NHP GMP Compliance and GMP Quality Assurance

See also Natural Health Products Site Licencing

NHP GMP compliance is a requirement of any company that manufactures, packages, labels, and/or imports natural health products. Natural health products good manufacturing practices (GMPs), as per Part 3 of the Natural Health Products Regulations, are a system of processes, procedures and documentation to set the appropriate standards and practices for manufacturing, packaging, labeling, importing and storage activities. Distributors are also included in the natural health products GMPs and also responsible for meeting their own applicable GMP requirements which include having an appointed Quality Assurance Person.

GMP regulations state that companies must have a designated individual responsible for Quality Assurance (i.e. a QAP) that is qualified through a combination of education, training and experience – dicentra can fulfill this vital role on your behalf. Complying with GMPs is an ongoing, post-marketing activity required for natural health products in Canada. GMP compliance is also an excellent approach to quality and risk management. dicentra’s qualified staff can serve as either your formal QA personnel, or simply as your informal advisor on all matters related to QA.

Our services in NHP GMP Compliance include:

• Development/Implementation of a GMP Compliant Quality System or Improvements on Current System through the following measures:

• • Drafting Standard Operating Procedures (SOPs) and revisions
  • Drafting technical agreements
  • Preparation of stability protocols
  • Preparation and review of Finished Product Specifications
  • Creation of Complaint handling programs
  • GMP Audits
  • Custom designed GMP training (on-site, off-site or on-line) (See also on-line GMP training program)
  • GMP Training
  • Preparing Quality Assurance Reports (QAR) and Foreign Site Reference Numbers Applications for international manufacturing, packaging, and labeling facilities
• Ongoing Quality Assurance:
  • Quality assurance for the assessment and release of finished products for sale
  • Investigation of complaints, deviations and non-conformances
  • Assessment of product returns
  • Change Control Assessment

Training in GMPs for manufacturers, packagers, labelers, and importers is mandatory in Canada. dicentra has a long history of providing effective regulatory and GMP training and strives to make the training experience a meaningful and enjoyable one.