GMP Cannabis Certification

If you are a regulated company producing medicinal cannabis you may be required by the authorities to be Good Manufacturing Practices (GMP) certified by your national healthcare inspectorate.

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.

Does GMP Apply To My Company?

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 helps producers or processors of Medicinal Cannabis achieve GMP certification worldwide.

PCS offers a comprehensive, four-phase program to aid you in achieving GMP certification for your medicinal cannabis production facility.

You may be familiar with terms as Quality Assurance, ISO and Quality Culture. GMP is the proactive part of Quality Assurance. As quality cannot be tested in the final product, it must be built into the entire process, from raw material to transportation of the finished product. Even though GMP stands for "Good Manufacturing Practices" it's scope is not limited to manufacturing and even includes components such as Human Resource Management, Management Involvement and Financial Resource Allocation.


Our Four-Phase Program to Achieving GMP Certification

1.

Phase One - Project Planning and Initiation

This phase aims at establishing a baseline and envisioning a project plan adapted to your specific facility. If you already have an ISO (9001) Quality System, we will interweave your existing principles with the GMP requirements.

Phase One Approach

  • Project Meeting to confirm scope, objectives, deliverables, approach and timelines
  • The creation of a detailed project plan containing milestones
  • QMS (documentation) management including Master Document List, policies, Quality Manual, VMP, etc.
  • Appointment of a person responsible for the authorization of documentation
  • Guidance in the establishment of a (digital) document management system

Phase One Required Resources (PCS)

  • One Month
  • 1 PCS Project Director (40 hours)
  • 1 PCS GMP Consultant (120 hours)
  • 1 PCS Project Manager (25 hours)

Phase One Est. Cost: € 29,000.-*

*Price estimation for indicative purposes only. Price does not include expenses directly related to the assignment such as airfares, accomodation and other travel expenses. Indicated price does not include direct or indirect taxes such as VAT and transfer taxes which are directly payable by the client. Indicated price does not include unforeseen activities which might otherwise prolong the required amount of time for this phase.


2.

Phase Two - Strategy Development

To ensure you meet both GMP and national/regional medicinal cannabis regulatory requirements, PCS will develop a set of principles for the cannabis Supply Chain. Additionally government requirements will be reviewed and adopted into the (GMP) QMS.

Phase Two Approach

  • Supply Chain mapping at a basic level
  • Draft documents for the distribution and manufacturing of medicinal cannabis
  • Informing supply chain members of their renewed responsibilities as well as meetings with key suppliers
  • Finalization of client personnel requirements for maintaining the GMP quality level
  • Finalization of any User Requirement Specifications (URS) for new equipment (if needed) including IT systems

Phase Two Required Resources (PCS)

  • One Month
  • 1 PCS Project Director (25 hours)
  • 1 PCS GMP Consultant (130 hours)
  • 1 PCS Project Manager (25 hours)

Phase Two Est. Cost: € 27,750.-*

*Price estimation for indicative purposes only. Price does not include expenses directly related to the assignment such as airfares, accomodation and other travel expenses. Indicated price does not include direct or indirect taxes such as VAT and transfer taxes which are directly payable by the client. Indicated price does not include unforeseen activities which might otherwise prolong the required amount of time for this phase.


3.

Phase Three - Process Design

Development of Standard Operating Procedures (SOP's) and Process Flow Diagrams (PFD's). This includes the description of roles, responsibilities and independencies for all internal- and external stakeholders. Approximately 20 SOP's will need to be written during this phase. The extensive PCS library of standard SOP's can be used to reduced workload and costs.

Phase Three Approach

  • Writing SOP's and related documentation
  • The creation of Process Flow Diagrams (PFD's)
  • Development of principles, responsibilities and job descriptions

Phase Three Required Resources (PCS)

  • One Month
  • 1 PCS Project Director (35 hours)
  • 1 PCS GMP Consultant (160 hours)

Phase Three Est. Cost: € 32,500.-*

*Price estimation for indicative purposes only. Price does not include expenses directly related to the assignment such as airfares, accomodation and other travel expenses. Indicated price does not include direct or indirect taxes such as VAT and transfer taxes which are directly payable by the client. Indicated price does not include unforeseen activities which might otherwise prolong the required amount of time for this phase.


4.

Phase Four - Implementation

This phase is aimed at getting all the planned systems, SOP's and so forth operational. The following components will be made operational; the QMS, Annual Product Quality Review (APQR), Cleaning Rationale, Computerized Systems Validation (CSV), Personnel Training, Equipment and Files, Formal Quality Management Review (QMR), Hygiene Approaches and the Quality Manual.

Phase Four Approach

  • Authorization and Implementation of 20 SOP's
  • Annual Product Quality Review (APQR)
  • Cleaning Rationale / Cleaning Validation Start
  • Draft QMS to Operational QMS Start
  • Computerized Systems Validation (CSV) Start
  • Personnel Training including Documentation Start
  • Equipment Validation / Qualification and Files Start
  • Formal Quality Management Review (QMR)
  • Determination of Hygiene Approach
  • Implementation of the Quality Manual (QM) and VMP

Phase Four Required Resources (PCS)

  • One Month
  • 1 PCS Project Director (35 hours)
  • 1 PCS GMP Consultant (160 hours)

Phase Four Est. Cost: € 32,500.-*

*Price estimation for indicative purposes only. Price does not include expenses directly related to the assignment such as airfares, accomodation and other travel expenses. Indicated price does not include direct or indirect taxes such as VAT and transfer taxes which are directly payable by the client. Indicated price does not include unforeseen activities which might otherwise prolong the required amount of time for this phase.


Continued GMP Support

After Phase Four

Upon conclusion of phase four you should be able to continue the work with your own staff. This includes performing the Computerized Systems Validation, Cleaning Validation and Process Validation for example. Additionally, you will need to instill continuous improvement through Quality Culture initiatives whilst maintaining your QMS. If needed, PCS can provide continuous support on these topics (and more). Since we've already helped you create an approach, PCS can ensure that all activities are in full accordance with the your wishes and requirements. As well as those requirements dictated by GMP.


Our Advantages

Experience

We have already aided in the GMP certification of a Medicinal Cannabis producer. And have many years of GMP implementation for producers of Finished Products.

Broad Knowledge

We are a dedicated team of GMP & GDP experts who know all ins and outs of Quality Systems, GMP and how to efficiently implement these.

Seasoned Consultants

Our GMP & GDP experts work in a great number of companies across the pharmaceutical industry as Subject Matter Experts.

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