Handbook of Process Chromatography 2nd Edition: Development, Manufacturing, Validation and Economics


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Designees could be, for example, vendor representatives. If a system is comprised of several modules, it is recommended to perform system tests holistic testing , rather than performing tests module by module modular testing. Individual module tests should be performed as part of the diagnosis if the system fails. If a laboratory uses the same type of instruments from different vendors, it is more efficient to use the same test procedures for all instruments than to use different ones for different vendor instruments.

We also recommend using the same test procedure for a specific instrument throughout the company, independent from the location. This allows comparing instrument performance across the company and facilitates exchange of instruments and analytical methods. The frequency of OQ depends on the type of instrument, on the stability of the performance characteristics, but also on the specified acceptance criteria. In general, the time intervals should be selected so that the probability is high that all parameters are still within the operational specifications.

Otherwise, analytical results obtained with that particular instrument are questionable. Here the importance of proper selection of the procedures and acceptance limits becomes very apparent. Inspectors expect OQ tests to be quantitative. This means that the test protocol should include expected results and actual results. Figure 13 includes an example for recording of test results of a balance. The header includes three control weights and acceptable limits for the weight. The daily protocol records actual weights and the name and signature of the test person. Important for consistent instrument performance are regular preventive maintenance, making changes to a system in a controlled manner and regular testing.

The PQ test frequency is much higher than for OQ. Another difference is that PQ should always be performed under conditions that are similar to routine sample analysis. For a chromatograph system this means using the same column, the same analysis conditions and the same or similar test compounds. PQ should be performed on a daily basis or whenever the instrument is used. The test frequency depends on the criticality of the tests, on the ruggedness of the instrument and on everything in the system that may contribute to the reliability of analysis results.

In practice, PQ testing can mean system suitability testing or the analysis of quality control samples. For example, a well characterized standard can be injected 5 or 6 times and the standard deviation of amounts is then compared with a predefined value. For ongoing quality control checks samples with known amounts are interspersed among actual samples at intervals determined by the total number of samples, the stability of the system and the specified precision. The advantage of this procedure is that quantitative system performance is measured more or less concurrently with sample analyses under conditions that are very close to the actual application.

Figure 14 shows a template with examples for a PQ test protocol. Analytical instruments should be well maintained to ensure proper ongoing performance. Procedures should be in place for regular preventive maintenance of hardware to detect and fix problems before they can have a negative impact on analytical data. The procedure should describe:. Planned maintenance activities should follow a documented instrument maintenance plan.

Some vendors offer maintenance contracts with services for preventive maintenance at scheduled time intervals.

A set of diagnostic procedures is performed and critical parts are replaced to ensure ongoing reliable system uptime. Unplanned activities that are necessary in addition to the planned activities should be formally requested by the user of the instrument or by the person who is responsible for the instrument. An example of a request form is shown in figure The reason for the requested maintenance should be entered as well as a priority. A template with examples is shown in figure Defective instruments should be either removed from the laboratory area or clearly labeled as being defective.

Procedures should be available for most common problems such as defective UV detector lamps. Procedures should also include information if and what type of requalification is required. Uncommon problems, for example, if an HPLC pump becomes defect without any obvious reason, should be handled through a special procedure that guides users of instruments through the repair process and reinstallation. In this case the impact of the failure on previously generated data should be evaluated.

Analytical instruments and systems go through many changes during their lifetime. New hardware modules may be added to enhance functionality, for example, an automated sampling system replaces a manual one for unattended operation. Vendors may change the firmware to a new revision to remove software errors or application software may be upgraded to be compatible with a new operating system.

Or a complete system is moved to a newly designed laboratory. Some changes are also initiated when new technologies are introduced, for example, a standard HPLC pump is replaced by a rapid resolution pump for higher sample throughput. Any changes to instrument hardware, firmware and software should follow written procedures and be documented. Before any change request is approved, business benefits should be compared with the risks a change may bring. USP also recommends following the same 4Q model for changes as for initial qualifications. This means:.

