For Pharma & Biotech

What is GMP certification?

Good Manufacturing Practice (GMP) is a quality standard for the manufacture of pharmaceuticals. GMP ensures that pharmaceutical manufacturers must always follow the same quality requirements. Manufacturers are inspected against the GMP by governments.

When a manufacturer has been inspected by the government and meets the GMP regulations, the government will issue a GMP license and GMP certificate.

How can a company apply for a GMP certificate?

To get an EU GMP certificate you need to manufacture medicine in the EU or export medicine to the EU.

If you are a manufacturer in the EU you can apply for a GMP license to your national regulatory authority like the MHRA (UK), BfArM (DE) and the IGJ (NL).

Manufacturing sites outside the EU are inspected by the regulatory authority of the country where their importer is located, unless a mutual recognition agreement (MRA) is in place between the EU and the country concerned. If an MRA applies, the authorities mutually rely on each other's inspections.

Example of an EU GMP certificate issued by the Dutch regulatory inspectorate
An example of an EU GMP certificate.

Why does a company need a GMP certificate?

Companies that produce medicine for the EU market must have a GMP license for the following reasons:

  1. GMP requires that medicine are of consistent high quality,
  2. You cannot sell medicine to the EU market without a GMP license,
  3. A GMP license shows your commitment to quality and patient safety,
  4. If you have a GMP license your medicine meet the requirements of the Marketing Authorisation,
  5. Inspections are harmonised: ensuring you don't get inspections from each member state individually,
  6. The EU GMP is arguably the strictest GMP standard, meeting other GMP standards becomes easier.

Why choose PCS for GMP certification?

PCS helps clients achieve EU GMP certification. We use the expertise of our ex-EU GMP inspectors, now consultants. They know what the government expects and inspects.

Customers choose PCS because of our extensive regulatory experience. Time always plays a role in our projects. With our team of ex-EU GMP inspectors and industry experts we get companies EU GMP certified within time and on budget.

Download our whitepaper

Download our FREE whitepaper to learn more about GMP certification!

What GMP certification services does PCS offer?

  1. Assessment of your current GMP compliance
  2. CAPA definition
  3. CAPA implementation
  4. Verifying CAPA implementation
  5. (Commercial) GMP certification
  6. Inspection guidance, during inspection

Getting Started with GMP certification

We are a pharmaceutical consultancy dedicated to quality and patient safety. Are you looking for a GMP certificate or GMP certification assistance? We have the expertise and experience to help you achieve one!

Feel free to contact us if you have any questions about our GMP certification services or GMP in general.