Pharmaceutical Instrument Qualification
Accurate. Traceable. Compliant.
Pharmaceutical and biopharmaceutical manufacturing is tightly regulated, to ensure product safety. Manufacturers seek to operate in a fully qualified environment, with validated processes.
For business reasons, time- and cost-efficient qualification and validation protocols must be balanced against the intensive, in-depth, comprehensive, and of course fully traceable efforts involved. The current trend is to focus on single-test approaches, employing tests and evaluations that are as safe, effective, and efficient as possible.
To support your compliance and traceability needs, Anton Paar offers more than 80 instrument-specific qualification packages as well as qualified installation support. This qualification service reduces the work required by your in-house personnel to make your new instrument ready for routine operation by 60 % - 70 %.
The packages go significantly beyond simple installation: they’re prepared individually for every system, and include all required documents for complying with relevant regulations.
Working in a regulated industry requires compliance to strict regulations, full traceability of all your actions, systems, and processes in your environment, expert know-how to perform all needed steps in a detailed and efficient way, and the overcoming of other demanding challenges. Below, you can find a full list of the Anton Paar services that let you successfully complete these tasks comprising detailed information about our qualification documents, our qualification services and processes, how to prepare for an audit, and information about our lab execution software AP Connect Pharma.
More than the sum of their pages, Anton Paar qualification documents are designed according to regulatory standards, and help avoid risks and non-compliance. With the in-depth knowledge and experience from the experts for your instrument, these are the basis for your validated measurement protocols and processes.
Comprehensive chapters also cover electronic signatures and validation of software used. Seamlessly integrated in your own qualification process, you save valuable time, and attain system productivity quicker.
This and follow-up documents for regular service and maintenance activities ensure the instrument, the measurements it performs, and the method fit its intended analytical purpose over the complete usage life-cycle.
Clear risk assessment to avoid non-compliance
Instrument qualification and method validation can take a lot of time and cost a lot of money. Detailed risk analysis, performed by experts, in the design qualification part of an Anton Paar qualification document lists an extensive list of risks as well as measures to prevent them. There is no need to perform basic risk analysis on the actual device or system yourself, saving your qualification team time for the specific analysis in your environment.
Crucial but time-consuming instrument and software qualification
To fulfill regulatory requirements, all instruments, equipment, and software used in your lab/company/production need to be thoroughly qualified. This process usually costs a lot of money and takes a lot of time, sometimes even months. The combination of qualification documents and execution through trained and experienced specialists from Anton Paar offer ideal support (covering basic IQ/OQ, performance qualification, detailed risk analysis, deviation lists, traceability matrixes, final qualification reports, documented user training).
Expert equipment know-how
For in-house qualification documents, you have to expend great effort and perform detailed investigations to obtain a complete picture of all system, instrument, and device specifications. Avoiding significant consultant costs, the combination of Anton Paar qualification packages and services offers the most detailed insight for your own, highly efficient documentation and qualification processes. Reduce your efforts in achieving productive operation and focus on the parts that are specific for your measurement challenge.
Basis for validated system use – the instrument SOP
It’s not only the qualified instrument that needs to be validated. So do all processes and methods in a user's laboratory. Writing the SOP for each of the methods and handling steps is one of the most time-consuming and cost-driven parts of the whole qualification process. Each Anton Paar qualification package comes with a set of important documents; a time-saving customizable SOP template is one of them – you don’t have to create one on your own.
Computer System Validation (CSV) as part of the package
For any device or system involving software, computer system validation (CSV) has to be performed during qualification. Pharma qualification documents from Anton Paar include steps to qualify the embedded software on instruments and systems involving desktop control software for the instruments. When it comes to qualification of the Anton Paar lab execution software AP Connect Pharma, a complete validation package is also available, which covers all the necessary steps to complete CSV.
21 CFR Part 11 compliance
User identification and electronic signatures in systems need to be FDA 21 CFR Part 11-compliant, and this must be documented for each system that is applied, or else there could be risks and non-compliance. Compliance of Anton Paar’s solutions for regulated industries is proven during qualification. The AP Connect Pharma edition even allows utilization of Active Directory systems to import users.
Following regulatory guidelines – FDA 4Q model
Anton Paar qualification documents for regulated industries follow the guidelines in <USP 1058>, <USP 1225>, EP Annex 4 Part 11 & PIC/S chapters 5 & 6. They’re designed along the FDA 4Q model, comprising chapters of qualification instructions (QI), design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and finally summarizing everything in a final qualification.
- DQ: As-built specification and risk analysis
- IQ: Detailed individual test points for complete installation and all relevant certificates (e.g. for wetted parts, software certificates, etc.)
- OQ: Detailed protocols of measured reference values with limits, protocols of performed checks and eventual adjustments, and a 21 CFR Part 11 checklist
- PQ: Detailed report of customer samples
Additional chapters in Anton Paar documents:
- FQ: Deviation list and traceability matrix leading to a final qualification report
- QI: Detailed instructions for all qualification steps and test points
No other qualification documentation is as comprehensive as that from Anton Paar. Combined with qualification services, you get the best package available.
Continued productivity – GMP-compliant service activities
Qualification and validation are not a one-time process: After initial installation, there is an instrument life-cycle approach. The instrument must retain the qualified-and-validated status every year. Anton Paar’s tailored requalification maintains a device or system's qualification status and therefore its productivity over the whole instrument lifetime.
