Author: Christine OechsleinPublisher:
ISBN: 9783934971592
Category :
Languages : en
Pages : 123
Book Description
Checklist GMP Inspections
Author: Christine OechsleinPublisher:
ISBN: 9783934971592
Category :
Languages : en
Pages : 123
Book Description
GMP Inspections
Author: Brendan CooperPublisher: Createspace Independent Publishing Platform
ISBN: 9781548715328
Category :
Languages : en
Pages : 434
Book Description
At over 400 pages, this book introduces the area of Good manufacturing and compliance for Regulated industries (Medical devices, pharmaceuticals and Biotechnology). The opening chapter covers the basics- principles of GMP, how it applies to people, equipment, materials and processes. This is then followed with chapters outlining the key themes and areas that arise within the various industries or specialties. While many GMP requirements apply to all medical and medicinal products, some area's exhibit additional requirements and focus points when it comes to audits and GMP inspections. Each chapter is clear, concise and draws heavily on published guidance from the FDA and other regulatory bodies. This results in a well structured summary or road map that details key topics and technical points subject to inspection. The following chapters are included: Introduction to Good Manufacturing Practices, Preparation for Audits, Inspection of Quality Systems, During the Inspection, Biotechnology Inspection Guide, Medical Device Inspection Guide, Sterile Drugs Inspection Guide, Computerised Systems Inspection Guide and Cleaning Inspection Guide.
Gmp Audit Trainer
Author: Brendan Cooper, Mr.Publisher:
ISBN: 9781548711931
Category :
Languages : en
Pages : 122
Book Description
Both internal and external GMP audits/inspections are a key requirement of Quality Management systems across medical device, biotechnology and pharmaceutical industries. Achieving a successful audit outcome is essential to maintaining an effective QMS and fundamental to retaining manufacturing licenses. In order to align systems and processes to ensure compliance and favorable audit outcomes personnel must understand the auditor focus and methodologies. This book summarises key areas that inspections cover along typical areas of risk and concern. The following chapters are included:Introduction to Good Manufacturing Preparation for AuditsInspection of Quality Systems During the InspectionBiotechnology Inspection GuideMedical Device Inspection GuideDrugs Inspection Guide Computerised Systems Inspection GuideCHAPTER 8Computerised Systems Inspection GuideIntroduction 94Hardware 94Validation of Hardware 96Software 98Electronic Records and Signatures 106Electronic Records Verification Methods 117
The Business of Pharmaceutical Inspection
Author: Convention for the Mutual Recognition of Inspection in Respect of the Manufacture of Pharmaceutical Products Cambridge, England)Publisher:
ISBN:
Category : Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products
Languages : en
Pages : 168
Book Description
FDA Biotechnology Inspection Guide
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Biotechnology
Languages : en
Pages : 62
Book Description
GMP Audit Checklist for Pharmaceutical and API Manufacturers
Author: GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - With Checklists and Software Package)
Author: Leonard SteinbornPublisher: CRC Press
ISBN: 0429525826
Category : Medical
Languages : en
Pages : 633
Book Description
Volume 1 of this two-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these
Guidelines for Good Manufacturing Practice of Cosmetic Products (GMPC)
Author: Council of EuropePublisher: Council of Europe
ISBN: 9789287128492
Category : Political Science
Languages : en
Pages : 40
Book Description
These guidelines, aimed at governments, and in particular cosmetics manufacturers, in order to improve public health safety, offer organisational and practical advice on the management of the human, technical and administrative factors affecting product quality. They describe the manufacturing conditions and management activities involved in the different stages of production, from the purchase of the raw materials to the dispatch of the packaged end-products.
Quality Assurance of Pharmaceuticals
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9789241546195
Category : Business & Economics
Languages : en
Pages : 250
Book Description
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).
Medical Device GMP Inspections
Author: Dale A. MaddenPublisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 43
Book Description