Classical Pharmaceuticals
Small Molecule Manufacturing Expertise

Aligning with Regulatory Requirements

Complying with evolving and increasingly stringent regulations for excipient risk assessment is challenging. Our expertise and understanding of global regulatory requirements can help ensure compliance of the chemicals, hardware and consumables used in your manufacturing process.


1. Take the Fast Track to Obtaining Regulatory Approval

In March 2016, the European "Guidelines on Formalized Risk Assessment for Ascertaining the Appropriate GMP for Excipients of Medicinal Products for Human Use" became official, emphasizing the need for drug manufacturers to understand and assess the risk of the excipients in their drug products as it relates to appropriate GMP.

Solution

The innovative Emprove® Program can accelerate your pathway to regulatory approval by providing comprehensive product information and documentation.

The Emprove® Program simplifies your processes by:

  • Facilitating the qualification process
  • Supporting risk assessment, management, and mitigation
  • Increasing supply chain transparency
  • Expediting approval preparation and extending compliance—saving you time and money

Emprove® dossiers contain detailed documentation on our pharmaceutical raw and starting materials as well as filters and single-use components. Learn more about this program.

2. Select Appropriate Raw Materials for Transition to a Commercial Scale

A major challenge in small molecule drug development is the change in quality and supply chain as manufacturers progress from discovery to commercialization. A key risk consideration is whether the chemicals used in drug synthesis have the appropriate quality level for use in clinical trials and commercialization. If the right products are not used early in the development process, additional time and costs are required to convert to the correct quality level of raw materials at later stages in development. Changes in later steps also require more validation. This can lead to a higher total cost of ownership.

Solution

When transitioning to a commercial manufacturing process, understanding raw material requirements and cost implications is essential. A consistent supplier strategy should be developed, allowing you to identify the changes needed to convert to raw materials that are fit for purpose in a regulated product. View our approach which includes evaluation and assessment of raw materials used to manufacture a small molecule drug during development.

3. Meet New Regulatory Guidelines

Featured Solution

Webinars:

Associated Products:

Recent regulatory changes require improved characterization of excipients and additives used in pharmaceuticals. In June 2016, the ICH Q3D guideline on elemental impurities for new drug products became effective. This guideline provides limits set for elemental impurities that may arise from elements that have been added intentionally or may be present as contaminants. This guideline has a significant impact on the control strategy of metal and other inorganic impurities for drug products worldwide. How do the guidelines for the final product affect the excipients used?

Solution

Although this guideline applies only to the final product, drug manufacturers look to their suppliers for more information to develop adequate risk assessments of the excipients used. With evolving regulatory requirements, it is also important to understand current and upcoming regulatory requirements for elemental impurities, including recent developments in the pharmacopoeias (Ph. Eur. and USP).

By establishing a consistent supplier strategy to manage elemental impurity data for excipients, drug manufacturers can help control the risk of inadvertently introducing elemental impurities. Also, by understanding the risk and potential presence of elemental impurities, manufacturers can be more confident that their drugs will meet the industry guidelines for elemental impurities established under ICH Q3D.

Learn more about how excipient suppliers can support drug manufacturers to get meaningful data needed to obtain regulatory approval.