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Achieving Complete and Cost-Effective Regulatory Compliance for Molecular Spectroscopy Systems
Achieving Complete and Cost-Effective Regulatory Compliance for Molecular Spectroscopy Systems
by Mike Garry, Product Manager Spectroscopy Software and Compliance Products, Thermo Fisher Scientific
Regulatory compliance for molecular spectroscopy systems is essential but the complex processes involved can often lead to misconceptions about specific compliance requirements. Recent research has shown that with the involvement of the instrument vendor, companies can substantially reduce the overall cost of regulatory compliance and compress the entire process by as much as 75%.
Regulations
The standards set for spectrometers are often developed by third-party organizations such as ASTM, NIST, and the U.S., European and Japanese Pharmacopeia. However, where guidelines do not already exist, instrument vendors may establish their own. In addition, instruments must comply with the guidelines concerning the environment in which they are used, namely FDA 21 CFR Part 11. These regulations require FDA-regulated industries to implement control processes including regular audits, validation programs, and full documentation of products and systems.
In order to comply with this wide range of regulatory requirements, it is essential that companies using spectroscopy
systems implement a carefully planned compliance program.
Compliance
The term “compliance” refers to the overall process of meeting a set of reg-
ulations or guidance, whether these are government-mandated or self-imposed. Compliance comprises a number of processes, including verification, qualification and validation. These can be carried out in-house or by an external company such as the instrument vendor.
Verification
Verification is an ongoing, important process used to demonstrate that instruments are working correctly. It involves
taking a set of preset measurements on a regular basis to monitor for any changes.
If the measurements exceed the specified acceptance limits, corrections must be
made in order to prevent out-of-specification results. Instrument downtime is minimized because potential problems are detected at an early stage. The process can be adapted to suit moderately to highly regulated environments, where selected qualification tests can be re-run or quality control samples can be measured on a regular basis to ensure optimum instrument performance.
Qualification
Qualification aims to provide assurance that the spectroscopy system will work for its intended purpose. It involves a strict and well-documented evaluation process initially at the time of purchase, often called design qualification (DQ), and again when commissioning the instrument. It comprises a more extensive set of procedures compared to verification. Verification involves checking the system when it is operational, while with qualification the instrument performance is checked and documented at all stages of use.
Where qualification is required, the procedures used are typically based on the installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) models. These involve documenting that the instrument is properly installed and performing to factory specifications. IQ, OQ and PQ tests are more controlled than those used in verification-only environments, being more appropriate for moderately to highly regulated situations.
Validation
Validation is the process of proving and documenting that a spectrometer is appropriate for the intended task. Qualification is typically a step in the validation process. During validation, the installation and operation of the complete spectroscopy system are inspected. Full system validation is an essential part of any compliance program in highly regulated environments helping to achieve compliance with FDA 21 CFR Part 11, FDA CFR Parts 58, 210, 211 and 820 and Eudralex regulations governing medicinal products in the E.U.
Cost Considerations
Source: Choosing the Right Instrument Vendor for Complete, Cost-Effective Spectrometer Compliance, Thermo Fisher Scientific, 2007. Click to enlarge. |
The costs of the compliance program vary depending on the level required. The level, and thus the overall cost, is determined by the degree of regulation (moderate, high or self-imposed) or the criticality of the instrumental measurements being made; the availability and cost-effectiveness of using the company’s human resources to perform the compliance-related tasks; and the degree of compliance expertise of those developing, documenting and performing the necessary activities.
Any compliance program can be broken down into two stages of commissioning and maintenance. Each of these stages involves a separate set of costs (see Table).
A compliance program often contains hidden costs such as the impact on human and instrument resources when compared to the life of the system. These costs can significantly impact profitability for smaller companies, while for larger organizations coordinating compliance
programs involving multiple instruments can lead to increased costs, particularly if instrument procurement and commissioning is not properly managed.
Streamlining Instrument Commissioning
When carried out with the right expertise, instrument validation and commissioning time on new instruments can be cut by up to 75%. This can be achieved by outsourcing compliance program implantation to an instrument vendor with the right knowledge and experience.
First, an instrument vendor’s qualification offering should include:
• Complete documentation for instrument design qualification
• Fully documented procedure with
signoffs for installation qualification and operational qualification for the entire system
• Software and traceable reference materials to complete the qualification and for ongoing performance qualification
• Certified service engineers trained on the technical service and qualification procedures for the specific instrument and software purchased
• Factory certification of instrument
performance results when the system is installed and qualified by company service representatives
These elements will ensure that the qualification will withstand any regulatory and audit challenges, and that the instrument qualification process can be completed in the minimum amount of time. Second, an instrument vendor with regulatory and technical knowledge can streamline the commissioning process. However, time and cost savings can be realized only if the vendor is able to work with the customer in a consultative relationship to tailor the implantation to the customer’s exact needs.
Example
A large biopharmaceutical company had an aggressive time-to-market goal on a newly approved drug of 180 days following approval. In order to accomplish this goal, while achieving compliance with cGMP and 21 CFR Part 11 regulations, the
company needed to streamline its system validation and instrument qualification processes. Although the company had the in-house resources to deal with a compliance program, they chose to outsource it to their instrument supplier, Thermo Fisher Scientific. The company also streamlined the internal paperwork and approval processes by including the equipment, factory qualification and system validation on a single purchase order.
By using Thermo Fisher Scientific to implement these processes, the company was able to save approximately $90,000, as well as cut the instrument commission time by six months. This enabled the company to achieve regulatory compliance while also attaining its self-imposed time-to-market goal. These time and cost savings are expected to continue as new system purchases will fall into the same validation plan.
Conclusion
Achieving compliance for spectroscopy systems can be time-consuming and costly in any
regulated environment. In many cases, the instrument vendor can be a valuable resource when developing and implementing a compliance program.
For more information,
contact Mike Garry at mike.garry@thermofisher.com or by phone at 608-276-6207. For more information about Thermo Scientific compliance and validation products and services, please call 800-532-4752 or E-mail analyze@thermofisher.com.
At A Glance
• In order to comply with regulatory requirements, companies using spectroscopy systems must implement a carefully planned compliance program
• Compliance comprises verification, qualification and validation
• Any compliance program can be broken down into two stages of commissioning and maintenance, each with a separate set of costs
• When carried out with the right expertise, instrument validation and commissioning time on new instruments can be cut by up to 75%
Online
For additional information on the
company discussed in this article,
see Laboratory Equipment
magazine online at www.LaboratoryEquipment.com or
the following Web site:
• www.thermo.com/comply
Laboratory Equipment
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