Good automated manufacturing practice (GAMP) -Computer System Validation

 

Good automated manufacturing practice (GAMP) is a set of guidelines for manufacturers and other automation users follow to maintain operational efficiency and reliability. GAMP is also a subcommittee of the International Society for Pharmaceutical Engineering (ISPE).GAMP represents a structured approach to validating computer systems in digital pharmaceutical products. . aims to provide a comprehensive explanation of how pharmaceutical companies should validate their computer systems. In practice, this means that these recommendations apply both to the users of automated pharmaceutical products, as well as the manufacturers who create and market them. For users, the guideline outlines the principles that they should be aware of which assure computerized pharmaceutical products are appropriate for their intended purpose. For manufacturers, GAMP 5 guides them to ensure their products meet necessary standards according to a risk-based approach to compliance.the ISPE's guide 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.

 The new Good automated manufacturing practices (GAMP)-5 guidelines were released February 2008 at the ISPE(International Society for Pharmaceutical Engineering) Manufacturing Excellence Conference in Tampa, Florida. These guidelines are the latest, up-to-date thinking in the approach to validation of GxP computerized systems. The purpose of the guidelines is to “provide a cost effective framework of good practice to ensure that computerized systems are fit for use and compliant with regulation.” There are five key concepts to GAMP 5:

1.Product and Process Understanding.

2. Lifecycle approach within QMS.

3. scalable Lifecycle Activities.

4. Science Based Quality Risk Management.

5. Leveraging Supplier Involvement.

 

systems are first evaluated and categorized by predefined labels depending on what the manufacturers intend to use it for and how complex the system is. one size fits all approach”, GAMP 5 standards recommend different lifecycles depending on the category of software the product falls into:

 

1.     Infrastructure software: This refer to the operating system where the application software resides.Unless a very simple control system (PLC and HMI) there is likely to be some elements of infrastructure software. Infrastructure software in its most simple form is the operating system which the application software resides. Additional software for managing the infrastructure the process control system includes:

·         Operating Systems

·         Anti-virus Software

·         Active Directory / Domain Controller

·         Database Software (SQL / Oracle)

·         Server and Network Hardware

·         Virtual Environments

·         Firewalls, including configuration

·         Server and Network Monitoring Tools

·         Backup Systems

Note: Infrastructure should be built, configured and deployed in accordance with defined process / procedure and critical aspects and / or configuration verified. Infrastructure is qualified but not validated. The validation is performed on the hosted application not on the infrastructure. (example: operating system, databases, programming language)

2.     Nonconfigured products: This category includes software which can meet the requirements of the business process without       modification, or is ‘used as installed’, as well as configurable software that is used but only with its default settings.GAMP category 3 would be systems that are provided with computerised controllers, including Programmable Logic Controllers (PLC’s) where the application is not modified (although may be parameterised) to meet the business need. Within the pharmaceutical industry there are many examples of these including Labelling and Packaging equipment.There is no fixed rule as to the validation approach for GAMP Category 3 systems. This should be combined with the impact or criticality of the process that the system is monitoring and / or controlling. It can support decisions as to lifecycle steps that may not need to be performed for example Source Code Reviews, limited verification activities and greater reliance on vendor test documentation. (Examples: commercial off the shelf software, lab instruments, Programmable Logic controllers)

3.     Configured products : Here the guideline describes software applications which are configured to meet user-specific business needs, which is the broadest and most complicated category of the four. GAMP Category 4 – Configured Software range in complexity from simple configuration of SCADA system graphics to complex process control within a DCS or PLC (linking standard library objects to control the process).

Examples of configurable software for a Process Control System includes:

·         DCS / SCADA Mimics

·         DCS / SCADA Databases (Alarms, Tags, History)

·         PLC / DCS programs configured from Standard functions library / IEC61131-3

For GAMP Category 4 software the approach to the computer systems validation may be to use the supplier’s documentation and verification to demonstrate the suitability of the standard modules and limit the regulated company’s verification to the critical functions of the business process and functions to support regulatory compliance. (Examples: LIMS, SCADA, DCS, etc.)

4.     Custom software:The last category includes software that is created to meet a bespoke business need. This is possibly the riskiest category, since it is often developed in-house from scratch and then customized, meaning a higher level of risk in the code.

Bespoke software is software that is generally written from scratch to fulfil the business need. As this software is going the full development lifecycle there is a higher level of risk of errors within the application code.

In terms of a Process Control System GAMP Category 5 software may range from PLC logic (Ladder, Sequence Flow Chart, C++, etc.) to custom scripts written within the SCADA / DCS system.

 GAMP V Model:-