Before any change is approved and implemented a thorough evaluation should be made if OQ tests should be repeated. Depending on the change, an instrument may need no, partial or full testing of a system. Validation of software and computer systems follows the same principle as the qualification of instrument hardware. Software is divided into three categories.

Indeed the qualification of hardware is not possible without operating its firmware. No separate on-site qualification of the firmware is needed. For software categories two and three the chapter refers to the 4Q activities and recommends the FDA guide on software validation for more detail7. In general, the effort to validate a computer system is higher than for instrument hardware. The main reason is that software offers more and more functionality.

All software functions with high impact on drug or API quality should be validated. This chapter will go into more detail on what is important for validation of software and computer systems. We will follow the same 4Q Lifecycle model as for instrument hardware.

The main focus is on relatively small and less complex software and computer systems. As a model we will use a chromatographic data system CDS with no or little customization. For more complex systems, for systems with high level of customization and for any software development activities, we refer to literature references with more detail, for example, references Software and computer system validation should be well planned.

A computer system validation master plan should not only describe validation approaches but should also have an appendix with a list of all computer systems used in a laboratory. Typically, inspectors ask for a list when inspecting data that have been generated by a computer system. The list should uniquely identify all computer systems. It should include a short description of the system and information on the location, the application and whether the system is used in regulated areas. Inspectors also will ask for the risk category of the system. The risk categories can be, for example, high, medium or low.

The categories should have been determined following a documented process and should be justified. Criteria are complexity and impact of the system on drug product quality. Most likely the inspector will focus during the inspection on systems that have been classified as high risk. Figure 17 shows a template with examples on how to document a computer system inventory. The list should also include information on the state of validation. Non-validated systems should have a timeframe for system validation.

Now the importance of the risk category becomes obvious: Non-validated systems classified as high risk must not be used for any regulated work. The content items of project plans for computer systems are similar to equipment hardware.

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However, because of a higher complexity and higher validation effort, the document is longer. For practical reasons table templates will not work well. Longer project plans are written in text form and a hyperlinked table of contents will help to find individual sections. Project plans should have a section on risk assessment. It should describe how risk assessment is planned and documented and what risk levels mean for the extent of validation.

Requirement specifications of software and computer systems should be linked to test cases in some kind of traceability matrix. This can be a table on its own or the link can be built into the requirements table. Each specification should have a unique ID code. Criticality of the function can be defined as high, medium or low. Most important questions to ask are: what happens if the function does not work at all or if it produces wrong results? In the next column the test priority is documented. Figure Example for requirement specifications of a chromatographic data system.

Requirements of a CDS should not only be specified on the ability to run a chromatographic analysis, but also on other requirements that are mainly related to system and data security, and data integrity. Very important is the electronic audit trail function. Selected specifications for audit trail functionality are shown in figure A thorough vendor assessment is even more important for computer systems than it is for instrument hardware.

When instrument hardware arrives in a laboratory it can be physically inspected for any damage and specifications can be fully tested so users can get a good impression of the quality. This is not so easy with software. DVD covers always look very nice but they say nothing about the quality of the product. Also most likely it is impossible for a user to test all functions of a complex commercial computer system. Errors may not even become obvious during initial use, but only later when certain functions are executed together. During vendor assessment, the user should verify that the software has been designed, developed and validated during and at the end of development.

Figure 20 lists different assessment methodologies. Costs for the assessment increase from 1 to 5. Vendor audits are most expensive but could make sense when a company plans to purchase complex computer systems for multiple laboratories or sites. The final decision on the methodology should be based on risk assessment. Criteria are vendor risk and product risk. When users purchase software such as CDS they need support from a specific vendor for a lengthy time to ensure retrieval and readability of data for several years.

Therefore, the future outlook of a company and the ability to support data is important. The way to make an assessment is to look for how long older data can be supported by the current system. This in combination with the size of the company and the position of the company in the target market are good indications to assess the vendor risk. The selection decision for a specific vendor should be justified and documented.

Key points for IQ of computer systems are to verify correct software installation and to document all computer hardware, software and configuration settings as the initial baseline configuration. Recommended steps for installation of computer systems include:. Information should be entered into a data base and should be readily available when contacting vendors to report a problem during operation. Figure 21 shows a template with examples of an installation protocol. Testing software and computer systems can be a complex task.

