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GAMP 4 AND GAMP 5 GUIDELINES. MANUAL
GAMP 4 AND GAMP 5 GUIDELINES. VERIFICATION
GAMP 4 AND GAMP 5 GUIDELINES. ISO

One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. As part of the concept phase associated with an upgrade/replacement, we need to consider our data and record retention requirements for the system being retired.Good automated manufacturing practice ( GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. Therefore, the last lifecycle phase, retirement, usually coincides with the first of the lifecycle phases ‘concept’. Usually we tend to upgrade/replace computerised systems as opposed to retiring or withdrawing them entirely from service.

Operational change and configuration management.

Establishing and managing support services.

Regardless of the application, most computerised systems require a suite of procedures to maintain the validated state of the system. The operation and maintenance phase begins once the supplier hands over ownership of the system to the end-user from the project phase. It is important to note that the lengthiest period of a computerised system’s lifecycle phase is the operation and maintenance phase. This focus on effective supplier relationships is also an underlying principle of ‘Lean’ manufacturing practices.įigure 1: V-model approach for a category 4 configured product (Based on 4.3 from GAMP® 5) The most recent version, GAMP®-5, sensibly talks about an ‘effective supplier relationship’, and leveraging existing documentation and knowledge from the supplier’s internal good engineering design and testing documents. It is important that both the end-user and the supplier are fully conversant with both their unique and shared deliverables across the lifecycle, in accordance with good engineering practices and norms. But, for me, it was the layout of GAMP®-3 into a separate user and supplier guide that will forever be the crux of the whole GAMP® philosophy: ‘responsibility’. Multiple ‘V-Models’ are illustrated in GAMP®-5 for varying degrees of scalability. Whereas GAMP®-4 focussed on more of a one-size-fits-all lifecycle model for bespoke and complex configurable systems, GAMP®-5 scales the lifecycle deliverables based on a computerised system’s impact on product quality and patient safety, and on its relatively complexity and novelty. One unique aspect of GAMP®-5 is its scalable approach to GxP compliance.

GAMP 4 AND GAMP 5 GUIDELINES. VERIFICATION

GAMP®-5 (published in 2008) fully aligns itself with ASTM standard E2500 ‘Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment’ (first published in 2007). I still reference this model regularly, as it can be applied to any bespoke system or any complex configurable system. For me, the most memorable aspect of GAMP®-4 was a fully illustrated lifecycle model for a process control system (based on figure 6.3 in GAMP®-4). The next version, GAMP®-4 was then published in 2001. In a nutshell, GAMP® covers good industry best practices and regulatory requirements associated with specification, design and validation (verification) activities across the lifecycle phases. Nowadays we consider the computer system lifecycle to involve four discrete phases: the concept phase, the project phase, the operation and maintenance phase, and the inevitable retirement phase.

GAMP 4 AND GAMP 5 GUIDELINES. ISO

There is good alignment with the ‘Product Realisation’ section found in ISO 9001 (‘Quality Management Systems – Requirements’, Section-7). GAMP® makes use of a lifecycle ‘V-Model’ that simply aligns specification and design inputs against verification and testing outputs (see Figure-1). It is about what we now refer to as a system’s lifecycle, where validation forms a part of the lifecycle activities. The first thing I realised back in 1998 is that GAMP® isn’t just about computer system validation. I got my hands on GAMP®-3 in 1998 and read it from cover to cover. With a future focus on computer system validation I decided GAMP was something I should learn more about.

GAMP 4 AND GAMP 5 GUIDELINES. MANUAL

They had a glorious ‘how-to’ manual that they all kept referring to, they kept quoting from a highly topical FDA guidance at the time called ’21 CFR Part 11’. My first exposure to the ‘GAMP®’ (Good Automated Manufacturing Practice) Guidelines was back in 1997 during a conversation with some ‘computer system validation’ specialists. Written by Joe Brady, Director for Global Compliance and Validation