GMP Consulting Services for Drugs, APIs & NHPs/Dietary Supplements in Canada

GMP CONSULTING SERVICES for Drugs, APIs & NHPs / Dietary Supplements in Canada

What is GMP?gmp consultant british columbia

Why Implement GMP?

What is a Drug?

What is an API?

Site Reference File Development

Implementation, Training and Coaching

GMP Lab Constuction

Internal Audits of Your Quality System

Third-Party Audits of Your Supplier’s Quality Systems

Validation Studies

 


What is GMP?

Good Manufacturing Practices is a set of regulations, mandated by Health Canada’s Health Products and Food Branch Inspectorate (HPFBI). These regulations ensure the product (pharmaceutical / drug / NHP / dietary supplement) offered for sale to the public is fit for its intended use and is safe. It addresses all activities relating to the fabrication, packaging, labelling / labeling, testing, distribution, import, and wholesaling of drugs for human use.

As such, GMP is the overriding set of principals which govern the quality of every aspect of making a drug. Our GMP consulting services therefore include:

  • every action will only be undertaken by following written instructions (Standard Operating Procedures – SOPs);
  • raw materials, packaging materials, labels, and the finished products must be stored & handled correctly, and that exactly the right materials must be used at all times;
  • all facilities and machinery are correct for their purpose, and that they, and the environment in which they are situated, is properly cleaned
  • Quality Control (QC) is undertaken at every stage of the storage, handling, production, packaging, and labeling cycle;
  • people must dress and behave as required, be properly supervised – and above all, be trained correctly;
  • all work must be undertaken precisely and accurately;
  • contamination of materials, from either physical or viable sources, must be prevented at all times;
  • everything is labeled at every stage of production; and
  • finally, and quite importantly: not only that records are kept at every stage, but that they are kept accurately.

If all of these principles are followed, then there should be a high level of assurance that the product sent to the customer should be fit for its intended purposes.

Why Implement GMP?

If you fabricate, package / label, import, distribute, or wholesale any product classified as a drug, then you are required by law to implement GMP. Furthermore, if this is for drugs, then you will need to obtain a Drug Establishment License (DEL) and (optional but highly recommended) develop a Site Reference File. If it’s for Natural Health Products (NHPs) / Dietary Supplements, then you will require a Site License.

What is a Drug?

A drug is any substance or mixture of substances manufactured, sold, or represented for use in:

  • the diagnosis, treatment, mitigation or prevention of a disease, disorder, an abnormal physical state, or the symptoms thereof; and/or
  • restoring correcting, or modifying organic functions in humans or animals.

And now that extracts / derivatives / oils of medical marihuana (marijuana) are now allowed by the Supreme Court of Canada (SCoC), the GMP requirements might also apply to their production. Furthermore, if the oil is then added as an ingredient to a formulation, it might be considered an Active Pharmaceutical Ingredient (API – see below).

What is an API?

Active Pharmaceutical Ingredient.  This has it’s own section of GMP requirements, for which we have separate auditing checklists.  For example, the making of cannabis extracts can greatly follow those SOPs.  More info to follow.

Establishment Licensing

We can provide assistance with:

  • completing the application forms to ensure that the correct Activities, Categories, and Dosage Form Classes are selected;
  • calculations of the initial and annual fees, including requests for fee reductions or adjustments;
  • development of the (recommended) Site Reference File.

Site Reference File Development

We can prepare this 30-page document for submission Health Canada on your behalf. It can then be used as a starting point for developing all of the required procedures and forms. It is also an excellent sales tool for attracting investors, bank lenders, insurance brokers, and other key stakeholders.

This document provides the local drug inspector with details about your operations such as: corporate structure, facility location & layout, pest control measures, personnel, method of record retention, etc.

Implementation, Training and Coaching

As part of our GMP consulting services, we can:

  • conduct an assessment of your present Quality Management System and procedures;
  • perform a “Gap Analysis” to determine the deficiencies;
  • provide a general overview for Management and Staff;
  • select and coach personnel involved in the implementation process;
  • provide detailed training to individual departments, regarding specific GMP requirements;
  • conduct the internal quality audit, and assist with implementing the required corrective actions;
  • liaise with the drug inspector from Health Canada;
  • be present and provide consultation during the Inspection Audit; and
  • perform regular follow-ups, thereafter.

No need to reinvent the wheelwe have also developed various template Policies, protocols, SOPs, forms & checklists for some of the more intensive requirements such as Product Recall, Complaint Handling & Investigation, Corrective and Preventive ActiGMP Consulting serviceson (CAPA), Out of Specification (OOS) Investigation, Adverse Reaction Reporting, Performing internal & third party audits, product stability, Creation of Master Production Documents (MPDs) / Master Batch Records

Health Canada product recall assistance

Product Recall

, Annual Product Quality Review (APQR), etc. We then just have to tweak them to your specific situation.

For further details, about our GMP consulting services, please see our our QA Implementation & Training services web page.

We also provide practical guidance & assistance for Health Canada product recalls.

GMP Lab ConstructionMany people in the industry like to interchange the term “GMP lab” with “GMP product fabrication facilities”. In a small “pilot plant”, the term “GMP lab” might apply. But when commercial quanitities of material is being produced, I prefer to use the term “production facility”. Therefore, I herein use the the term “GMP Lab”, as the part of the facilities that performs the QC testing for the in-process & finished product fabricated. This is also to ensure no terminology confusion with Health Canada or any other third party auditor. Therefore, if one is looking for commercial production facility design please refer to this page. But if looking for analytical / QC testing lab info ….

As a chemist, the president of ICS Inc. had worked in numerous labs, and eventually been promoted to lab manager at a couple of facilities. During that time, his input was solicited for upgrades or new construction. Since 1999, as a consultant, based on his experience as well as in-depth knowledge of GxP & ISO 17025 regulations has since been consulted on the layout, design, construction, and on-site oversight of numerous GMP & GLP labs, as he has toured & audited well over 100 labs. 

Internal Audits of Your Quality System

ICS can provide an objective and unbiased review, to assess conformance to the regulations, and determine the level of implementation & effectiveness of the quality system requirements. This is done using our extensive checklists, which have evolved and are continually improved over time.

We can then identify opportunities for improvement, within the scope of the quality system requirements.

For further details, please see our QA Auditing services web page.

Third-Party Audits of Your Supplier’s Quality Systems

ICS can let you know whether your suppliers are meeting their contractual agreements, no matter where they are located throughout the world. These suppliers may include contract manufacturers and/ or testing laboratories.

No matter where your suppliers are located, we can most likely provide these services at less travel expenses. This is due to our network of strategic alliances or subcontracted auditors, or we may also have other clients in the city that your supplier is located.

Validation Studies

This is the documented act of demonstrating that any of your critical procedures, processes, equipment, materials, activities, or systems will consistently lead to expected results. We can perform (or at least assist via the documentation process):

  • Installation Qualifications (IQ);
  • Operational Qualifications (OQ);
  • Performance Qualifications (PQ);
  • Retrospective Validations; and
  • Prospective Validations.

ICS can prepare all of the required documentation and perform the actual work, when requested. For further details, please see our Validation services web page.

Why use a consultant?

Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house? Please see our web pageWhy Use a Consultantas part of that critical thinking process. For example, is your contract QC / Stability lab recommending you to hire them to perform Accelerated Stability Studies? Nine times out of 10, ICS Inc. recommends against it – not only for cost reasons, but the GMP regulations stipulate that you have to follow up with Real Time Stability Studies anyway. And we know how to justify & document that approach with Health Canada.

Based in British Columbia, but covering all of Canada – and beyond.


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