scope:

This standard is intended to define a standardized approach for auditing to determine the level of compliance of OTC drug products to 21 C.F.R. Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General and 21 C.F.R. Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals, International Council for Harmonisation of Technical Requirements for Pharmaceutical for Human Use (ICH) Quality Guidelines, 1, 7 and 10, as well as incorporating additional retailer requirements. It refers to the requirements for good manufacturing practices (GMPs) applicable to all OTC drugs. It will assist in the determination of adequate facilities and controls for OTC drug manufacture with sufficient quality to ensure suitability for intended use.

Purpose

The principles outlined in this standard provide a comprehensive basis for the quality management system used in the manufacture of over-the-counter (OTC) drugs. Implementation of these principles shall result in the achievement of three main objectives:

- achieve OTC drug realization: the organization shall implement and maintain a system that delivers OTC drugs with the quality attributes necessary to meet the requirements and expectations of customers, retailers, and regulatory authorities;

- establish and maintain a state of control: the organization shall ensure the manufacture and supply of OTC drugs is in accordance with this standard, thus providing customers with some assurance of continued suitability and reliability of supply; and

- facilitate continual improvement: the organization shall collect objective evidence to continually develop and enhance the application of these quality management system principles to further assure OTC drug consistency.