Merck - Robust risk assessment

Risk-assessment programmes help ensure safe and robust manufacturing processes to mitigate risks to patient safety. Gathering the data for an initiative, however, can be time and resource intensive, and detailed information about consumables is often not readily available. Heike Michaelis, director of the Emprove programme from Merck Millipore - part of Merck - explains the value of an effective manufacturer-supplier partnership.

The International Conference on Harmonization (ICH) Q9 guideline on quality risk management is known as the 'gold standard' for risk assessment, advising companies on how to establish robust systems and providing tools for successful implementation. But success depends on an understanding of the foundational science, components and processes of the risks in question.

In pharmaceuticals, this means access to documentation and regulatory information on all of the chemicals and consumables used in a process. Data gathered from suppliers should include how products are manufactured, how quality is managed and how the manufacturer manages their own suppliers. How this information is used depends on the chemical or consumable.

Navigating the obstacles

Drug manufacturers often experience discrepancies between the information available, and what they need to ensure compliance and risk management. This can be especially challenging for companies in early development that may not be aware of the depth of information required for biopharmaceutical production.

In comparison with the relatively mature regulation of raw and starting materials, the regulatory landscape for biopharmaceutical processing is far less developed. When consumables are added to manufacturing processes, therefore, there is no clear expectation for what information is needed in risk-assessment documentation. At the very least, manufacturers need to know the risk of potential impurities from consumables, including extractables and leachables. While regulators attempt to establish a definitive way to assess risk from filters and single-use technology, current methods rely on evaluations of studies to determine levels of acceptable toxicological exposure. Not only is this approach time-consuming, but it may also require specific expertise, equipment and operator training.

In such uncertainty, biopharmaceutical manufacturers must partner with suppliers to facilitate quality risk-management programmes, which puts suppliers in a unique position to ease the burden on manufacturers. A strong manufacturer-supplier partnership can be especially beneficial for emerging companies scaling up from pre-clinical to full production.

Together in success

With access to state-of-the-art testing and knowledge, suppliers can help drug manufacturers access the information they need. In the past, manufacturers have contacted multiple parties to collect this data, but supplier risk-assessment programmes such as Emprove from MilliporeSigma simplify this process, and save manufacturers time and money associated with performing their own testing. Such programmes address the challenges manufacturers face in preparation of quality risk management.

The Emprove programme today encompasses hundreds of raw and starting materials used by drug manufacturers and, in June, it was expanded to include products for filtration and single-use processing. It addresses current and future regulatory needs, and helps risk reduction throughout manufacture. The programme also expedites approval preparation. For drug manufacturers, understanding the chain of custody aids in assessing the risk of falsification, so Emprove provides details of who produces, fills, labels, tests and releases the material. Information is accessed by customers through the online electronic original-manufacturer-tracking (eOMT) procedure.

With Emprove, biopharmaceutical manufacturers can access information for over 400 products online, plus dossiers on material qualification, risk assessment and process optimisation. The qualification dossier supports qualification efforts, with content on manufacturing processes, certificates, stability summary and more. The quality-management dossier supports risk assessment with information on supply chain, supplier management and product stability. The operational-excellence dossier offers elemental-impurity information (ICH Q3D) and analytical procedures.

For filtration and single-use products, documentation includes details on extractables, residual solvents and elemental impurities for products used in manufacturing. Customers also have easy access to labelling information, shelf-life data, sterilisation procedures, packaging testing, audit report summaries and management processes for suppliers.

The operational-excellence dossier also includes a product-quality report, derived from MilliporeSigma. It includes information about batches, trends in ongoing stability studies, changes during a surveillance period, significant parameters for which effective values are required by pharmacopoeias, and intentionally added elements and results from testing of different batches for 24 elements, in line with ICH Q3D guidelines.

In the potentially complex process of formulating quality risk management, biomanufacturers can benefit from working with trusted suppliers that are in unique positions to provide risk-assessment information. This type of supplier-manufacturer partnership can ensure manufacturers have what they need to produce safe products for patients around the world.

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