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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
starting material and finished product. When
calculating and checking results, the analyst
should refer to the current specification to decide
the status of the sample. These specifications are
often registered with the regulatory agency and
cannot be changed.
Importance of specifications
Specification documents define official tests, test methods, and limits, and relate
to starting materials, packaging materials, components, bulk products and
finished products, but may also apply to critical steps of manufacture.
QC specifications should conform to statutory standards (e.g. pharmacopoeias)
and any specifications accepted by regulatory bodies for approval of the product
or in connection with its registration.
Failure to meet specification should result in an out-of-specification (OOS) notice
and investigation. If the OOS is confirmed, the sample will be rejected, and a
nonconformance report issued.
IMPORTANCE OF SPECIFICATIONS
Starting Materials:
In the pharmaceutical industry, the requirements
for starting materials must be well-defined and
documented to ensure that you get the material
specified or ordered, and that there are no mixups.
Starting materials are defined by a standard name,
the supplier's/manufacturer's code, and a unique
item code.
Specifications for starting materials should
include:
inspections and/or tests required
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