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Measurement Good Pract WHO-Computerized syste Countryside For All Observations on PCB As Process Control System Q7a Good Manufacturing Defense Programs Beryl Software Support for M In the first part, I present an overview of the Guide, different approach to life cycle validation and system classification. Over the past years I have not spoken in any great detail about guidance documents on computer validation for chromatographic systems and chromatography data systems CDS but concentrated on a specific topic from the regulations themselves.

This is because most guidance has concentrated largely on computerized manufacturing and corporate systems, rather than laboratory systems.

This will be a two-part discussion of the guide and where we should go to cover adequately both equipment qualification and validation of chromatography-based laboratory systems. Overview of the Guide Published in , the stated aim of the GPG is to develop a rational approach for computerized system validation in the laboratory and provide guidance for strategic and tactical issues in the area. Section 5 of the GPG also notes that " The Guide assumes that these two factors are of equal importance.

Of interest, the inside page of the GPG states that if companies manage their laboratory systems with the principles in the guide there is no guarantee that they will pass an inspection — therefore caveat emptor! The guide consists of a number of chapters and appendices as shown in Table 1. As you can see, the order of some of the chapters is a little strange. For example, why is the validation plan written so late in a life cycle or why is the chapter on training of personnel positioned after the validation report has been written?

However, at least the main computer validation subjects are covered in the whole life cycle including system retirement. PDA Technical Report 18 on validation of computer-related systems that contains a more specific computer validation definition than the FDA process validation definition quoted in Section 3.

Overall, the problem with this GPG is that you have to cherry pick the good bits from the bad. As with any performance appraisal system, let's start with the good news first and work our way downhill afterwards. Unit, module and integration or system testing is conveniently forgotten, ignored totally or implied rather than explicitly stated. The two models illustrated in the laboratory GPG are shown in Figure 1. The left-hand side shows the system development life cycle SDLC that is intended for more complex systems and the righthand side which shows the system implementation life cycle SILC for simpler systems.

This reflects the fact that we can purchase a system, install it and then operate it as shown on the right-hand of Figure 1.

The vast majority of equipment and systems in our laboratories are similar to this, but consider the question: has the SILC oversimplified the implementation process for all spectroscopy and other laboratory computer systems? The argument for the SILC: For most computerized chromatographs and CDS in a postPart 11 world, you will need to add user types and users to the system that will need to be documented for regulatory reasons, for example, authorized users and access levels required by both predicate rules and 21 CFR However, after doing this for simpler systems, such as an integrator, we can go into the performance qualification stage; this is not mentioned specifically in the SILC.

This can be as simple as selecting which function will be used from two or three options or, in more complex systems such as a laboratory information management system LIMS , using a language to set up a laboratory procedure or method. This factor is not accommodated specifically in either of the life cycle models. However, regardless of the approach taken, the system configuration must be documented partly for your business to allow reconfiguration of the system in case of disaster but also for performing the validation.

A macro development. The definitions of the different types of GAMP software are? The SILC for this type of software is shown on the right-hand side of Figure 2 In essence, this is a modification of the GPG implementation cycle where the documentation of security, access control and any other small software configurations for run time operation are substituted for the design qualification.

Once the software functions have been understood, an application configuration specification can be written that will state what functions in the software will be used, turned on, turned off or modified. After the software has been installed and undergone the IQ and operational qualification OQ has been performed, then the software can be configured according to the configuration specification documents.

GAMP 5 software: Although this is usually a unique and custom application. However, in the context of CDS software, this is typically a custom calculation, a macro or custom program that is written to perform a specific function. Here, there needs to be a specification for the macro name plus version number , the calculation or the programming or recording of the macro. Against this will be formal testing to ensure that the functionality works as specified.

Once this has been performed, then the macro is installed with the application and it is tested under the performance qualification PQ phase of validation as an integral part of the overall system. My rationale is that computer validation is considered difficult by some people — therefore conceptual simplicity is a key issue for communication and understanding to ensure that we do not do more than is necessary, dependent on the risk posed by the data generated by a system.

In the words of Albert Einstein: keep it as simple as possible — but no simpler. Don't look for simplicity in certain sections of this guide as it's not there. Do We Validate or Qualify? There is always a debate in the laboratory between qualification or validation of laboratory equipment and computerized systems. Section 3. However, this goes against how the rest of the organization works; it is important to emphasize that laboratories are not unique islands inside an organization — rather they are an integral component of it.

The inclusion of ANY item of laboratory equipment with a computer chip from a pH meter GAMP Category 2 software upwards as a "computerized laboratory system" is wrong, in my view, as it will create much confusion. Especially as it goes against the advice of the GAMP Guide in Appendix M4, which states that the validation approaches for Category 2 systems consist of qualification steps or activities.

Therefore, we now have conflicting guidance from the same organization on the same subject — you can't make this stuff up!

Therefore, let us get the terminology right. These simple principles are easy to grasp and allow any laboratory full flexibility to be made of the risk-based approaches to regulatory compliance.

