Page 47 - Introduction QC

GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com

reference to test methods and acceptance
criteria

material storage conditions

a retest or expiry date

reference to pharmacopoeial method (if
available)

approved supplier and manufacturer (if
available)

sampling instruction or reference

any precautions

Intermediate Products:
In the pharmaceutical industry, specifications for

intermediate and bulk products should be
available if these are received or dispatched, or if
data obtained from tests on intermediate or bulk
products are used for the evaluation of the finished
product or further processing.

The specifications should be similar to
specifications for starting materials or for finished
products, as appropriate.

Packaging Materials:
In the pharmaceutical industry, the requirements
for pre-printed packaging materials must be well-
defined and documented to ensure that you get the

items you specified or ordered and that there are
no mixups.

Packaging materials are defined by a standard
name, and a unique item code.

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