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"Helping People Learn Compliance and Science" SM
A POCKET GUIDE TO LABORATORY CGMPS
DESCRIPTION
Delphi Analytical Services, Inc. has spent years helping companies in the Pharmaceutical Industry improve their level of compliance with Current Good Manufacturing Practices (CGMPs). This involvement has included large and small companies who have already been subject to regulatory action from FDA as well as companies who are taking preventative measures to avoid regulatory action. As part of this effort, a significant amount of time has been spent reviewing the Quality Systems associated with analytical laboratories.
This “pocket guide” is designed to provide an overview of the Quality Systems Based approach to Laboratory CGMPs. This is the same approach that FDA currently uses to evaluate if drug manufacturing facilities and laboratories are in compliance with 21 CFR 210 and 211.
INTENDED AUDIENCE AND USE
This guide is intended to be used as a quick reference or “sanity check” to insure that you are addressing the major issues associated with compliance within your laboratory. It also provides a list of resources where you may find additional help in bringing your laboratory up to the highest level of compliance with current good manufacturing practices.
It is an excellent starting point for development of more comprehensive CGMP compliant systems within your laboratory. It may serve as the starting point for development of a work breakdown structure to implement CGMP compliant systems within your laboratory.
This guide may also be used as a primer or introduction to laboratory CGMPs for new employees or for employees who are cross-training from other areas within the organization.
CONTENTS
Introduction to the Systems Based Approach to Laboratory CGMPs.
Section 1: Laboratory Managerial and Administrative Systems
Section 2: Laboratory Documentation Practices and Standard Operating Procedures
Section 3: Laboratory Equipment Qualification and Calibration
Section 4: Laboratory Facilities
Section 5: Methods Validation
Section 6: Laboratory Computer Systems
Section 7: Laboratory Investigations
Section 8: Glossary of Common Terms
Section 9: Selected References
Section 10: Selected Vendors
COST
“A Pocket Guide to Laboratory CGMPs” is a 54 page booklet available for $9.95 plus $3.00 for shipping and handling. Volume orders and discounts are available.
ORDERING INFORMATION
“A Pocket Guide to Laboratory CGMPs” is available for purchase on Delphi Analytical Services, Inc.’s website www.delphianalytical.com. Go to product purchase and choose either e-mail or fax purchase or contact:
Marketing and Communications Department
Delphi Analytical Services, Inc.
P.O. Box 487
Indian Rocks Beach, FL 33785
Phone 727-642-0192
Fax 727-593-3595
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