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Good Laboratory Practices (GLPs) vs GMPs – Comparisons and Contrasts

This course clarifies the operational and regulatory distinctions between GLPs and GMPs, enabling professionals to evaluate laboratory compliance practices, documentation controls, and data integrity expectations tied to FDA-regulated nonclinical studies and related quality systems. This Course is designed for professionals responsible for laboratory oversight, quality systems, regulated documentation, and compliance activities.

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US $190 per learner

30-Days Unlimited Streaming Access

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To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor :  Joy Mcelroy
  • Study time : 75 Minutes
  • Skill Level: Intermediate
  • Course ID: TF2758
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Good laboratory practices establish the framework for conducting nonclinical laboratory studies used to support FDA research and marketing applications for regulated products, including drugs, medical devices, biological products, and food additives. These requirements apply to studies performed under laboratory conditions to evaluate product safety and exclude clinical investigations involving human subjects or field trials on animals. Clear distinction between GLPs and GMPs remains important because laboratory data, documentation quality, instrumentation validation, and record maintenance directly affect the credibility of regulated research activities.


The course addresses the regulatory basis of GLPs under FDA 21 CFR Part 58, the historical reasons for their development, and the objectives supporting consistent laboratory operations. Attention is also given to statistical procedures for data evaluation, analytical and laboratory certification practices, consequences of noncompliance, grounds for facility disqualification, and conditions associated with reinstatement. Understanding these relationships helps organizations align laboratory controls, SOP structures, and manufacturing quality expectations within regulated environments.

  • Differentiate GLP and GMP Responsibilities:

    Understanding where GLP requirements intersect with GMP expectations helps professionals evaluate laboratory practices, documentation standards, and operational responsibilities more accurately. The course clarifies how nonclinical laboratory studies are regulated under FDA requirements and why weak controls around data evaluation, validation, or record maintenance can create significant compliance exposure during regulatory review.

  • Strengthen Laboratory Compliance Oversight:

    The material provides practical regulatory context for managing laboratory certification activities, instrumentation validation, SOP relationships, and statistical procedures tied to safety studies. It also explains the operational consequences of noncompliance, including disqualification risks and reinstatement considerations, supporting more informed quality decisions in FDA-regulated laboratory and manufacturing environments.

Key Areas Covered

  • FDA 21 CFR Part 58 requirements governing good laboratory practices for nonclinical laboratory studies
  • Definitions, objectives, mission, and historical development of GLPs
  • Differences and operational relationships between GLPs, GMPs, and SOP requirements
  • Statistical procedures used for laboratory data evaluation and study reliability
  • Instrumentation validation and analytical laboratory certification expectations
  • Documentation practices, maintenance of laboratory records, and compliance controls
  • Consequences of noncompliance and regulatory grounds for facility disqualification
  • Reinstatement considerations for previously disqualified laboratory facilities

Who Must Attend

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • Laboratory Personnel
  • Validation Departments

Quality training, expert insights, and answers that matter. Know your Expert

JOY MCELROY

Joy McElroy has more than 25 years of pharmaceutical and biotech industry experience spanning Quality Control, Quality Assurance, GMP compliance auditing, equipment qualification, cleaning validation, and technical training. Her background includes batch record review, annual GMP training, and validation protocol development for multiple regulated companies, including Merck, Wyeth Lederle, Novartis, and Catalent. She has also provided consulting and compliance training through McElroy Training and Consultancy, LLC, supporting regulated laboratory and manufacturing operations.

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