Good Quality Control Laboratory Practices

Aims:

To facilitate the development of knowledge, and expertise in the USFDA and PIC/S regulations, quality standards and guidelines that govern the quality control of pharmaceuticals.

Outline Syllabus: 

• Basic concepts and requirements of Good Laboratory Practices (GLPs) for a regulated Pharmaceutical Laboratory.
• Techniques and procedures for the validation, analysis and control of analytical test methods.
• Theory and application of statistics in G(QC)LP
• cGMP requirements for the establishment of stability programs – pre and post approval

Learning Outcomes:
On successful completion of this module, the student will be able to:

(1) Knowledge and Understanding

• List the key elements and basic principles that make up GLPs in an analytical chemical laboratory.
• Relate the importance of laboratory records, raw data, traceability and documents to GMP compliance and regulatory inspections.
• List the performance parameters required for analytical method validation.
• List requirements for inter-laboratory method transfer.
• State the rules and regulations regarding stability programs.
• Utilize appropriate statistical controls for G(QC)LP

(2) Discipline skills

• Devise strategies for handling out of specification conditions.
• Design a table of content for the Laboratory Quality Management Systems
• Review laboratory systems for compliance with recognized standards.
• Prepare an analytical method validation protocol.
• Calculate the capability of a test method and determine the optimum number of workups.
• Set up a stability programs schedule.
• Evaluate basic stability data using regression analysis.
• Calculate an expiry time for a typical stability trial.
• Describe the difference between precision and accuracy.
• State the basis and principle of hypothesis testing.