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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