Management controls for GMP compliance

In September 2004, the US Food and Drug Administration issued a new draft document entitled, "Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations." Certain management-control activities are designed specifically to address GMP i...

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Bibliographic Details
Published inPharmaceutical Technology Vol. 29; no. 4; pp. 64 - 72
Main Author CHESNEY, David L
Format Magazine Article Trade Publication Article
LanguageEnglish
Published Duluth, MN Advanstar Communications 01.04.2005
MultiMedia Healthcare Inc
Subjects
Biological and medical sciences
Biotechnology industry
CFR
Compliance
Executives
Federal regulation
General pharmacology
Good Manufacturing Practice
Management controls
Manufacturing
Medical sciences
Objectives
Performance management
Pharmaceutical industry
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Quality control
Regulated industries
Responsibilities
Systematic review
Trends
Violations
Workloads
United States > US
Mechanical compliance
Pharmaceutical technology
Management
Compliance
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Summary:In September 2004, the US Food and Drug Administration issued a new draft document entitled, "Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations." Certain management-control activities are designed specifically to address GMP issues such as the establishment of policies that communicate management's intentions or the establishment of a periodic, systematic review of quality data trends. Executive management must establish a clear vision that pharmaceutical manufacturing quality and compliance system is important. The GMP regulations require that companies perform, at minimum, an annual comprehensive review of batch records, complaints, failures, and other issues associated with products to determine whether changes must be made to the specifications or manufacturing control procedures [211.180(e)].
ISSN:1543-2521
2150-7376