The EAHP Board, elected for three-year terms, oversees the association’s activities. Comprising directors responsible for core functions, it meets regularly to implement strategic goals. Supported by EAHP staff, the Board controls finances, coordinates congress organization, and ensures compliance with statutes and codes of conduct.
The European Paediatric Formulary: a reinforced approach for improved monographs
European Statement
Production and Compounding
Author(s)
Théo Henriet, Jane Francomb, Dirk Leutner, Jörg Breitkreutz
Why was it done?
The PaedForm project was launched as a bibliographical exercise, with the aim of collecting age-appropriate formulations from existing formularies or from established sources in Europe and incorporating them into the PaedForm.
However, the data underpinning existing monographs were not as complete as expected and errors in the source data were observed. Adding an experimental verification step was therefore crucial to ensuring the reliability and the appropriate quality of the formulations described in PaedForm and demonstrating that the monographs could be used in practice.
What was done?
A decision to add an experimental verification to the elaboration process for monographs to be published in the European Paediatric Formulary (PaedForm) was recommended by the experts from the PaedF working party (PaedF WP) – assisted by the European Directorate for the Quality of Medicines & Healthcare (EDQM) – and supported by the European Committee on Pharmaceuticals and Pharmaceutical Care and the European Pharmacopoeia Commission.
This verification step involved checking the preparation against the description in the monograph and, where necessary, completing it. Samples prepared during this step were then tested to check that the quality control methods included in the monograph were suitable. The findings were used to determine whether the monograph could be completed.
Where necessary, this experimental verification would include tests such as the microbial challenge test as described in European Pharmacopoeia (Ph. Eur.) general chapter 5.1.3.
How was it done?
Experts from the PaedF WP support the need for practical verification and perform the experimental verification if needed. The EDQM supported this work by sourcing active substances and consumables and by organising analytical testing for techniques not available to the experts.
What has been achieved?
This approach enabled the enhancement of a furosemide oral formulation. The composition of this formulation as described in the source material did not meet the Ph. Eur. requirements for antimicrobial preservation, so it was changed to include a higher concentration of the preservative and comply with the Ph. Eur. requirements.
What next?
The PaedF WP will continue to expand PaedForm by elaborating new monographs covering unmet therapeutic needs. Users are invited to contribute to this process by commenting on texts published in the PaedForm Pharmeuropa public consultation platform.
Implementation of a Ph. Eur. compliant recombinant method for testing of bacterial endotoxins in sterile pharmaceuticals
European Statement
Production and Compounding
Author(s)
Randi Hamre Svendsen, Vilde Pettersen, Theo Dogbeten
Why was it done?
Endotoxin testing by the gel-clot method is a limit test and relies on the operator’s subjective evaluation of the results. The procedure itself contains several steps and dilutions, and it is time and resource consuming. The availability of the amoebocyte lysate reagent can also vary since it is harvested from the endangered horseshoe crab. The recombinant factor C method (rFC) is a fluorimetric method based on the gene sequence of the horseshoe crab, providing quantitative results with no interpretation by an operator. The rFC method consists of less handling and is less susceptible to human error.
What was done?
The hospital pharmacy implemented a modern system for testing of bacterial endotoxins as a part of the quality control of raw materials (i.e. water for injection (WFI)) and sterile pharmaceuticals manufactured at the pharmacy, replacing the old gel-clot test.
How was it done?
All sterile pharmaceuticals manufactured at the hospital pharmacy were evaluated for maximum valid dilution (MVD) and endotoxin limit. Firstly, the optimal dilution of the products was established, and then tested with three different batches to ensure valid results regardless of any batch-to-batch variation. WFI was validated undiluted with batches from three separate days. Validation started with the most frequently manufactured products, and subsequently continued over the next year with the rest. To expedite the full validation of some products, expired batches were used simultaneously with at least one recently produced batch due to infrequent production times, otherwise a full transfer of method would not be achieved for up to six years.
What has been achieved?
In total, 25 sterile pharmaceuticals and raw materials were successfully validated for endotoxin testing by rFC during 2021 and 2022. The gel-clot method is no longer in use at the hospital pharmacy, reducing the negative impact on the horseshoe crab population. The rFC method streamlined the testing for endotoxins, reducing the time spent on performing the analysis by 50% with less handling and increased capacity. Results are quantitative and objective, not relying on observations by the operator, thereby improving the quality.
What next?
The rFC method increases both quality and capacity of testing, opening up for expanded testing in pharmacy, and of samples from other departments or hospitals.
COMPLETING SELF INSPECTION AUDITS IN THE PHARMACY ASEPTIC UNIT
European Statement
Patient Safety and Quality Assurance
Author(s)
Louise Byrne
Why was it done?
H/PICs are guidelines of professional practice developed by pharmacists working in aseptic compounding units In Ireland in 2013. Chapter 9 advises that ‘a self -audit programme should be established and conducted in an independent and detailed way by designated trained competent people’. In order to adhere to these guidelines a self-audit of one section of the H/PICs was completed.
What was done?
A self-audit against one chapter of the H/PICs guideline was completed.
Changes were implemented where possible.
Issues were escalated to senior managers where required.
How was it done?
Obtain audit skills.
An audit checklist was prepared and an audit, for the premises and equipment section of the H/PICs guidelines was completed.
Non-conformances were identified and graded.
Corrective and preventative action (CAPA) was put in place where possible.
Major/critical non-conformances were escalated to higher management where necessary.
What has been achieved?
An audit training day was completed in November 2014. Skilled auditors in the laboratory were observed completing self-audits.
A checklist for the premises and equipment section of the H/PICs was prepared and an audit of that chapter was completed in March 2015. There were 32 statements in this chapter and non-conformances of various grades were identified. CAPA was put in place where possible. 9 non-conformances were rectified with internal changes. 10 major/critical non-conformances requiring capital/HR funding were presented to higher management, these were summarised into 4 main risks. Business cases were prepared to support the correction of these risks and a summary was added to the risk register. The remaining non-conformances were classified as minor deficiencies and will be corrected at a later date.
What next?
Self-audit is a useful tool and aids compliance with H/PICs guidelines. It allows the identification of high risk activities and grading non-conformances assists in the prioritisation of process improvement projects. It supports the feedback of performance against recognised guidelines to management. An annual self audit plan will be put in place and a peer audit group within a number of other hospitals has been established.