Author: Emmet P. Tobin
Publisher: Createspace Independent Publishing Platform
ISBN: 9781532702129
Category :
Languages : en
Pages : 72
Book Description
This concise book provides an introduction to Current Good Manufacturing Practices (aka cGMP). It introduces those who wish to work in regulated industries to GMP, highlighting key areas and practices. It is also a useful refresher for those with previous experience of cGMP.
Cgmp Starter Guide
Author: Emmet P. Tobin
Publisher: Createspace Independent Publishing Platform
ISBN: 9781532702129
Category :
Languages : en
Pages : 72
Book Description
This concise book provides an introduction to Current Good Manufacturing Practices (aka cGMP). It introduces those who wish to work in regulated industries to GMP, highlighting key areas and practices. It is also a useful refresher for those with previous experience of cGMP.
Publisher: Createspace Independent Publishing Platform
ISBN: 9781532702129
Category :
Languages : en
Pages : 72
Book Description
This concise book provides an introduction to Current Good Manufacturing Practices (aka cGMP). It introduces those who wish to work in regulated industries to GMP, highlighting key areas and practices. It is also a useful refresher for those with previous experience of cGMP.
The GMP Handbook
Author: Brendan Cooper
Publisher: Createspace Independent Publishing Platform
ISBN: 9781548370251
Category :
Languages : en
Pages : 150
Book Description
CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s AND Eudralex provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters: Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality Management Chapter 3-Personnel Chapter 4-Buildings and Facilities Chapter 5-Process Equipment Chapter 6-Documentation and Records Chapter 7-Materials Management Chapter 8-Rejection and re-use of materials Chapter 9-Validation Chapter 10- Change Control Chapter 11-Complaints and recalls Page count 160. Paperback book. Large 8" x 10" format.
Publisher: Createspace Independent Publishing Platform
ISBN: 9781548370251
Category :
Languages : en
Pages : 150
Book Description
CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s AND Eudralex provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters: Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality Management Chapter 3-Personnel Chapter 4-Buildings and Facilities Chapter 5-Process Equipment Chapter 6-Documentation and Records Chapter 7-Materials Management Chapter 8-Rejection and re-use of materials Chapter 9-Validation Chapter 10- Change Control Chapter 11-Complaints and recalls Page count 160. Paperback book. Large 8" x 10" format.
CGMP A Complete Guide - 2021 Edition
Author: Gerardus Blokdyk
Publisher:
ISBN: 9781867465379
Category :
Languages : en
Pages : 0
Book Description
Publisher:
ISBN: 9781867465379
Category :
Languages : en
Pages : 0
Book Description
FDA CGMP Guide
Author:
Publisher:
ISBN: 9783947770144
Category :
Languages : en
Pages :
Book Description
Publisher:
ISBN: 9783947770144
Category :
Languages : en
Pages :
Book Description
FDA CGMP Guide
Author:
Publisher:
ISBN: 9783947770038
Category :
Languages : en
Pages :
Book Description
Publisher:
ISBN: 9783947770038
Category :
Languages : en
Pages :
Book Description
Good Manufacturing Practices for Pharmaceuticals
Author: Joseph D. Nally
Publisher: CRC Press
ISBN: 1420020935
Category : Medical
Languages : en
Pages : 418
Book Description
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
Publisher: CRC Press
ISBN: 1420020935
Category : Medical
Languages : en
Pages : 418
Book Description
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
CGMP Orientation Guide
Author: Warner-Lambert/Parke-Davis
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 135
Book Description
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 135
Book Description
A Pocket Guide to CGMP Sampling
Author: Institute of Validation Technology
Publisher:
ISBN:
Category : Pharmaceutical industry
Languages : en
Pages : 37
Book Description
Publisher:
ISBN:
Category : Pharmaceutical industry
Languages : en
Pages : 37
Book Description
A Pocket Guide to CGMP Sampling
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 37
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages : 37
Book Description
GMP Inspections
Author: Brendan Cooper
Publisher: 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.
Publisher: 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.