Implementation walkthrough
How to implement GMP for medicines (PIC/S, EU, WHO): video walkthrough
A walkthrough of building a pharmaceutical quality system to GMP and preparing for the medicines regulator's inspection.
Key takeaways
- GMP requirements are written by regulators, such as the EU, PIC/S and WHO.
- The applicable text depends on products, sites and markets.
- Senior management is ultimately responsible for the pharmaceutical quality system.
- Annexes apply to particular products and activities, such as sterile manufacture.
- The regulator inspects and decides; there is no certification-body route.
Every batch made and checked to its authorised quality
Good manufacturing practice is the part of pharmaceutical quality management that makes sure every batch of a medicine is made and checked to the quality its intended use and its marketing authorisation demand. Regulators write the requirements, not a standards body: the EU guide in EudraLex Volume 4; the PIC/S GMP Guide, developed in parallel with the EU text and practically identical to it; the WHO GMP texts; and national codes such as the US FDA's rules and India's revised Schedule M.
The practical test is not whether standard operating procedures exist, but whether an inspector finds the quality system working on the day. No certification body is involved: compliance is established by inspection by the national medicines regulator, which issues a GMP certificate or licence where it is satisfied. This short film walks through how the system is built.
Building the pharmaceutical quality system
Define the products, sites and the GMP text that applies: dosage forms, sterile or not, active substances, biologicals, contract work and the markets supplied, which together decide the regulator's guide and the annexes that apply. A gap analysis then compares current practice with that text, paragraph by paragraph.
Implementation builds the pharmaceutical quality system, incorporating GMP and quality risk management with senior management ultimately responsible: management review, annual product quality reviews, change control, deviations and corrective and preventive action, and risk assessments sized to the risk. Personnel, premises and equipment, documentation, production, quality control, outsourced activities, complaints and recalls, and self-inspection follow, together with the annexes for particular products and activities, such as sterile manufacture under the revised Annex 1. The system then runs until it has produced the records that prove it, and self-inspection tests it before the inspectorate, partners' auditors and Qualified Persons do.
Sterling's expert and experienced consultants build the system and the evidence with your team under Sterling OS™. Nobody can sell GMP compliance: it is a finding the regulator makes by inspecting.
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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