Page 34 - GMP for warehouse

GMP Training – GMP for Warehouse by www.gmpsop.com

Many mis-formulation incidents commence with the wrong issue of starting
materials or other chemicals from the store.

The GMP rules clearly state that each issue of starting materials from the store
must be accompanied by requisition paperwork and that there is a cross-check
that issues match the documented request before being issued.

The reason for this requirement is that material issue is the first point of control
inside the factory. It is much better to prevent incorrect chemicals being issued
in the first place rather than finding them (or not) later on. Mis-formulation can
cause patient medication to be unsafe, which can result in serious injury or even
death of patients.

What do the GMP rules say?

US FDA CFR211

Subpart B—Organization and Personnel
Sec. 211.22 Responsibilities of quality control unit. (extract)

(a) There shall be a quality control unit that shall have the responsibility and
authority to approve or reject all components, drug product containers, closures,

in-process materials, packaging material, labeling, and drug products, and the
authority to review production records to assure that no errors have occurred or,
if errors have occurred, that they have been fully investigated, The quality control
unit shall be responsible for approving or rejecting drug products manufactured,
processed, packed, or held under contract by another company.

International GMPs

Chapter 4 Documentation
Procedures and records

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