cGxP
Dr. Rachel Benett
September 30, 2026
One belief I encounter in almost every quality audit I conduct is that a single GxP certificate covers every role. A bioanalytical scientist whose file holds only a Good Manufacturing Practice (GMP) certificate is treated as qualified for a nonclinical safety study. A clinical monitor trained in Good Clinical Practice (GCP) moves into a laboratory quality assurance role, and no one revisits the training record. Neither assumption holds up once an inspector compares the record with the work. Good Laboratory Practice (GLP), GMP and GCP are three separate frameworks, each with its own personnel requirements, and the training a person needs first should follow the work that person actually performs.
Neither the FDA nor the EMA names a specific course, provider or renewal frequency for any of the three practices. What the regulations and guidelines do require is that each person engaged in regulated work has the education, training and experience needed for their assigned functions, and that the organization keeps a current record showing it. Inspectors on both sides of the Atlantic expect that record to be specific to the role and ready for review. This article sets out which requirement applies to which role, what each one actually asks for, and where certified training fits.
Good Laboratory Practice governs the nonclinical safety studies that support an application to test or market a product. In the United States the rule is 21 CFR Part 58, and its personnel clause is direct. Section 58.29 requires that each individual engaged in the conduct of, or responsible for the supervision of, a nonclinical laboratory study shall have education, training and experience, or a combination thereof, to enable that individual to perform the assigned functions. The same section requires each testing facility to maintain a current summary of training and experience and a job description for each such individual. Those are two codified obligations: the person must be qualified, and the facility must hold the evidence.
The OECD Principles of Good Laboratory Practice apply the same logic to studies conducted for European and other OECD member regulators. Section 1.1 places the responsibility on test facility management to ensure that a sufficient number of qualified personnel are available and that a record of the qualifications, training, experience and job description of each professional and technical individual is maintained. Section 1.4 then turns to study personnel themselves, who must be knowledgeable in those parts of the Principles that apply to their involvement in the study. Neither text names a course. Both make it impossible to defend a study director or a bench technician whose file shows no Good Laboratory Practice training at all. A structured, certified GLP course is the simplest way to give the training summary a defensible, dated entry.
Good Manufacturing Practice governs the manufacture, processing, packing, holding and quality control testing of the product itself. In the United States the personnel clause is 21 CFR 211.25. It requires that each person engaged in these operations shall have education, training and experience, or a combination, to perform the assigned functions, and it adds a second layer that GLP does not: 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 the CGMP requirements applicable to them. The regulation defines neither “continuing” nor “sufficient frequency”; your written training program does, and FDA expects it to be followed.
The European text is Chapter 2 of EudraLex Volume 4. Paragraph 2.10 requires the manufacturer to provide training for all personnel whose duties take them into production and storage areas or control laboratories, and for any other personnel whose activities could affect the quality of the product. Paragraph 2.11 requires that newly recruited personnel receive training appropriate to their duties in addition to basic training on the theory and practice of the Pharmaceutical Quality System and GMP, that continuing training is given, that its practical effectiveness is periodically assessed, and that training records are kept. Paragraph 2.12 extends specific training to personnel working where contamination is a hazard. If your role is on the manufacturing floor, in packaging or in a quality control laboratory releasing batches, the Introduction To Good Manufacturing Practice (GMP) course is the one that maps to these clauses. A GLP certificate on a QC analyst’s file does not answer 211.25 or Chapter 2.
Good Clinical Practice governs trials in human participants, and the international standard is ICH E6(R3), which reached Step 4 on 6 January 2025 and came into effect in the European Union on 23 July 2025. The renumbered guideline places the investigator clause at section 2.1.1: the investigator should be qualified by education, training and experience to assume responsibility for the proper conduct of the trial and should provide evidence of such qualifications. Section 2.3.2 extends that expectation to delegated staff, whom the investigator should ensure are appropriately qualified and adequately informed about their assigned activities. On the sponsor side, section 3.4 calls for appropriately qualified individuals for the activities to which they are assigned, and section 3.7.1 asks the sponsor to select investigators who are qualified by education, training and experience.
