Quality Assurance/Quality Control Issues in GMP Regulatory Compliance
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QUALITY ASSURANCE/QUALITY CONTROL ISSUES IN GMP REGULATORY COMPLIANCE MOHAMMED BARKAT Director, Quality Control, Quality Assurance, Janssen-Ortho Inc., Ontario, Canada
This paper covers key quality assurancdquality 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 (APls) is explained. GMPs. with a focus on APls, 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. I S 0 9ooo as not being a substitute for GMP compliance is also mentioned. Key Words: Quality; Compliance; Canadian; GMP;API
INTRODUCTION
and therapeutic efficacy of the pharmaceutical products under the author’s control. QA/ THE GOAL OF THIS paper is to share some QC professionals use the external factorof the author’s quality assurance (QA)/qualthe GMP regulations and guidelines-as ity control (QC) experiences by discussing tools to help achieve Janssen-Ortho’s quality a few of the current QA/QC issues from a assurance goals. Canadian perspective. As the director of At Janssen-Ortho Inc., in Canada, the Quality Assurance/Quality Control at a leadQuality Control Department performs the ing innovative Canadian p h m c e u t i c a l manclassical QC functions of testing and assessufacturer, the author has developed a philosoing operations from receipt of raw materials phy on QA/QC which has been influenced through production and packaging to distriby internal and external factors. bution. The Quality Assurance Department The key external factor is the Good Manufacturing Practices regulations. The key in- ensures that systems, facilities, and proceternal factor is a personal and professional dures are adequate and are being followed. commitment to assuring the safety, quality, The goal of Janssen-Ortho Canada’s QNQC program is to ensure a state of appropriate control that will ensure the safety, quality, Resented at the DIA Workshop “Building the Bridges: and therapeutic effectiveness of the comGMP Regulatory Compliance For Drugs-Developed/ pany’s products. The vision is to achieve total Developing Countries’ Issues.” March. 5-7, 1996, Bom- control of quality. bay, India. India’s pharmaceutical industry has been Reprint address: Mohammed Barkat, Director, developing. The supply of both final dosage Quality Control, Quality Assurance, Janssen-Ortho Inc., 19 Green Belt Drive, North York, Ontario, M3C forms and active pharmaceutical ingredients 1L9,Canada. to foreign markets, including Canada
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