Since January 2020, Health Canada has adapted to conduct virtual GMP inspections in lieu of on-site inspections. Establishments eligible for virtual inspections are those where the regulated activity is any combination of importation, wholesale, and/or distribution.
If your establishment is due for an inspection and/or you have recently submitted a DEL or MDEL application or amendment, it is essential that you are prepared for this new process in order to ensure the inspection proceeds smoothly.
Goldman Regulatory Compliance is now offering virtual GMP Pre-Inspection Audits.
Why have a virtual pre-inspection audit?
Virtual GMP inspections have only recently been introduced and as such, your next Health Canada inspection may be virtual and not on-site as you have been accustomed to.
To best be prepared, you will need to be comfortable using the technology which will be employed by Health Canada during the inspection. During your pre-inspection audit, Goldman Regulatory Compliance will provide guidance on which applications to use, how to connect, how to use the tools within the application and identify potential glitches in advance, all of which may impact the quality of your virtual inspection.
Goldman Regulatory Compliance will also advise you of precisely which documents you will have to present to an inspector in advance and if they are acceptable.
We will conduct a full GMP audit which will be a combination of virtual meetings and time to allow for offline document review.
Upon completion of the audit, Goldman Regulatory Compliance will issue a Pre-Inspection GMP Audit Report detailing all observations classified according to risk.
By doing a pre-inspection audit in advance, your operation will have the opportunity to correct any deficiencies prior to the actual inspection.
Preparation is essential for a smooth and successful inspection to ensure your products obtain and maintain market authorization.
Contact us for a quote on your Virtual GMP Pre-Inspection.
Copyright © 2020 Goldman Regulatory Compliance - All Rights Reserved.
Powered by GoDaddy Website Builder