Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Quality assessment (drug product)

A quality assessment of the drug product package is one of the most important parts of a technical due diligence exercise. It as a key area of the assessors review where many potential issues are highlighted on the assessment report. BioVentures Consulting Limited has experience and expertise in assessing drug product quality. We can review our clients description and composition of the drug product section, and can check whether all components of the presentation are as intended for marketing, including reconstitution diluents, the container closure system (especially for sterile or labile products). BioVentures Consulting Limited can assess the pharmaceutical development section including components of the drug product, manufacturing process development, the container closure system, the microbial attribute and compatibility. We can review the completeness of the manufacturer(s) information, the batch formula, description of manufacturing process controls, controls of critical steps and intermediates and the process validation elements. Such a review will include the flow diagram, with critical steps.

Our assessment of the control of excipients will include an assessment of the specifications, the analytical procedures (and their validation), the justification of specifications and whether there are any likely issues arising from the use of excipients of human or mammalian origin and novel, untested excipients. Note that ‘new’ excipients not present in products authorised in the EU may be regarded as new active substance requiring a full data package.

BioVentures Consulting Limited can assess the control of drug product, which will include a likewise assessment of the specifications, analytical procedures and their validation.

BioVentures Consulting Limited can help determine…. whether these are in accordance with the current ICH/CHMP guidelines

In addition the batch analysis, characterisation of impurities and justification for the specifications can be assessed for content robustness. In order to complete a technical due diligence of the drug product component assessment of the reference standards, the container closure system (including whether the identity of the materials of the construction of each primary packaging component and its specifications, and confirmation that the containers proposed for routine storage are those which have been used in the stability studies supporting the shelf-life.

The drug product stability programme will be of particular importance to the due diligence exercise since it is also a key component for the regulatory assessor. BioVentures Consulting Limited can help review the stability summary and conclusions section, determining whether these are in accordance with the current ICH/CHMP guidelines. We can review the post-approval stability protocol and stability commitment, and stability data assess whether the methods shown are validated and shown to be stability indicating, whether the shelf-life is justified.

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