You do not usually need to do as much work to qualify an instrument for an intended purpose as you would validate a computerized system. In overview, the reason is that typically you'll need to qualify the instrument, as well as validate the software, which implies more work because it's usually a more complex system. Is this separation of "qualify equipment" and "validate systems" too simplistic?

Yes for two reasons: 1. Do we have clear and agreed definitions of "laboratory equipment" and "laboratory system"? Have we forgotten that all CDS have both the instrument equipment and system components computer and training elements? You can't operate the equipment without the system and vice-versa. Therefore, we need an integrated approach to these two issues which will be discussed in part two of this column. The debate is also clouded by the lack of suitable definition of "qualification".

It is a difficult word to define as it is used in a variety of ways such as in design, installation, operational and performance qualification.

A definition for qualification is defined in ICH Q7A GMP for active pharmaceutical ingredients as Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.

So we have a problem. Many suppliers have always performed equipment checks to confirm functionality of their equipment to defined specifications, both prior to and after installation. So for the purposes of our discussion we can start to tease out what a qualification process actually is:? Equipment is specified by the laboratory Installation is properlyundertaken Equipmentworkscorrectly. Therefore, don't forget the impact of calibration: either on a formal basis against traceable standards typically after a chromatograph has been serviced as well as on a regular basis before a system is being used to make a measurement, for example, system suitability test.

This all adds up to scientific-based control of the system, the chromatograph and potentially also a method. The proposed approach in this Guide is that Laboratory Computerized Systems can be assigned a single classification based upon the technical complexity of the system as a whole and risk to data integrity.

This is shown in Figure 3 on the left-hand side. Note, as we have discussed earlier, that more than one class of software can exist in a system; for example, GAMP Categories 1 and 3 for a basic CDS integrator commercial off-the-shelf package running on a PC plus Category 2 firmware within the chromatograph.

In an attempt to be all-encompassing for laboratory systems, the GPG has included ALL instruments, equipment or system with software of any description. Instead of five categories of software, we now have seven Categories A to G. The categories that have been devised for the Laboratory GPG are based on four principles: 1.

Configuration: The software used in the system varies from firmware that cannot be modified, to parameterization of firmware operating functions, proprietary configurable elements up to bespoke software these are encompassed in GAMP version 4 software categories 2—5. Interfaces: From stand-alone instruments to a single interface to another system and through to multiple interfaces to the system. Data processing: From conversion of analogue to digital signals to post-acquisition processing.

Results and data storage: From no data generated to methods, electronic records and post-acquisition processing results. We cannot have an interpreter at the door of the laboratory who interprets the GAMP categories used in the rest of an organization to Lablish Laboratory computerized system validation English.

There needs to be a single, unified approach to computerized system validation throughout an organization at a high level that acknowledges that there will be differences in approach as one gets closer to the individual quality systems, for example, GMP, GLP etc.

To do otherwise is sheer stupidity. Some of the typical systems classified by the GPG are shown in Figure 3 on the right-hand side. In contrast, the left-hand side and centre columns show how systems from the traditional GAMP software categories map to the new GPG categories.

You'll also note that a system can be classified in more than one GPG class depending on the software functions. In devising this classification system, the GPG proposes to include balances, pH meters, centrifuges and glass washers as "laboratory computerized systems". Strictly speaking this is correct — the equipment mentioned above all have firmware or ROM chips that allow the system to function.

According to the main GAMP Guide all these items of equipment would be classified as Category 2 and "qualified" as fit for intended use. The comparison of the GAMP Guide and the Laboratory GPG software classifications are shown in Figure 3 on the right-hand side of the diagram and the arrows in the middle indicate how the two classification systems are mapped and are compared with each other.

The horror that some of you may be having now around the suggestion to validate a balance, pH meter or centrifuge is more about terminology used rather than the work that you would do. It really depends on the functions that the equipment or system does and how critical it is. The main CDS systems used with a regulated laboratory must be configured to work correctly. This coupled with their use either to release or develop product means are high profile systems in any inspection.

Summary In today's risk- based environment, computer validation and equipment should be getting easier, quicker and simpler. Although the GAMP GPG for laboratory computerized systems was published in , it reads as if it were published under the older and more stringent regulatory approach that existed before and FDA's Pharmaceutical Quality Initiative in


GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems (Second Edition)

ISPE provides a wide range of Member-driven educational programs and resources to pharmaceutical industry practitioners worldwide, and is the originator and owner of all GAMP programs. The new publication joins ISPE's extensive library of technical guides, developed in cooperation with global regulatory agencies and industry professionals. The GAMP Good Practice Guide: Validation of Laboratory Computerized Systems is targeted to laboratory, quality, and computer validation professionals responsible for defining and managing laboratory validation practices in regulated life science industries. Information technology personnel supporting these systems, end users, software developers, and suppliers of laboratory computerized systems will also benefit.


ISPE Releases New GAMP® Good Practice Guide On Validation Of Laboratory Computerized Systems



New GAMP Good Practice Guide "Validation of Laboratory Computerized Systems" Published




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