GMP Certification Services
For (potential) manufacturers of medicinal cannabis
What Is GMP Certification?
The Good Manufacturing Practices (GMP) are a set of laws/regulations adopted by governments in most countries. These laws are designed to ensure pharmaceutical products are produced in a safe manner. Before you can be certified you will receive an inspection by your national healthcare inspectorate against the GMP laws/regulations.
When you produce medicinal cannabis in -or deliver to- any of the following countries the Good Manufacturing Practices (GMP) laws/regulations apply to you: the United States of America, Canada, Mexico, Argentina, South Africa, Japan, Iran, Australia, New Zealand, Turkey, China, Russia and all nations of the European Union. Other nations may also require you to adhere to GMP regulatory requirements.
PCS has the experience and expertise to analyse your current situation accurately and help you navigate the regulatory hurdles.
- Assessment of strategy/current situation
- GMP GAP-assessment
- Writing, review and execution of action plan
- Quality system set-up or upgrade to GMP standards
- License application
- Government GMP inspection preparation (more info)
- Government GMP inspection support
- Government GMP inspection response assistance
Medicinal Cannabis Experience
PCS has implemented a Quality Management System (QMS) for a herbal medicine company in the Netherlands. The project included the creation of a solid QA department, installing and maintaining GMP awareness, validation of cleaning and processes and finally preparing the company for a regulatory inspection by the Dutch Healthcare Inspectorate (IGJ i.o.) and the Federal Drug Administration (FDA). The organization has achieved GMP certification.
"PCS (est. 1990) is your partner for GMP certification."
PCS has the experience and expertise to analyse your current situation accurately and help you navigate the regulatory hurdles. We have experience building and upgrading Quality Management Systems, assisting in GMP license applications and supporting organizations succesfully achieve GMP certificates.
Proven Track Record
- Serum Institute of India (Pune). Support in the design and construction and implementation of quality systems for three new buildings including two vaccines and one sterile finished dosage form. FDA approved.
- Assistance in start-up and quality systems for Protein Sciences (Meriden U.S.). FDA approved.
- Long-term support for Boehringer Ingelheim IT, (Biberach, Germany). FDA approved.
- Long-Term QA support for Roche (Mannheim, Germany). FDA approved.
- WHO Prequalification audit and support for Yuxi Walvax (China).
- Acambis (Cambridge U.S.) QA support in startup and operation of a vaccine manufacturing plant. FDA approved.
- Genibet (Lisbon, Portugal). Design Qualification of a Biotech Manufacturing facility and QA support to Licensing. EU approved.
Our consultants have performed a significant number of assignments globally, in a range of different industries.
We are a dedicated team of consultants who know all ins and outs of Quality Systems and its potential issues.
Our consultants work in a great number of companies across the pharmaceutical industry as Subject Matter Experts.
Overview of Our Services
Click here to contact us if the service you require is not listed below.
- GAP Analysis and Benchmarking
- Risk Assessments of (Proposed) QA Systems
- Development of Pharmaceutical Quality Systems & Quality Culture
- Definition of Suitable Metrics for Quality Monitoring and Improvement
- Practical Implementation Support of Entire Quality Systems or parts thereof
- Coaching and training of personnel at all levels within the organization in the principles and practice of Quality Systems
- Independent inspections to determine ongoing compliance to in-house, corporate or official Quality System requirements
- United States Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- World Health Organization (WHO) Qualification
- World Health Organization (WHO) Pre-Qualification
- Russian Good Manufacturing Practices (SID & GP)
- Indian National Regulatory Authority (NRA)
- Other National Regulatory Authorities