documentation or corrective actions, creating automation and further reducing handling time and the possibility of errors.
- Monitoring of the quality system, its critical metrics and its all-round performance
- Inclusion of training in business objectives (e.g. reduction of deviations)
- Increased accountability of staff, who are more closely monitored
- Greater involvement of staff in training tailored to their tasks and activities
- Linking the updating of SOPs and documentation to any staff training
- Automatic correction of questionnaires
- Recording of classroom training
- Distance learning management
- Periodic or occasional retraining programme, the latter linked for instance to other processes, such as corrective actions
- Extraction of useful statistics and reports, with the possibility of relating them to other processes
- Centralised documentation, accessible only to authorised persons and available everywhere in real time on request
- Traceability and documentation of all activities, both in Audit Trail and in Dossier
- Reducing the possibility of errors or loss of documents
- Facilitating the sequencing of activities and adherence to schedules thanks to specific automatisms
- Ability to send real-time alerts
- automatic formalisation of an SOP at the end of the training courses