Establishing a CGMP Audit System

P.O. Box 487

Indian Rocks Beach, FL 33785

(727) 642-0182

(813) 774-8657

(727) 593-3595 FAX

DESCRIPTION

FDA mandates that a Drug Firm, and therefore the laboratory, be operated in a state of control by employing conditions and practices that assure compliance with the intent of The Federal Food, Drug, and Cosmetic Act and portions of the CGMP regulations which pertain to it. Specifically, a laboratory, which is in a state of control, provides services that confirm the company is producing finished drug products of sufficient quality, known strength, proper identity, and known purity.

In order to demonstrate that you are in control, you need data to support your position. These data are obtained by executing a well organized and systematic laboratory audit.

In addition to demonstrating you are currently in control, you must show that you will be in control in the future. Therefore, you must also demonstrate you have a system in place to continually monitor the status of compliance within your laboratory and correct deficiencies if they are discovered.

”Establishing a CGMP Laboratory Audit System: A Practical Guide” is a systematic approach for auditing your laboratory to demonstrate to your organization and ultimately to FDA that you are in control of your laboratory system. In addition, the Guide accomplishes the goal of establishing sustainable compliance within your laboratory.

INTENDED AUDIENCE AND USE

”Establishing a CGMP Laboratory Audit System: A Practical Guide” was specifically designed for laboratories which are regulated by government, namely:

     • Facilities operating under Current Good Manufacturing Practices (CGMPs).
     • Facilities operating under Current Good Laboratory Practices (CGLPs).
     • Facilities operating under ISO 9000 Standards.

However, any laboratory can benefit from the level of control obtained by the Guide and the corresponding incremental gains in efficiency and productivity one seems from implementing such a system. Managers, Quality Assurance Personnel, and Laboratory Technicians within these organizations will find value in the Guide.

CONTENTS

To help you accomplish the goal of executing a well organized and systematic laboratory audit, the Guide is organized into phases. Each of the required steps, in addition to other details, for performing laboratory audits, is clearly detailed and documented in a series of flow diagrams and checklists. All procedures are compiled into a concise and user friendly manual, which also contains numerous templates, tools, and instruments provided on CD-ROM for modification and use. Sections of the Guide include:

1. Introduction to Quality Systems Approach to CGMP Compliance

2. Preparing for the Audit
3. Auditing and Data Capture
4. Organizing Data and Reporting the Results
5. Developing and Implementing a Corrective Action Plan
6. Developing and Implementing a Verification Plan
7. Developing and Implementing a Monitoring Plan

d. FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL 7356.002 “DRUG MANUFACTURING INSPECTIONS’

e. 21 CODE OF FEDERAL REGULATIONS PARTS 210 AND 211 CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS

The Guide 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: