Page 57 - GMP for warehouse

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

A mix-up of sodium chloride and potassium chloride may be undetected by the
laboratory, but could have fatal consequences for patients injected with the
wrong salt.

GMP rules require that there is extensive record keeping on the receipt, testing,
storage, issue, and use of starting materials for this very reason. Without

accurate and detailed records in the warehouse, it may not be possible to
investigate a problem quickly or thoroughly. Any delay may cause additional
problems for patients. Certainly in the case of a recall the size of the recall will
be determined by the accuracy and completeness of the warehouse records.

What do the GMP rules say?

US FDA CFR211

Subpart J-Records and Reports
Sec. 211.188 Batch production and control records.

Batch production and control records shall be prepared for each batch of drug
product produced and shall include complete information relating to the
production and control of each batch. These records shall include:
(a) An accurate reproduction of the appropriate master production or control
record, checked for accuracy, dated, and signed;

(b) Documentation that each significant step in the manufacture, processing,
packing, or holding of the batch was accomplished, including:
(1) Dates
(3) Specific identification of each batch of component or in-process material used.

Subpart J-Records and Reports
Sec. 211.196 Distribution records.

Distribution records shall contain the name and strength of the product and
description of the dosage form, name and address of the consignee, date and
quantity shipped, and lot or control number of the drug product.

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