Good Manufacturing Practices Consultancy
Helping manufacturers & importers of medicinal products comply with the Good Manufacturing Practices (GMP) guidelines. Interim & project consultancy.
Over 100 satisfied clients preceded you!
PCS has 33 years of experience in pharmaceutical manufacturing and the requirements of the GMP guideline. We specialize in helping GMP regulated organizations maintain or achieve a solid compliance level by focusing on their people, their manufacturing process and most important; the patient.
PCS will identify the gaps, draw up a plan to upgrade your organization, implement this plan and subsequently prepares your entire organization and QMS for regulatory GMP inspection.
Curious to see how our GMP consultants can help? Plan a free consult today!
If you are a (starting) pharmaceutical manufacturer and you want to implement or upgrade the GMP’s you may need help from an experienced GMP consultant.
PCS is known for helping GMP regulated organizations implement, repair or upgrade their quality to current standards. This includes organizations who were disapproved by the EU, the WHO or the U.S. FDA. Our core expertise is process-centered quality that can be maintained by your own team.
Below is an overview of some of the popular GMP consultancy services PCS can provide:
- Regulatory inspection preparation,
- Regulatory inspection response,
- Post-regulatory inspection CAPA implementation,
- Quality system implementation or upgrade,
- GMP training,
- Supply chain mapping,
- Transport route validation,
- Audits of clients and suppliers,
- Qualified Person services,
- Support with (re-)construction of pharmaceutical manufacturing facilities.
PCS organizes training courses in GMP. These training courses are organized as seminars or as in-house courses. Typically, you would need one day of GMP training to be up-to-date. Our “GMP for mid-level management” courses take up to three days and provides participants with a solid overview of the GMP requirements and what their practical implications are.
Upon completion of a GMP training course by PCS you will receive a certificate of attendance.
Let me help you explore all the benefits of our services!
Good Manufacturing Practice, also known by its common abbreviation “GMP”, is a quality assurance system for the pharmaceutical industry. Only a carefully defined and controlled production process ensures the quality of a medicine.
Without a GMP license, also known as a “MIA” or Manufacturing and Import Authorization, drug manufacturers are not allowed to sell their products to pharmacies or hospital pharmacies.
PCS helps clients to achieve the desired level of quality. We do this by providing GMP training. In addition, we can also be called in for GMP consultancy and we help you with the application for GMP licenses.
Our services range from implementation of quality systems, obtaining GMP licenses to interim management and training. Our approach is simple: understanding and mastering your process is key to GMP.
Supply chains are very complex, the quality department often has a full-time job keeping the quality system up-to-date and production struggles to meet demand. PCS comes to the rescue to ensure that everything goes according to the right guidelines.
Customers choose PCS because of our extensive regulatory experience. Time always plays a role in our projects. We know how the authorities work and what they expect.
In this way we bring our clients to a higher level of GMP compliance efficiently, within time and within budget. Thanks to our team of passionate consultants, consisting of ex-EU GMP inspectors and leading industry experts, we can provide this unique service to the pharmaceutical market.
Process
People
But its not just the complex problems we solve. If you need a GMP license, we will help you obtain it. From audits to equipment qualification, its all handled by our team of industry and regulatory experts.
If you need a simple GMP training, we can help. We have a wide range of GMP training courses that can be organized as a seminar or in-house covering a wide range of topics from operator training to quality culture implementation. We provide in-house training, seminars and online courses.
The GMP training courses are divided into three levels;
- Beginner
- Intermediate
- Professional
Are you a beginner in the pharmaceutical industry? Then we offer the GMP training for beginners. These trainings provide a solid foundation for participants new to GMP regulatory requirements. No experience in GMPs or the pharmaceutical industry as a whole is required for the GMP beginner training.
GMP intermediate level courses can be taken with a basic understanding of GMP regulations and some experience in the pharmaceutical industry. They are designed to provide a high level explanation to the public about the essential GMP elements such as the quality system, personnel qualification and equipment qualification for example.
If you want to follow a GMP training at a professional level, the participants are expected to have a solid knowledge of the GMP regulations. These trainings are designed to provide participants with advanced knowledge on complex topics in the pharmaceutical and biotechnology industry.
Companies choose the GMP services of PCS for their GMP projects, new construction or inspection preparation.
Design, project support and start-up services for a GMP factory.
Transgene TUP
Long-term GMP support for Boehringer Ingelheim.
Boehringer Ingelheim
GMP quality system and facilities support for Solvay, Germany.
Solvay
- Medicines in the supply chain are authorized in accordance with European Union (EU) legislation;
- 33 years of GMP and GDP training experience
- More than 10,000 students have successfully obtained a GMP or GDP PCS training certificate
- Expert educators from industry and regulatory authorities
- Proven didactic methods that optimize your knowledge retention
- Courses are updated every year, implementing the latest GMP or GDP developments and industry standards
- Our training certificates are widely accepted
- Many interactive workshops that allow you to put theory into practice
