Risk Management & Compliance

Making Informed Decisions

Manufacturing Characteristics and QbD

All steps in a manufacturing process where materials are exposed to the ambient atmospheric conditions create a situation for moisture uptake or loss. The outcome for materials and processes can have a huge impact on quality, time and costs. Managing moisture as a quality risk to the patient is part of the overall Quality Target Product Profile (QTPP). Within this quality framework, successful risk management of moisture requires identifying the critical quality attributes (CQAs), and critical process parameters (CPP) for each drug product.

Until now, technology has not been available with high enough specificity and precision to test and define moisture as a CQA.  Relequa’s precision Moisture Profiling™ opens up an opportunity to implement the Quality by Design (QbD) approach recently adopted by the International Conference on Harmonization (ICH). The diagram below shows how QbD can be applied to controlling moisture in a manufacture process environment.

risk-decision-chart

In Phase 1 we characterise the moisture status of in-process materials and defined the critical points. The moisture status of materials is defined by the Water Vapour Equilibrium Point or WVEP that we measure using Moisture Profiling™. These results become the moisture CQAs for the product.

In Phase 2 we align the WVEP of in-process materials with the process room’s %RH to create a map that identifies the moisture control points and defines the CPPs. Focusing on, where in the process the product is exposed to humidity; at what level and for how long, before a significant change in moisture status occurs. For example, tablets being transferred to a hopper at a packing line and exposure to the environment before they are sealed within their packaging.

By Phase 3 we have assessed the risk of moisture exposure throughout the manufacturing process and set limits for an acceptable WVEP at each stage (IPCs). This becomes part of the overall QTTP for regulatory compliance and patient safety. At Relequa we have developed an innovative protocol to run as a Moisture Profiling™ Test. The principle behind the Moisture Profiling™ Test uses the natural ability of materials to adjust to the %RH of the surrounding air in a closed chamber. Where the WVEP (moisture status) of a material has changed from its specification we can detect the change in the Moisture Profiling™ Test in as little as 3 minutes.

Our new Moisture Profiling Test offers you a 21 CFR Part 11 compliant rapid test for controlling the moisture in your products.

Contact us to find out how we can help you manage the risk of moisture from the manufacturing site to throughout the commercial supply chain.

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Handling and Shipping

Products from commercial manufacture are stored in a warehouse/finished goods area, then shipped to a distribution site to be stored again until they are shipped to pharmacies. The drugs within their packaging have a shelf-life based on formal stability studies that are performed under controlled temperature and humidity conditions. Because of complexity and cost, such stability studies cannot take into consideration the range of temperature and humidity conditions a product undergoes when being handled and shipped within the post-manufacture supply chain. A recent introduction to pharmaceutical supply chain logistics is Controlled Room Temperature (CRT) shipment.

Indications from the US Food and Drug Administration (FDA) is that CRT is to come under regulatory scrutiny. Also the UK Medicines and Healthcare products Regulatory Agency (MHRA) have talked at supply chain conferences about CRT scrutiny where the recently updated (November 2013) Good Distribution Practice of medicinal products for human use Guidelines (2013/C 343/01) is being cited. These guidelines mention humidity as a consideration in storage and that products need to be protected from the harmful effects of moisture.

Relequa’s precision Moisture Profiling™ offers Point-to-Point analysis of the moisture status of your drug products. Whatever ambient conditions, CRT shipment and/or temperature-humidity excursions your products may have experienced in transit and storage, any change due to moisture gain, or loss, can now easily be detected using Relequa’s unique technology.

By comparing your product’s moisture profile at release from the manufacturing site to its profile at any point in the supply chain, will quickly show if its moisture status has changed, or remains within its moisture specification. Our Moisture Profiling™ software allows you to overlay moisture profiles for easy comparisons.