Page 16 - GMP for warehouse

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

A fundamental GMP control is to ensure that only approved starting materials
that meet specifications are used to formulate medicines. Patient safety depends
on it. Removing the protection of status controls will raise the risk of an error
occurring.

The government regulatory agencies and their auditors are very aware that lack

of control over material movement in the warehouse can, and has, led to defective
product. For this reason, they regularly conduct inspections of the warehouse
and the warehouse procedures to ensure that GMP rules are in place.

What do the GMP rules say?

US FDA CFR 211

Subpart H~Holding and Distribution
Sec. 211.142 Warehousing procedures.

Written procedures describing the warehousing of drug products shall be
established and followed.

They shall include:
(a) Quarantine of drug products before release by the quality control unit.

(b) Storage of drug products under appropriate conditions of temperature,

humidity, and light so that the identity, strength, quality, and purity of the drug
products are not affected.

International GMPs

Chapter 5
Production

5.40. The purchase, handling and control of primary and printed packaging
materials shall be accorded attention similar to that given to starting materials.

Copyright©www.gmpsop.com. All rights reserved
Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited.
Page 16 of 64