Monday, July 13, 2009


The following definitions apply to the terms as used in these gmp guidelines. They may
have different meanings in other contexts.
control (verb)
The taking of all necessary actions to ensure and maintain compliance with the
criteria established in the HACCP plan.
control (noun)
The state wherein correct procedures are being followed and criteria are being
control measure
Any action and activity that can be used to prevent or eliminate a pharmaceutical
quality hazard or reduce it to an acceptable level.
corrective action
Any action to be taken when the results of monitoring at the CCP (see below)
indicate a loss of control.
critical control point (CCP)
A step at which control can be applied and is essential to prevent or eliminate a
pharmaceutical quality hazard or reduce it to an acceptable level.
critical limit
A criterion which separates acceptability from unacceptability.
Failure to meet a critical limit.
flow diagram
A systematic representation of the sequence of steps or operations used in the
production, control and distribution of a particular pharmaceutical.

HACCP plan
A document prepared in accordance with the principles of HACCP to ensure the
control of hazards which are significant for pharmaceutical quality in the production
and supply chain.
Any circumstance in the production, control and distribution of a pharmaceutical
which can cause an adverse health effect.
hazard analysis
The process of collecting and evaluating information on hazards which should be
addressed in the HACCP plan.
The act of conducting a planned sequence of observations or measurements of
control parameters to assess whether a CCP is under control pharmaceuticals
All products related to pharmacy, including starting materials (active pharmaceutical
ingredients and excipients), finished dosage forms, and biological and other
specific products.
The collection and evaluation of data, beginning at the process development stage
and continuing through the production phase, which ensure that the manufacturing
processes — including equipment, buildings, personnel and materials — are
capable of achieving the intended results on a consistent and continuous basis.
Validation is the establishment of documented evidence that a system does what
it is supposed to do.
verification regulatory affairs in pharmaceutical
The application of methods, procedures, tests and other evaluations, in addition
to monitoring, to determine compliance with the HACCP plan.
4. Principles
The HACCP system is based on seven principles. In applying these principles, 12
stages are recommended and are discussed in section
7. Some stages are linked to
specific principles while others serve as an introduction to the concept.
The seven principles are:
1. Conduct a hazard analysis.
2. Determine the critical control points (CCPs).
3. Establish target levels and critical limit(s).

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