Manufacturing Advanced
ssuring time- and cost-efficient compliance and traceability – crucial to the delivery of safe, high-quality products – is a turn-key challenge in the tightly regulated pharmaceutical and biopharmaceutical industry. Anton Paar’s 80+ instrument- specific qualification packages, along with qualified installation support, deliver a fully qualified analytical environment and reduce in-house personnel work to prepare new instruments for routine operation by 60% to 70%. The packages go significantly beyond simple installation; they’re prepared individually for every system.
instrumentation services A
AP Connect Pharma User training is provided for each new device.
Package highlights Qualification documents The combination of qualification documents and execution by Anton Paar specialists covers more than a basic IQ/OQ. A detailed risk analysis, a performance qualification, a traceability matrix, and a final qualification report increases the value of the qualification package for the whole process for the customer. If needed, 21 CFR Part 11 compliance is proven during qualification. Plus, each Anton Paar qualification package comes with a customisable SOP template as base for the customer’s own SOP. Overall, the documents used can fully and seamlessly be integrated into the user’s own qualification process, and comply with USP 1058, USP 1225, and EP Annex 4 Part 11 & PIC/S chapters five and six. Tailored requalification maintains an instrument or system’s qualification status – and thus its productivity – over the whole instrument lifetime.
Qualification services and processes Anton Paar’s qualification documents are designed with stringent pharmaceutical industry regulations in mind. The actual qualification process is supported by Anton
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Paar’s pharma experts. Each package follows the FDA 4Q model, but it provides even more content. During each device qualification, there is user training, adapted to the specific needs of each user group and clearly documented in the protocol, which establishes a line of responsibility for system and instrument operation, management, and configuration.
A complete validation package is also available for AP Connect Pharma, which is the pharma edition of Anton Paar’s lab execution software, AP Connect. AP Connect Pharma streamlines data flows, fulfills data integrity requirements, eliminates transcription errors, sets up approval processes, and ensures the security of the system by assigning dedicated permissions, to determine who can do what – all within a company-wide user management system, and user rules. Tens of thousands of measurements and audit trail entries from all connected instruments can be stored in a single
“Anton Paar continues its mission to serve customers with the most advanced instrumentation and services through seamless collaboration and a trustworthy partnership.”
In the operational qualification chapter, certified reference material is used to assure correct instrument function. In the performance qualification chapter, test points using customer samples continue to assure that the actual life samples can be safely measured.
Audit readiness
All points and chapters are signed off via a six-eye principle, and the key facts are summed up at the front of the
digital space, accessible at any time, from any computer in the network. With 80+ instrument-specific qualification packages, along with qualified installation support, Anton Paar continues its mission to serve customers with the most advanced instrumentation and services through seamless collaboration and a consistently trustworthy partnership. ●
www.anton-paar.com World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
Anton Paar’s pharmaceutical instrument qualification packages provide a high-quality, analytical environment for clients and reduce the need for in-house personnel.
documentation. There is a clear chain of traceability from instrument delivery to regular operation. Anton Paar’s qualification documentation contains a final qualification report, the adjoint deviation list, and the traceability matrix. Thousands of qualified instruments have passed audits with the company’s qualification documents.
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