Pharma Change Control: Strategies for Successful Company-Wide Implementation
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 muchmore
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.
Meet your guides, co-authors Dr. Michael Hiob and Thomas L. Peither:
- Dr. Hiob has worked for the State of Schleswig-Holstein (Germany) in drug control since 1991, first as head of the Laboratory for Drug Analysis and later as GMP Inspector for the Regional Authorities for Health and Occupational Safety. Since 2006, he has been with the Ministry for Social Affairs, Health, Family, Youth and Senior Citizens as supervising surveillance member of the Expert Group on Qualification/Validation. He is active in international committees, including as expert on FMEA and the International Conference on Harmonization (ICH).
- Mr. Peither, a GMP consultant and expert in the European GMPs, cofounded the GMP publishing company Maas & Peither (Germany, USA) and the midsize pharma consulting company Halfmann Goetsch Peither (Switzerland, Germany, Singapore), which advises numerous pharmaceutical companies.
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.
Pharma Change Control: Strategies for Successful Company-Wide Implementation is available in PDF format.