GMP Glossary & Definitions

Official Standards:

Official Standards are commonly reference Standards, which had been provided by a Compendial body, the WHO organization or another certified body.

Operational Qualification (OQ):

Operational Qualification is the documented verification after the Installation Qualification that a System or sub-system performs as intended.

or

Operational Qualification (OQ) is the documented verification that the identified system or subsystem performs as intended throughout all operating ranges of pressure and temperature.

Out of Specification Results (OOS):

An OOS is a result that fall outside the predefined specifications or acceptance criteria.

Over-the-counter drug (OTC):

Any drug that can be bought without a prescription. Distribution of nonprescription drugs is unrestricted, and may be sold , for example, in grocery stores and pharmacies.