Regulated labs

Why it matters

The same HPLC method can run in a university research lab, a pharmaceutical QC lab, a contract environmental lab and an accredited testing lab, but the rules around it differ enormously. Who approves the method, how data are recorded, what happens when a result is out of specification, and who inspects the lab all depend on the regulatory framework. Analytical chemists move between these sectors, and employers expect you to know which rules apply where.

Requirements drift. Regulations and standards are revised. Use the official links (checked on 2026-10-23) for current text rather than summaries.

GMP: making medicines

Good Manufacturing PracticeRegulations governing the manufacture and testing of medicines (GMP, or cGMP in the US). (in the US, current GMP or cGMP, 21 CFR Parts 210 and 211; FDA overview: CGMP regulations) governs the manufacture and testing of medicines. The QC lab tests raw materials, in-process samples, finished products and stability samples against specifications.

Key features:

• Methods are validated (ICH Q2) or verified (compendial methods such as USP).
• Instruments are qualified (IQ/OQ/PQ) and calibrated.
• Out-of-specificationA result outside the specification, which in GMP triggers a formal investigation (OOS). (OOS) results trigger a formal investigation: first a lab investigation for an assignable cause (calculation error, instrument fault), then, if none is found, a full investigation including manufacturing. Retesting until a passing result appears ("testing into compliance") is prohibited.
• Data integrity follows ALCOA+Data-integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate, plus complete, consistent, enduring and available.: data must be Attributable, Legible, Contemporaneous, Original and Accurate, plus complete, consistent, enduring and available. Electronic records follow 21 CFR Part 11 (audit trails, access control, electronic signatures).
• The FDA (and other national regulators) inspect.

GLP: safety studies

Good Laboratory PracticeRegulations for nonclinical safety studies, built around a study director, protocol and QA unit (GLP). (21 CFR Part 58, and the OECD GLP principles internationally) governs nonclinical safety studies submitted to regulators, such as toxicology studies and the bioanalysis that supports them. It is about the integrity and reconstructability of a study:

• A study director is the single point of responsibility.
• A protocol is approved before the study starts, and deviations are documented.
• An independent quality assurance unit (QAU) inspects the study and audits the final report.
• Raw data, specimens and records are archived so the study can be reconstructed years later.

GLP is not the same as "good lab habits," and it does not apply to routine product release testing (that is GMP).

EPA methods: environmental testing

Environmental labs measure pollutants in water, soil, air and waste for regulatory compliance. In the US they use EPA-approved methods: for example the Clean Water Act methods in 40 CFR Part 136 (EPA CWA methods), drinking-water methods, and SW-846 for solid waste. Features:

• Methods are often prescriptive: specified sample containers, preservation, holding times, calibration and QC (method blanks, laboratory control samples, matrix spikes, duplicates).
• Results carry qualifiers when QC fails.
• Labs are usually certified or accredited by state programs (and many through NELAP/TNI) for each method and matrix.
• Chain of custody is routine, because results may end up in enforcement cases.

ISO/IEC 17025: competence of testing labs

ISO/IEC 17025 (ISO 17025) is an international standard for the competence of testing and calibration laboratories in any sector: food, materials, forensics, calibration, environmental. Labs are accredited by bodies such as A2LA or ANAB in the US. Features:

• A management system (document control, corrective action, internal audits, management review).
• Validated or verified methods and trained, authorized staff.
• Metrological traceabilityLinking measurements to SI units through calibrated equipment and reference materials. of measurements to SI units through calibrated equipment and reference materials.
• Measurement uncertainty estimated for results.
• Proficiency testingAnalysing blind samples from an external provider and comparing results with other labs.: analysing blind samples from an external provider and comparing results with other labs.
• Impartiality and confidentiality requirements.

Side-by-side

Working in these labs

Employers typically ask for a bachelor's degree in chemistry (ACS-approved programs are preferred by many employers; see ACS approval) with substantial hands-on lab courses, and they provide sector-specific GMP, GLP or quality-system training on the job. Research leadership roles usually need an MS or PhD.

Common mistakes

• Calling any careful lab "GLP." GLP is a specific regulation for nonclinical studies.
• Retesting an OOS result without an investigation.
• Assuming ISO 17025 accreditation covers every test a lab offers (it covers a defined scope).
• Ignoring holding times and QC requirements written into EPA methods.

Quick recap

• GMP: product quality, OOS investigations, ALCOA+ data integrity.
• GLP: nonclinical safety studies, study director, protocol, QAU.
• EPA methods: prescriptive environmental methods with built-in QC and state certification.
• ISO/IEC 17025: competence, traceability, uncertainty, proficiency testing; accreditation with a defined scope.

Try it

Open the Do tab for the quiz: match situations to the framework that applies.