Laboratory Controls Overview & Establishment of Specifications

David E. Wiggins

Course description

In FDA’s Guide to Inspections of Pharmaceutical Quality Control Laboratories (7/93), it is stated The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing. Consistent with current Good Manufacturing Practices (cGMPs), such testing must always be performed using a product specification based on sound scientific principles and approved by the Quality Control unit.

This training course will provide participants with a broad understanding of the requirements for establishing a drug product specification that meets these FDA expectations. Current accepted practices of following ICH guidelines for establishing universal and specific tests as well as specifications for organic impurities will be covered.

Upon completion of this course, you will be able to:

• List and explain the six systems that FDA includes in their systems‐based inspections
• Explain the specific areas that FDA will focus on in a laboratory inspection
• Create a drug product specification that meets ICH and FDA requirements
• Select appropriate organic impurities specifications consistent with ICH requirements

This training is one part of the 10-course series required for the GMP Laboratory Control Professional Certification Program. Attend this course as part of the certification process or as a stand-along course for personal career advancement and training.