Page 48 - QA and QC

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

Specifications

Specifications are documented for starting materials, in-process product, and
finished products. These specifications are submitted to the regulatory
authorities when products are first registered. If specifications need to be altered
for whatever reason, approval must be sought from the government regulators.

The finished product is required to meet the specifications throughout the full

shelf life under the approved storage condition.

Each batch must conform to each specification when tested. All out-of-
specification (OOS) conditions must be investigated.

Pharmacopoeias are legal standards for the quality of products and materials.
They specify the quality attributes of products and materials in “monographs”,
and provide information on how tests should be conducted.

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 mix ups.

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

reference to test methods and acceptance criteria

material storage conditions

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