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Good Automation Manufacturing Practice

posted 25 Sept 2015, 05:18 by John O'Sullivan
First published on LinkedIn 8th Sep 2015

Good Automation Manufacturing Practice

How GAMP5 reduces risk and improves quality

As an automation and control system integrator, we at Douglas provide hardware and software solutions to industry. Our customers range from local indigenous industry (manufacturing, dairy, brewing, distilling) to multinational manufacturers (pharmaceuticals, medical device, biotechnology). We also provide projects, services and support to airports, railway signaling and energy clients.

 With this wide range of clients, their expectations of deliverables can differ greatly. This is a as a result of a number of factors. Common practice, regulatory requirements, project budgets vary across the sectors. 

Unless the system integrator has one client or works exclusively in a single sector, the automation provider needs to be flexible and able to adapt its offering. 

The way we have addressed this is through the use of GAMP. Good Automation Manufacturing Practice is a guidance document produced by the ISPE (International Society for Pharmaceutical Engineering). It “aims to achieve validated and compliant automated systems”. GAMP initially started in the 1990s and version 1.0 was published in 1995. GAMP4 arrived in 2002.

 We used GAMP4 to develop a suite of template documents to ensure:

  1. Common approach and content in Douglas documents
  2. Coverage of all GAMP recommendations
  3. Elimination of repeated work.

In 2008 GAMP5 was published which is subtitled “A Risk-Based Approach to Compliant GxP Computerised Systems”. At this stage we realigned our templates with the new guidelines. This did not mean many changes but I received some training and learned that the approach was changing. Risk-Based meant a more sensible approach to validating systems. It seems that GAMP had been taken to heart in the industry to the extent that the approach had become rigid. Systems were being tested and retested needlessly. Off the shelf components were being tested and qualified too rigorously. Utility systems that had limited influence on quality were being validated to the same degree as production facilities. Time and engineering effort was being wasted and this was affecting schedules and budgets.

GAMP5 had a new message. Assess the risk and achieve compliance by putting the correct proportional effort into the appropriate areas. Also it encouraged the leveraging of supplier quality systems. The overarching message was to ensure Patient Safety, Product Quality and Data Integrity.

At Douglas I carried out a cross-reference between GAMP and our own Operating Procedures to ensure we had captured the requirements correctly. This resulted in a matrix which we can present to our clients to show GAMP compliance.

When we are bidding for a project we include a list of the full suite of documents that we can offer, as per GAMP. These range from Quality and Project Plan, various Design Specifications, Source Code Reviews, Factory and Site Test Protocols, Reports, User Manuals, Drawings, Training documents, Configuration Records etc.

We select the appropriate combination of documents, based on the clients’ requirements and the scale and scope of the project. On a macro level, this means we can provide the correct level of documentation for the project.

Within the documents, because we have templates, we can delete, as appropriate, sections that do not apply or are unnecessary. After the bid is successful, the Quality and Project Plan outlines not only the documents to be provided, but who will author them and who will review and approve them.

I have found that using GAMP has helped us deliver a well validated compliant solution to the customer. It also sets out a flexible framework which can be modified to suit the customer’s needs.