May 21, 2020

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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Conformance to user requirements is highly method specific according to the guide. 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.

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

The laboratory is not a unique part of a facility anymore than production is. Results and data storage: However, the central point of this new guideline is the new classification into seven categories A through G.

The publication offers guidance for addressing strategic and tactical computer system validation issues such as: 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?

How many spectrometers can you name that don’t have computer-controlled equipment and data acquisition?

You can’t operate the equipment without the system and vice-versa. Tampa, Florida, USA By using our services, you agree that we use cookies. 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!

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

Do We Validate or Qualify? Therefore, we need an integrated approach to these two issues which will be discussed in part two of this column. These simple principles are easy to grasp and allow any laboratory full flexibility to be made of the risk-based approaches to regulatory compliance.

News June 15, The authors themselves state that e. 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. The risk assessment should focus the testing effort where it is needed most but built on the testing that a vendor has already done as the GPG notes on page The scope of the guidance and proposed USP chapter is limited only to commercial off-the-shelf analytical instrumentation and equipment.


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. This is in contrast to the introductory statements in the GPG mentioned at the start of this column. 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.

I agree to the Terms and Privacy Statement. 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.

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. However, at least the main computer validation subjects are covered in the whole life cycle including system retirement.

If you have problems displaying the website, is maybe JavaScript disabled on your browser, or your browser does not support JavaScript! 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. 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.

Summary In today’s risk- based environment, computer validation and equipment should be getting easier, quicker and simpler. 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.

Not really — we are just nibbling at the problem from a different perspective but without solving it decisively. The main CDS systems used with a regulated laboratory must be configured to work correctly.

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.

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? This is shown in Figure 3 on the left-hand side. 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.


So are we any further forward?

The testing approach outlined in Sections 10 Qualification, Testing and Release and Appendix 2 need to be viewed critically. 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 It really depends on the functions that the equipment or system does and how critical it is. To do otherwise is sheer stupidity.

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. Simple classification of laboratory equipment software — based on the existing GAMP software categories to be consistent with the rest of the organization.

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

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. The argument for the SILC: The new publication joins Glod extensive library of technical guides, developed in cooperation with global regulatory agencies and industry professionals.

gampp According to the main GAMP Guide all these items of equipment would be classified as Category 2 and “qualified” as fit for intended use. Group C instruments cover a wide spectrum of complexity and risk, and may have very diverse requirements. From no data generated to methods, electronic records and post-acquisition processing results.

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

ISPE Like what you are reading? Against this will be formal testing to ensure that the ov works as specified. Section 5 of the GPG also notes that ” 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.