Dietary Supplement Good Manufacturing Practices: Preparing for Compliance, 1st Edition (e-Book) book cover

Dietary Supplement Good Manufacturing Practices

Preparing for Compliance, 1st Edition

By William J. Mead

CRC Press

312 pages

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Hardback: 9781420077407
pub: 2011-11-17
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pub: 2016-04-19
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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 implementati

Table 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.

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Nutrition
MEDICAL / Pharmacology