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Good Manufacturing Practices and Inspection 1st Edition by World Health Organization ISBN 9241547081 9789241547086

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Good Manufacturing Practices and Inspection 2 Updated Edition World Health Organization Digital Instant Download

Author(s): World Health Organization
ISBN(s): 9789241547086, 9241547081
Edition: 2 Updated
File Details: PDF, 4.71 MB
Year: 2007
Language: english
SKU: EB-1133324 Category: Tag:

Good Manufacturing Practices and Inspection 1st Edition by World Health Organization – Ebook PDF Instant Download/Delivery: 9241547081, 9789241547086
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Product details:

ISBN 10: 9241547081 
ISBN 13: 9789241547086
Author: World Health Organization

Over the years, the World Health Organization’s Expert Committee on Specifications for Pharmaceutical Preparations, originally created to prepare The International Pharmacopoeia, has made numerous recommendations relevant to quality assurance and control for national regulatory and control systems and the implementation of international standards, but for the most part they have only been available in the annexes to various technical reports. In this second of two volumes, those annexes providing guidelines related to good manufacturing practices and to inspection of manufacturers and drug distribution channels have been gathered and revised. Annotation ©2004 Book News, Inc., Portland, OR (booknews.com)

Good Manufacturing Practices and Inspection 1st Table of contents:

chapter 1 – quality management systems
quality assurance vs quality control
documentation and record-keeping
standard operating procedures (SOPs)

chapter 2 – personnel and training
roles and responsibilities
training programs and competency assessment
hygiene and safety practices

chapter 3 – facilities and equipment
design and layout of manufacturing areas
maintenance and calibration of equipment
cleaning and sanitation requirements

chapter 4 – production and process control
manufacturing processes and workflow
in-process controls
batch production and traceability

chapter 5 – raw materials and suppliers
material specifications
supplier qualification and audits
receiving and storage procedures

chapter 6 – laboratory control and testing
analytical methods and validation
sampling and testing procedures
stability studies and release criteria

chapter 7 – documentation and record keeping
types of GMP documents
documentation practices and review
handling deviations and corrections

chapter 8 – packaging and labeling
packaging materials and specifications
labeling requirements
inspection of finished products

chapter 9 – storage and distribution
warehousing conditions
transportation and handling
inventory management

chapter 10 – inspections and regulatory compliance
inspection types and procedures
audit preparation
handling non-compliance and corrective actions

chapter 11 – risk management and continuous improvement
identifying and mitigating risks
process improvement strategies
GMP in the context of quality culture

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Tags: World Health Organization, Good Manufacturing