Good Manufacturing Practice (GMP) is the set of legally binding quality rules for how medicines are made, from the premises and staff to documentation and batch release. In the EU, every manufacturer of medicines needs a manufacturing licence and must comply with GMP, while for cosmetics GMP is also required but compliance is presumed when you follow the harmonised standard EN ISO 22716.
In the Netherlands, the Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd, IGJ) inspects pharmaceutical manufacturers and issues GMP certificates. Cosmetics fall under a different regime and a different supervisor. Below we explain where the GMP rules come from, what they require, who is responsible and what happens when a manufacturer does not comply.
What is GMP?
GMP is a quality assurance system that ensures products are consistently produced and controlled according to fixed standards. The idea is that quality cannot be tested into a product afterwards; it must be built into every step of production.
Testing a finished medicine has its limits. Not every impurity can be detected and not every unit can be analysed. Quality can only be guaranteed if the whole production process is carried out in a prescribed and controlled way. GMP therefore specifies how, and under which conditions, a medicine is made. All materials, intermediate products and the finished product are checked, and every step is recorded in the batch documentation. If a problem later appears in a batch, it must be possible to trace how it was made, who tested it and which materials were used.
GMP focuses on the typical risks of pharmaceutical production, such as cross-contamination (one product contaminated with components of another) and mix-ups caused by wrong labelling. It is part of the wider pharmaceutical quality system, which also covers product development, risk management and continuous improvement.
GMP also matters for international trade. Most countries only allow the import and sale of medicines produced in accordance with recognised GMP standards. The EU has mutual recognition agreements with several countries, including the United States, under which the authorities rely on each other’s GMP inspections.
Where do the GMP rules come from?
GMP developed in the United States after a series of incidents with contaminated and unsafe medicines. The US Federal Food, Drug and Cosmetic Act of 1938 required proof of safety before a medicine could be marketed, and GMP requirements were added to US law in the 1960s. The World Health Organization later published international GMP guidelines, and the European countries developed common rules that are now part of EU law.
United States
Companies that export medicines to the United States must comply with the current Good Manufacturing Practice (cGMP) rules of the Food and Drug Administration (FDA). These are set out in Title 21 of the Code of Federal Regulations, in particular Parts 210 and 211 for finished pharmaceuticals. The FDA also inspects manufacturers outside the United States.
European Union
In the EU, the basic rules for medicines for human use are in Directive 2001/83/EC. The GMP principles for human medicines are set out in Commission Directive (EU) 2017/1572, which replaced the older Directive 2003/94/EC. For active substances, Commission Delegated Regulation (EU) No 1252/2014 applies. For veterinary medicines, GMP now follows from Regulation (EU) 2019/6 on veterinary medicinal products and its implementing rules.
The detailed guidelines are in Volume 4 of EudraLex, the collection of EU rules on medicines. It works as a practical manual for applying the GMP principles, with chapters on the quality system, personnel, premises and equipment, documentation, production, quality control, outsourced activities, complaints and recalls, and self-inspection, plus annexes for specific products such as sterile medicines. The European Medicines Agency (EMA) coordinates inspections and the scientific assessment of medicines in the EU.
The Netherlands
In the Netherlands, the Medicines Act (Geneesmiddelenwet) implements the EU rules. Anyone who manufactures medicines, including packaging and labelling, needs a manufacturing licence (fabrikantenvergunning), and must comply with GMP. The licence is issued on behalf of the Minister of Health, Welfare and Sport after an inspection by the IGJ. The Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen, CBG) assesses applications for marketing authorisations.
Other rules may apply alongside GMP. The Falsified Medicines Directive (2011/62/EU) and Delegated Regulation (EU) 2016/161 require a unique identifier and an anti-tampering device on the packaging of most prescription medicines. Substances that can be used to make drugs (precursors) are subject to separate EU and Dutch rules, and the Opium Act (Opiumwet) applies to controlled substances.
What does GMP require in practice?
GMP requires a documented pharmaceutical quality system that covers staff, premises, equipment, materials, production, quality control and complaints. The manufacturer must set it up, apply it and keep it up to date, also for medicines intended only for export.
In practice, the main requirements are the following.
- Qualified, trained staff with clearly described tasks, and hygiene rules, including a duty to report illnesses or open wounds that could affect the product
- Suitable premises and equipment that are qualified, cleaned and maintained
- Approved materials, containers and labels, and correct labelling of raw materials, intermediate and finished products
- Written, approved work instructions (standard operating procedures) in clear language, and training in their use
- Validated manufacturing processes and complete batch records showing that every step was carried out correctly
- Recording and investigation of every deviation from the instructions
- Quality control with adequate laboratories and instruments, and full traceability of each batch from raw material to customer
- Correct storage and transport, a procedure to recall batches, and proper handling of quality complaints
Documentation is at the heart of the system. The rule of thumb in inspections is simple: if it was not recorded, it did not happen. A process that is carried out correctly but not documented will still be treated as a GMP deficiency.
Who is responsible within the company?
GMP assigns specific responsibilities to key personnel: the head of production, the head of quality control and the Qualified Person (QP). The heads of production and quality control must be independent of each other.
