|
S.
No. |
Terms |
Definition |
|
A |
||
|
1 |
Acceptance Criteria |
The
acceptance criteria are pre-defined and agreed standards, limits or ranges
between different parties such as Quality Assurance and Quality Control or
Manufacturing and Quality Assurance or suppliers |
|
2 |
Accuracy of Measurement |
Closeness
of the agreement between the result of a measurement and a true value of the
measurement. |
|
3 |
Action Level |
The
action level is a pre-defined and between different parties agreed written
level. Once these levels are exceeded, actions must be undertaken. A complete
investigation must be carried out and documented accordingly. |
|
4 |
Active Pharmaceutical Ingredient
(API) |
An
API also called Drug Substance (DS) is any physiologically active substance
that is intended for use in a Drug Product. An API is also a substance when
used in the manufacturing, processing, or packaging of a drug, becomes an
active ingredient or a finished Dosage Form of the Drug. |
|
5 |
Actual Yield |
The
quantity that is actually produced at any appropriate phase of manufacture,
processing, or packing of a particular API or intermediate |
|
6 |
Airlock |
An
airlock is called a room or space with two or more doors that is interposed
between two or more rooms. This is usually build in between different class
of cleanliness, for the purpose of controlling the air flow and pressure
differential between those rooms. An airlock is designed for personnel or
goods. |
|
7 |
Alert Level |
The alert level is a pre-defined and between different parties agreed written level. This level should be used to predict an action level. Once these levels are exceeded an investigation may not be necessary, but closer attention to the indicator is required. |
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