Machine translation: this English text was automatically translated from the original Dutch article. If anything is unclear or differs, please refer to the Dutch original.
Event language: This event was held in Dutch.
On Thursday 5 June 2025, around 25 people took part in an interactive webinar on applying the GLP principles in a QA professional’s day-to-day work.
After a brief round of introductions by the GLP Committee, the composition of the group was surveyed: how many years of GLP experience participants had, the fields in which they worked, and so on.
A large proportion of the participants had many years of GLP experience and worked mainly in biotechnology and pharmaceuticals.
Participants could then choose from five topics. Topic 1 was not selected. Each chosen topic was discussed in a breakout session, after which a short summary was presented to the full group. The feedback for each topic is reported below.
1. Conducting internal audits (this topic was not discussed in a breakout session)
- How are internal audits organised within the organisation?
- Are they focused only on compliance, or also on other matters such as improvement and safety?
- Do you use checklists?
2. Staff training and awareness
- How do you provide training?
- How do you provide refresher or update training?
- Does the training consist of theory, practice or a combination of the two?
Feedback from the breakout session:
Training can be provided in several ways:
- E-learning, for example basic GLP training.
- Classroom training, for example discussing a new OECD guideline or a high-impact SOP.
- Investigating, working through and discussing cases from the participants’ own organisations; this is regarded as particularly enjoyable.
Various ideas about SOP training were discussed, including the question: “What do we think about Read & Understood?” This does not always prove effective in ensuring that people retain a procedure, and sometimes many procedures have to be read in a single day. Some organisations use a completion period within which SOPs must be read: the most important ones first and the rest later. It is important to know where to find your SOPs and why you are required to read them.
3. QA’s role in the organisational structure
- Where is QA positioned within the organisation?
- How do you communicate matters back to operations?
- How is QA communication with management organised, and how are responsibilities assigned when there is no QA manager?
- How does QA contribute to the organisation’s culture?
Feedback from the breakout session:
Depending on the size of the organisation, reporting is directed to designated responsible persons within the organisation, who are responsible for following up findings. Management responsibility is sometimes organised differently in large organisations.
QA’s role in SOPs is to oversee compliance. QA is sometimes also involved in reviewing SOPs, including their layout and textual content.
4. Interpreting GLP rules in practice
- The Study Director has prepared an extensive Note to File that also contains instructions. Should this be an amendment, or is a Note to File acceptable?
- The Study Director has prepared a deviation that also contains instructions for the next time the relevant activity is performed. Is this acceptable, or should it be included in an amendment?
- Escalating findings: what should you do if you cannot reach agreement?
Feedback from the breakout session:
Amendments to the study plan are used to document additions. A Note to File is not formally recognised in GLP, and its use should be limited. When QA and a Study Director cannot reach agreement, it is advisable to meet with a representative of Test Facility Management. The last resort is to refuse to sign a QA statement, but it is better to address the issue earlier.
Documents such as batch records and Certificates of Analysis are verified in vaccine production. The group discussed how a GLP QA professional should approach this in the light of OECD Document No. 19 and where the responsibilities lie. QA’s check concerns the completeness and accuracy of the documents; it does not entail specific responsibility for the product.
Paper records are still used, but much more information will be recorded electronically in the foreseeable future. It is therefore important to pay attention to the use of audit trails to record changes to the data.
5. Using AI in a GLP environment
- Is AI used for GLP activities in your organisation?
- If so, how has validation of this system been addressed?
Feedback from the breakout session:
Several organisations have established, or are in the process of establishing, a policy on the use of AI within their organisation and are investigating where AI can be used for GLP activities.
When applying AI, you must ask carefully what you intend to use it for and identify the associated risks. Depending on the application, you must determine the required level of validation. Here too, it is important to define who is responsible for what. This also applies when AI activities are outsourced.
It is important for an organisation to have a policy or procedure governing the use of AI as soon as it begins using AI in the GLP field. Supplier-related matters must also be considered: do you know whether your suppliers use AI and, if so, for which activities?
Conclusion
It was a highly inspiring webinar, and participants gave very positive feedback at the end of the meeting. The use of AI for GLP activities may well be revisited at a future DARQA Theme Day.