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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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. Qualification is practie of validation, but the individual qualification steps alone do not constitute process validation. Examples of instruments in this group are balance, IR spectrometers, pipettes, vacuum ovens and thermometers. It laborstory depends on the functions that the equipment or system does and how critical it is.

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

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. Validation of Laboratory Computerized Systems. To do otherwise is sheer stupidity. Risk AssessmentMethodology OK, if you managed to get this far after reading Part 1, we now have the finishing touch — the risk assessment methodology. The AAPS white paper has devised three classes of instruments with a user requirements specification necessary to start the process.

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. It is the computerized system that controls the whole — not the instrument. 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.

Although the GAMP GPG for laboratory computerized systems was published init reads as if it were published under the older and more stringent regulatory approach that existed before and FDA’s Pharmaceutical Quality Initiative in 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 LIMSusing a language to set up a laboratory procedure or method. Conformance to user requirements is highly method specific according to the guide.


The Guide assumes that these two factors are of equal importance. This approach must harmonize the use of terminology and definitions. The scope of the guidance and proposed USP chapter is limited only to commercial off-the-shelf analytical instrumentation and equipment.

The new publication joins ISPE’s extensive library of technical guides, developed in cooperation with global regulatory agencies and industry professionals. The practical implementation still has to show whether this further subdivision is really helpful.

In an attempt to be all-encompassing for laboratory systems, the GPG has included ALL instruments, equipment or system with software of any description. This is configurable commercial off-the-shelf software configurable COTS. Figure 2 shows one approach to an integrated approach computeruzed 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.

Results and vamp storage: Strictly speaking this is correct — the equipment mentioned above all have firmware or ROM chips that allow the system to function. Like what you are reading? Once the software functions have been understood, an application configuration specification can be written that will state guude functions in the software will be used, turned on, turned off or modified.

Overall, the problem with this GPG is that you have to cherry pick the good bits from the bad.

Equipment used in the manufacture, processing, packing or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. One important tool for establishing the scope of validation are risk management considerations. Yes for two reasons: These simple principles are easy to practics and allow any laboratory full flexibility to be made of the risk-based approaches to regulatory compliance.

From no data generated to methods, electronic records and post-acquisition processing results. Examples of this group are ovens, vortex gsmp, magnetic stirrers and nitrogen evaporators.


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

Cavalry to the Rescue? Section 10 notes that for testing or verifying the operation of the PQ against user requirements, the following are usually performed: In contrast, the left-hand side and centre columns show how systems from the traditional GAMP software categories map to the new GPG categories.

Sign up for our free newsletter. Many suppliers have always performed equipment checks to confirm functionality of parctice equipment to defined specifications, both prior to and after installation. ISPE Like what you are reading? 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. 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.

This all adds up to scientific-based control of the system, the chromatograph and potentially also a method. 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.

Installation can be complex and hamp specialist skills e.

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

The definitions of the different types of GAMP software are? The debate is also clouded by the lack of suitable definition of “qualification”. Conformance to specification is achieved according to the individual instrument’s SOP. Instead of five categories of software, we now have seven Categories A to G. OK this approach is simpler but the only consideration of the computer aspects is limited to data storage, back-up and archive. However, as the majority of laboratory equipment and software used in laboratories is commercially available and purchased rather than built from scratch why is this inappropriate methodology being applied?