Quality assessment (drug substance)
Quality assessments of the drug substance components are one of the most important aspects of technical due diligence, since may key potential issues and deficiencies occur in this area. BioVentures Consulting Limited has experience and expertise in assessing drug substance quality components. We can review our Client’s Active Substance Master File (ASMF), whether a confidential or closed part (if the information is protected by intellectual property rights); the General information, such as nomenclature (including link to similar compounds), structure and general properties (such as pKa and solubility) or whether any parameters should be included in the deficiency letter. BioVentures Consulting Limited can review the manufacture, and the description of the manufacturing process and process controls, control of materials, and control of critical steps and intermediates; and importantly, the process validation methods and evaluation. We will assess the adequacy of the description of synthesis, the control of the materials and intermediates, reproducibility of the manufacturing process identifying those issues not adequately covered.
The drug substance stability programme will always be closely reviewed by the assessor, and hence too its importance in technical due diligence
BioVentures Consulting Limited can also review the data and report for the elucidation of structure and other characteristics, and impurities.
This will include process-related impurities, degradation products, solvents and reagents, and ensure that these are all adequately documented.
The control of the drug substance is also an important part of the quality assessment. This includes an assessment of the specifications, analytical procedures (and the validation of these procedures), the batch analysis (to confirm the consistency and uniformity of the procedure) and justification and adequacy of the specification. BioVentures Consulting Limited can assess the Reference standards component and whether these have been adequately documented. The container closure system can also be assessed, including its description, identify of materials of construction of each primary packaging component, their specifications and justifications, including whether it provides adequate protection from microbial contamination, choice of materials, protection from moisture and light, compatibility of the materials with the drug substance itself (e.g. sorption to container and leaching, and safety of construction materials).
The drug substance stability programme will always be closely reviewed by the assessor, and hence too its importance in technical due diligence. BioVentures Consulting Limited can conduct a technical review of the stability summary and conclusions, the post-approval stability protocol, the stability commitments and stability data. We will assess whether the studies were carried out in accordance with current ICH/CHMP guidelines, whether there were any deviations, with relevant justifications, and whether the analytical methods are stability-indicating.