1What the US drug CGMP regulations require.
Section 211.25 sets the rule for finished pharmaceuticals. Each person engaged in the manufacture, processing, packing or holding of a drug product must have the education, training and experience, or a combination, to perform their assigned functions. Training must cover “the particular operations that the employee performs” and CGMP, including the regulations and the written procedures they require, as they relate to the employee’s functions. CGMP training must 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”.¹ Supervisors need the education, training and experience to give assurance that the product has the safety, identity, strength, quality and purity it is meant to have, and there must be enough qualified people to do and supervise the work.¹ Consultants need the same kind of qualification for the subject they advise on, and records must state each consultant’s name, address, qualifications and type of service.²
Other rules add to this. Part 11 requires a determination that people who develop, maintain or use electronic record and signature systems have the education, training and experience for their tasks.³ FDA’s data integrity guidance says training staff to prevent and detect data integrity issues is consistent with § 211.25.⁴
FDA’s 2006 quality systems guidance describes what a training programme should include: evaluation of training needs, training to meet them, evaluation of its effectiveness, and documentation of training and retraining. It asks managers to verify that skills gained in training are used in day-to-day work.⁵
2What EU GMP, ICH Q7 and WHO add.
In the EU the obligation is in law. Article 7(4) of Directive (EU) 2017/1572 says personnel “shall receive initial and ongoing training, the effectiveness of which shall be verified”, covering the theory and application of quality assurance and GMP.⁶ Chapter 2 of the EU GMP Guide sets out how:⁷
- Training is for everyone whose duties take them into production, storage or control laboratories, including technical, maintenance and cleaning staff, and anyone else whose work could affect quality (2.10).
- New staff receive basic GMP and quality system training and training for their duties; continuing training follows, “and its practical effectiveness should be periodically assessed” (2.11).
- Training programmes are approved by the head of Production or the head of Quality Control, and “Training records should be kept” (2.11).
- People working where contamination is a hazard receive specific training, and visitors or untrained people are kept out of production and QC areas where possible, or briefed and closely supervised (2.12, 2.13).
The heads of Production and Quality Control each ensure that their department’s initial and continuing training is carried out and adapted to need (2.7, 2.8). Chapter 4 lists personnel matters, including signature lists, GMP and technical training and “verification of the effectiveness of training”, among the subjects that need written procedures and records.⁸
For active substances, ICH Q7 section 3.12 says training should be regularly conducted by qualified individuals, cover at minimum the employee’s operations and GMP as it relates to their functions, be recorded and be periodically assessed.⁹ WHO’s GMP main principles carry the same expectations and add that evidence of consultant and contract staff qualification should be included in the training records.¹⁰
| Expectation | US (21 CFR 211) | EU GMP | ICH Q7 (APIs) |
|---|---|---|---|
| Who is trained | Everyone who manufactures, processes, packs or holds drug product | Everyone in production, storage and QC areas, and anyone whose work could affect quality | Personnel who make or supervise intermediates and APIs |
| Content | Their operations, CGMP and the written procedures | GMP, the quality system and assigned duties | Their operations and GMP |
| Frequency | Continuing, often enough to stay familiar | Initial and continuing | Regular |
| Effectiveness | Not stated in 211.25 | Periodically assessed; verified under Article 7(4) | Periodically assessed |
| Records | No separate clause; FDA treats training records as CGMP records | Training records should be kept | Records of training should be maintained |
3Aseptic and cleanroom training.
EU GMP Annex 1, in operation since 25 August 2023, sets the most specific rules. Everyone who accesses cleanrooms, including cleaning, maintenance and monitoring staff, should receive regular training, gowning qualification and assessment, with the level of training based on the criticality of their function and area. People entering grade A and B areas are trained in aseptic gowning and behaviour; compliance is confirmed by assessment and periodic reassessment “at least annually”, with both visual and microbial assessment. Unsupervised access to those areas is limited to people who have passed the gowning assessment and taken part in a successful aseptic process simulation. Each operator should take part in at least one successful aseptic process simulation a year, and operators who inspect filled containers by eye should requalify in visual inspection at least annually.¹¹ There should also be a way to disqualify people, for example after an adverse trend in personnel monitoring or a failed simulation, with retraining and requalification before they return to aseptic work.¹¹
4What training records should show.
None of these texts prescribes a form for a training record. Read together, they point to what one should be able to show: the person and their role; the operations, procedures and GMP topics they were trained in; when; that the trainer was qualified; and how effectiveness was assessed.¹⁷⁸ For cleanroom staff the record also needs the gowning assessments, requalifications and aseptic process simulations behind their access.¹¹
Where records are kept matters. FDA says CGMP records relating to training “should not be retained solely in a filing system that a firm considers largely out of scope of FDA’s inspectional authority”, such as an HR file, and that refusing to provide them may limit an inspection.¹²
5How long to keep training records.
The drug CGMP regulations set no separate retention period for training records. Section 211.180(a) sets at least one year after the batch’s expiry date for production, control and distribution records specifically associated with a batch.¹³ ICH Q7 lists training records among the documents that need a retention procedure, and says retention periods “should be specified”.⁹ EU GMP Chapter 4 says the retention period for documents other than batch records depends on the business activity they support.⁸ In practice, then, the period is one your procedure defines and justifies. Training records are often the evidence that the person who did a batch’s work was qualified, which is a reason to keep them at least as long as those batch records.
6How it runs in Seal.
