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

Summary Qualification of laboratory equipment and validation of computerized laboratory systems are going into two different directions that lack an integrated approach. 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.

Therefore, why should a risk analysis methodology that is very effective for new designs and processes be dumped or foisted on laboratories using mainly commercial systems? Get the latest articles from Pharmaceutical Online delivered to your inbox. Using this approach, I believe that you will be performing over complex and over detailed risk assessments forever for commercial systems that constitute the majority of laboratory systems.

How likely is the occurrence of this mistake? No wonder if we don’t take a considered and holistic view of the whole problem.

The overall process flow for the risk assessment is shown in Figure 1: From no data generated to methods, electronic records and post-acquisition processing results. From my perspective, this is wrong and emphasis should be placed on defining the intended purpose of the system and hence functions of the instrument and software that are required first and foremost.

These events systemd held in Copenhagen from September.

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

Software Support for M The debate is also clouded by the lack of suitable definition of “qualification”. This coupled with their use either to release or develop product means are high profile systems in any inspection. The definitions of the different types of GAMP software are? 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.


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

This over complicates the issue Table 1: As you can see, the order of some of the chapters is a little strange. Installation of the instrument is relatively simple and causes of failure can be easily observed. The main CDS systems used with a regulated laboratory must be configured to work correctly. Validation of Laboratory Computerized Systems.

However, on the bright side the dishwashers bit the dust long before the final version of this publication! Conformance to specification is achieved according to the individual instrument’s SOP.

Therefore, don’t forget the impact of calibration: Section 10 notes that for testing or verifying the operation of the PQ against user requirements, the following are usually performed: In the next column, I’ll look at the risk assessment methodology outlined in the guide, work by the AAPS and the USP on equipment qualification and a proposed way forward.

Examples of instruments in this group are balance, IR spectrometers, pipettes, vacuum ovens and thermometers. Why this over complex methodology was selected for laboratory systems is not discussed although I suspect that it is aimed at consistency throughout the GAMP series of publications. Therefore, we need to develop the following guidance as a minimum: 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.

If you qualify the instrument you will usually need the software to undertake many of the qualification tests with an option to validate the software at the time. 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.

Integrated Approach to Computer Validation AND Instrument Qualification What we really need for any regulated laboratory is an integrated approach to the twin problems of instrument qualification and computer validation.

The vast majority of equipment and systems in our laboratories are similar to this, but consider the question: The testing approach outlined in Sections 10 Qualification, Testing and Release and Appendix 2 need to be viewed critically. 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.


You can’t operate the equipment without the system and vice-versa. The Guide assumes that these two factors are of equal importance. 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.

There is always a debate in the laboratory between qualification or validation of laboratory equipment and computerized systems.

Commercially available software that has been qualified does not require the same level of testing. As to the wording, the authors of the new GAMP Guide have again chosen the term “validation” instead of “qualification”, since “validation” is considered to be the more comprehensive and therefore more suitable term.

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

McDowall, Quality Assurance Journal, 9, — A high-risk classification coupled with a low likelihood of detection determines the highest class of test priority.

According to the main GAMP Guide all these items of equipment would be classified as Pracice 2 and “qualified” as fit for intended use. 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.

Group C instruments cover a wide spectrum of complexity and risk, and may have very diverse requirements. Integrated terminology covering both the qualification of the instrument and validation of laboatory software. This is shown in Figure 3 on the left-hand side.

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. Strictly speaking this is correct — the equipment mentioned above all have firmware or ROM chips that allow the system to function.