Pharmaceutical Instrument Qualification

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.

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).

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.

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.

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.

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.

Anton Paar qualification documents for regulated industries follow the guidelines in , , 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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.