Personnel in Pharmaceutical QC Laboratories: WHO Good Practices

In short: A QC laboratory needs enough people who are qualified, trained and supervised for the work they do. WHO’s good practices for QC laboratories (TRS 1052, Annex 4, 2024) and EU GMP Chapter 2 expect defined roles, written job descriptions, documented competence and continuing training. This article is for QC analysts, supervisors and students.

Why personnel come first

Test results are only as reliable as the people producing them. Both WHO and EU GMP start from the same idea: there must be sufficient qualified staff, each person’s responsibilities must be clear and recorded, and everyone must receive initial and continuing training relevant to their work (EU GMP Part I, Chapter 2, Principle).

Staffing and competence

According to WHO TRS 1052 Annex 4 (section 5.1), a laboratory should have personnel with the education, training, technical knowledge and experience needed for their functions, whether employed permanently or under contract. The competence requirements for each function should be documented, and the laboratory needs procedures and criteria for selecting staff and assessing their competence under its quality management system.

Points that follow from this:

• Authorisation. The laboratory director or a designated person authorises staff to do specific laboratory activities. Only sufficiently qualified and trained people may perform them (section 5.5).
• Continuous assessment. Procedures and criteria for assessing competence on an ongoing basis should be documented (section 5.6).
• Contract staff. Everyone acting for the laboratory, including contractors, should act impartially and competently and work in accordance with the laboratory’s quality management system (sections 3.3 and 5.1).
• Trainees. Staff, including trainees, should be supervised by senior staff familiar with the methods and with how results are assessed (section 3.3). Trainees should be assessed when the training ends, and the assessment fully documented (section 5.4).
• Substitutes. The laboratory should nominate trained substitutes or deputies for key management and specialised scientific roles, so that work is not stopped by absence (section 3.3).

Job descriptions and records

Job descriptions should exist for everyone involved in tests and other laboratory activities, for example calibration, validation, verification, qualification and maintenance. The laboratory should also keep records of each person’s competence, including education, qualifications, training and experience (WHO TRS 1052 Annex 4, section 5.2). The laboratory should also keep a list or matrix of each staff member’s competencies (sections 5.7 to 5.11). EU GMP Chapter 2, clause 2.1, similarly expects an adequate number of personnel with the necessary qualifications and practical experience.

Training, competence and authorisation records are GMP records. Keep them at least 1 year after the expiry date of the respective product batch (EU GMP Part I Chapter 4, clause 4.11; 21 CFR 211.180(a)), longer if local law or the marketing authorisation requires.

Typical roles in a QC laboratory

WHO Annex 4, section 5.3, lists the managerial and technical personnel a laboratory should have. The first role it describes is the laboratory director (also called manager or head of laboratory), who holds a university degree in an appropriate discipline and has supervisory experience in pharmaceutical analysis in a quality control laboratory, the regulatory sector or industry, and who takes full responsibility for all operations: analytical, organisational, administrative and educational. This person also makes sure that:

• staff have competencies suited to their functions and that grades reflect responsibilities;
• training procedures are reviewed periodically for adequacy;
• the technical management is adequately supervised; and
• certificates of analysis, test reports and other important reports and protocols are approved.

The same section also describes:

• Technical managers (or senior analysts) with extensive experience in pharmaceutical analysis, who preferably support the director and directly manage and supervise analysts and technicians.
• A quality manager responsible for implementing the quality management system, who should stay independent of routine analysis where the laboratory’s size allows. The quality manager organises internal audits and makes sure that staff are competent for the equipment and tests they use, that regular in-service training is arranged, that the laboratory takes part in suitable proficiency testing, and that substances under poison, narcotic, psychotropic or radioactive controls are kept under lock and key and used under the supervision of an authorised person.
• Qualified analysts, normally graduates in pharmacy, analytical chemistry or another relevant subject. Experienced analysts who understand result review, chain of custody and CAPA should also be available to act as supervisors.
• Technicians holding diplomas from technical or vocational schools, or with the hands-on experience needed for their tasks.

In a manufacturing site, the roles below are usually found in QC. The EU GMP responsibilities of the head of Quality Control (Chapter 2, clause 2.8) include approving or rejecting materials and products, making sure all necessary testing is done and records are evaluated, approving specifications, sampling instructions and test methods, approving and monitoring contract analysts, ensuring qualification and maintenance of the department’s premises and equipment, ensuring validations are done, and ensuring initial and continuing training of department staff.

Training

EU GMP Chapter 2 sets out the training expectations that apply directly to QC staff:

• Training is required for everyone whose duties take them into control laboratories, including technical, maintenance and cleaning staff, and others whose work could affect product quality (clause 2.10).
• New staff receive basic training in the quality management system and GMP, then training suited to their duties. Continuing training must be given and its practical effectiveness periodically assessed. Training programmes are approved by the head of Production or Quality Control as appropriate, and records are kept (clause 2.11).

In a QC laboratory this commonly includes GMP and data integrity, lab safety, each method or instrument the person will use, and SOP read-and-understand. An analyst should normally demonstrate competence, for example by supervised analysis or comparison with an experienced analyst’s results, before working independently. How exactly this is done is an example in-house criterion, set by each site.

Practical checklist

1. Written job description and organisation chart for each role.
2. Qualification matrix showing who may perform which test or use which instrument.
3. Induction and GMP training before first laboratory work.
4. Method- and instrument-specific training with documented sign-off.
5. Periodic effectiveness checks and refresher training.
6. Named deputies for key roles.
7. Controlled files of CVs, certificates and training records.

Frequently asked questions

Can a trainee analyst report results?

Not independently. A trainee works under supervision and is assessed at the end of training; only authorised, competent staff should generate and approve reportable results.

Do contract staff need the same training?

Yes. Contract staff must be competent, act impartially and work under the laboratory’s quality management system.

How often should training be repeated?

The guidelines say continuing training must be given and its effectiveness assessed, but they do not fix a frequency. Many sites use an annual refresher plan, which is an example in-house criterion.

Who approves the training programme?

Under EU GMP clause 2.11, the head of Production or the head of Quality Control, as appropriate.

See also: General safety rules of the quality control laboratory and Records maintenance in a quality control laboratory.

References

1. World Health Organization, WHO good practices for pharmaceutical quality control laboratories, Annex 4, WHO Technical Report Series No. 1052 (57th report of the Expert Committee on Specifications for Pharmaceutical Preparations), 2024, sections 3.3 and 5.1-5.11.
2. European Commission, EudraLex Volume 4, Part I, Chapter 2: Personnel (version dated 16 August 2013, in operation from 2014).
3. European Commission, EudraLex Volume 4, Part I, Chapter 4: Documentation, clause 4.11.
4. US FDA, 21 CFR 211.180(a), General requirements (record retention).