In plain English
Good Manufacturing Practice, or GMP, is a set of rules for making medicines. They cover staff, buildings, equipment, paperwork and testing [1, 3].
The main idea is simple. Quality cannot be “tested into” a finished product. A test only checks a small sample, so quality has to be built in at every step [4].
In Australia, the Therapeutic Goods Administration (TGA, the national medicines regulator) uses an international GMP rulebook called the PIC/S Guide [1]. Australian factories need a TGA manufacturing licence. Overseas factories that make medicines for Australia need TGA “GMP clearance” or certification instead [5].
GMP belongs to a site and its systems, not to one vial. A statement such as “made under GMP” can only be checked if it names the site, the regulator that inspected it, and the batch records (the production paperwork) for the material in hand [3, 11].
The short version
- GMP means making a product the same way every time, and recording it [3].
- The TGA applies PIC/S Guide version PE009-17 [1].
- A licence or GMP certificate covers a site, not a batch [5, 11].
- A “research grade” label says nothing about GMP [2, 8].
What is GMP?
The PIC/S Guide describes GMP as the part of quality management that ensures products are consistently produced and controlled to the quality standards suited to their intended use. It covers both production and quality control [3]. The TGA puts the core principle in one line: quality cannot be tested into a batch; it must be built into each batch during all stages of manufacture [4].
The Guide lists the basic requirements. In summary [3]:
- manufacturing processes are clearly defined and shown to be capable of consistently meeting specifications;
- critical steps, and significant changes to them, are validated;
- trained staff, suitable premises and equipment, correct materials and labels, and approved procedures are in place;
- records made during manufacture show that every required step was actually done;
- significant deviations are recorded and investigated to find the root cause;
- records of manufacture and distribution let the complete history of a batch be traced;
- a system exists to recall any batch, and complaints are investigated.
Part I of the PIC/S Guide is organised into nine chapters [3]:
| Chapter | Topic | What it covers (from the chapter headings) |
|---|---|---|
| 1 | Pharmaceutical quality system | GMP, quality control, product quality review, quality risk management |
| 2 | Personnel | Key personnel, training, hygiene, consultants |
| 3 | Premises and equipment | Production, storage, quality control and ancillary areas; equipment |
| 4 | Documentation | Specifications, instructions, batch processing and packaging records, good documentation practice, retention |
| 5 | Production | Prevention of cross-contamination, validation, starting materials, packaging operations |
| 6 | Quality control | Sampling, testing, ongoing stability program, transfer of test methods |
| 7 | Outsourced activities | Duties of the contract giver and contract acceptor; the written contract |
| 8 | Complaints and product recall | Investigation, root cause analysis, corrective and preventive action, recalls |
| 9 | Self inspection | Internal checks of GMP compliance |
Documentation sits at the centre. Records should be made at the time each action is taken, and any alteration should be signed and dated so the original entry can still be read [3]. See Data Integrity and ALCOA+.
Where the rules come from: PIC/S, ICH Q7 and ICH Q10
PIC/S
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was set up in 1995 as an extension of the Pharmaceutical Inspection Convention of 1970. It is an informal, non-binding co-operative arrangement between regulators that inspect GMP, and it lists 57 participating authorities [6]. The TGA joined the Convention in January 1993 and the Scheme in November 1995 [7].
The PIC/S Guide began as the “PIC Basic Standards” of 1972, derived from the WHO GMP Guide. The European Union adopted its own GMP guide in 1989; since then the two have been developed in parallel and are practically identical. One visible difference: PIC/S uses the term “authorised person” where the EU uses “Qualified Person” [2].
The Guide has two parts plus annexes. Part I covers medicinal products. Part II covers active substances used as starting materials [2]. The TGA’s current version has 20 annexes [1].
