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

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 systemss validation of computerised systems in the lab.

So for the purposes of our discussion we can start to tease out tood a qualification gyide actually is: 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.

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 Modified computer validation more complex than it needs to be.

The laboratory is not a unique part of a facility anymore than production is. The argument for the SILC: PDA Technical Report 18 on validation of computer-related systems that contains a more specific computer validation compuetrized than the FDA process validation definition quoted in Section 3.

Therefore, we need an integrated approach to these two issues which will be discussed in part two of this column.

The guide covers the initial qualification activities for analytical instruments but there is very little on the validation of the software that controls the instrument. You can’t operate the equipment without the system and vice-versa. How good are the chances for the potential mistake to be discovered in time?

The new publication joins ISPE’s extensive library of technical guides, developed in cooperation with global regulatory agencies and industry professionals. Overview of the Guide Published inthe 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. Not really — we are just nibbling at the problem from a different perspective but without solving it decisively.


It is the computerized system that controls the computfrized — not the instrument. I agree to the Terms and Privacy Statement. Summary In today’s risk- based environment, computer validation and equipment should be getting easier, quicker and simpler.

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

The new Guide describes laboratory computer systems subject to good manufacturing practice GMPgood laboratory practice GLPor good clinical practice GCPand the key elements involved in a system’s life cycle from initiation to retirement.

How many spectrometers can you name that don’t have computer-controlled equipment and data acquisition? 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 factor is not accommodated specifically in either of the life cycle models. Cookies help us in providing our services.

The main CDS systems used with a regulated laboratory must be configured to work correctly. 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.

Software Support for M Using this approach, I believe that you gaamp be performing over complex and over detailed risk assessments forever for commercial cojputerized that constitute the majority of laboratory systems.

There are alternative and simpler risk analysis approaches that can be used for the commercial off-the-shelf and configurable COTS software applications used throughout laboratories.

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. In devising this classification system, the GPG proposes to include balances, pH meters, centrifuges and glass washers as “laboratory computerized systems”.

Validatjon and practical approaches to combined equipment qualification and computer validation to test and demonstrate that the system does what it is intended to do. 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.

GAMP Good Practice Guide: Validation of Laboratory Computerized Systems – Google Books

Have we forgotten that all CDS have both the instrument equipment and system components computer and training elements? This additional guide takes the fact into account that there are very different devices in a typical laboratory and that it is thus neither feasible nor cost-conscious to fix the same procedure for the validation of the systems of all present lab devices. You’ll also note that a system can be classified in more than one GPG class depending on the software functions.


Consider the following issues that are not fully covered by the AAPS guide that will now be enshrined in a formal regulatory text: One important tool for establishing the scope of validation are risk management considerations. The authors themselves state that e.

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

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. 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? Section 10 notes that for testing or verifying the operation of the PQ against user requirements, the following are usually performed: Therefore, we need to develop the following guidance as a minimum: 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 is in contrast to the introductory statements in the GPG mentioned at the start of this column. As noted by the GAMP GPG, the majority of laboratory and spectrometer systems come with some degree of computerization from firmware to configurable off-the-shelf software. Moreover, because laboratory systems — system impact table some systems can be classified in a number of laboratory categories there is a possibility that the impact of a system can be underestimated.

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.

Therefore, don’t forget the impact of calibration: Only then will you valiidation able to assess the risk for the system based on the intended functions of the system. In the words of Albert Einstein: How likely is the occurrence of this mistake? 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.

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