Dietary Supplement Good Manufacturing Practices - Preparing for Compliance

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 technolog

List of contents

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.

Summary

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 technolog

Product details

• Authors: William J. Mead, Mead William J.
• Publisher: Taylor and Francis
• Languages: English
• Product format: Paperback / Softback
• Released: 14.10.2024
• EAN: 9781032922522
• ISBN: 978-1-032-92252-2
• No. of pages: 312
• Weight: 453 g
• Subjects: Natural sciences, medicine, IT, technology > Technology > Chemical engineering; SCIENCE / Chemistry / General, MEDICAL / Pharmacology, MEDICAL / Nutrition, Dietetics & nutrition, Biology, life sciences, Dietetics and nutrition, Pharmaceutical technology, Pharmaceutical chemistry and technology