Quality Assurance
We develop GxP Quality Management Systems and GxP procedures for pharmaceutical manufacturers & wholesalers
A Quality Management System (commonly abbreviated as QMS) is a collection of documents that aims to attain a quality objective. A Quality Management System is referred to as a Pharmaceutical Quality System (PQS) in the WHO and EU GMP regulatory guidelines.
Quality Management is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Management therefore incorporates Good Manufacturing Practice.
PCS has developed a large database of GMP and GDP procedures over the past 33 years. Our experience combined with this large database allows PCS to implement or upgrade your quality system quickly.
Our procedures are continually tested during regulatory inspections at our clients and updated accordingly. We can deliver a GDP quality system template set starting from € 1,000.-. All you need to do is add your details to get a fully compliant set of GDP SOP’s.
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QMS implementation
These are some of the recent GxP QMS implementation or upgrade projects we completed for our customers.
PCS can implement a Quality Management System in GMP or GDP for any major international regulatory framework. We are specialized in the following GxP regulatory frameworks:
- European Union GMP,
- U.S. FDA GMP,
- World Health Organization GMP,
- PIC/S GMP,
- ICH GMP.
We can implement Quality Management Systems for the following industry types:
- Pharmaceutical,
- Finished Product including Medicinal Cannabis,
- Intermediates,
- API including Medicinal Cannabis,
- Excipients.
- Biotechnology,
- Chemical,
- Food,
- Medical
- Hospitals,
- Pharmacies.
