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GMP Process Validation
Consulting
Our team has extensive experience
in both setting up and monitoring Process Validation
programs. Process Validation has been a major focus of the
FDA in recent years. Conferences in Berlin and Washington DC
have reinforced and clarified regulatory expectations. This
is an area where having the latest information makes all the
difference. It is critical to begin thinking about Process
Validation during the early stages of product development.
Starting early will save your company potentially years in time to
approval for your product. Let us help you set up a program
or review your existing program for compliance with current
industry trends.
We can with all the details:
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Process Validation Master Plans |
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Protocols and Reports |
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Critical Parameter selection
and studies |
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Evaluation of small scale
studies and their applicability to full scale work |
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Methods validation and other QC
support functions |
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Support Studies required:
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Process Pool Hold Time
Studies |
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Buffer Hold Studies |
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Product Specific Cleaning
Validation |
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Final Filter Validation |
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Final Bulk Container
Validation |
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Shipping Validation |
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Support
Studies required for biopharmaceutical products:
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Genetic Stability |
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DNA and Host-Cell Protein
Removal |
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Clearance of Process
Additives |
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Viral
Clearance/Inactivation |
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Chromatography Cleaning,
Storage & Reuse Studies |
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Membrane Cleaning, Storage
& Reuse Studies |
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Industry
Hot Topic |
| Comparability
between clinical trial and commercial material plagues
both industry in the EU and the US. Recently FDA
noted this as one of the major causes of product
approval delays in the U.S.
BioQuality
November 2002
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How
Much to do When |
| Production
processes for investigational medicinal products are not
expected to be validated to the extent necessary for
routine production but premises and equipment are
expected to be validated. For sterile products, the
validation of sterilising processes should be of the
same standard as for products authorised for marketing.
Likewise, when required, virus inactivation/removal and
that of other impurities of biological origin should be
demonstrated, to assure the safety of biotechnologically
derived products, by following the scientific principles
and techniques defined in the available guidance in this
area.
EU GMPs, Annex 13
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