Dietary Supplement Good Manufacturing Practices: Preparing for Compliance

ISBN-13: 9781420077407 / Angielski / Twarda / 2011 / 298 str.

William J. Mead

Opis

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

The recent regulations, outlining broad goals, intentionally avoid specifics to allow for future technological advances, which leaves 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.

Spis treści

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.

O autorze

William J. Mead