Frequent inspection deficiencies in training and qualification systems
5 findings or reasons for criticism of the training and qualification system for cleanroom personnel and how companies can respond to them.
Overview
What authorities expect – and where companies regularly encounter difficulties
International regulatory authorities such as the EMA and FDA repeatedly emphasize how crucial competent employees are for product safety, process stability, and GMP compliance. Nevertheless, deficiencies in training and qualification systems are among the most common findings—often recurring, frequently avoidable, and almost always with clearly identifiable causes.Original regulatory sources
Basis of findings or assessments by supervisory authorities
- EU GMP Guidelines Part 1, Chapters 2 & 3; Annex 1
- PIC/S PE 009-17 GMP for Medicinal Products; PI‑044 Aide-Memoire GDP inspections
- FDA 21 CFR 211.25; 211.113; current FDA Warning Letters
1. Unclear or inadequate training of new employees
Many findings arise on the very first day—namely, when new employees have to start without a clear concept. Authorities regularly criticize induction programs for being unstructured, not role-specific, or not documented in a comprehensible manner.
EU GMP Guideline Part 1, Chapter 2.11 clearly states that new employees may only take on tasks if they have received appropriate training in advance: "In addition to basic training in the theory and practice of the quality management system and good manufacturing practice, newly hired personnelshould be trained in accordance with the tasks assigned to them." PIC/S PI-044 asks the following critical questions regarding GDP: "Have personnel received training in SOPs relevant to their role? Is training provided in updated revisions to SOPs?"
Here is an example from the warning letter #681977 August 19, 2024:
“You failed to ensure the following: Each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience...to perform his or her assigned functions (21 CFR 211.25(a))”.
2. Training courses impart knowledge—but not confidence in taking action
In numerous inspection reports, authorities criticize the fact that training courses are held but have little influence on actual behavior in cleanrooms or production environments. Explanations are given, but there is no practical training. Terms are understood, but processes are not carried out reliably. PIC/S expressly requires that learners acquire practical skills, while the FDA routinely criticizes the fact that critical actions are performed incorrectly despite training. The EU GMP Guide Part 1, Chapter 2.11 requires the following: "[There] should be ongoing training and its effective implementation in practice should be periodically evaluated."
Here is an example from the warning letter #699291 May 5, 2025:
“We acknowledge that your company conducted training on September 20, 2024, with visual inspection operators regarding the proper technique requirements for full rotation. However, your company did not provide documentation addressing corrective actions/preventative actions for the company's current visual inspection (VI) inspectors who passed VI qualification but did not adhere to the timeframe requirements set forth in the company's written procedure.”
3. Participated ≠ Competent – insufficient evidence
Another recurring theme: training certificates document participation, but not learning success. Authorities expect clear evidence that employees understand their tasks and can perform them competently. The EU GMP Guideline Part 1, in Chapter 2.11, again calls for regular evaluation of the effectiveness of training. And Annex 1 of the GMP Guideline states: "7.4 Personnel accessing grade A and B areas should be trained in aseptic gowning and aseptic behaviors. Compliance ... should be confirmed by assessment and periodic reassessment at least annually."
Here is an example from the warning letter 320-20-35 May 13, 2020:
“You did not address the reasons for the lapse in oversight of your training program, and you did not provide a detailed plan for assessing the effectiveness of your training.”
4. Trainers without proven qualifications
Many companies rely on technically experienced employees as trainers—but technical expertise does not automatically replace the ability to convey knowledge in a comprehensible, structured, and target group-oriented manner. Authorities often complain that individuals are appointed but not qualified. PIC/S PI-044 requires both technical competence and training personnel.
Here is an example from the warning letter #628196 June 30, 2022:
Specific gaps should be identified for remediation after assessing the capability of your program to ensure: Qualified individuals perform training.
And in Warning Letter #623494 April 20, 2022, the following deficiency is mentioned:
“Failure to ensure training is regularly conducted by qualified individuals and covers, at a minimum, the particular operations that each employee performs and cGMP as they relate to the employee’s functions”.
5. Knowledge becomes outdated – lack of refresher training and further development
One-time training does not mean permanent competence. Authorities have found that refresher courses are too infrequent, too general, or unrelated to changes. The EU GMP Guidelines, Chapter 2.10, require regular continuing education. PIC/S emphasizes that training must be continuous, risk-based, and state-of-the-art.
PIC/S PI-044 asks, among other things, the critical question: "Is training provided in updated revisions to SOPs?" GMP Annex 1 requires: "7.3 All personnel... should receive regular training, gowning qualification , and assessment in disciplines relevant to the correct manufacture of sterile products."
How companies can reduce these risks
An effective training system is structured and role-based, practical and behavior-oriented, focused on skills development, supported by proven learning facilitators, and continuously refined.
How comprei can support you
Our learning solutions help companies meet the above requirements in a sustainable manner—through practical seminars for newcomers and continuous learning support, train-the-trainer programs, and structured competency and role management.
