Focus on the things you can change and let go of the things you can’t!
At Tepnel we focus on delivering a specific set of services in a manner that unlocks greater value for both our customers and ourselves. Through the use of the Vested outsourcing philosophy and lean manufacturing tools, we seek to eliminate waste through innovating the way in which we manage your ICH Stability testing.
By value Stream mapping of the processes, including upstream and downstream activity, we are able to offer our customers additional economic value, which results in reduced outsourcing cost to the Contract Giver and increase efficiency and speed, reporting data earlier whilst maintaining compliance.
The advantages of our approach to outsourcing provides our partners with:
Zero cost at T(0) on all ICH stability programmes
Upto 50% cost saving on full stability management of your product portfolio
Process innovation that results in approximately 35% reduction in turnaround times
A management approach to L2L method transfer which is based on reciprocity and which takes away the risk of changing from your current supplier
Contact us today to take advantage of our experience and use this opportunity to drive down your outsourcing budget, whilst your Programme Managers have ensured supply chain trust and improved efficiencies that help you to manage the economics of bringing a drug to market.
Please complete the form below or call 01506 424270 to speak with your Relationship Managers at Tepnel Pharma Services.
Continue reading to find out more about our ICH stability testing services
Tepnel Pharma Services have been supporting global partners in pharmaceutical development for over 30 years. Supporting all key ICH climatic zones from our in-house stability storage suite, our services are suitable for long term, intermediate, accelerated, photo-stability, in-use and FUST stability trials.
We understand that stability testing is a key component of the chemical, manufacturing and control (CMC) section of the Common Technical Document. We recognise that the data generated is important in ensuring both patient safety and delivery of the efficacious amount of active ingredient throughout the shelf life of the manufactured product.
At Tepnel we have gained over 30 years of experience across API’s and a specific range of formulation types for small molecules and complex peptide mixtures; tablets, capsules, parenteral and inhalation devices/formulations.
Our GMP compliant facilities in Livingston, Scotland are MHRA and FDA inspected and contain an environment for storage which is continuously monitored, mapped, annually qualified and validated to ensure ongoing compliance and traceability to national standards. With an investment in technology our analytical testing laboratories including full on site pharmaceutical microbiology support, we have the range of detection systems and compendial testing capability to deliver physical, analytical and microbiological data.
Our ICH stability testing services include:
- ICH Storage conditions: 25°C/60% RH, 30°C/65% RH, 40°C/75% RH, 3-8ºC and -20ºC
- Other non-standard temperatures and relative humidity’s on request in our on-site stability suite
- Stability testing and analysis (HPLC, LC/MS, GC, CE)
- Forced degradation studies including; photo stability, oxidation, thermal stability
- EP/BP/USP and JP Compendial testing
- Isolator technology for Sterility assessment
- Package integrity
- Endotoxin levels (LAL) and Bioburden
- Dedicated project management and analytical staff