Good practices for pharmaceutical Quality Control laboratories (GLP)

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About Course

Course Description:
Provides the principles for a quality system concerned with the organizational process and the conditions under which sample testing process is planned, performed, monitored, recorded, archived and reported with ensuring the quality, integrity, and traceability of data. It is a mandatory requirement for laboratories conducting studies to support the registration of pharmaceutical products, pesticides, cosmetics, and medical devices with regulatory bodies like the EDA.

What Will You Learn?

  • Study Oversight: Learning the specific roles and legal responsibilities of the lab manager, Quality Assurance (QA) unit, technical and quality staff.
  • Data Integrity: Mastering "Good Documentation Practices" to ensure all raw data is accurate, legible, and verifiable.
  • Process Standardization: knowledge and implementing Standard Operating Procedures (SOPs) that allow any qualified person to replicate the study results.
  • Audit Readiness: Preparing for internal audits and external inspections from national regulatory authorities.

Course Content

Module 1 – Organization and Management Systems

  • Why QC Lab Shall Follow GLP requirements
    51:05

Module 2 – Planning and Strategic Management

Module 3 – Resources

Module 4 – Technical Execution and Data Generation

Module 5 – Technical Activities

Final Assessment

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