GMP and Quality
Language: English
Published by Independently Published, 2024
- Softcover
- New
Seller: Rarewaves.com USA, London, London, United KingdomRarewaves.com USA
AbeBooks seller since June 11, 2025
Condition: New
£ 17.39
Quantity: Over 20 available
Add to basketSeller Inventory # LU-9798882160141
- Title
- GMP and Quality
- Author
- Beverly White
- Publisher
- Independently Published
- Publication year
- 2024
- Condition
- New
- Binding
- Paperback
- Language
- English
- ISBN 13
- 9798882160141
- Item weight
- 245 grams
- Dimensions
- 17.78 x 0.76 x 25.4 cm
GMP covers all aspects of production, from the raw materials, premises, and equipment to the training and hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. This framework not only benefits the health and safety of the public but also enhances the efficiency and quality of the pharmaceutical manufacturing process. Compliance with GMP is a mandatory aspect in pharmaceutical manufacturing, and adherence is closely monitored through inspections and audits by regulatory authorities.
### Introduction to GMP for Medical Devices
Good Manufacturing Practice (GMP) for medical devices is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any medical device production that cannot be eliminated through final product testing. GMP encompasses all aspects of the manufacturing process, including the training and qualifications of staff, cleanliness of the facilities, and the handling and documentation of materials.
The goal of GMP in the context of medical devices is to prevent harm to the user. Regulations and guidelines under GMP for medical devices are internationally recognized and are specifically tailored to meet the unique requirements of this sector. They ensure that medical devices are manufactured consistently and are safe for their intended use. This includes implementing a quality management system (QMS), which encompasses the organizational structure, procedures, processes, and resources needed to implement quality management.
In the medical device industry, adherence to GMP standards is rigorously enforced by health authorities and regulatory agencies worldwide. Companies that fail to comply with these regulations can face severe penalties, including product recalls, bans, and legal action. For manufacturers, compliance is not just about meeting regulatory requirements; it's about ensuring the trust of healthcare professionals and patients in the safety and effectiveness of their products.
1.0 Quality Management Systems
2.0 Personnel, Buildings And Facilities
3.0 Materials Management
4.0 Validation
5.0 Complaints And Recalls
6.0 Risk Management
7.0 Data Integrity And Principles Of Compliance
8.0 Facilities, Utilities And Cleanrooms
"Synopsis" may belong to another edition of this title.
Rarewaves.com USA
London, London, United Kingdom
AbeBooks seller since June 11, 2025
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