The definitions given below apply to the terms used in these guidelines. They may
have different meanings in other contexts.
Measurable terms under which a test result will be considered acceptable.
WHO Guidelines for Transfer of Technology 63
Active pharmaceutical ingredient (API)
Any substance or mixture of substances intended to be used in the manufacture of a
pharmaceutical dosage form and that, when so used, becomes an active ingredient of
that pharmaceutical dosage form. Such substances are intended to furnish
pharmacological activity or another direct effect in the diagnosis, cure, mitigation,
treatment, or prevention of disease or to affect the structure and function of the body.
An experimental design to test only the extremes of, for example, dosage strength.
The design assumes that the extremes will be representative of all the samples between
A formal system by which qualified representatives of appropriate disciplines review
proposed or actual changes that might affect a validated status. The intent is to
determine the need for action that would ensure that the system is maintained in a
The setting up, adjustment and testing of equipment or a system to ensure that it
meets all the requirements, as specified in the user requirement specification, and
capacities as specified by the designer or developer. Commissioning is carried out
before qualification and validation.
A planned set of controls, derived from current product and process understanding,
that assures process performance and product quality. The controls can include
parameters and attributes related to materials and components related to drug
substances and drug product materials and components, facility and equipment
operating conditions, in-process controls, finished product specifications, and the
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