Two-minute brief
GMP requirements explained (PIC/S, EU, WHO): video brief
A two-minute brief on the structure of the EU and PIC/S GMP guides and what each chapter asks of a medicines manufacturer.
Key takeaways
- EU and PIC/S GMP share Part I, Part II and the annexes.
- Chapter 1 requires a pharmaceutical quality system with quality risk management.
- Senior management is ultimately responsible for the quality system.
- The revised Annex 1 for sterile manufacture has applied since 25 August 2024.
- Regulators inspect and issue GMP certificates or licences.
One structure shared by the EU and PIC/S
The EU and PIC/S GMP guides share one structure: Part I, nine chapters for medicinal products; Part II for active pharmaceutical ingredients, on a text developed by ICH; and annexes for particular products and activities. The EU adds Part III for related documents such as ICH Q9(R1) and Q10, and Part IV for advanced therapy medicinal products. WHO GMP and national codes cover the same ground in their own order. This short film walks through Part I.
Chapter 1 requires a pharmaceutical quality system incorporating GMP and quality risk management, with senior management ultimately responsible for it; in practice management review, annual product quality reviews, change control, deviations and CAPA, and risk assessments sized to the risk. Chapter 2 covers personnel: enough qualified people, key personnel with defined responsibilities, training and hygiene. Chapter 3 covers premises and equipment, chapter 4 documentation, and chapter 5 production.
Quality control through self-inspection
Chapter 6 covers quality control, chapter 7 outsourced activities, chapter 8 complaints and product recall, and chapter 9 self-inspection. The annexes then address particular products and activities, such as the manufacture of sterile medicinal products under the revised Annex 1, fully applicable since 25 August 2024, and computerised systems, qualification and validation, and certification by a Qualified Person and batch release.
GMP applies to finished-dose, sterile, biological and API manufacturers, contract manufacturers, packagers, testing laboratories and importers that release batches. The PIC/S GMP Guide is currently PE 009-18. There is no certification-body route: the national medicines regulator inspects and, where it finds compliance, issues its GMP certificate or licence, and PIC/S itself does not certify companies.
The EU and PIC/S guides are developed in parallel and are practically identical, with differences mostly in vocabulary, while WHO GMP covers the same ground in its own structure. The revised Annex 1 governs sterile manufacture. ISO 9001 cannot replace GMP: it is a management system standard certified by certification bodies, whereas GMP is a regulatory requirement inspected by medicines regulators, although the pharmaceutical quality system model of ICH Q10 lets the two run as one system.
GMP (PIC/S, EU, WHO) at a glance
- Purpose
- Medicines produced and controlled, batch after batch, to the quality their intended use and marketing authorisation require, so no batch puts a patient at risk
- Relevant to
- Finished-dose, sterile, biological and API manufacturers, contract manufacturers, packagers, testing laboratories and importers that release batches
- Edition
- PIC/S GMP Guide PE 009-18, in force since 24 September 2026; EU GMP in EudraLex Volume 4, with the revised Annex 1 fully applicable since 25 August 2024; WHO GMP main principles in TRS 986, Annex 2
- Certification
- No certification-body route. The national medicines regulator inspects and, where it finds compliance, issues its GMP certificate or licence; PIC/S does not certify companies
- Sterling's role
- Pharmaceutical quality system build with your team, Effivity, training, self-inspection and inspection readiness, then Sustain™
- Cost and timing
- Total investment for a GMP-compliant pharmaceutical quality system depends on the current maturity of your processes, the scope, locations and number of employees. The process typically takes 6 to 18 months, before the regulator's inspection
GMP (PIC/S, EU, WHO): questions people ask
Is there such a thing as GMP certification?
Not from a certification body. Compliance with pharmaceutical GMP is established by the national medicines regulator through inspection; where it finds compliance it issues a GMP certificate or licence, and in the EU the certificate, or a statement of non-compliance, is entered in EudraGMDP. PIC/S states that it does not inspect or certify companies and that GMP certificates are issued by its Participating Authorities. A "GMP certificate" from a certification body has no regulatory standing.
What is the difference between EU GMP, the PIC/S GMP Guide and WHO GMP?
The EU guide and the PIC/S guide are developed in parallel and are practically identical; the visible differences are mostly vocabulary, such as the PIC/S "authorised person" for the EU's "Qualified Person". WHO GMP, with its main principles in TRS 986, Annex 2, covers the same ground in its own structure and underpins the WHO Certification Scheme and WHO prequalification. Your regulator decides which text it inspects against.
Our regulator is not a PIC/S member. Why should PIC/S matter to us?
Because your partners and importing markets may be. PIC/S brings together 57 regulatory authorities, among them the US FDA, the UK's MHRA, Health Canada, Australia's TGA, Singapore's HSA and, since January 2026, Jordan's JFDA; the UAE's Emirates Drug Establishment has a pre-accession application under review. An importing regulator or a partner may assess your site against that standard, whatever your national code says.
Does the revised Annex 1 apply to us?
It governs sterile manufacture. In the EU it came into operation on 25 August 2023, with point 8.123 from 25 August 2024, and the PIC/S guide carries it from PE 009-17. Its scope notes that some of its principles may support the manufacture of products not intended to be sterile, so non-sterile sites with microbiological risks read it too. Its centre is a contamination control strategy, actively reviewed, across the facility and process.
Can ISO 9001 certification replace GMP?
No. ISO 9001 is a management system standard certified by certification bodies; GMP is a regulatory requirement inspected by medicines regulators. They sit together well: ICH Q10, in the EU's Part III, describes a pharmaceutical quality system model across the product lifecycle, and the two can run as one system. The inspector still looks for GMP, chapter by chapter.
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