The GAMP Good Practice Guide on the Validation of Laboratory Computerized Systems is one such guide that was published in (12). GAMP Good Practice Guide: Page 3. Validation of Laboratory Computerized Systems. Table of Contents. 1 Laboratory Computerized System Categorization. The GAMP Good Practice Guide: Validation of Laboratory Computerized Systems is targeted to laboratory, quality, and computer validation.

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As you can see, the order of some of the chapters is a little strange.

The three instrument groups are described along with suggested testing approaches to be conducted for each. Tampa, Florida, USA Cavalry to the Rescue? You can’t operate the equipment without the system and vice-versa.

Countryside For All 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.

ISPE Like what you are reading? Instead of five categories of software, we now have seven Categories A to G. 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.

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. Conformance to the specification is achieved visually with no further qualification required.

Qualification is part of validation, but the individual qualification steps alone do not constitute process validation. The software used in some laboratory computerized systems may need to be configured — this is a term for either selecting an option in the software to alter its function within limits set by the vendor.

This is configurable commercial off-the-shelf software configurable COTS. This over complicates the issue Table 1: The recommendations given in this guide are meant to help the user in the pharmaceutical industry to develop a rationale for a graded scope of the validation of computerised systems in the lab. In an attempt to be all-encompassing for laboratory systems, the GPG has included ALL instruments, equipment or system with software of any description.

Some of the typical systems classified by the GPG are shown in Figure 3 on the right-hand side. Section 5 of the GPG also notes that ” The horror that some of you may be having now around the suggestion to validate a balance, pH meter or centrifuge is more about comuterized used rather than the work that laboratoty would do.


For example, we use the same qualification terminology IQ, OQ and PQ for both instrument qualification and computer system validation but they mean different things. McDowall, Quality Assurance Journal, 11 1 Overall, the problem with this GPG is that validaation have to cherry pick the good bits from the bad. Commercially available software that has been qualified does not require the same level of testing.

Therefore, we need to develop the following guidance as a minimum: 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, guixe example, authorized users and access levels required by both predicate rules and 21 CFR You’ll zystems note that a system can be classified in more than one GPG class depending on the software functions.

The inclusion comluterized ANY item of laboratory equipment with a computer chip from a pH meter GAMP Category 2 software prxctice as a “computerized laboratory system” is wrong, in my view, as it will create much confusion.

The definitions of the different types of GAMP software are? Over the past years I have gam 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.

There is little guidance on operational, maintenance and control activities following implementation such as access control, change control, configuration management and data back-up. Until we have this integrated approach there systemms be confusion in this area.

GAMP Good Practice Guide for Validation of Laboratory Computerized Systems_百度文库

So for the purposes of our discussion we can bood to tease out what a qualification process actually is: Figure 2 shows one approach to an integrated approach by considering the equipment operational requirements at both the modular and holistic levels and the software functions required; both of which are based on the way of working in a specific laboratory.

Overview of the Guide Published inthe stated aim of guid 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.

I can go on and usually do in more detail but the plain truth is that we don’t have this holistic approach yet. Strictly oaboratory this is correct — the equipment mentioned above all have firmware or ROM chips that allow the system to function. Validtaion for the laboratory, the former five GAMP categories have been subdivided further. 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.


This coupled with their use either to release or develop goos means are high profile systems in any inspection. This all adds up to scientific-based control of the system, the chromatograph and potentially also a method. Therefore, we now have conflicting guidance from the same organization on the same subject — you can’t make this stuff up! 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.

New GAMP Good Practice Guide “Validation of Laboratory Computerized Systems” Published

The great concept is the system implementation life cycle and a realistic at last! To do otherwise is sheer stupidity. Company Profile Email Us. This is shown in Figure 3 on the left-hand side. Realistic life cycle s based on the further development of the simple SILC outlined in the GPG that reflect the computefized options that we face in the laboratory: Like what you are reading?

If you have problems displaying the website, is maybe JavaScript disabled on your browser, or your browser does not support JavaScript! Of interest, the inside page of the GPG states that if companies manage their laboratory gapm with the principles in the guide there is no guarantee that they will pass an inspection — therefore caveat emptor! The testing approach outlined in Sections 10 Qualification, Testing and Release and Appendix 2 need to be viewed critically.

Therefore, don’t forget the impact of calibration: 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 contrast, the left-hand side and centre columns show how systems from the traditional GAMP software categories map to the new GPG categories. There is always a debate in the laboratory between qualification or validation of laboratory equipment and computerized systems.