top of page

Training and regulatory requirements

Updated: Aug 10, 2023

Let's collect all requirements on training from GMP.


EU GMP Volume 4 Chapter 2 Section 2: Training

'2.10 The manufacturer should provide training for all the personnel whose duties take them into production and storage areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product.

2.11 Besides the basic training on the theory and practice of the quality management system and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.

[...]

2.14 The pharmaceutical quality system and all the measures capable of improving its understanding and implementation should be fully discussed during the training sessions. '


21 CFR Part 211 Section 25: Personnel qualifications

(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have 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 in 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.

(b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.


ICH Q7 Section 3.1: Personnel qualifications

3.10 There should be an adequate number of personnel qualified by appropriate education, training and/or experience to perform and supervise the manufacture of intermediates and APIs.

[...]

3.12 Training should be regularly conducted by qualified individuals and should cover, at a minimum, the particular operations that the employee performs and GMP as it relates to the employee's functions. Records of training should be maintained. Training should be periodically assessed.


______________________________


OK, so what does this mean? let's extract the operative requirements.


Who needs to have training?

All the personnel whose activities could affect the quality of the product


Who can give training?

Qualified individuals


What should be trained?

- basic training on the theory and practice of the quality management system and Good Manufacturing Practice as it relates to the employee's functions

- particular operations that the employee performs


How frequent the training should be?

sufficiently frequent to assure that employees remain familiar with CGMP requirements applicable to them


What documentation we need?

- training records

- training programme, approved by either the head of Production or the head of Quality Control, as appropriate

- periodic training assessment, practical effectiveness assessment


_____________________________


Yeah, it's not that much...


One key requirement is not spelled out, but it's obvious: the training about a certain operation must be done before the employee does that operation. And this is where it gets to an endless war on training KPIs, audit observations about lack of training, etc.


What would my advice be? Give the authorities what the authorities deserve: fulfill all basic requirements as rigorously as you can, but keep it at a minimum. Have your read&understand trainings on procedures, have your GMP training documented, etc.


But what you need is the real explanations, mentoring talk-through sessions about processes, methods. Grow you colleagues not only with telling them what to do, but why: what is the background of certain activities and responsibilities, why is it to measure certain metrics, etc.

This is the real world's real training for the people to achieve engagement and professional quality mindset. And you don't need the formal documentation to do that.







9 views0 comments

Recent Posts

See All

Chromatographic columns and their qualifications

We have mentioned earlier the importance of choosing and testing of the column when developing a chromatographic method. But what should be the routine process for qualifying a newly purchased column,

תגובות


bottom of page