E13 – Qualification of Analytical Instruments for the Pharmaceutical Laboratory

Qualification of Analytical Instruments for the Pharmaceutical Laboratory

New One-Day Course E13-12, Sunday, November 17th, 8:30am – 5:00pm

Mr. Gregory Martin, Complectors Consulting, Pottstown, PA

This interactive course is designed to provide participants with an understanding of the need for qualification of instruments in the pharmaceutical laboratory, and practical information about how to implement a successful instrument qualification program designed to meet scientific needs and regulatory inspection expectations.  The course will describe the steps in the qualification process, using USP <1058> as a guideline, and the roles and responsibilities of various groups in this process.  We will touch on requirements for instruments with firmware or instrument control, although the validation of stand-alone software is outside the scope of this course.   Examples of documentation will be provided, with practical suggestions for some common laboratory instruments.  Change control will be discussed, including addressing maintenance, preventative maintenance and periodic requalification.  There will also be discussion on what to expect, related to instrument qualification, during a regulatory inspection.  

There will be ample opportunity for questions and discussion.  Upon completion of this course the learner should be able to:
1)     Understand the rationale for instrument qualification.
2)     Be familiar with the contents and intent of USP General Chapter <1058> and related information in USP.
3)     Identify and address the various steps in the qualification process:  design qualification, installation qualification, operational qualification and performance qualification, and understand the differences between the steps.  Be able to draft a qualification protocol.
4)     Understand he rationale for preventive maintenance, periodic calibration/requalification and change control. Be able to design an instrument inventory that will be useful throughout the life of the instruments.
5)     Effectively prepare for a regulatory inspection of their analytical instruments

Laboratory personnel (pharmaceutical quality control or research and development, contract labs, OTC or nutraceuticals) responsible for analytical instruments, managers of analytical or Quality Control Laboratories, Metrologists and Quality Assurance personnel responsible for assuring compliance with instrument qualification requirements.

1. Assessment of Participants Needs
2. The Basis for Requiring Qualification of Analytical Instruments
3. Hands on Activity:  Designing an Instrument Inventory
4. The Analytical Instrument Qualification Process
     * Design qualification
     * Installation qualification
     * Operational qualification
     * Performance qualification
5. Hands on Activity:  Designing DQ/IQ/OQ/PQ Protocols for a Lab Instrument
6. The Roles and Responsibilities of Various Groups
7. The Relationship Between Qualification and System Suitability or Quality Control Check Samples
8. Scope of USP  General Chapter <1058>
     * Software controls
     * Instrument categories
9. Documentation: Practical Examples for Common Laboratory Instruments
10. The Rationale for Preventive Maintenance, Periodic Calibration/Requalification and Change Control
11. Hands on Activity:  Revisit the Instrument Inventory
12. Hands on Activity:  Change Control for Lab Instruments
13. Change Control:  Maintenance, Preventative Main-tenance, Requalification
14. What to Expect from a FDA Inspection of Analytical Instruments:  Common Citations for Instruments During Regulatory Inspections
15. Attendee Questions and Discussion

Mr. Greg Martin is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry.  He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources.  Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years.  In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.  He is also Chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.  Mr. Martin is co-author (with Vivian A. Gray) of the series “Dissolution Concepts and Applications” which has appeared in Journal of Validation Technology and Journal of GXP Compliance.