Vitex Analytical Services (VAS) boasts a brand new, state-of-the-art chemical and microbiological laboratory. The high-quality laboratory division, driven by an exceptional team of scientists offers a broad range of knowledge and expertise for your regulatory submissions and quality compliance. Underscored by the breadth of experience of manufacturing thousands of products, you’ll feel assured of the quality and integrity of your product and the scientific data of which it is founded.
We work at every stage of the product lifecycle allowing speed and efficiency of being in-house. The fully equipped GMP laboratories provide comprehensive analysis of:
Finished products and release for sale (complementary medicines, pharmaceutical products, household products, veterinary products and personal care/cosmetics)
We cover a diverse range of international compendial and standard methods for chemical analysis including but not limited to the British, European, Japanese, United States Pharmacopeia, International Conference on Harmonisation (ICH), International Organization for Standardization (ISO) and Food Chemicals Codex (FCC). We can also accommodate customer supplied methods.
Our strong method development capabilities have yielded the successful development and validation of many new methods across various analytical techniques. Specialising in method development for UPLC, HPLC, GC and ICP analysis. We can support the entire process from protocol preparation, analytical testing to the final report.
Quality and integrity of data is paramount at Vitex and is governed by our Quality Assurance procedures. Protocols are strictly adhered to and established investigation procedures require the evaluation of results using sound scientific reasoning including but not limited to the following areas:
The general principles around stability testing is to provide evidence on how the quality of a material or product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light. It also provides supportive data to establish the shelf life and recommended storage conditions for the product or retest period for a material. Stability information is vital for initial product registration and/or Product Quality Review (PQR).
The study approach varies depending on the product and at Vitex we offer a comprehensive stability trial design providing scope and rationale while taking into consideration the composition of a product (for example, the closure system, the technical difficulties that may be associated with stability testing of a complex multi-ingredient complementary medicine), as well as selecting the appropriate climatic zones for the end market:
The stability chambers at Vitex are secure and fully validated to meet GMP regulations and can be utilised for both long term and short-term shelf life studies. All are monitored in real time with audible and visual alarms for temperature and humidity (above and below set conditions) with emergency back-up utilities on site, guaranteeing that the conditions are maintained at all times.
Vitex Analytical Services provide a full suite of analytical tests to generate data which allows a definitive conclusion regarding the stability of a product. The strong method development capabilities have yielded the successful development and validation of stability indicating methods across various analytical techniques.
Reporting of stability data is performed in a timely manner and any out of specification results are acted on immediately. Reports are issued providing a summary of the study detailing any trends along with recommendations for product reformulation.