ABSTRACT

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

chapter 1|7 pages

The basics of good manufacturing practice

chapter 2|9 pages

Regulatory overview

chapter 3|8 pages

Personnel matters

chapter 4|15 pages

Physical plant and grounds

chapter 5|12 pages

Equipment and utensils

chapter 6|11 pages

Cleaning and sanitation

chapter 7|5 pages

Maintenance and GMP

chapter 8|5 pages

Calibration

chapter 9|5 pages

Production and process controls

chapter 10|14 pages

Specifications

chapter 11|11 pages

Sampling

chapter 12|4 pages

Deviations and corrective actions

chapter 14|5 pages

Master manufacturing record

chapter 15|4 pages

Batch production record

chapter 16|16 pages

Manufacturing operations

chapter 17|8 pages

Packaging and labeling operations

chapter 18|8 pages

Quality control responsibilities

chapter 19|15 pages

Laboratory operations

chapter 20|2 pages

Returned goods

chapter 21|4 pages

Product complaint handling

chapter 22|5 pages

Holding and distributing

chapter 23|3 pages

Handling recalls

chapter 24|4 pages

Top management responsibility

chapter 25|8 pages

Record keeping, documentation, and SOPs

chapter 26|3 pages

Change control

chapter 27|3 pages

Adverse event reporting and record keeping

chapter 28|11 pages

Adulteration and contamination

chapter 29|5 pages

Supply chain integrity

chapter 30|7 pages

Audits

chapter 31|7 pages

Outsourcing

chapter 32|10 pages

The Food and Drug Administration

chapter 33|9 pages

FDA inspections