Extent of testing should be based on a justified and documented risk assessment.

The required effort mainly depends on:. Most extensive tests are necessary if the system has been developed for a specific user. In this case the user should test all functions. For commercial off-the-shelf systems that come with a validation certificate, only tests should be done of functions that are highly critical for the operation or that can be influenced by the environment. Examples are data acquisition over relatively long distances from analytical instruments at high acquisition rates. Specific user configurations should be documented and tested, for example, correct settings of network IP addresses should be verified through connectivity testing.

When computer systems can control and obtain data from multiple analytical instruments, tests should be conducted with a high number of instruments transmitting data. The example in figure 22 illustrates that, according to specifications, 4 instruments can be controlled. Correct functioning of the system should be verified with all four instruments connected and delivering data at high acquisition rates. Test results should be formally documented. Figure 23 shows a template and examples for a test protocol. It consists of three parts.

The header describes the test system, test objective and the specification. The step - by - step test procedure, expected results and actual results are documented in the middle. The test protocol also has a column to document evidence of testing. This can be a print out, a screen capture or just handwritten recording of visual observations. The lower part documents the names of the test engineer and reviewer and has s signature section. For a computerized analytical system this can mean, for example, running system suitability testing, where critical key system performance characteristics are measured and compared with documented, preset limits.

Most efficient is to use software for automated regression testing. The software runs typical data sets through a series of applications and calculates and stores the final result using processing parameters as defined by the user. During regression testing the data are processed again and results are compared with previously recorded results. The purpose of configuration management is to be aware of the lifetime composition of the system from planning to retirement.

The initial or baseline configuration of a system has been documented as part of IQ. Any changes to specifications, programming codes or the initial set up of computer hardware should follow written change control procedures and be documented. Changes may be initiated because errors have been found in the program or because additional or different software functions or hardware may be desirable. Figure 24 shows a form that can be used to request changes.

The form should include information on the priority and on business benefits versus costs for additional validation tasks. This information is important to assess if the change has a business advantage and should be approved or rejected. The form should also include information about whether regulatory notification is required and the roll back plan.

A roll back plan is like a contingency plan that becomes effective when a change introduces an error, which causes the system to fail. The roll back plan ensures that the system can be brought back to the last working system configuration. At the end of validation, a summary report should be developed. This should be a mirror of the validation project plan. It should be organized in such a way that it has all the elements and follows the outline of the validation plan. This makes it easy to check if all plan items have been completed successfully.

The report should include a statement that the instrument or system is qualified or validated. After the statement and the report have been signed by management, the product can be released for operation. Typically, the validation plan and the report are the first documents inspectors want to see when they inspect a validation project. If everything is well organized and documented, it may well be that after looking at both documents inspectors get such a good impression about the validation work that they will focus on other inspection areas. It frequently happens that existing instruments and systems are not formally validated if they are not used in a regulated environment.

Sometimes these systems are called legacy systems. They should be validated if they will be used in a regulated environment, a process called retrospective validation.

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Inspectors expect the same documented evidence that the system is suitable for its intended use as for new systems. We recommend following the same 4Q model for validation as for new systems. The main difference is in the DQ phase. Most likely there is not much information from the vendor available and vendors cannot be assessed. There is also no need to develop requirement specifications from scratch. The big advantage of an existing system is that there is a lot of information from past use and the used functions are well known. The most important task for an existing system is to document the system functions used along with any comments about problems with the functions.

The system should be fully documented for IQ, like a new system. OQ and PQ testing should focus on functions that caused problems in the past. After successful OQ and PQ testing, a summary report should be developed and signed by management. This means the system can be released for use in a regulated environment. Spreadsheets are widely used in laboratories for data capture, data evaluation and report generation.

For example, they can be used to correlate data from a single sample analyzed on different instruments and to obtain long-term statistical information for a single sample type. The processes may be automated, for example, enabling the analytical data to be transferred, evaluated and reported automatically. In all of these programs, analytical data are converted using mathematical formulae. MS Excel. What should be validated are the custom calculations and program steps written by the laboratory.

