Q. Our company needs more stability storage. What issues should we consider when deciding whether to build our own biorepository facility or outsource our storage?

A. In addition to questions of location, available facility space, and capital-equipment cost, as discussed in an article in September’s Equipment and Processing Report, you should consider the time and expertise needed to maintain regulatory compliance. Any cGMP facility should incorporate chambers and rooms that are built using the most modern techniques. They must be mapped and validated for pharmaceutical stability storage and biotechnology product storage. Outsourcing companies can tailor these temperature and humidity-controlled rooms and chambers to suit individual customer requirements, as well as to accomodate shelf-life studies, intermediate testing, and accelerated testing per International Conference on Harmonization’s (ICH) Q1A (R2) (1).

The assessment of drug-substance stability is a vital and essential aspect of the development of pharmaceutical products. Stability testing is capable of providing information on how environmental factors such as temperature, humidity, and light affect a product’s quality over a period of time. Data derived from a stability study enables recommended storage conditions, retest intervals, and shelf lives to be evaluated and established.

It is the norm for controlled environment rooms to be built and validated to provide climatic conditions specified in ICH guidelines. Rooms should include equipment to allow for simulating conditions in all four climatic zones for long-term, intermediate, and accelerated testing. An outsourcing facility should have a comprehensive range of conditions including ICH Photostability Option 1 and Option 2 studies, as well as the capacity for customization. All staff should be fully accountable and provide a service that complies with regulatory requirements.

Reference

1. ICH, Q1A (R2), Stability Testing of New Drug Substances and Products (2003).

—Patrick Jackson is business development director at Vindon Scientific.

If you have a problem with your equipment or process, an industry expert may have the solution. Please send your question to Jennifer Markarian, editor of Equipment and Processing Report, and we may be able to provide an answer in a future issue. All questions will remain anonymous.