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DOXPUB 12-0075-SOP PDF

DOXPUB 12-0075-SOP PDF

Name:
DOXPUB 12-0075-SOP PDF

Published Date:
08/01/2007

Status:
Active

Description:

Validation of Aseptic Filling Processes

Publisher:
Doxpub, Inc.

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$32.7
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Summary:

Defines procedures for validating and maintaining the validation of all aseptic filling processes (AFPs), as well as general content requirements for sterile media AFP Master Batch Records (MBR) and Part Number Specifications (PNS). Applies to all aseptically filled sterile products intended for human use. Does not apply to products that are terminally sterilized after filling. See also SOP 12-0015, QVD Protocol and Report Preparation and SOP 12-0020, MBR Document Preparation.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures


Edition : 1.0
File Size : 1 file , 440 KB
Number of Pages : 11
Published : 08/01/2007

History

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