【FDA CFR 820 QSR Compliance】Storage Provision

¥200

【FDA CFR 820 QSR Compliance】Storage Provision

【FDA CFR 820 QSR Compliance】Storage Provision

¥200

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Clarification of product storage provision allows for standardization within the company.
By standardizing the rules, it will be easier to respond to FDA inspections.

List of Forms
The following forms are included with your purchase.
・MD-QMS-K11 Storage Provision
・MD-QMS-F1101 Temperature and Humidity Record Confirmation Chart


Table of Contents

Provision

1 Objective.
2 scope (of a document)
3 identification
4 Principles of Product Preservation
5 Product Storage
6 Receiving and shipping of final products
6.1 Management of incoming and outgoing shipments
6.2 Control items in product warehousing
6.3 Controls on product delivery
7 Treatment in case of abnormality
8 Outsourced Storage
9 Corrective and preventive action requirements
10 reference
11 by-laws