What is the difference between GLP, GMP and GCP?

1Three practices for three kinds of work.

The three practices follow a medicine through its life. Good laboratory practice (GLP) applies to the nonclinical safety studies that support an application to FDA, such as an investigational new drug application.¹ Good clinical practice (GCP) applies to trials in human participants.² Good manufacturing practice (GMP) applies to making the product, from investigational supplies to the commercial batch.³²

2Good laboratory practice covers nonclinical safety studies.

Part 58 prescribes GLP for “nonclinical laboratory studies that support or are intended to support applications for research or marketing permits” for FDA-regulated products, and is “intended to assure the quality and integrity of the safety data” filed with FDA.¹ A nonclinical laboratory study means in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions “to determine their safety”. Studies in human subjects, clinical studies, field trials in animals and basic exploratory studies are excluded.¹

Each study has an approved written protocol, and any change to it is documented, dated and signed by the study director.¹ The study director has overall responsibility for the study and “represents the single point of study control”. A quality assurance unit, “entirely separate from and independent of” the people running the study, inspects it at intervals, reviews the final report against the raw data and signs a statement included with that report.¹ Records are kept for whichever is shortest: at least 2 years after FDA approves the application the study supports, at least 5 years after the results are submitted, or, where they are never submitted, at least 2 years after the study ends.¹

In the EU, Directive 2004/10/EC requires laboratories testing chemical products to comply with the principles of GLP in its Annex I, which are the OECD principles, and to certify that compliance when they submit results. Its recitals note that the EU codes for human and veterinary medicines require non-clinical tests on pharmaceutical products to follow those principles.⁷

3Good manufacturing practice covers making the product.

Parts 210 and 211 contain “the minimum current good manufacturing practice” for the methods, facilities and controls used to manufacture, process, pack or hold a drug, so that it meets the Act’s requirements for safety and has the identity, strength, quality and purity it is represented to have. A drug made without complying is adulterated under section 501(a)(2)(B) of the Act.³

GMP is organised around the product and the batch. Production follows written procedures approved by the quality control unit, and deviations are recorded and justified.⁴ The quality control unit has the authority to approve or reject components, materials and drug products, and to review production records; it has laboratory facilities for that testing.⁴ Each batch has a batch production and control record, and batch records are kept for at least 1 year after the batch’s expiry date.⁴

In the EU, Directive (EU) 2017/1572 lays down the principles and guidelines of GMP for medicinal products for human use that need a manufacturing authorisation, and requires manufacturers to work in accordance with GMP.⁸ EudraLex Volume 4 holds the guidance for interpreting those principles.⁹

4Good clinical practice covers trials in people.

ICH E6(R3) defines GCP as “an international, ethical, scientific and quality standard for the conduct of trials that involve human participants”. Following it helps assure that participants’ rights, safety and well-being are protected, that the conduct is consistent with principles that originate in the Declaration of Helsinki, and that results are reliable. It applies to interventional clinical trials of investigational products intended to be submitted to regulators.² ICH adopted E6(R3) on 6 January 2025.²

E6(R3) is guidance, not law. FDA issued it as guidance for industry in September 2025, with nonbinding recommendations.⁶ The binding US rules sit in the regulations. No investigator may involve a person in covered research without legally effective informed consent (21 CFR 50.20).¹² A clinical investigation that needs prior submission to FDA may not start until an institutional review board has approved it (21 CFR 56.103).¹³ Sponsors select qualified investigators and ensure proper monitoring; investigators protect the rights, safety and welfare of participants and keep records for 2 years after approval, or after the investigation is discontinued and FDA notified (21 CFR 312.50, 312.60 and 312.62).⁵

In the EU, Article 47 of Regulation (EU) No 536/2014 requires the sponsor and the investigator to conduct a trial in accordance with the protocol and the principles of GCP, taking account of the ICH GCP guidelines.¹⁰ In the EU, the E6(R3) principles and Annex 1 came into effect on 23 July 2025; Annex 2, on non-traditional designs such as pragmatic and decentralised trials, comes into effect on 15 January 2027.¹¹

5Where the three meet.

The practices hand over to one another. GLP safety studies support an investigational new drug application, which Part 58 lists among the applications it covers.¹ The product given to trial participants must itself be made under GMP: E6(R3) says investigational products “should be manufactured in accordance with applicable Good Manufacturing Practice (GMP) standards”, and the EU Clinical Trials Regulation requires the same.²¹⁰ In the US, a drug for a phase 1 study must meet the statutory CGMP requirement but is exempt from Part 211, until it is used in a phase 2 or phase 3 study or marketed.³

A laboratory can sit under either. A quality control laboratory testing components and batches for release works under GMP, as part of the quality control unit’s responsibilities.⁴ A laboratory running nonclinical safety studies of a test article works under GLP.¹

6How it runs in Seal.

Seal configures workflows for GMP, GLP, GCP, GDP and GPvP operations to the regulations and jurisdictions that apply to your products, alongside the rest of the quality system. In the QC laboratory, samples enter one controlled intake with their requirements attached, instrument data keeps its source, and results are checked against the applicable specification version before the approved decision returns to the batch.

For clinical operations, trial data, safety records and documents can stay in their existing systems and are connected through scoped connections or exports, and Neil can prepare a review brief with source references and evidence gaps for the study team to verify. Every record keeps its audit history and electronic signatures, with controls to support 21 CFR Part 11 and EU GMP Annex 11, as set out under Regulatory and validation.