There should be some documentation on what the application program, written by the user as an add on to the core software, is supposed to do, who defined and entered the formulae and what the formulae are. Development and validation of spreadsheets should follow a standard operating procedure. Recommended steps are:.

Even though as a chapter with a number above , generally, it is not mandated and alternative approaches are possible. Nevertheless, we would recommend implementing it for FDA regulated environments because of several reasons. Analytical laboratories typically include a set of tools ranging from simple nitrogen evaporators to complex automated instruments. Depending on the complexity, the qualification efforts vary. The concept is always the same, but the extent of testing and the required amount of documentation will change. For example, a very simple instrument may only need one or two minutes for physical inspection and making a tick mark in a check list, while more complex systems can easily take several days for full validation.

Because of the large variety of instruments, with different qualification and documentation requirements, it can be very complicated if each type of instrument is handled differently. To simplify the process, USP recommends dividing all instruments into three groups A, B, and C and to define for each group a specific set of qualification tasks. The standard lists examples for each group but at the same time makes it clear that the categories are not only instrument but also applications specific.

Examples for all three groups are shown in figure Group A includes standard equipment with no measurement capability. Examples are nitrogen evaporators, magnetic stirrers, vortex mixers and centrifuges. Group B includes standard equipment and instruments providing measure values, for example, a balance. This group also includes equipment controlling physical parameters, such temperature, pressure or flow. Examples are water baths and ovens. Group C includes instruments and computerized analytical systems. USP recommends dividing analytical instruments into groups, but does not include a matrix with instruments allocated to groups.

On the other hand such a matrix is of utmost importance for a company; otherwise discussions will start over and over again about the right allocation whenever an instrument has to be qualified. Our recommendations are:. Within a company the lists, procedures and tasks for groups A, B, and C should be developed at the highest possible level; and preferably there should only be one set available.

Having a harmonized approach reduces subjectivity for qualification and it is not only very efficient but also ensures consistency. We would suggest putting examples of instrument categories and applications in an equipment validation master plan. A harmonized approach is also advantageous for external audits or inspections, especially when several laboratories are inspected by the same inspector in the same time frame.

The number of procedures required increases from groups A to C. Each company should have a document that specifies which type of procedures should be developed. A template with examples is shown in Figure The point here is not to exactly follow the examples, and this list does not originate from the USP, but it is very important to have a list available within an organization.

The number of documents increases from A to C. An operating instruction and a procedure for reporting problems are enough for group A devices. Group B requires additional procedures for qualification, change control and preventive maintenance and repair. Additional procedures for group C are specific to computer systems, for example, back-up, security, and system administration. A company should also provide information on which qualification steps should be executed.

An example is shown in figure Some recommendations are from the USP chapter. This means a simple checklist can be enough for documentation. The difference between B and C are mainly in areas of vendor qualification and risk assessment. For computerized systems in C we should have a vendor assessment program. Risk assessment is also recommended for C. The number of required documents for B and C does not vary much. However, the size of the documents and the format will be different. For example, a qualification plan in B can be documented on a one or two-page template. For C this could be easily a 20 page text document.

People should receive training on the USP chapter, on why the company decided to implement the chapter and what it means for day-to-day operation.

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The training should be documented and supervisors should follow-up to verify effectiveness. Vendors should also be informed about implementation of USP and they should be advised to study the chapter and follow-up to fulfill vendor requirements. Users of analytical equipment have the ultimate responsibility for instrument operations and data quality. It is an FDA GMP requirement that analysts must sign the analytical test result and therefore also have the ultimate responsibility to make sure instruments and computer systems are qualified and validated. Training can be provided by anybody who is proven to be competent, for example by vendor representations, 3rd parties and by internal resources.

The fact that users have ultimate responsibilities for instrument qualification does not mean that they have to conduct all qualification activities. For example, IQ and OQ can be delegated to the instrument vendors or to a 3rd party organization. On the other hand PQ should be performed by users because the tests are applications specific and require a good knowledge of the application.

