Page 49 - QA and QC

GMP Training – Quality Assurance and Quality Control by www.gmpsop.com

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 mix ups.

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

Specifications for packaging materials should include:

a detailed description of the item

inspections and/or tests required

acceptance criteria

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