Quality terms travel. "GMP," "GLP," "ISO certified," "ISO/IEC 17025 accredited" and "quality unit" appear on websites, labels and laboratory documents, often side by side and often without explanation. They are not interchangeable. Each comes from a different framework, governs a different activity and answers a different question.
This guide explains what each term means according to its source document, and how a researcher can read these terms critically. It is about literacy, not about any particular supplier's status.
The Short Version
| Term | What it governs | The question it answers |
|---|---|---|
| GMP (Good Manufacturing Practice) | How a material is manufactured, controlled and released | Was this batch made and released under a controlled quality system? |
| GLP (Good Laboratory Practice) | How non-clinical safety studies are planned, run, recorded and reported | Can a regulator reconstruct and trust this safety study? |
| ISO/IEC 17025 | The competence and impartiality of a testing or calibration laboratory | Is this lab competent to run these specific tests? |
| Accreditation | Independent evaluation of a lab against a standard such as ISO/IEC 17025 | Has an authoritative body checked that competence? |
GMP: Good Manufacturing Practice
GMP is a set of expectations for manufacturing. For active pharmaceutical ingredients, the internationally harmonised reference is ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Step 4 version dated 10 November 2000). It covers quality management, personnel, buildings, equipment, documentation, materials management, production, laboratory controls, validation, change control and more.
Research-grade peptides are generally not manufactured as pharmaceutical ingredients, so GMP is not the governing framework for them. ICH Q7 is still useful as a model: it describes, in plain language, what a well-run quality system expects. Two parts are especially helpful for reading documents.
The independent quality unit
ICH Q7 says the quality unit(s) should be involved in all quality-related matters and should review and approve quality-related documents. It also says the main responsibilities of the independent quality unit(s) should not be delegated. Those responsibilities include releasing or rejecting materials and reviewing completed batch production and laboratory control records.
The lesson for document readers: a quality document is meaningful because someone independent of production checked it and is accountable for it.
What ICH Q7 expects from a certificate of analysis
Section 11.4 of ICH Q7 sets out what a certificate of analysis should contain for an intermediate or API. In summary:
- Authentic certificates should be issued for each batch on request.
- The name of the material, its grade where appropriate, the batch number and the date of release.
- The expiry date or retest date, where applicable.
- Each test performed, with its acceptance limits and the numerical results obtained, where results are numerical.
- Dated and signed by authorised personnel of the quality unit, with the name, address and telephone number of the original manufacturer.
- Where analysis was done by a repacker or reprocessor, their details and a reference to the original manufacturer.
This list is a good general checklist for any analytical document, whatever framework it comes from. A result without an acceptance limit, a document without a batch number, or a certificate with no date or responsible person gives you less to work with. Our guide How to Read a Peptide Analytical Report applies these ideas to peptide data.
Trust, but verify
ICH Q7 is also realistic about supplier documents. It says a supplier's certificate of analysis can be used in place of some testing only if the manufacturer has a system to evaluate suppliers. Full analyses should be done on at least three batches before reducing in-house testing, and a full analysis should still be performed at appropriate intervals and compared with the certificates. The principle is that documents are checked against independent data over time, not accepted on faith.
GLP: Good Laboratory Practice
GLP is often confused with "good lab practice" in the everyday sense of working carefully. In regulatory usage it is much narrower. The OECD Principles of Good Laboratory Practice (as revised in 1997) define GLP as:
"a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported."
Key points:
- GLP applies to studies, specifically non-clinical health and environmental safety studies. It does not apply to manufacturing a batch.
- Each study has a Study Director, the person responsible for the overall conduct of the study.
- A Quality Assurance Programme is a defined system, including personnel, that is independent of study conduct and assures management that the Principles are being followed.
- Standard Operating Procedures (SOPs) describe how tests and activities are done.
- The OECD framework supports the Mutual Acceptance of Data: data generated under OECD Test Guidelines and GLP in one member country are accepted in others.
So "GLP" on a document should refer to a study conducted under a GLP quality system. It is not a property of a vial. If a document uses "GLP" loosely, it is reasonable to ask which study, which test facility and which compliance monitoring programme are meant.
ISO/IEC 17025: Competence of Testing Laboratories
ISO/IEC 17025 is the international standard for the competence of testing and calibration laboratories. ILAC, the International Laboratory Accreditation Cooperation, describes itself as the international organisation for accreditation bodies operating under ISO/IEC 17011 and accrediting, among others, calibration and testing laboratories using ISO/IEC 17025.
Accreditation vs. certification
These words are often mixed up:
- Accreditation is, in ILAC's words, the independent evaluation of conformity assessment bodies against recognised standards to carry out specific activities, to ensure their impartiality and competence. A laboratory is accredited for a defined scope: specific tests, methods and materials.
- Certification usually refers to a management system, for example a quality management system, being certified against a standard. It says a system exists and is followed. It is not the same as being assessed as technically competent to perform a specific test.
When a document says a lab is "ISO/IEC 17025 accredited," the useful follow-up questions are: by which accreditation body, and is the specific test on this report within the accredited scope? Accreditation for one method does not cover every test a lab performs.
International recognition
ILAC explains that in 2000, 36 ILAC Full Members (laboratory accreditation bodies from 28 economies) signed the ILAC Mutual Recognition Arrangement (MRA) in Washington DC. The ILAC MRA for calibration and testing laboratories came into effect on 31 January 2001. Signatory accreditation bodies are peer-evaluated, and the arrangement supports acceptance of accredited test results across borders.
Reading These Terms on a Document
A practical checklist:
- Which framework is named, and does it fit the claim? GMP is about manufacturing and release. GLP is about safety studies. ISO/IEC 17025 is about a testing lab's competence. A mismatch, such as "GLP-grade powder", is a signal to read more carefully.
- Who is accountable? Look for a named, dated sign-off by a person or unit independent of the work being reported.
- Is it batch-specific? A quality document should tie results to a batch or lot, with a date.
- Are limits and numbers shown? Results should come with acceptance criteria and, where numerical, actual values.
- For accreditation claims: which body, and is the test within scope?
- Does independent data agree? As ICH Q7 notes, documents are best trusted when they are periodically checked against independent analysis.
Remember also that a test result only means as much as the method behind it. See Is the Test Method Fit for Purpose?. And a quality term on a document does not change what a material is for. See What "Research Use Only" Means.
FAQ
Is "GMP-grade" the same as "high purity"? No. GMP describes how material is made and released under a quality system. Purity is a measured result. A high-purity material can be made outside GMP, and GMP does not by itself specify a purity level.
Does an ISO/IEC 17025-accredited lab guarantee a correct result? Accreditation provides independent assurance of competence and impartiality for the accredited scope. It does not replace reading the result, the method and the limits.
Why does GLP not apply to analytical testing of a product batch? GLP governs non-clinical safety studies. Routine batch testing is governed by other frameworks, such as GMP laboratory controls or ISO/IEC 17025.
Sources
- ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Step 4, 10 November 2000): https://database.ich.org/sites/default/files/Q7%20Guideline.pdf
- OECD Principles on Good Laboratory Practice (as revised in 1997), ENV/MC/CHEM(98)17: https://www.utu.fi/sites/default/files/media/env-mc-chem(98)17.pdf
- International Laboratory Accreditation Cooperation (ILAC). About ILAC: https://ilac.org/about-ilac/
Every Peptide Privé batch is tested by an independent lab.
Contact our team with documentation questions.
For in-vitro laboratory research only. Not for human or animal use.