You receive a high-performing, comprehensive package. Industry-leading scope combined with specialist knowledge will have your Anton Paar instrument in operation quicker – user training, proof of performance for certified standards and your own sample included. You’ll have the best solution: a qualified system from beginning to end.
More than regular installation
Many vendors provide a regular IQ/OQ, often claiming it is compliant to pharma-industry regulations. The content and degree of details varies and doesn’t always satisfy the expectations of regulated industry. Anton Paar's qualification documents were designed with stringent pharma-industry regulations and expectations in mind. The whole qualification process is supported by Anton Paar’s pharma experts, plus, each package follows the FDA 4Q model (see “Following regulatory guidelines – FDA 4Q model ”).
User training included
User responsibility and user authorizations to perform certain tasks according to validated process steps, measurement methods, and standard operation protocols are important. Accordingly, trained users and administrators are a requirement for regulated industries and a common check point during audits. During each device qualification a user training, adapted to the specific needs of the respective user group, is performed, and clearly documented in the protocol, establishing a line of responsibility for system and instrument operation, management, and configuration.
Instrument calibration and proof of specification (with traceable standards)
Qualified and documented installation is good, but instrument performance needs to be proofed with traceable standards. In the operational qualification chapter certified reference material is used to assure correct instrument function. This is done through clear check procedures. The standards available for such actions can be provided from traceable sources. For some parameters, Anton Paar is itself ISO 17025-certified. So be sure that your instrument measures correctly with reference values that are traceable back to official reference institutions.
Sample feasibility check
Once it is established that the instrument measures a standard correctly, it needs to be proven that it also performs measurements with the intended samples, not exceeding the internal and/or external quality limits. The performance qualification chapter of the documentation is dedicated to precisely this purpose. The measurement of customer samples can be performed in the qualification process by a trained Anton Paar engineer, or without Anton Paar staff present, on request.
Qualified system from instrument to results, data management, and review
All your operations have to be validated and all systems used for these need to be qualified, which is crucial for business in regulated industries. Anton Paar provides qualification documents for every step of the way – from installation to use of one of our measuring instruments. The combination of Anton Paar instruments, software packages, and qualification documents ensure you have an entirely qualified environment at every stage of the process.
Our solutions are proven and ready when needed – no matter if for internal purposes or an external regulatory audit.
All points and chapters are signed off via a six-eye principle and the key facts are summed up at the front of the documentation. This allows you to easily provide information, reduce questions, diminish the effort required for proof, and focus on other topics related to the inspections.
Step-by-step, to full documentation
Traceability of every action performed is ultimately the most critical point in any regulated environment. Each step of an instrument or software qualification process needs to be defined and documented. This is especially important for internal and external audits. With Anton Paar’s qualification documents and trained field staff, there is a clear chain of traceability from instrument delivery to regular operation, in alignment with customer expectations.
Ready for the audit at any time – system status at a glance
Part of internal and external audits can always be checks of the qualification status of each individual system in laboratories. To avoid problems during these activities, all relevant information about a system and its status needs to be available quickly. 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 Anton Paar qualification documents. Plus, our services prevent investigations and minimize the effort involved in providing responses and data to other audit inquiries.
Streamline your data flow and fulfill all your data integrity requirements with Anton Paar’s lab execution software AP Connect Pharma: Go paperless. Eliminate transcription errors. Set up approval processes. Ensure the security of the system by assigning dedicated permissions, to determine who can do what. Use your company-wide user management system, and your user rules. Centralize your lab data with storage of tens of thousands of measurements and audit trail entries from all connected instruments in a single digital space, and tap into it whenever you want.
With the AP Connect Pharma edition your data is available at a snap, and it’s accessible from any computer in your network. Configure automatic exports according to your needs and ensure a fast and error-free transfer of your laboratory data into your data management system.
Data and metadata in one place
Data and metadata from different labs and production points can be difficult to access – if they are properly recorded at all. This task becomes even harder if more parameters and instruments are involved. The AP Connect Pharma edition collects all data, metadata (e.g. pictures of filled measuring cells), and the audit trail of each connected instrument in a single database. Remote access is possible. Requests for audit data can be fulfilled simply on-the-spot, allowing you to focus on the more important parts of your audit.
Traceability of changes – simple deviation detection
Changes in measurement or instrument settings need to be easily traceable to detect out-of-specification results, wrongly performed measurements, or incorrect settings. Not being able to detect these can lead to delays in production and quality control as well as batch release, which translates into effort and costs related to investigation and rectification. The combination of instrument features and the AP Connect Pharma edition allows full review of data and events.
Customized remote review and approval
In regulated environments, it is all about a four- or six-eye principle for review, approval, and the establishment of a chain of responsibility. These processes have to comply with ALCOA+ principles on data integrity and 21 CFR Part 11. But the exact details are different from plant to plant and need to be customizable. The AP Connect Pharma edition facilitates simple and efficient review possibilities throughout the complete production life cycle. Based on the user’s needs and policies, and according to GMP guidelines it helps you to keep track of every step in your process.
Connectivity to other computer systems
A single database for a group of instruments is not where all your production and analytical data are ultimately going to be stored. The AP Connect Pharma edition allows simple and automatic export of data to your central data repository for all instruments and machines. Of course, the data transfer from the connected and compatible instruments into AP Connect is also validated. Thus, measurement results are in the systems they need to be in.