Gamp 4 to Gamp 5 ONG Overview
Most computerised systems are now based on configurable packages, with
many of them networked.
Validate were there can be an impact on Customer / Patient / Safety, Product Quality,
Data Integrity. If none of these are impacted there should be no need to validate,
good engineering practice is sufficient with Gamp documented procedures in operation.
We Need to be clear on the differences between
system owner and process owners.
QA should be less involved than in the past. For example QA should review a URS
against the applicable regulations. URS technical review is for technical subject
matter experts. QA does not need to sign a design spec, as they do not understand
it (technical SMEs are required to sign, as they have the knowledge.
QA must verify that design specs are being produced for projects (i.e. verify that
Processes / Procedures are being followed) but QA does not need to sign every document
in a project. In other words QA should sign quality documents (e.g. URS, Validation
Plans, Project Plans), not engineering documents (e.g. design spec). At ONG Engineering
Project Management plays a key role in the final approval of Design Specifications
and auditing of finished documents.
Historically far tomany signatures have been required on documents, moving to limit
to more reasonable numbers. Its suggested maximum of three signatures per document
(QA not always needed, as mentioned above). Ask if signatures really add value.
Don’t waste time, resources and cost.
GAMP category 2 (firmware) has been removed from the old standard. Firmware has
become so complex that it is no longer functionally distinguishable from software.
Changes have been implemented to the descriptions of the GAMP category types.
It’s Important to know if suppliers are outsourcing. This will need careful control
of where / how work will be done, whether people are suitably qualified. There is
a need to have a Quality Plan with your supplier, verify suppliers have quality
processes such as continuous improvement, change control, root cause analysis or approved ISO Systems in place. Support post go-live needs to be considered, especially
with small suppliers.
Leveraging of supplier documents and Audits are vital, this needs to be carefully
evaluated with suppliers to ensure that documents will be of a suitable standard.
Integrate into the Life Cycle Phases : Build "Acceptance Testing" into the process
( FAT / FDS / SAT / UAT), Commissioning, Qualification.
Provide evidence at all levels "Especially Test Plans built into the Risk Assessment
of Projects". At ONG project management takes responsibility for all test
and inspection activities, to ensure they are planned in advance and conducted and
documented professionally to suit our customers. Compliance is key to all our activities.
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