Quality Control & Stability

Supporting the release of
life-enhancing products to market

Quality Control and Batch Release Testing
iStock-509611551
successful-partnership-picture-id1189618237
Product reliability
Product Stability

Product stability is important to determine shelf-life, the duration for which the product is effective and safe for use. A longer shelf-life is beneficial for managing the supply chain and is often preferred by consumers.
We work with clients to support their product stability requirements from business continuity and storage only to full study management to support the life cycle of medicinal and drug products from development through to post market compliance.

Capabilities
Stability storage is provided in dedicated purpose built walk-in climatic chambers located in a controlled area. The chambers are controlled via a fully validated data management system in accordance with FDA requirements and ICH harmonized guidelines for stability testing of new drug products and substances. Each chamber is temperature and humidity controlled to +/-2°C and +/-5%RH of its target conditions, with 24hr monitoring of chamber conditions.  

We are experienced in offering stability services across the following subject areas:

  • New Drug Development
As part of your submission, stability data is a key aspect in providing evidence of your product’s efficacy and safety over time. We frequently collaborate with clients and support their drug development pathway from raw materials to finished products and identifying suitable intermediates to bulk up as you go into manufacturing. For each key intermediate we place on stability to observe how the product decomposes and assess if the degradants are harmful.
  • Accelerated Studies
We conduct accelerated studies on a product to preview the potential degradation process in a shorter period. These studies support the development of a product’s stability profile and are an efficient way to highlight and troubleshoot problem areas early.
  • Annual Studies
Regulations require license holders to conduct annual stability studies to monitor product quality during routine manufacture. Our team works closely with clients to ensure annual studies are conducted and the necessary data is captured and reported to maintain compliance.
  • Excursion and Transit Studies
Quite often product is manufactured in a different country than the destination. In route, the storage conditions can reach outside tolerance and pose a risk to product safety and efficacy. Therefore, our team is here to support you by conducting excursion studies. We will provide you a full analysis on the quality of your product during exposure to a rise in temperature and humidity.
  • Photostability
Providing photostability data is a standard requirement for any new drug application. We have the capacity to support your photostability requirements and provide you with a full analysis from direct exposure to exposure in final packaged product. At the end of each exposure period, we examine physical changes and report assay and impurities which are likely to arise from photochemical degradation processes.
  • Stability Storage

We also work with clients who have storage only requirements. They may need a special condition for which they don’t have the capacity, or they simply don’t have the space or budget to house their own stability chambers. We can pull and ship in the same day, accommodate next day delivery, and we can also accommodate controlled shipping conditions.

  • Business Continuity
Having a plan in place in the event of a disaster is general good practice for any business. We offer business continuity support to our clients detailing transfer protocols that can be executed within an agreed time frame should a disaster occur.
Test Method Transfer
Method transfers, as a regulatory requirement, ensure a laboratory demonstrates its capability and competency to perform a transferred method correctly. The purpose of method transfer activities are to avoid release of product that does not meet specification and likewise, avoid rejection of compliant product.
Whether you are looking for a new laboratory for QC release testing, or you need support on method development and validation, our team of analytical development scientists have an integrated approach for both transfers in and out of our laboratory.
iStock-905433716

A fully integrated approach to analytical studies

Our team of scientific and regulatory experts, backed by our well-established analytical capabilities, understand your specific challenges and opportunities and are committed to working with you to bring life-enhancing healthcare products to market.

Need a consultation?

Contact us today to discuss your requirements for a laboratory Partnership.