Lean Changeover in Biopharm Facilities: Using a Data Driven Paperless System
The trend in Biopharmaceutical manufacturing is shifting away from large, single-product facilities to smaller-scale, flexible, multiproduct facilities. This in turn is leading to greater equipment changeover efforts between campaigns/batches and associated GMP documentation efforts required to manage and record that all activities have been completed successfully in compliance with corporate and regulatory requirements.
Manufacturers employ various documentation processes but typically they require that procedures are followed and confirmation/test sheets are executed for all equipment that record that the equipment is clean, sampling confirmed, new equipment setup is implemented, applicable elastomers are changed, relevant calibrations and maintenance jobs are complete etc. ensuring and verifying that the equipment is ready for manufacture of the incoming product. Depending on the equipment and its category e.g. shared product contact, dedicated product, non-product contact etc. many forms may be required to verify that the equipment is changed out into a neutral state from the previous process and again to verify that it is changed in from the neutral state and suitable for manufacture of the incoming product.
The executed documentation must be consolidated and a final report created to summarize the completed work, any non-conformances encountered and their resolution. The full suite of documentation will be reviewed and approved by QA prior to manufacture. A entire process changeover can take weeks and the required documentation effort takes a significant proportion of this time.
Electronic data driven process
A streamlined lean electronic documentation process can enable greater productivity, faster changeover times and enhanced compliance.
Armed with an equipment list a configurable electronic system should auto-generate all the various changeover deliverables for all the listed equipment in a central folder. The system shall allow these deliverables to be effortlessly routed for review and approval before being released to the shop floor for electronic execution. No paper should ever be needed and as a part 11/ Annex 11 system it should capture the users e-signature with the recorded results/tests. Non-conformances shall be easy to document and process and shall be permanently linked to the test data/test case etc.
A final report shall be auto generated and should be configurable to include a summary of all executed tests and non-conformances. All aspects of the process shall be configurable to meet the varying needs of the industry.
The process should be managed in a central web based application. QA can access and view any record in real time even as the record is being executed on the shop floor. Any report is instantly available on any aspect of the changeover process.
Kneat develops and markets the leading edge Kneat Gx software platform. Kneat Gx is an e-Validation tool which enables the Life Sciences industry to become fully electronic with their many Validation and testing processes. The system is proven to scale globally and delivers productivity increases of more than 100%, cycle time reductions of up to 60% and a higher repeatable compliance standard. A key feature of the tool is that it does not restrict the user to a specific process rather the user can quickly configure his process in the system.
Customers are streamlining and automating all Validations (Process, Equipment, Computer, Cleaning, Laboratory etc.), Commissioning & Qualification, Product Changeover Management, Automation Lifecycle Management, Vendor & Project Turnover Management and more.
For more information, please visit www.kneat.com.