Establishing quality assurance in personalised preparations

Proficiency testing programmes aim to increase the product analysis and knowledge to contribute to overall improvement in drug product quality. A paper published in Pharmaceutics has proposed how a personalised preparation quality assurance programme can achieve this when these products are developed in compounding laboratories.

Quality assurance for personalised preparations

According to the authors, the personalised preparation quality assurance program (PACMI) was created in 2010 at the Faculty of Health Sciences of San Jorge University in Spain. PACMI selects a drug on a quarterly basis. It requests that compounding laboratories adhering to the programme send samples of it. After samples are received, PACMI performs quality control assessments.

PACMI has several advantages, including:

• Making it possible to expand the samples and destructive tests and dedicate more resources, facilities, and equipment
• Allows for more in-depth knowledge of the product and the processes used
• Allows for proposed improvements that increase the overall quality for improved patient health.

The process was intended to resolve limitations in personalised preparation quality systems. These include unregulated routes of administration and pharmaceutical forms (sterile) and the possibility of formulation of products for stock. The authors called for legislation to advance and adapt to the needs of personalised preparations and fill current deficiencies in the field.

The paper referenced the “pharmaceutical quality system” as defined in ICH10, which describes a comprehensive and effective model based on the quality concepts of the International Organization for Standardization (ISO).

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A strategy for improving drug product quality

Uriel et al. explained that the corrective and preventive action (CAPA) system is used to analyse quality results. The data obtained is included in two documents and sent to all participants in the test:

• An individual report with details of the results specific to each participant. The deviations or non-conformities found are detailed and preventive or corrective measures are proposed. The aim is to input improvements into the processes at the compounding laboratory.
• A general report containing the comparative results of all the laboratories for all the tests done and a general overview of the incidents or deviations identified related to quality, anonymously identifying the affected samples. These are documented and their root cause is sought.

As a next step, the participating laboratories record the proposed measures and monitor the incorporation of these measures into their processes, the paper noted. Thus, the impact of PACMI on quality does not end in the correction of a specific compounding, but will be applied to the continuous improvement of the processes at the compounding laboratory.

Successive comparative rounds of PACMI allow the practical effectiveness of the corrective measures adopted to be verified.

Applying corrective and preventive action (CAPA) for quality assurance

The authors shared a practical application for when to use the CAPA system: if a field is missing in the documentation included in the manufacturing guide is not the same as a preparation that does not comply with the content uniformity test.

Frequency or likelihood of the detected risk happening would be assessed, as well as the severity or impact of this risk, and whether it may affect the health of patients.

Overall, the PACMI has a positive impact on the quality of the personalised preparations, to benefit patient health and the laboratory, which may even see a reduction in costs associated with “non-quality”.

Uriel et al. explained that the conclusions gained from each study, in addition to experience obtained from the 850 samples analysed across 26 proficiency tests, “allow us to build another tool that contributes to organising all the variables that affect critical quality attributes of personalised preparation formulation. This provides valuable information to identify the root cause when specifications are not met.”

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