Quality Assurance/Quality Control Issues in GMP Regulatory Compliance

This paper covers key quality assurance/quality control issues from a Canadian perspective. Canadian Good Manufacturing Practices (GMP) regulations and guidelines, present and future, are discussed. The Canadian situation with respect to GMPs for active pharmaceutical ingredients (APIs) is explained. GMPs, with a focus on APIs, are discussed. A future direction for GMPs for APIs is offered. Key Canadian GMP regulation and guideline issues in development are reviewed. Concerns for APIs manufactured without GMP compliance are expressed, suggestions for API GMP requirements are offered, guiding principles for GMP regulations are suggested, a need for uniform quality standards is stated, and quality standard compliance advice for drug exporters to Canada is offered. ISO 9000 as not being a substitute for GMP compliance is also mentioned.