The USP Certificate of Lab Procedures gives prospects a comprehensive understanding of the USP Standards that are applicable and essential in a laboratory. This certificate is currently composed of Key Analytical Instrumentation lab procedures as well as Fundamental Courses – Uniformity in Dosage Units, USP Requirements for Balances and Good Documentation Practices that reinforce the skills that support good laboratory practices.
Analytical Instrument Courses (minimum of 1)
Fundamentals of Dissolution: Guidance for the Verification and Qualification of a Dissolution Apparatus: UNDER DEVELOPMENT AND NOT AVAILABLE
Course will provide prospects with the history and theory behind the applicable standards and allow prospects to manage and address the compendial application of system suitability tests, instrument qualification, validation of analytical procedures and dissolution testing
Compendial HPLC Practices
This course covers USP General Chapter <621> Chromatography, with focus on system suitability parameters and adjustments allowed to the chromatographic system. Additional topics covered in this course are HPLC theory, column selection and practice. Harmonization details will also be discussed.
Spectroscopic General Chapters and Updates
This course will provide essential training and tools to assist the generation of spectroscopic measurement data that is ‘fit for purpose’ and which can be used with confidence for the manufacture and supply of drug substances, according to the requirements as specified in the US Pharmacopeia for the protection of human health around the World.
Fundamental lab Courses (Minimum 2)
Fundamental Courses provide the essential skills and tools for calculations, testing and recording of laboratory procedures.
Prospects can choose a minimum of two (2) of three Supplemental courses –
• Uniformity of Dosage Units: USP–NF General Chapter <905>,
• Understanding USP Requirements for Balances and/or
• Good Documentation Practices (GDP): USP-NF General Chapter <1029>
Subject area:
cGMP
Objectives (If applicable):
Fundamental Lab Courses (Two of Three)
Understanding USP Requirements for Balances
– Outline the scope of <41>
– Explain the requirement of assessing balance performance according to <41>
– Perform the repeatability assessment by following the new requirement in <41>
– Perform the accuracy assessment
– Outline the scope of <1251>
– Assess the minimum weight of analytical balances
Uniformity of Dosage Units: USP–NF General Chapter <905>
– Explain the rationale of the current harmonized compendial approach to the problem of uniformity of dosage units
– Calculate the Acceptance Value in determining conformance with the acceptance criteria
– Describe and use the concepts of the Acceptance Value, L1 and L2, Target Value, Reference Value, and Acceptability Constant
– Apply USP–NF General Chapter <905> to various types of formulations
– Determine when to use the “Weight Variation Test” and when to use the “Content Uniformity Test”
Good Documentation Practices (GDP) and USP–NF General Chapter <1029>
– Recall the definition, purpose, and importance of Good Documentation Practices
– Identify: general rules and principles of GDP, records requirements, general laboratory notebook documentation requirements
– Explain the proper handling of e-records and e-signatures (21 CFR Part 11)
– Describe USP Pharmacopeia General Chapter <1029> and its importance in GDP
– Demonstrate knowledge of the rules governing medicinal products in the EU (Vol. 4:
– Identify and describe outcomes of FDA warnings related to lack of GDP compliance
Analytical Instumentation Courses
Fundamentals of Dissolution: Guidance for the Verification and Qualification of a Dissolution Apparatus
– Understand the theory of dissolution testing presented in USP–NF General Chapter <711> to apply in practical application
– Explain key definitions of dissolution testing
– Set up, verify and qualify a dissolution apparatus (focus on apparatus 2)
– Use acceptance tables
– Explain the operational parameters of a dissolution apparatus that could affect dissolution results
Target Audience (If applicable):
QC/QA personnel and management, regulatory compliance personnel and management, analytical scientist and workbench chemists responsible for quality assessments, regulatory agencies