ICH Q7: GMP for active pharmaceutical ingredients
Part II of the PIC/S Guide is the International Council for Harmonisation (ICH) guideline Q7, which PIC/S adopted in 2001 and made Part II in 2006 [2]. Q7 reached its final step in November 2000. It covers active pharmaceutical ingredients (APIs) made by chemical synthesis, extraction, cell culture or fermentation [8]. Two of its features matter for peptides:
- “Manufacturing” is defined broadly. It includes receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage and distribution [8].
- An independent quality unit. There should be a quality unit, independent of production, that carries both quality assurance and quality control responsibilities [8].
ICH Q10: the pharmaceutical quality system
ICH Q10 (2008) describes a model quality management system for the pharmaceutical industry. It is based on ISO quality concepts, includes GMP, and is meant to work alongside regional GMP rules. Content in Q10 that goes beyond regional GMP is optional [9]. Q10 names four elements [9]:
- a monitoring system for the manufacturing process and product quality;
- corrective action and preventive action (CAPA);
- change management;
- management review.
A 2021 analysis of manufacturers’ self-assessment data found measurable shifts in quality-system practices after Q10 was released, although the management-responsibility area scored lower [10]. A 2015 review of 102 publications identified guidelines from WHO, the US FDA, the EU and ICH as the main sources of pharmaceutical quality guidance, and noted that few published case studies show how sites apply them [12].
How GMP works in Australia: licences, clearance and certification
Since 1 September 2025, the Therapeutic Goods (Manufacturing Principles) Determination has required manufacturing of medicinal products in Australia to meet the PIC/S Guide to GMP PE009-17 (dated 25 August 2023), except Annexes 4, 5 and 14. Through section 36 and other provisions of the Therapeutic Goods Act 1989, the Guide has legal force. It applies to the manufacture of medicines, APIs and sunscreens unless an exemption applies [1]. The previous version, PE009-16, had been adopted on 3 June 2024; the changes in version 17 relate only to Annex 1, on sterile products [13].
The TGA uses different tools for local and overseas sites:
| Term | Issued by | What it covers | What it is not |
|---|---|---|---|
| Manufacturing licence | TGA, for an Australian site [5] | A named Australian manufacturing site, granted after the manufacturer shows compliance with the relevant code of GMP [4, 5] | Evidence that a particular batch met its specification |
| GMP certification | TGA, after its own on-site inspection of an overseas site [5] | That site’s compliance as found by the TGA | A licence (only Australian sites can hold one) [5] |
| GMP clearance | TGA, on application by the Australian sponsor [5] | Use of a named overseas site, based on evidence such as a partner regulator’s inspection (MRA or compliance verification pathways) or TGA certification [5, 14] | Permanent; clearances expire and must be renewed [15] |
| EU GMP certificate | An EU competent authority, after inspecting a site [11] | The site’s compliance at that inspection; recorded in the EudraGMDP database [11] | A statement about any later batch |
A few details make these documents easier to read:
- To get a licence, a manufacturer must show compliance with the relevant code of GMP, usually through an on-site inspection. It is an offence to manufacture therapeutic goods without a licence or certification unless an exemption applies [4].
- Licensing an Australian site can take up to 12 months; certifying an overseas site can take up to 15 months [5].
- Before accepting another regulator’s evidence, the TGA assesses that regulator’s GMP program for equivalence [14]. Australia has mutual recognition agreements (MRAs) with the European Union (since 1999) and with Iceland, Liechtenstein and Norway (since 2000) [14].
- Sponsors are expected to keep evidence of GMP compliance for every overseas site they use, and to apply to renew a clearance at least six months before it expires [15].
Why research-grade material usually sits outside GMP
GMP codes define their own scope. The PIC/S standards are written for medicines [2]. ICH Q7 applies to APIs for use in medicinal products, and says that a material should be made to the Guide when it is classified as an API where it is made or used in a medicine [8]. “Research grade” is not a GMP category. A research chemical is made under GMP only if its maker says so and can prove it, site by site and batch by batch.