Vendors with worldwide presence typically also offer qualification services around the globe. This is important for companies operating in multinational environments. Whoever is doing the qualification work should be trained and training certificates should be filed with the qualification documents. The role of the Quality Assurance unit is the same as for any other regulated activity.

QA personnel are responsible for assuring that the qualification process meets compliance requirements and conforms to internal procedures. QA personnel should also train or advise user groups on regulations and lead or help with the vendor assessment process. Developers and manufacturers are responsible for the design of the instrument or software program and for providing specifications to the user. They should validate processes used in development and manufacturing as well as during the entire support period.

Manufacturers should allow user audits and share validation processes, test procedures and test results with regulated users. Furthermore, manufacturers or vendors should provide user training, installation and qualification support and repair services. A good relationship with industry and FDA has always been my highest priority.

Most issues between industry and FDA can be resolved by having a good understanding of each others position. The examples below show interactions with the FDA. Audio Seminars. Video Seminars. Validation Examples. Free Literature. Risk Management Practices. Computer Validation. Method Validation. ISO Lab Equipment Qualification. Good Laboratory Practices. About Labcompliance. Contact Labcompliance. Ludwig Huber 1. Introduction The objective of any chemical analytical measurement is to get consistent, reliable and accurate data.

It covers: Literature overview with milestones on instrument qualification and system validation in laboratories. Overview on regulations and quality standards with impact on analytical instrument qualification. Qualification of equipment hardware, for example, a spectrometer or liquid chromatograph. Validation of analytical computerized systems. Literature Overview Due to their importance, equipment qualification issues have been addressed by several organizations.

In addition, private authors published reference books with practical recommendations for implementation: The Pharmaceutical Analysis Science Group UK developed a position paper on the qualification of analytical equipment 6. This paper was a benchmark because it introduced the 4Q model with design qualification DQ , installation qualification IQ , operational qualification OQ and performance qualification PQ for analytical equipment qualification.

The Laboratory of the Government Chemist LGC and Eurachem-UK, developed a guidance document with definitions and step-by-step instructions for equipment qualification 3. These guides have been specifically developed for computer systems in general, and because of their importance have also been used for validation of laboratory systems. It recommends validation activities and procedures for seven different instrument categories.

The first one covers all validation aspects of an analytical laboratory including equipment, analytical methods, reference compounds and people qualification. The second one covers the validation of computerized and networked systems in analytical laboratories.


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The Parenteral Drug Association PDA developed a technical paper on the validation of laboratory data acquisition system Coombes authored a book on laboratory systems validation testing and practice 4. This book has several chapters with practical recommendations for instrument qualification. This document has been written by inspectors for inspectors as a guide to inspect computerized systems. All these guidelines and publications follow a couple of principles: Qualification of equipment and validation of computer systems are not one time events.

They start with the definition of the product or project and setting user requirement specifications and cover the vendor selection process, installation, initial operation, ongoing use and change control. All publications refer to some kind of life cycle model with a formal change control procedure being an important part of the whole process.

Terminology: Validation vs. Qualification An agreement on terminology is of utmost importance for a common understanding of validation and qualification. Figure 1. Components of analytical data quality Whether you validate methods or systems, verify the suitability of a system for its intended use or analyze quality control samples, you should always qualify the instrument first. Regulations and Quality Standards Qualification of instruments and validation of systems is a requirement of the FDA and equivalent international regulations.

Warning letters are published on the FDA website The only problem is that there are thousands of them and they mostly relate to marketing and labeling, so it is difficult to find the ones that are of interest to laboratories. Good Laboratory Practice Regulations Good laboratory practice GLP regulations deal with the organization, processes and conditions under which preclinical laboratory studies are planned, performed, monitored, recorded and reported. Written records shall be maintained on all inspection operations. The GLP principles of the OECD include similar but shorter sections on equipment 17 : The apparatus used for the generation of data and for controlling environmental factors relevant to the study should be suitably located and of appropriate design and adequate capacity.

