Parallel Workshops
Workshop A
Mr. Donald C. Singer,
GlaxoSmithKline &
American Society for Quality
Develop your Own Procedure for Objectionable Organisms
As a pharmaceutical microbiologist you have to make decisions relating to risk and compliance (cGMPs). One of the most discussed topics without crystal clear guidance is “objectionable microorganisms”. This workshop will be interactive to ensure sharing of a breadth of knowledge and practical information. We will define and develop a foundation to allow for you to customize or compare a procedural approach for objectionable microorganisms for your laboratory.
Workshop C
Dr. Marian McKee
BioReliance
Ms. Vikki Smith
GlaxoSmithKline
Stock Culture Maintenance and the Importance of Dilutions
Handling of Culture Organisms
One of the most important, yet often neglected, tasks in any routine microbiology laboratory is to maintain a collection of bacterial and fungal stock cultures. In a busy laboratory it is all too easy for the stock culture collection to deteriorate into a jumble of poorly labeled, partially dried-out agar slant cultures at the back of a refrigerator. But it does not have to be, nor should it be, like that.
During this workshop you will find the reasons why a microbiology laboratory needs stock cultures in good condition and explores the methods for Establishing and Maintaining a Culture Collection.
In addition examples for Growth Promotion and the Changing Regulations for the Specifications Surrounding This Test, will be provided.
Workshop E
Mr. Praful Bhusari
Medimmune Inc.
Microbiological Equipment Validation Studies
- URS, DQ, FAT, IQ, OQ and PQ
- Format for a clear, concise and user-friendly document
- What and how much information to be included
- The validation report
- Re-validation
Workshop B
Ms. Carolyn Phillips
IBA Molecular
Harmonization of Microbiological Methods for Non-sterile Products – Practical Challenge
The pharmacopoeial harmonization, as a concept, is not new. From the informal discussions within the pharmaceutical industry over 20 years ago, came the formation, in 1989, of the Pharmacopoeial Discussion Group (PDG), consisting of representatives from the pharmacopoeial authorities of Japan, USA and Europe (Britain withdrew in 1992 having aligned with Europe).
In terms of microbiology, the harmonized chapters closest to implementation are those associated with the testing of non-sterile products. Formerly the Microbial Limits Tests, the harmonized chapters now refer to Microbial Enumeration Tests (USP <61>, EP 2.6.12); Tests for Specified Micro-organisms (USP <62>, EP 2.6.13); and Microbiological Quality of Non-Sterile Pharmaceutical Products (USP <1111>, EP 5.1.4). Implementation dates have been pushed-out from 2007 to 2009 or 2010 depending upon region but allowance is made for the early adoption of harmonized chapters in the development of new products.
Workshop D
Ms. Cheryl Moser
Merck Research Laboratories
Bacterial Endotoxin Tests; USP <85>, BP/EP
The essential elements of the bacterial endotoxins test are addressed in this workshop. Performance of properly understood endotoxins tests benefits any company releasing products with endotoxin specifications and may avoid significant compliance problems.
The standard gel, chromogenic and turbidimetric Bacterial Endotoxins Test test methods, as described in harmonized USP chapter <85> are validated, meaning that the methodology has been proven and accepted. However, the QC laboratory can't assume that these validated test methods are suitable for the products under test.
The following questions will also be addressed during this workshop:
- How does one identify interference?
- How does one overcome interference?
- Description of the test methods
- how they are performed
- best uses
- limitations and advantages
- Discussion about what it means to perform a cGMP test vs. test for information only
- Resolving test interferences
- Specifications development for finished product, excipients, API
- Calculations for endotoxin limits and maximum valid dilution
- Description of what a maximum valid dilution is?
- How does one structure a suitability study that will meet FDA expectations for new product submissions?
- How does one test for and overcome interference when testing medical devices?
- Has the retirement of the 1987 LAL Guideline affected how we think about GMP and interference testing
- General Principles and Introduction The USP, EP and JP Harmonized
- Prerequisites for endotoxins tests
- USP bacterial endotoxins test requirements
- How, when, and why the LAL tests had been removed from FDA guidelines
- Qualitative or Quantitative?
- Sampling requirements
Workshop F
Ms. Mary Griffin
MG Quality Microbiology Consulting LLC
Selecting the Right Microbial Characterization Methods and Identification Systems
A major challenge for the pharmaceutical microbiology laboratory is to ensure the right characterization methods, identification systems and procedures are in place to meet the demands of the manufacturing facility. There is an increasing need for a plan for characterization and/or a precise identification of the microorganisms detected, and a rapid reporting of these results to demonstrate microbial control, exclusion of objectionable microorganisms and to assist in product failure investigations. You, as a microbiology manager, must have the knowledge to select the right methods and systems, and to create procedures to streamline the identification process flow to meet these needs efficiently, timely and all this at a low cost. This may include a contract testing laboratory. This interactive workshop will provide case studies to help you apply the information you need to share. You will leave workshop with a plan for your laboratory. Discussion will include:
- USP <1113>, new general informational chapter, Microbial Characterization, Identification and Strain Typing to be in USP 35/NF30
- Review of methods and systems – the strengths and weaknesses
- Points to consider when selecting method, system, or contract laboratory
- Developing an identification process flow for your laboratory
- Evaluating novel and rapid emerging microbial identification technologies
