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LABORATORY NHP Compliance’s laboratory services are extensive. We truly are a full-service company. For more details, contact Graham Mills at 1-877-877-5152 x210 or send an email to: gmills@qualityandcompliance.com About Our Lab Services We offer the following laboratory services for NHPs:
Our laboratory is fully licenced by Health Canada and U.S. FDA registered. We offer full analytical testing capabilities. Analyses are performed to standardized compendial methods (e.g., USP), as well as to in-house and client methods. See a list of Analytical Services performed by NHP Compliance as well as the instrumentation available for testing. Finished Product Testing Every lot of product must be assessed for compliance with the specification prior to release. The Natural Health Products Regulations came into force on January 1, 2004, and apply to all natural health products as of this date. You can be inspected. Health Canada will be implementing a program of routine inspections of NHP site licence holders. This may commence in 2009 or 2010. Importers may apply a reduced testing program that relies on the results from their supplier provided that a certificate of analysis is submitted with each lot received. See a list of the Types of Products Tested by NHP Compliance. Note: All medicinal ingredients (actives) must be tested for content. In some circumstances, quantification by input is considered acceptable. Method Qualification Analytical procedures are required to be accurate and consistent. Compendial methods are acceptable. Our laboratory is equipped with an array of the latest instrumentation and techniques. We work closely with our clients to ensure specific, sensitive and accurate methods. Reduced Testing Programs What amount of testing do you need? Natural health products require testing against submitted specifications. Every lot must be tested for conformance with its finished product specifications. Importers may follow a reduced testing program in which:
Initial and long-term stability studies are required for NHPs to support the shelf life of the product. We can help you develop a compliant stability program for your products. We offer the following services:
Reduced Heavy Metal Testing Justifications Heavy metals testing needs to be performed on every batch unless it is controlled at the raw material level. We can assist in preparing this justification for submission in the Product Licence Application. NHP Compliance can help you determine if you qualify for this. In our labs, we can perform USP testing and testing by Inductively Coupled Plasma for heavy metals. |