The Qualified Person has a special legal position. Under Directive 2001/83/EC and the Medicines Act, every manufacturer must have at least one QP permanently at its disposal. The QP must certify that each batch has been manufactured and checked in accordance with the law and the marketing authorisation before it is released. Without that certification, the batch may not be placed on the market. The QP also carries personal responsibility, which is why QPs usually want a clear written description of their tasks and the authority to stop a batch.
Outsourcing and quality agreements
When a company outsources manufacturing or testing to another company, GMP requires a written contract that sets out the responsibilities of each party. Chapter 7 of EudraLex Volume 4 describes what such a quality agreement must cover.
The contract giver remains responsible for the quality of its product and must assess whether the contract manufacturer is competent. The quality agreement specifies, among other things, who releases batches, how deviations and changes are reported, whether subcontracting is allowed and how audits take place. From a legal point of view, it is wise to align the quality agreement with the commercial supply agreement. Conflicts between the two, for example about who bears the costs of a recall, often only come to light when a batch is rejected.
Supervision, the GMP certificate and enforcement
In the Netherlands, the IGJ inspects manufacturers periodically and issues a GMP certificate if they comply. If a manufacturer does not meet the requirements, it can be refused a GMP certificate and its manufacturing licence can be suspended or withdrawn.
The IGJ also inspects manufacturers outside the EU, at the request of the EMA or the CBG. When a manufacturer mentioned in a marketing authorisation does not work in accordance with GMP, the CBG may decide, in consultation with the IGJ and other European authorities, to remove that manufacturer from the authorisation dossier. If this could lead to a shortage of a medicine in the Netherlands, the marketing authorisation holder must report it to the Medicine Shortages and Defects Notification Centre (Meldpunt Geneesmiddelentekorten en -defecten).
The IGJ can also impose administrative measures, such as an order subject to a penalty payment (last onder dwangsom) or an administrative fine (bestuurlijke boete) under the Medicines Act. Against such decisions you can lodge an objection (bezwaar) with the authority and then appeal to the administrative court. The deadline for an objection is six weeks from the date the decision was sent (Article 6:7 of the General Administrative Law Act, Awb).
A GMP failure can also have civil consequences. A buyer or licensee can hold the manufacturer liable for breach of contract, and a producer of a defective product is liable towards injured persons under the product liability rules in Articles 6:185 to 6:193 BW. For claims for bodily injury, we refer clients to a personal injury specialist.
Does GMP also apply to cosmetics?
Yes. Under Article 8 of the EU Cosmetics Regulation (EC) No 1223/2009, cosmetic products must be manufactured in accordance with GMP. Compliance is presumed when the manufacture follows the relevant harmonised standard, which is EN ISO 22716:2007.
ISO 22716 contains guidelines for the production, control, storage and shipment of cosmetic products. It covers matters such as personnel, premises, equipment, raw materials and packaging, production, finished products, quality control laboratory, treatment of products out of specification, waste, subcontracting, deviations, complaints and recalls, change control and internal audits. The standard itself states that it does not cover research and development, the distribution of finished products, the safety of personnel or the protection of the environment. Those subjects are governed by other rules, such as occupational health and safety and environmental law.
Using the standard is voluntary, but it is the easiest way to show compliance. A manufacturer that uses another method must be able to show that it achieves the same level of quality and safety.
In the Netherlands, the Cosmetics Regulation is supplemented by the Commodities Act Decree on cosmetic products (Warenwetbesluit cosmetische producten). Supervision of cosmetics lies with the Netherlands Food and Consumer Product Safety Authority (NVWA), not with the IGJ. The responsible person who places a cosmetic product on the EU market must keep a product information file that includes a description of the method of manufacturing and a statement of compliance with GMP (Article 11 of the Cosmetics Regulation).
In summary
- GMP is a legally binding quality system for manufacturing medicines, based in the EU on Directive 2001/83/EC, Directive (EU) 2017/1572 and EudraLex Volume 4.
- In the Netherlands, manufacturers need a manufacturing licence under the Medicines Act; the IGJ inspects and issues GMP certificates.
- Each batch must be certified by a Qualified Person before release.
- When outsourcing, a written quality agreement is mandatory; align it with your commercial contract.
- For cosmetics, GMP is required under Article 8 of Regulation (EC) No 1223/2009, and compliance is presumed when EN ISO 22716 is followed; the NVWA supervises.
Frequently asked questions
Is a GMP certificate the same as a manufacturing licence?
No. The manufacturing licence is the permission to manufacture medicines. The GMP certificate confirms that an inspection found the manufacturer to comply with GMP. In practice both are linked: without GMP compliance, you will not obtain or keep a licence.
Who inspects GMP compliance in the Netherlands?
For medicines, the IGJ. It inspects manufacturers in the Netherlands and, at the request of the EMA or the CBG, also outside the EU. For cosmetics, the NVWA is the supervisory authority.
Can I object to a measure taken by the IGJ?
Yes. Against a decision such as an administrative fine or an order subject to a penalty payment, you can lodge an objection within six weeks. After the decision on the objection, you can appeal to the administrative court.
Law & More advises manufacturers, contract manufacturers and distributors on pharmaceutical and cosmetics law, including quality and supply agreements and proceedings against enforcement measures.
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