The gap matters for experiments. A review of impurities in peptide medicines described contamination of a peptide product by unrelated peptides, which the authors linked to a lack of appropriate GMP, and noted that impurities can distort early functional studies and lead to wrong conclusions [16]. In a 2020 report, quantitative NMR found undeclared mannitol at 20% and 43% w/w in two commercially sourced custom peptides. The authors concluded that experimental verification should take the place of trust in research quality control [17]. See Peptide Impurities.
What should back a GMP claim?
A GMP statement on a research product is believable only when it comes with documents that link the site’s GMP status to the batch in hand. A practical checklist:
- A named site and legal entity. Licences and certificates belong to sites [5, 11]. “Made in a GMP facility” with no name cannot be checked.
- The issuing authority, document number and date. Clearances expire, and an EU authority can issue a non-compliance statement after an inspection [11, 15].
- A matching scope. The activity behind the claim (synthesis of the active substance, filling, labelling) should be covered. The TGA expects the scope of a GMP application to match the activities actually carried out at the site [15].
- Batch documents. The batch number on the vial should trace to batch processing and packaging records [3]. The certificate of analysis should give the batch number and release date, list each test with its acceptance limit and the numerical value found, and be dated and signed by the quality unit [8].
- The original certificate. If a distributor or repacker reissues a certificate, it should name the laboratory that did the analysis, refer to the original manufacturer and the original batch certificate, and attach a copy [8].
Worked example: checking “manufactured in a GMP-certified facility”
| Step | Question | What a satisfactory answer looks like |
|---|---|---|
| 1 | Which facility? | Company name and full site address |
| 2 | Certified by whom? | A regulator that is a PIC/S participating authority [7], with a certificate or licence number |
| 3 | Does the record exist? | For an EU site, a current GMP certificate (and no non-compliance statement) in EudraGMDP [11] |
| 4 | Does it cover this work? | The certificate’s scope includes the step claimed, for example manufacture of the active substance |
| 5 | Was this batch made there? | A certificate of analysis for the same batch number, naming the site and signed by its quality unit [8] |
If steps 1–3 pass but step 5 fails, the claim describes a building, not the material. See Batch Numbers and Traceability and How to Read a Peptide COA.
How to look up GMP status
- Australian sites. The TGA publishes a list of licensed Australian manufacturers [5].
- EU and EEA sites. EudraGMDP is a public EU database of manufacturing and import authorisations, registrations of active substance manufacturers, GMP certificates and non-compliance statements [11].
- Inspectorates. The PIC/S website lists its participating authorities, with their accession dates [7].
Pharmacopoeial quality standards are a separate question from GMP. See Pharmacopoeias Explained.
What this means in Australia
- Legal force. The PIC/S Guide PE009-17 is the Australian manufacturing standard for medicines and APIs, with legal force under the Therapeutic Goods Act 1989 [1].
- Licences. Australian manufacturing sites need a TGA licence; manufacturing without a licence or certification is an offence unless an exemption applies [4, 5].
- What counts as manufacture. In July 2026 the TGA stated that manufacture includes any step in the process, including applying a label to a blank vial, packaging for distribution, and storage before the product is in its final state [18].
- Research-use labels. In April 2026 the TGA stated that a “research use only” disclaimer does not make supply lawful, and does not change a product’s regulatory status, permit importation, or remove advertising or supply obligations [19]. Unapproved peptide products have not been assessed by the TGA for safety, quality or effectiveness [19]. See What Is the ARTG?.
This is general information, not legal advice. Laws change; check the current Poisons Standard and TGA guidance.
Frequently asked questions
What does GMP stand for?
Good Manufacturing Practice: the part of quality management that ensures products are consistently produced and controlled to standards suited to their intended use [3].
Which GMP guide does the TGA use?
Since 1 September 2025, the PIC/S Guide to GMP PE009-17 (25 August 2023), except Annexes 4, 5 and 14 [1].
Is a GMP certificate the same as a TGA licence?