One point of precision matters here. ICH E6(R3) is a guideline, so the operative verb is “should” rather than “shall”, and it does not prescribe a named course or a renewal interval. The evidence of qualification is what matters, and an accredited certificate is the most direct evidence a coordinator or monitor can file. For anyone at a clinical site, in a contract research organization or in sponsor clinical operations, the ICH-GCP: Introduction to Good Clinical Practice course is the training that matches these sections. It does not replace GLP training for the nonclinical team whose toxicology package sits behind the Investigator’s Brochure.
I apply a simple test with every client: identify the regulated activity that produces the data or the product your signature stands behind, then hold the training that matches the clause governing that activity. The following mapping is the one I use during 2026 training-matrix reviews.
The mapping also explains why the misconception persists. A GMP certificate and a GLP one look similar on a wall, and both sit inside the wider GxP family. The clauses behind them are separate, and the training record must reflect the one that governs the work. When I close a training-matrix review, the first gap I flag is almost always a nonclinical scientist whose file holds a GMP certificate and no online GLP training record at all, because the site trained everyone on the manufacturing framework by default.
The Introduction to GLP course from GxP Training gives nonclinical laboratory staff the structured foundation that 21 CFR 58.29 and the OECD Principles presuppose. It traces the origin of GLP, positions it within the drug development process, and works through the fundamental points of resources, rules, characterization and quality assurance that an inspector will test on site. The course was built by a team of Regulatory Affairs Experts with qualifications from Northeastern University, Boston.
The Introduction to GMP course gives manufacturing, packaging and quality control staff the basic training on the theory and practice of GMP that 21 CFR 211.25 and Chapter 2 of EudraLex Volume 4 expect. It sets out the scope and principles of GMP, then works through organization and personnel, facilities, equipment, materials, the quality management system, manufacturing operations, validation, outsourcing and audits: the areas an inspection typically covers.
The ICH-GCP: Introduction to Good Clinical Practice course gives investigators, site staff, monitors and sponsor teams a foundation in the principles that ICH E6 asks them to demonstrate. It explains why GCP exists, the ethical principles and safety concerns behind it, and the role of the International Council for Harmonisation. It then sets out the responsibilities of sponsors, investigators and monitors, the trial documentation that must be written and maintained, and the informed consent process.
The financial argument is not about the price of a course. It is about what a training gap costs once it surfaces in an inspection or a submission review, and that cost looks different in each framework.
In a nonclinical laboratory, a pivotal toxicology study that a regulator declines to rely on because of GLP non-compliance may have to be repeated, and the delay to a development program is typically measured in months. In manufacturing, inadequate training is a familiar inspection observation, and it rarely appears alone: it tends to surface alongside the deviations, documentation errors and investigations it helped cause. At a clinical site, an investigator who cannot show that delegated staff were qualified invites questions about the reliability of the data that site generated.
Against those exposures, a certified course in the framework that governs each person’s work, with a dated, traceable certificate in the training record, is an investment any quality manager can defend to finance.
Every GxP Training course is developed by regulatory experts who have worked inside the frameworks they teach. Successful completion produces a unique, verifiable CPD/CEU certificate that can be checked through the online certificate checker and shared directly on LinkedIn. Clients enjoy 12 months of self-paced access, and managers can track team progress through the built-in HR and reporting tools. Content is refreshed monthly to reflect regulatory updates, and each course is SCORM compatible for organizations that host training in their own learning management system.
The misconception I opened with persists because it is convenient: one certificate, one line in the training record. The regulations do not work that way, and neither do inspectors. 21 CFR 58.29, 21 CFR 211.25, EU GMP Chapter 2 and ICH E6(R3) each describe a different population, a different activity and a different standard of evidence, and the training a person needs first should follow the work that person actually performs.
