Facilities handling medical devices and pharmaceutical drugs have always been expected to follow procedures that ensure safe, high-quality products, and Health Canada has the right to inspect (audit) Canadian facilities. Recently, Health Canada has taken a step towards transparency that highlights to stakeholders how well (or how poorly) a facility meets regulations and industry standards such as Good Manufacturing Practice (GMP), ISO13485, and other relevant standards.
In the past, Health Canada audit results were not published, but, as of 2017, Health Canada now posts all audit results for Medical Device Establishment License (MDEL) and Drug Establishment License (DEL) holders in a public forum. This change means consumers and competitors of medical device and pharmaceutical companies can access any company’s audit results when evaluating contractual and purchasing decisions. The certainty of negative results being published makes it more important than ever to minimize observations of non-compliance during an audit.
In addition to (and in preparation for) audits by Health Canada, manufacturers, distributors and importers of pharmaceutical products and medical devices should regularly conduct proactive and/or reactive internal audits to keep a pulse on the general status of the quality processes in the company and to pinpoint potential causes of reported quality concerns.
What is an internal audit?
An internal audit is the best strategy to identify and correct aspects of non-compliance prior to a Health Canada Inspector entering your facility. In an internal audit, a qualified individual examines a process or quality system to ensure it complies with related requirements. The intent is to provide the company being audited with an exclusive status report on the company’s compliance with relevant regulations. A formal audit report identifies deficiencies and can provide recommendations for improvement, giving the opportunity for correction prior to a quality failure or Health Canada audit.
Internal audits can completed against any number of “ideal standards“ such as:
- Government regulations (Food and Drug Regulations)
- Recognized standards (ISO 13485 / 9001; Good Manufacturing Practices)
- Internal procedures (quality system)
- Customer or supplier requirements (contractual obligations)
- Other standards or parameters dictated by the scope of need
When should you organize an internal audit?
The question of when and how often you should organize your internal audits depends on various factors:
- Mandated audit cycles
- Some standards and regulations mandate a specific cycle of internal audits (e.g. GMPs)
- Company size and manpower availability
- Audits take time and remove employees from their day to day jobs
- Temporary ramp up or ramp down
- If gaps are identified in a prior audit, the cycle of the internal audits may temporarily increase until deficiencies are corrected
- After several successful internal audits, a company may choose to decrease audit cycles not mandated by regulatory bodies
- New business or major changes
- New business integrations or major changes in business may trigger a cycle of internal audits or an increase in the frequency of the cycle in order to identify and correct any new gaps resulting from the new processes.
Who should conduct an internal audit?
Internal audits can be conducted by company employees or by external service providers. The decision on who to use depends on a few factors such as
- Training as auditors
- Subject matter expertise on area being audited
- Regulatory requirements (specific training such as B.Sc. in science for GMPs)
- Communication skills (both written and verbal)
How we can help:
For over ten years, we have helped our clients attain and maintain regulatory and quality compliance over a varied range of regulated products, An internal audit or pre-licence inspection by NHP Consulting could be the difference between retaining/obtaining your license or losing/being refused your license after your Health Canada audit
We can support you in preparing for a pending Health Canada audit, running a scheduled internal audit, and preparing for the next government or registrar audit (based on Health Canada/registrar audit cycle). Our experienced consultants can help you by planning, scheduling, and implementing the audit on your behalf and providing you with a professional report including a summary meeting to review the opportunities for improvement with your team
We are also available to provide post-audit support in process improvement, as well as quality and regulatory support for your facility, products and processes. For more information on our internal audit and other services, please contact us.
Our other services:
We are happy to offer other services related to medical devices such as:
- Pipeline project planning
- Facility audits
- Registration support
- Process mapping and improvement
- Project management
- Product classification support
- Market research
- Clinical trial support
- Label review
- Quality Management System development, implementation and support
- Virtual QA/RA department
- Post market support
- Let us manage on your behalf difficult recalls and complaints.
- Product and process changes