About GMP – CGMP

GMP refers to Good Manufacturing Practice while CGMP refers to Current Good Manufacturing Practice. Health Canada and European Commission regulate GMP for pharmaceutical industries while US FDA enforces CGMP. World Health Organization (WHO) defines Good Manufacturing Practices (GMP, also referred to as 'cGMP' or 'current Good Manufacturing Practices') as the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.

GMP – CGMP Certification

To avoid confusion or misinterpretation in the industrial or regulatory bodies, this certificate has been designed to present as a GMP/cGMP certificate after completion of the required studies.  The GMP/ cGMP regulations for drugs (pharmaceuticals even OTC products) contain minimum requirements for the methods, facilities, and controls used in the manufacturing, processing, and packing of a product. The regulations require that manufacturers, processors, and packagers of drugs, medical devices, some specialty foods such as medical foods, and blood take proactive steps to ensure that a product is safe for use and that it has the ingredients and strength it claims to have. The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulations.

Learning objectives

Upon completion of this course, the participant will be able to:

• Explain the pharmaceutical industry’s good manufacturing practices;
• Understand the basics of GMP for medicinal products for human use;
• Get familiar with the regulations and guidelines related to the pharmaceutical industry;
• Explain validation principles and their importance to the industry professional;
• Apply GMP principles to everyday roles and responsibilities as described above.

Audience

GMP/cGMP training is appropriate for all employees involved in the drug and pharmaceutical industry, including but not limited to:

• Manufacturing Technicians, Supervisors and/ or Managers;
• Team Leaders and Supervisors, R & D personnel and Business Owners;
• QC personnel such as those performing in- and outbound inspections/ monitoring;
• QA personnel such as those performing program/procedure reviews and verifications;
• Maintenance/ Engineers – aseptic emphasis, and specific equipment operations;
• Future Medical Device Industry employees including emerging technologies;

Professionals intend to work and contribute to the drug and pharmaceutical industries.

Course description

Canadian College of Food and Health (CCFH) offers both in-class and online GMP/ cGMP training.

The course covers 7 Lectures:

• Lecture 1: International GMP/ cGMP - the history of USA and Canadian GMP;
• Lecture 2: GMP of Health Canada - GMP Guide Document NNHP (HC 2014) and US FDA - 21 CFR Part 1, 11, 16, 106, 110, 210, 211, et al., explained;
• Lecture 3: Health Canada GUI-0001 GMP Guide for Drug Products, GUI-0104 GMP Guide for API, et al.,  & NHP-NPN Licensing – NPN Application;
• Lecture 4: Case study: Health Canada “Food and Drug Act”, “Controlled Drugs and Substances Act” - GPP and ACMPR Application;
• Lecture 5: GMP applied in the food industry as pre-requisite programs regulated in Canada, USA and worldwide (1-2);
• Lecture 6: GMP applied in the food industry as pre-requisite programs regulated in Canada, USA and worldwide (2-2);
• Lecture 7: GMP associated Good Laboratory Practices (GLP) and Good Clinical Practices (GCP).

Upon the successful completion of the course, the participant will receive a GMP-cGMP certificate valid for life long.