The Good Automated Manufacturing Practice guides have for the last 10 years provided a universally accepted approach for the development and use of computerised systems within international Pharmaceutical regulations. The guides are intended for users, suppliers and regulators to the industry and are produced by the International Society Pharmaceutical of Engineers (ISPE).

In March of this year the latest version 5 of the guide has been released and includes some major revisions and updates to the practical best practice found in GAMP4, in this edition of ‘Call in for a Coffee’ we take a closer look..

Computer Systems Validation: Value added?
The new GAMP version 5 is built on the methodology established in version 4, usually referred to as the V-model. Succinctly, the V-Model approach is that at each step in the lifecycle of a Computerised System the functionality and behavior of the system(s) are verified and tested to ensure conformance with original specification and requirements.

In principle this is a simple concept but with increasing complexity, inter-operability and integration such validation projects have a sizable impact on the implementation costs and efforts for the installation of new technology, often validation is done with the aim only to fill a regulatory requirement and this can lead to a negative perception and a view that computer validation does not provide any value added.

The challenge of providing patient safety, meeting regulation and providing business benefits has deterred some manufactures, especially in regions where regulation for computer systems validation does not exist or is poorly understood. In addition the prevalence of legacy systems and insufficient local resources to manage such projects has lead to many manufacture having little or no verification of their systems.

In our experience, the benefits of validation are not only demonstrated by the leveraging of regulatory requirements to demolish trade barriers, but as the a key tool for tracking and ensuring successful and high quality delivery of Information System projects and product quality. Some of the business benefits of the GAMP approach are:

These factors can lead to a very effective return on investment as long as the validation is not overdone and is performed to industry accepted practices by experienced and knowledgeable resources.

Core components
GAMP5 has been revised with strong reference to three current focus areas for the industry and the US FDA’s 21 st Century Initiative:

In addition the revision was conducted to align with new documents and standards from PIC/S, ICH and the ASTM. GAMP5 aims to implement these new initiatives at lower cost by:

Good Practice
GAMP5 states that a QMS for Information Systems should cover the entire life cycle and is Risk Based. Standard Operating Procedures should be available for all aspects of the life cycle and roles and responsibilities affected.

Requirements for computerised systems must be clear, thorough and based on process understanding and identification of the critical quality attributes related to the drug product.

By utilising information, templates and documentation from suppliers and commissioning , a large reduction in duplication, inaccuracy and efforts can be made over reproducing such information.

Risk Assessment – Is an evaluation of the threat to quality and thus patient safety and should be made on scientific knowledge of the system specifications, design and the business process being supported. Based on the assessed threat, the nature and level of control is determined. GAMP5 outlines a 5 step process for Risk Management:

Change and Configuration Management – Change Control is the critical record and mechanism for ensuring that any changes of a system are made without affecting the validated state. The Change Control process has to ensure that modifications are authorized, documented, tested and approved prior to implementation. Configuration Management is the control and documentation of the baseline system and upon which Changes are made.

Conclusions & Considerations
Validation of Information Systems , either that already implemented or prospective have a large impact on the costs associated with the uptake of technology in Pharmaceutical manufacturing. The validation of such systems is not a necessary evil but rather a tool to ensure compliance , reduced cost of operation and a framework with which to manage projects. Experienced resources and best practice techniques can ensure the benefits are achieved.

Free Consultation
GAMP5 and CSV maybe new to some people and customers may have questions, we will provide satisfying, understandable answers.

Simply contact Factorytalk and “Call for a Coffee” for a free consultation.

We are located at :
Factorytalk Co., Ltd.
12th Floor, Liberty Square
287 Silom Road
Bangrak, Bangkok
10500 Thailand
Telephone : +66 (2) 630-4525      
Facsimile : +66 (2) 630-4527

Factorytalk Pte Ltd
25 International Business Park,
#04-106-107A,
German Centre,
Singapore 609916
Telephone :  +65 6562 7634       
Facsimile : +65 6562 7635

E-mail Address :
contact@factory-talk.com