E21: Prepare Your Analytical Laboratory for Quality Audit and Inspection

Monday, July 19 & Tuesday, July 20; 10:00am – 2:30pm EDT each day
Ms. Kim Huynh-Ba, Pharmalytik Consulting, Newark, DE

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The laboratory activities are the main functions; thus, the analytical laboratory goes through multiple internal and external regulatory inspections. The current pandemic provides additional challenges as audits and inspections take on the virtual format. All pharmaceutical products must comply with Good Manufacturing Practices (GMPs) to receive marketing approval rights in the US. The FDA developed the Pre-Approval Inspection (PAI) program to ensure that the application is accurate and that the sponsor has sufficient controls to the manufacturing of the respective drug product. In addition, they also have a Guide for Inspection of the Quality Control laboratories. This course will provide valuable insights to analytical chemists on how to prepare your laboratory for an internal or external quality audit. Pharmaceutical labs will be used as an example; however, critical discussions can also bring valuable techniques to benefit non-pharmaceutical analytical laboratories.

This course will benefit analytical chemists or investigators in QA/QC, R&D, project management, manufacturing, CROs, technical liaison, QA scientists, Regulatory scientists, and laboratory auditors involved with internal or external audits, quality inspections. It is not intended for microbiologists.

1.  Laboratory Audit Program
a. Background and Compliance impacts
b. Understand the scope of internal audit and external inspection
c. FDA Guide to the Quality Control Laboratory Inspection
d. Key factors that will impact the analytical laboratory
Interactive Exercise:  Discuss different inspections a lab may experience and the role of each participant.
2. Structure of a Laboratory Audit
a. Purpose of Audit and Inspection
b. Different types of laboratory audits
c. Expectations of a pre-approval inspection
d. Differences between internal and external audit
Interactive Exercise: Identify critical areas that are vulnerable to different types of audits.
3. Preparation for the Inspection
a. Know the roles and responsibilities
b. Understand the observations and findings
c. Establish criteria for regulatory inspections
d. Develop inspectional approaches and assemble a competent inspection team
Interactive Exercise: Evaluate critical areas and make a preparation plan.
4. Inspection Process and Preparation
a. Handling an onsite and virtual inspection
b. Interviewing and address observations
c. Discuss corrective and preventive actions
d. Evaluate the effectiveness of CAPA
e. Inspection as part of Quality Management System (QMS)

Kim Huynh-Ba has over 25 years of experience in analytical strategic drug development and stability sciences. She is the Executive Director and CEO of Pharmalytik (www.pharmalytik.com), where she provides consulting and training services to pharmaceutical companies since 2003. Kim is a member of the USP Council of Experts (2015-2025), where she chairs the Chemical Medicines IV Expert Committee and a Fellow of the American Association of Pharmaceutical Scientists (AAPS).

Kim is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology (IIT), teaching Quality Audit, Pharmaceutical Analysis, GMP, and ICH graduate courses. She is a member of the Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President. Kim has authored over 30 technical publications and book chapters. She delivered over 200 presentations, both domestic and internationally, in the compliance and quality areas. She is the editor of 2 well-known Stability books: the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010) and recently submitted a manuscript entitled “Analytical Chemistry: An Introduction to the Pharmaceutical GMP Laboratory” (2021).