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10 golden rules of GMP

This module reviews the good manufacturing practices (GMP) required in facility design and equipment, their upkeep, and the impact of quality-by-design on processes. It also reviews the importance of GMP in personnel training, role definitions, hygiene, and internal audits.

  • Regulatory expectations and implications of noncompliance to GMP

  • Rules 1, 2 and 3: Facility and equipment design, maintenance and upkeep, and following Quality by Design (QbD) for the entire product life cycle

  • Effective controls to assure product quality

  • Rule 4, 5 and 6: Importance of validation of processes, writing and following good procedures, and keeping good records

  • Rule 7 to 10: Understanding the importance of defined roles and responsibilities, training and development of employees, practicing good hygiene, and performing regular audits

Why it matters

Following GMP prevents any substandard\, adulterated and unsafe products from being introduced to\ markets. GMP protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including product recall\, seizure\, fines\, and even incarceration. Therefore\, understanding the rules of GMP that encompass all such regulations is critical

Who is it for

Employees in production\, quality assurance\, quality control\, as well as in management\, responsible for assuring best quality products and good manufacturing practices must be trained on this module

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