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GMP Quality Management - Pharma Change Control - Successful Implementation
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Pharma Change Control
€ 279.00
net
€ 332.01
  19% VAT included
PDF-Download
US$
397.00
Strategies for Successful Company-Wide Implementation
Edition: 1st edition 2013
56 Pages
ISBN: 978-3-943267-70-9
Excerpt from the GMP MANUAL

Drugmaking processes change constantly. New companies enter the supply chain, old ones drop off. New production machinery and software supplant old stuff. Things get complicated and before you know it, your files are filled with new specifications and revised SOPs.

But the FDA likes things simple, clear cut and well tracked. That leaves you a lot of questions:

- Which changes require FDA notification?
- What changes require revalidation?
- Who makes the decisions about change control?
- Where can you turn for answers?

Co-authored by GMP-Experts with international reputations, Pharma Change Control is the perfect starting point to rein in your pharmaceutical manufacturing processes.

Every page offers practical strategies to implement a company-wide change control program and meet FDA regulatory requirements, including:

- How to grade or classify changes
- Changes that may require revalidation
- Data needed for change control success
- Who should serve on the change control committee
- Responsibilities of the change control committee
- Plus much more

Look at what our experts have done for you! Check out the sample Change Control Procedure and a sample Change Control Form included in the report. You could spend weeks creating these documents from scratch, let alone thousands of dollars in staff and consultant time. But they’re yours at no extra cost when you purchase your copies of Pharma Change Control.

Life would be simpler if you didn’t have to worry about change control — but you do. Drugmaking is too complex and FDA requirements too stern. If you wait for the FDA to gig your drug GMP procedures, you’ve waited too long. Don’t take that risk.

Order now your copy of "Pharma Change Control"

Reading Sample

Pharma Change Control - Reading Sample

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Dr. Michael Hiob, Ministry for Health of Land Schleswig-Holstein, Germany
Thomas Peither, Maas & Peither AG - GMP Publishing, Germany
Recommendations
A Process Approach to Pharmaceutical Quality Systems
GMP Glossary and Abbreviations
GMP Audit Checklist (Download)