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GMP Training – Documentation and Records by www.gmpsop.com
A unique item code, including a revision code
Specifications for packaging materials should include:
A detailed description of this item
Inspections and/or tests required
Acceptance criteria
An approved label copy
Intermediate product
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.
The specifications should be similar to specifications
for starting materials or for finished products, as
appropriate.
Intermediate or bulk products that are purchased
should be handled as though they were starting
materials.
Finished product
Specifications for finished products should include or
reference:
An exact statement of the therapeutically active
substances
The product name and code (if any)
The pharmaceutical dosage form
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