In Seal, training and qualification records connect procedure versions, practical assessments and method authorisation to the work they permit, so a reviewer can see what a person is qualified for rather than a completion percentage. Each training item defines its verification method, such as a knowledge assessment, observed on-the-job training or document acknowledgement, and OJT records hold the trainee, trainer, date, duration and skills covered. Qualification checks can be configured and verified at the point of work, and learning management can show the requirement in force, the content version and the practical evidence behind each person who touched a batch, sample or result.
When a procedure changes, the revision’s training impact is assessed against the roles and methods it affects, and the prior version and its evidence are kept. The SOP revision training impact example works through three operators with different evidence for one revision. Neil can propose a role’s curriculum from supplied procedures; people assess competence and approve the configuration.
References
- 121 CFR 211.25, Personnel qualifications, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211/ subpart- B/ section- 211. 25 (read 6 November 2026) - 221 CFR 211.34, Consultants, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211/ subpart- B/ section- 211. 34 (read 6 November 2026) - 321 CFR 11.10(i), Controls for closed systems, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- A/ part- 11/ subpart- B/ section- 11. 10 (read 6 November 2026) - 4Data Integrity and Compliance With Drug CGMP, Questions and Answers, guidance for industry, FDA, December 2018, question 16. https:/
/ www. fda. gov/ media/ 119267/ download (read 6 November 2026) - 5Quality Systems Approach to Pharmaceutical CGMP Regulations, guidance for industry, FDA, September 2006. https:/
/ www. fda. gov/ media/ 71023/ download (read 6 November 2026) - 6Commission Directive (EU) 2017/1572 on the principles and guidelines of good manufacturing practice for medicinal products for human use, Article 7, EUR-Lex, 15 September 2017. https:/
/ eur- lex. europa. eu/ legal- content/ EN/ TXT/ HTML/ ?uri=CELEX:32017L1572 (read 6 November 2026) - 7EudraLex Volume 4, EU GMP Guide Part I, Chapter 2: Personnel, European Commission, in operation from 16 February 2014. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ 2014- 03_ chapter_ 2_ 0. pdf (read 6 November 2026) - 8EudraLex Volume 4, EU GMP Guide Part I, Chapter 4: Documentation, European Commission, in operation from 30 June 2011. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ chapter4_ 01- 2011_ en_ 0. pdf (read 6 November 2026) - 9ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, sections 3.12 and 6.12, ICH, 10 November 2000. https:/
/ database. ich. org/ sites/ default/ files/ Q7%20Guideline. pdf (read 6 November 2026) - 10WHO good manufacturing practices for pharmaceutical products: main principles, WHO Technical Report Series No. 986, Annex 2, section 10, World Health Organization, 2014. https:/
/ www. who. int/ publications/ m/ item/ trs986- annex2 (read 6 November 2026) - 11EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products, sections 7.3 to 7.6, 8.31 and 9.38, European Commission, 22 August 2022. https:/
/ health. ec. europa. eu/ system/ files/ 2022- 08/ 20220825_ gmp- an1_ en_ 0. pdf (read 6 November 2026) - 12Questions and Answers on Current Good Manufacturing Practice Requirements: Records and Reports, FDA, November 2022. https:/
/ www. fda. gov/ drugs/ guidances- drugs/ questions- and- answers- current- good- manufacturing- practice- requirements- records- and- reports (read 6 November 2026) - 1321 CFR 211.180, General requirements (records and reports), eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211/ subpart- J/ section- 211. 180 (read 6 November 2026)
AQuestions and answers
How often is GMP refresher training required?
No regulation sets a single interval. 21 CFR 211.25 asks for CGMP training on a continuing basis and often enough that staff stay familiar with the requirements that apply to them, and EU GMP asks for continuing training. The fixed intervals are in EU GMP Annex 1 for sterile manufacture: gowning for grade A and B areas is reassessed at least annually, each operator takes part in at least one successful aseptic process simulation a year, and people who inspect filled containers by eye requalify at least annually. Otherwise, set refresher periods by role and risk in your training procedure and justify them.
Does reading an SOP count as training?
Reading and acknowledging a procedure shows that a person was given it. Regulators also expect training in the operations each person performs and a periodic assessment of whether training works, so for a task that needs a skill, plan observed practice or an assessment as well before the person does it alone.
How long must GMP training records be kept?
The US drug CGMP regulations and EU GMP set no fixed period for training records. ICH Q7 expects a retention procedure that specifies one. Because training records show that the people who made a batch were qualified, it is sensible to keep them at least as long as the batch records they support.
Do contractors and consultants need training records?
Yes. 21 CFR 211.25 covers each person engaged in manufacturing, processing, packing or holding, and EU GMP covers everyone whose work could affect quality, naming technical, maintenance and cleaning staff. WHO adds that evidence of contract staff qualification belongs in the training records. For consultants, both 21 CFR 211.34 and EU GMP require records of their name, address, qualifications and the type of service they provide.
Can FDA inspect training records kept in an HR system?
Yes, to the extent they relate to the CGMP requirement for qualified personnel. FDA says CGMP training records should not be kept only in a filing system the firm treats as outside FDA’s inspection authority, and refusing to provide them may count as limiting an inspection.
What are the training requirements for medical device manufacturers?
Since 2 February 2026, FDA’s Quality Management System Regulation requires device makers to have a quality management system that complies with ISO 13485:2016, whose clause 6.2 covers human resources. The regulators’ MDSAP audit approach checks that a manufacturer has determined the competence needed for work affecting quality, provided training and kept records of training and competence.