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GMP SERVICES
What is GMPWhy Implement GMP?
What is a Drug?
Establishment Licensing
Site Reference File Development
Implementation, Training and Coaching
Internal Audits of Your Quality System
Third-Party Audits of Your Supplier's Quality Systems
Validation Studies
DIN Submissions
Facility Design and Construction Oversight Services to GMP Standards
What is GMP?
Good Manufacturing Practices is a set of regulations, mandated by Health Canada’s Therapeutic Products Program (TPP). These regulations ensure the product (drug) offered for sale to the public is fit for its intended use and is safe. It addresses all activities relating to the fabrication, packaging, 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. These include:
- every action will only be undertaken by following written instructions (documentation);
- 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 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, you will need to obtain an Establishment Licence and (optional but highly recommended) develop a Site Reference File.
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.
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; and
- 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
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;
- assist with writing and revising the policies, procedures, validations and forms;
- 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.
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.
Click here to see more detailed information. (Coming Soon)
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:
- Installation Qualifications;
- Operational Qualifications;
- Performance Qualifications;
- Retrospective Validations; and
- Prospective Validations.
ICS can prepare all of the required documentation and perform the actual work, when requested.
Click here to see more detailed information. (Coming Soon)
DIN Submissions
We can:
- assist with the development of product labels and prescribing information, to ensure they meet Health Canada’s requirements;
- assist with the DIN Submission Certification form (Drug Identification Number);
- if needed, perform Clinical Trials Management;
- select and liaise with laboratories and Contract Research Organizations (CROs), regarding Bioequivalence and/or pharmacodynamic / clinical studies;
- assist with the justification for waiver of these studies, through literature and market research; and
- select and liaise with laboratories for product stability determination.