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Your new facility is not GMP compliant

Unfortunately, your new facility or remodel turns out not be GMP compliant. This prevents you from starting you production and the costs will keep piling up. At PCS, we use our extensive knowledge in facility construction, project- and crisis management to see what is right and what needs to be remedied to get you up and running as soon as possible.

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Over 100 satisfied clients preceded you!

Why turn to PCS for a not compliant facility?

PCS is the world leader in pharmaceutical engineering support, quality assurance and GMP certification
We have over 32 years of experience in GMP
We have a large database of GMP standards & templates (cost-effective)
You will be 100% GMP compliant, our focus is on patient safety, manufacturing process and quality culture to ensure this

What can you do if your facility is not GMP compliant?

Good manufactering Practices (GMP) is a quality standard for the manufacture of pharmaceuticals. GMP ensures that pharmaceutical manufacturers always follow the same quality requirements. Government review manufacturers for GMP. When a manufacturer has been inspected by the government and complies with GMP regulations, the government issues a GMP permit with a GMP certificate.

It is not only the raw material, material and employees that must meet the proper requirements. There are also aspects related to the facility:

Cleanroom practices/Hygiene (including gowning)
Contamination control
Aseptic techniques

Why does a company need an GMP certifcate?

Companies that produce drugs for the EU markert must have GMP license for the following reasons:

GMP requires that medicines are of consistently high quality,
Without a GMP license, you are not allowed to sell medicines on the EU market,
If you have a GMP license, your medicines meets the requirements of the marketing authorization,
Inspections are harmonized ensuring that you do not receive separate inspections form each member state,
EU GMP is perhaps the most stringent GMP standard,
Meeting other GMP standards becomes easier.

Why choose PCS for GMP certification for your facility?

We leverage the expertise of our former EU GMP inspectors, now consultants
Our consultants have more than 39 years of experience in building chemical and pharmaceutical plants
Clients choose PCS because of our extensive experience with regulations
We get companies EU GMP certified within the scheduled time an with a keen eye on budget
Julian Koster, Business Development

Let me help you explore all the benefits of our services!

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Have a question about GMP compliance?

We’re here to help! We aim to respond within 1 hour or business day.

We help companies worldwide,
We have a 98% success rate,
Experienced, ex-EU GMP/GDP inspectors as consultants,

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We have the expertise and experience to help you after an IGJ inspection.

Would you like to train or re-train your employees in addition to using our consultancy services?
This is possible with our seminars, in-house training and e-learn courses.

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