No. Only Australian sites can hold a TGA manufacturing licence. Overseas sites can receive TGA GMP certification after a TGA inspection, and sponsors obtain GMP clearance to use them [5].
Does “research grade” mean a product was made under GMP?
No. GMP guides are written for medicines and APIs [2, 8]. A GMP claim for a research product needs its own evidence: the site, the authority and the records for that batch.
Can a GMP certificate prove that a particular vial is good?
Not on its own. A certificate describes a site’s compliance at inspection [11]. The link to a vial comes from the batch number, the batch records and a certificate of analysis for that batch [3, 8].
References
- Therapeutic Goods Administration. Complying with the PIC/S Guide to Good Manufacturing Practice for medicinal products. tga.gov.au. Accessed 25 October 2026.
- Pharmaceutical Inspection Co-operation Scheme. Guide to Good Manufacturing Practice for Medicinal Products, PE 009-17: Introduction. 25 August 2023. tga.gov.au. Accessed 25 October 2026.
- Pharmaceutical Inspection Co-operation Scheme. Guide to Good Manufacturing Practice for Medicinal Products, PE 009-17: Part I. 25 August 2023. tga.gov.au. Accessed 25 October 2026.
- Therapeutic Goods Administration. Good manufacturing practice: an overview. tga.gov.au. Accessed 25 October 2026.
- Therapeutic Goods Administration. Australian manufacturing licences and overseas GMP certification. tga.gov.au. Accessed 25 October 2026.
- Pharmaceutical Inspection Co-operation Scheme. Introduction. picscheme.org. Accessed 25 October 2026.
- Pharmaceutical Inspection Co-operation Scheme. Members. picscheme.org. Accessed 25 October 2026.
- International Council for Harmonisation. ICH Q7: Good manufacturing practice guide for active pharmaceutical ingredients. 2000. database.ich.org. Accessed 25 October 2026.
- International Council for Harmonisation. ICH Q10: Pharmaceutical quality system. 2008. database.ich.org. Accessed 25 October 2026.
- VanDuyse SA, Fulford MJ, Bartlett MG. ICH Q10 pharmaceutical quality system guidance: understanding its impact on pharmaceutical quality. AAPS J. 2021;23(6):117. doi:10.1208/s12248-021-00657-y. PMID: 34773177
- European Medicines Agency. Good manufacturing practice. ema.europa.eu. Accessed 25 October 2026.
- Haleem RM, Salem MY, Fatahallah FA, Abdelfattah LE. Quality in the pharmaceutical industry: a literature review. Saudi Pharm J. 2015;23(5):463–469. doi:10.1016/j.jsps.2013.11.004. PMID: 26594110
- Therapeutic Goods Administration. Planned update to manufacturing principles for medicines, APIs and sunscreens. Regulatory decision notice, 27 August 2025. tga.gov.au. Accessed 25 October 2026.
- Therapeutic Goods Administration. International agreements and arrangements for GMP clearance. tga.gov.au. Accessed 25 October 2026.
- Therapeutic Goods Administration. Sponsor responsibilities related to GMP clearance and certification. tga.gov.au. Accessed 25 October 2026.
- D’Hondt M, Bracke N, Taevernier L, et al. Related impurities in peptide medicines. J Pharm Biomed Anal. 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012. PMID: 25044089
- Choules MP, Bisson J, Simmler C, et al. NMR reveals an undeclared constituent in custom synthetic peptides. J Pharm Biomed Anal. 2020;178:112915. doi:10.1016/j.jpba.2019.112915. PMID: 31671336
- Therapeutic Goods Administration. Unapproved peptide product promoters and suppliers are put on notice. Media release, 20 July 2026. tga.gov.au. Accessed 25 October 2026.
- Therapeutic Goods Administration. Understanding your responsibilities when importing, compounding and supplying unapproved peptide products. Safety advisory, 13 April 2026. tga.gov.au. Accessed 25 October 2026.
