Document checking prior to submission
to ensure compliance with relevant regulations
Atinza will review to ensure client holds all the information required under Canadian Natural Health Product Good Manufacturing Practices (NHP GMPs). We will check client’s master production documents and batch documentation to ensure compliance with GMP.
We review your stability protocols to ensure your compliance with Canadian GMPs. Then we will review client’s stability data to ensure compliance with the corresponding protocol. We will advise you possible measures with investigation of OOS (out-of-specification)and OOT (out-of-trend) results.
Purpose of good manufacturing practices
to assure quality of a NHP before and while it is made available for sale
- Though a NHP may pass all of the finished product specification tests, it may have microbial, physical and/or chemical contamination if manufactured or packaged in poor GMP conditions. Therefore, complying with GMP is a mandatory aspect in the Regulations as it assures a higher level of quality and confidence in the product.
- The GMP requirements are ongoing measures designed to ensure an effective overall approach to product quality control and risk management.
- Adherence to GMP is the responsibility of everyone involved in the life cycle of a NHP, from the harvesting or manufacturing to its availability for sale to consumers.
- Every natural health product shall be manufactured, packaged, labelled and stored by personnel who are qualified by education, training or experience to perform their respective tasks.
- The appropriate personnel with sufficient training are necessary to manufacture, package, label, import, or store NHPs of high quality.
- Every manufacturer, packager, labeller, importer and distributor shall have a quality assurance person who is responsible for assuring the quality of the natural health product