Apparatus and materials used in a study should be periodically inspected, cleaned, maintained, and calibrated according to Standard Operating Procedures. Records of procedures should be maintained. Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used. Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance.

Written records of those calibration checks and inspections shall be maintained. International Conference for Harmonization The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industries in the three regions to discuss scientific and technical aspects of product registration.

Records of these calibrations should be maintained. The current calibration status of critical equipment should be known and verifiable. Instruments that do not meet calibration criteria should not be used. Deviations from approved standards of calibration on critical instruments should be investigated to determine if these could have had an impact on the quality of the intermediate s or API s manufactured using this equipment since the last successful calibration. GMP related computerized systems should be validated.

The depth and scope of validation depends on the diversity, complexity and criticality of the computerized application. Appropriate installation qualification and operational qualification should demonstrate the suitability of computer hardware and software to perform assigned tasks. The validation documentation should cover all the steps of the lifecycle with appropriate methods for measurement and reporting, e.

Handbook of Process Chromatography A Guide to Optimization, Scale Up, and Validation

Regulated users should be able to justify and defend their standards, protocols, acceptance criteria, procedures and records in the light of their own documented risk and complexity assessment. Calibration programs shall be established for key quantities or values of the instruments, where these properties have a significant effect on the results. Before being placed into service, equipment including that used for sampling shall be calibrated or checked to establish that it meets the laboratory's specification requirements and complies with the relevant standard specifications.

Each item of equipment and its software used for testing and calibration and significant to the result shall, when practicable, be uniquely identified. Equipment that has been subjected to overloading or mishandling, gives suspect results, or has been shown to be defective or outside specified limits, shall be taken out of service. Chapter 10 a states: Computer systems should be validated to ensure accuracy, reliability and consistent intended performance.

There is no further instruction on how computer systems should be validated. Learning from Regulations and Quality Standards As we have seen in this chapter, all important regulations and ISO have one or more chapters on equipment and computers. This means users should: Define the intended use, meaning write specifications.

Formally document installation. ICH Q7A calls this installation qualification. Verify ongoing performance through ongoing preventive maintenance system tests. Keep instruments under change control to ensure that the validated state is ensured after changes. Qualification of Analytical Instruments Equipment qualification and validation of computerized systems cover the entire life of a product.

Figure 2. Your name. Your email. Send Cancel. Check system status. Toggle navigation Menu. Name of resource. Problem URL. Describe the connection issue. SearchWorks Catalog Stanford Libraries. Handbook of process chromatography [electronic resource] : development, manufacturing, validation and economics. Edition 2nd ed. Physical description xvi, p. Online Available online. More options. Find it at other libraries via WorldCat Limited preview.

Sofer, G. ScienceDirect Online service. Bibliography Includes bibliographical references and index.

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Contents Preface Acknowledgements 1. Biopharmaceuticals Today 2. Process Capability and Production Scenarios 3. Process Design Concepts 4. Separation Technologies 5. Analysis 6. Cleaning and Sanitization 7.

Handbook of Process Chromatography 2nd Edition: Development, Manufacturing, Validation and Economics Handbook of Process Chromatography 2nd Edition: Development, Manufacturing, Validation and Economics
Handbook of Process Chromatography 2nd Edition: Development, Manufacturing, Validation and Economics Handbook of Process Chromatography 2nd Edition: Development, Manufacturing, Validation and Economics
Handbook of Process Chromatography 2nd Edition: Development, Manufacturing, Validation and Economics Handbook of Process Chromatography 2nd Edition: Development, Manufacturing, Validation and Economics
Handbook of Process Chromatography 2nd Edition: Development, Manufacturing, Validation and Economics Handbook of Process Chromatography 2nd Edition: Development, Manufacturing, Validation and Economics
Handbook of Process Chromatography 2nd Edition: Development, Manufacturing, Validation and Economics Handbook of Process Chromatography 2nd Edition: Development, Manufacturing, Validation and Economics
Handbook of Process Chromatography 2nd Edition: Development, Manufacturing, Validation and Economics Handbook of Process Chromatography 2nd Edition: Development, Manufacturing, Validation and Economics

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