IQS and ISPE coordinated the first presentation of the new GAMP® 5 Guide Second Edition in Spain, held at IQS on 21 September
On 21 September, IQS hosted the presentation of the new GAMP® 5 Guide Second Edition in a conference organized by ISPE (the International Society for Pharmaceutical Engineering), the creators of the guide, along with the IQS Executive Education division.
Dr Carles Malet, Assistant Director of IQS, led the opening of the event and welcomed the attendees and thanked the speakers for their presence and their contributions. Dr Malet highlighted the fact that IQS hosted the first presentation of the new GAMP guide in Spain, just the second in Europe.
Cristina Mazó, President of ISPE Iberia, thanked IQS for the opportunity to present this new guide, created and developed by the GAMP CoP (Community of Practice) with ISPE, based on their aim of training and connecting the people who make up the pharmaceutical sector.
New GAMP 5 Guide
Dr Beatriz Artalejo, Pharmaceutical Technical Director with IQS and Vice President of GAMP CoP Spain, and José Ramón Martínez, CEO of the company Asesoría y Validación SL, a member of the ISPE Iberia Committee, and President of the GAMP CoP Spain, presented the new guide.
Dr Artalejo analysed the "Perception of GAMP guidelines in the pharmaceutical industry" and the crucial nature of their existence. These guides are kept up to date thanks to the ISPE's GAMP CoP and are able to be integrated into the day-to-day activity of highly regulated work environments. Dr Artalejo added that "wherever we are in the chain, we can't forget that patients are our target, which is why we must work properly and be able to guarantee our work."
For his part, José Ramón Martínez gave a presentation on the latest features presented in the new GAMP® 5 Guide Second Edition, which did not modify either the objectives, the general approach, or the framework of application of the first edition of the guide (2008).
In summary, the new guide incorporates a series of updated annexes, derived from the increasingly frequent presence of numerous computerized systems in the management of the pharmaceutical sector, making "the new update essential for adapting to the requirements resulting from incorporating new areas of technology into the sector such as Blockchain, Artificial Intelligence, Machine Learning, and so on," stated José R. Martinez.
In addition to supporting the use of software and automation tools, the new GAMP guide is also aimed at eliminating duplicated efforts, promoting critical thinking as a key element in ensuring that validation practices are increasingly efficient and cost-effective, and emphasizing the participation and involvement of IT service providers.
To conclude the event, a discussion session was held that featured highly interesting questions and concerns from the attendees about certain key aspects from the presentation.
In the words of José Ramón Martínez, "the new edition of the GAMP® 5 guide seeks to simplify tasks and provide enhanced solutions to the ongoing challenges the pharmaceutical sector faces."
New working groups
The ISPE Spain GAMP CoP announced the creation of specific working groups to analyse the topics introduced in this edition of the GAMP 5 guide, such as:
- IT infrastructure
- Critical thinking
- Requirement specifications
- Agile software development
- Software tools
- Chain transaction systems (Blockchain)
- Artificial Intelligence and Machine Learning (AI/ML)
- Electronic production records
These groups are open to professionals who can contribute and exchange knowledge.
Based on the evolution of the different working groups and the needs of the sector, specific training sessions will be held within the framework of collaboration between IQS Executive Education and ISPE.
More information about the working groups
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