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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

 

 

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

 

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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