William J Mead

Dietary Supplement Good Manufacturing Practices

Preparing for Compliance

• Broschiertes Buch

Produktbeschreibung

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

Produktdetails

• Verlag: CRC Press
• Seitenzahl: 312
• Erscheinungstermin: 14. Oktober 2024
• Englisch
• Abmessung: 229mm x 152mm
• Gewicht: 580g
• ISBN-13: 9781032922522
• ISBN-10: 1032922524
• Artikelnr.: 71602027

Inhaltsangabe

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.