Dietary Supplement Good Manufacturing Practices

Preparing for Compliance

William J. Mead

$96.99

Paperback

Not in-store but you can order this
How long will it take?

Availability Information

We source books from suppliers in Australia and overseas. For books we don't currently have in stock, the time it takes to get them from our suppliers can vary widely - from a few days to a few months - so we check each book with each supplier to determine the expected time it will take to be supplied to us.

We then advise you accordingly. If the time taken to get any book is too long for you, you can let us know and we will cancel or adjust your order, and refund as required.

To find out the anticipated arrival time for specific items prior to ordering, please contact us by phone or email:

Phone +61 2 9264 3111, or 1800 4 BOOKS (1800 4 26657) if outside Sydney:
option 1 Abbey's Bookshop (Crime, History, Science, Kids & more) • info@abbeys.com.au
option 2 Language Book Centre (ESL & Foreign Languages) • language@abbeys.com.au
option 3 Galaxy Bookshop (Sci-fi, Fantasy, Romance, Graphic Novels) • sf@galaxybooks.com.au

QTY:

English

CRC Press
14 October 2024

Dietetics & nutrition; Biology, life sciences; Pharmaceutical technology

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

By: William J. Mead
Imprint: CRC Press
Country of Publication: United Kingdom
Dimensions: Height: 229mm, Width: 152mm,
Weight: 576g
ISBN: 9781032922522
ISBN 10: 1032922524
Pages: 312
Publication Date: 14 October 2024
Audience: Professional and scholarly , Undergraduate
Format: Paperback
Publisher's Status: Active

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.

Reviews for Dietary Supplement Good Manufacturing Practices: Preparing for Compliance

""This book may therefore become a useful tool to further the implementation of more “modern” approaches towards product safety and quality and to actually help transitioning dietary supplements to become food also in real life and not only from a regulatory stand point."" —Elena Vittadini, International Journal of Food Science and Nutrition ""Bill Mead’s primer Dietary Supplement Good Manufacturing Practices – Preparing for Compliance, should be required reading for every quality control department in the supplement industry. The book dissects and digests the FDA’s lengthy regulations and preamble, making the minutiae of a very complicated rulemaking understandable so the requirements can actually be implemented. Bill Mead offers not only ""what"" the rule requires but ""how"" to comply, and ""why"" each topic is critical to pass your next inspection. Conscientious firms will want to read cover to cover before the FDA inspector knocks on the door."" —Steve Mister, President & CEO, Council for Responsible Nutrition