Intro to Good Manufacturing Practice for Medicinal Products

For an organization to manufacture safe, quality, and effective medicinal products, it must follow Good Manufacturing Practice (GMP). GMP is a set of rules that manufacturers must follow and are supremely important for upholding the integrity of the organization as one that creates quality medicinal products.

Regulators will not allow medicinal products to be placed, or to remain, on the market in their country unless the products can be shown to be manufactured in compliance with GMP. To this end, they carry out inspections of manufacturing plants. Companies that persistently commit serious breaches of GMP requirements have suffered huge fines.

All manufacturing personnel must receive initial and ongoing training in the theory and practice of GMP. Everyone who works in a processing, quality control, packaging, or warehouse environment for a pharmaceutical or biotechnology company, or one of their contractors, must understand why GMP is important, how it applies to them, and how to comply with it. This module provides an ideal induction and refresher course in the basics of GMP. We begin by explaining what GMP is and why it is necessary. We then set out its main principles. Finally, we focus on two aspects of GMP that apply to everyone in the manufacturing environment: hygiene, cleaning, and sanitation; and documentation.

This course gives you an in-depth look into GMP and how to incorporate some of the most important aspects (hygiene, cleaning, and sanitation, and documentation) of it into your business. Although GMPs are mostly standardized internationally, some difference exist between international standards and US requirements.

The course covers:

• GMP – what and why – What GMP is and why it is important and some lessons from history. It introduces the regulations and guidance documents which are the source of GMP rules. Review regulatory inspections and the consequences that can arise from failure to comply with GMP requirements.
• Principles of GMP – An overview of the main principles of GMP, and we outline some things that manufacturing personnel need to do to comply with requirements. We identify the principal goals of GMP as prevention of contamination; prevention of mix-ups; scrupulous documentation; validation and maintenance of processes and equipment; quality assurance by an independent unit; and training. We place GMP in the context of a company’s quality management system.
• Hygiene, cleaning, and sanitation – Prevention of contamination is one of the most important goals of GMP. Contamination of products is often difficult to detect, so GMP rules emphasize preventive measures, including attention to personal health and hygiene, the wearing of special clothing, by staff; and cleaning and sanitation of premises and equipment. Review the basics of GMP requirements in these vital areas.
• Documentation and records – Comprehensive documentation of procedures, formulas, work instructions, and specifications, and thorough recording of batch data, are fundamental requirements of GMP. In this session, we explain why documentation is so important, identify different types of documents required, and set out some simple rules for recording and correcting data.

Learn:

• What Good Manufacturing Practices (GMPs) are, their importance, and primary goals
• The compliance requirements for documentation, hygiene practices, as well as cleaning and sanitation practices
• Where to find GMP rules and regulations plus internationally standardized guidance
• To highlight the difference between internationally standardized guidance and US regulations