Welcome To Performance PharmaTech |
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Paul Osborne founder - PPtech
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In January 2009 Paul Osborne founded Performance PharmaTech to provide a range of services to the pharmaceutical industry, to assist manufacturers, contract packaging services and to the suppliers of processes, systems and equipment. We offer:
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Strategy development, creation of documentation and execution for all regulatory requirements;
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Training – fully structured program development and performance;
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Project management - program planning, development and follow through to successful completion.
Computer technology plays an ever-increasing role in the pharmaceutical industry. It is also used throughout the whole supply chain with varying degrees of potential impact on patient safety.
Supplying validated computer based equipment into the pharmaceutical industry need not be a minefield.
Performance PharmaTech Ltd. has over 25 year experience in the supply of successfully validations on computer based primary and secondary packaging equipment. These machines having many associated auxiliary systems like barcode readers, machine vision systems and checkweighers.
Remember - the definition of validation discusses production of evidence that a system will meet its specification. In recent years, an increasing interest trend is the adoption of a risk-based approach within the industry as the key to cost containment. We fully embrace this approach where the testing of computer systems is wide-ranging and documented but not so heavily evidenced.
We spend considerable time and effort keeping up with the latest trends in legislation, like the new MHRA Annex 11, monitoring the latest FDA legislations, ISPE White papers, ASTM standards and the GAMP forums.
Additionally we are actively working on the latest trends in pharmaceutical packaging, such as carton level serialisation - as a very relevant part of the EU Falsified Medicines Directive.
We can provide you with training for your technical team on pharmaceutical regulatory requirements and through analysis of process, systems and equipment we can both create and implement suitable solutions for total system compliance.
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