Mead Dietary Supplement Good Manufacturing Practices

Preparing for Compliance
1. Auflage 2011
ISBN: 978-1-4200-7741-4
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 312 Seiten

Dietary Supplement GMP is a one-stop "how-to" road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging, and holding of dietary supplement products.

The recent regulations, outlining broad goals, intentionally avoid specifics to allow for future technological advances—leaving implementation to the discretion of each firm. Given this latitude and flexibility, this new resource is an essential source of workable and practical suggestions on ways the industry can best meet the goals. Based on broad experience with GMP compliance techniques worked out over the years in the food, drug, and medical device industries, it is a must-have guide for all DS companies, especially the many smaller firms for whom this is new territory.
Dietary Supplement GMP provides:

- a practical guide in easy to understand language to help navigate through the requirements for systems covering process and quality control

- suggestions and practical recommendations on "how-to" achieve full compliance

- explanation of the FDA’s role regarding inspection, enforcement, recall/seizure of products and prosecution

Dietary Supplement Good Manufacturing Practices (GMP) covers:

- Personnel

- Plants and Grounds

- Equipment and Utensils

- Sanitation of Buildings and Equipment

- Quality Assurance and Laboratory Operations

- The Quality Control Unit

- Production and Process Controls

Zielgruppe

Scientists involved in development, manufacturing, QC/QA, and testing of dietary supplement products, regulatory affairs professionals in DS industry and pharmaceutical science auditors, contract manufacturers, independent laboratories, and vendors of raw materials and components to the dietary supplement industry.

Autoren/Hrsg.

Mead, William J.

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Ernährungsmedizin, Diätetik

Inhaltsverzeichnis

The Basics of Good Manufacturing Practice
Regulatory Overview
Personnel Matters
Physical Plant and Grounds
Equipment and Utensils
Cleaning and Sanitation
Maintenance and GMP
Calibration
Production and Process Controls
Specifications
Sampling
Deviations and Corrective Actions
Incoming Components, Packaging Materials and Labels
Master Manufacturing Record
Batch Production Record
Manufacturing Operations
Packaging and Labeling Operations
Quality Control Responsibilities
Laboratory Operations
Returned Goods
Product Complaint Handling
Holding and Distributing
Handling Recalls
Top Management Responsibility
Record Keeping, Documentation, SOPs
Change Control
Adverse Event Reporting and Records Keeping
Continuous Improvement
Supply Chain Integrity
Audits
Outsourcing
The FDA
FDA Inspections