Agilent introduces service to cut cGMP lab validation timelines
Using the paperless process, pharma companies can run tests on multiple analytics instruments and computer systems simultaneously, cutting the time it takes to bring equipment up to cGMPs (current good manufacturing practices).
Talking to Outsourcing-Pharma, Agilent’s compliance programme manager Paul Smith heralded the updated software as a solution to “fragmented” cGMP equipment testing processes currently available in the industry.
He said: “There are no universally agreed standards that clearly define what should be done when performing laboratory compliance services such as maintenance, repair, functional verification or operational qualification (OQ).
“The content, format and definitions contained within installation qualification or OQ protocols, plans and reports vary between service providers and customers.”
Smith said Agilent’s service works with the company’s internal change control processes and ensures an understanding of the regulatory risks that could be raised during an audit.
He added: “Customers value the advice Agilent provides, as this supports the company’s internal change control processes, reducing regulatory risk, and helps customers understand and be able to explain differences during an audit.”
The company says one of its compliance engine’s key selling points is its flexibility which allows it to work with a broad range of instruments. Smith said: “The set points contained within the electronic protocol, for example flow rates and temperatures for an HPLC high-performance liquid chromatography) system, are not fixed.
“They are controlled by the customer and once approved are locked down. However, a range of limits are fully validated during the protocol development, which means it is possible to configure the testing to match the customer requirements to set points and limits.”
Changing the industry
In a bid to make the entire compliance services industry more harmonious, Agilent has been involved in updating the 2005 Good Automated Manufacturing Practice (GAMP) good practice guide titled “Validation of Laboratory Computerized Systems”.
Smith said one of the significant changes to the guide is the removal of the fixed categories contained within the first edition.
“This has been done to support implantation of risk-based thinking. The greater flexibility required by risk-based thinking will require approaches that are more flexible within a controlled framework such as Enterprise Edition,” he said.