| Equipment
All
automatic, mechanical, and electronic equipment used in the
production, quality control testing, packaging, and storage of
cGMP product must be validated. 21 CFR section 211.68
states the following:
Automatic,
mechanical, or electronic equipment or other types of equipment,
including computers, or related systems that will perform a
function satisfactorily, may be used in the manufacture,
processing, packing, and holding of a drug product. If such
equipment is used, it shall routinely be calibrated, inspected,
or checked according to a written program designed to assure
proper performance.
An
equipment validation protocol consists of the following: Design
Specification, Installation Qualification (IQ), Operational
Qualification (OQ), and Performance Qualification (PQ).
Validation
Services for all critical equipment including:
-
Autoclaves
-
Glassware
and Vial Washers
-
Depyrogenation
Ovens
-
Refrigerators
and Freezers
-
Microplate
Readers and Washers
-
Spectrophotometers
-
Centrifuges
-
Incubators
-
Titration
Systems
-
Freeze
Dryers
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