Process Qualification Optimization

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The document describes the process qualification procedures used by CVC Products Company for their sputtering tools. As demand increased, the company standardized the qualification process, which involved mechanical, electrical, vacuum, and process checks to ensure new modules were functioning properly before being shipped. The qualification process helped clear the pipeline and get more tools delivered each quarter as the company prepared for an IPO.

Technology Business

Process Qualification Optimization Martin Zess

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PDL World is your EPCm partner in the Caspian region for Oil & Gas projects. We offer: High quality, Good technical support, Wide network, Excellent references, 100% returning customers, Good prices Our capabilities are: Compressed air packages, Compressed Nitrogen, Blanketing, Nitrogen generation, Air separation, Water treatment, Metering, Turbine generators, Gas turbine packages, Steam turbine packages, Pumping packages, Valve services, Other utilities

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In the last year or so the FDA and the EMA have issued new guidance/ draft guidance on "Process Validation".These align process validation activities with a product lifecycle concept and the International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The earlier guidelines were developed before the elaboration of the new ICH guidelines.With these new guidelines, additional opportunities are available to verify the control of the process by alternative means to the manufacture of traditional process validation batches. The main objective of process validation remains that a process design yields a product meeting its pre-defined quality criteria. ICH Q8, Q9 and Q10 provide a structured way to define product critical quality attributes, design space, the manufacturing process and the control strategy. ICH Q8 refers to an ‘enhanced’ approach to pharmaceutical development which includes an alternative to the traditional process validation. Continuous process verification [see definition in ICH Q8(R2) glossary] can be utilised in process validation protocols for the initial commercial production and for manufacturing process changes for the continual improvement throughout the remainder of the product lifecycle. There is now a new paradigm in process validation. This presentation has been prepared from material available from FDA , EMA and ICH for beginners to have an overview of the new paradigm.

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