How GMP Audit Services and Gap Analysis Ensure Quality Management Compliance for Natural Health Product Facilities in Canada

How GMP Audit Services and Gap Analysis Ensure Quality Management Compliance for Natural Health Product Facilities in Canada In Canada, facilities licensed to produce, package, or label natural health products must adhere to strict regulatory standards under the Natural Health Product Regulations (NHPR). Meeting these standards is essential not only to gain and retain regulatory approval but also to ensure product quality, safety, and customer trust. To navigate these requirements, many companies rely on GMP audit services, a strategic solution that incorporates both quality management and quality control to ensure compliance. Here, we explore why conducting a [...]

2024-11-21T18:49:17+00:00November 18th, 2024|

NNHPD Site License Renewals: Is your renewal keeping you up at night?

NNHPD Site License Renewals: Is your renewal keeping you up at night? Canadian Site License Renewals:  Recently, we at MCS have seen that NNHPD site license renewal processes are becoming increasingly more detailed and difficult. The process has transformed from a quick matter of submitting documents generated from your Quality Management System to a truly comprehensive audit of not only your QMS system but a detailed evaluation of your past quality decisions. To design, implement, execute and sustain a robust QMS system that will meet NNHPD’s new, expanded expectations, your organization will need the support of a [...]

2024-06-05T20:38:46+00:00February 21st, 2024|

The End of Interim Site Licenses for Hand Sanitizers

The Natural and Non-Prescription Health Products Directorate (NNHPD) of Health Canada announced interim COVID-19 Site Licences (COVID-19 SL) for manufacturing, packaging, labelling and/or importing alcohol-based hand sanitizers will expire on September 30, 2021. The interim measures were introduced in March 2020 to expedite site licensing to address hand sanitizer shortages at the start of COVID-19.  During August 2020, the NNHPD notified COVID-19 SL holders their commitment to provide 60 days’ advance notice prior to ending of the temporary measures. If you are a COVID-19 SL holder, there are three options that will need to consider prior to your [...]

2021-07-27T17:30:10+00:00July 27th, 2021|
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