UK and EU IMP Release Testing
Focus on the things you can change and let go of the things you can’t!
For holders of a Manufacturer’s Authorisation for IMPs (MIA(IMP)) or equivalent, our IMP QC release testing services cover a wide range of formulations including oral dosage, parenteral, complex peptide and inhalation products.
Our focus is on delivering services in a manner that unlocks greater value for all stakeholders. 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 IMP release testing requirements.
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 increased efficiency and speed, reporting data earlier whilst maintaining compliance.
The advantages of our approach to outsourcing provides our partners with:
- A knowledge sharing environment which build both trust and transparency
- A focus on regular interaction which drives innovation
- A collaborative mindset which delivers outcomes through reciprocity
- An approach in which it is better to deliver outcomes rather than counting the steps taken
- 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
Batch release and lot release testing that requires both chemical and microbiology testing services, including:
- A wide range of analytical technologies including: HPLC (UV, PDA, FLU, ELSD, RI, CAD), UPLC (TUV, PDA, SQD), H-Class HPLC method development, LC/MS/MS, Maldi-Tof, GC, Isolator Technology, APSD (NGI, ACI), ELISA, SDS-PAGE
- Complete microbiological testing including: sterility testing, bacterial endotoxin (LAL) testing, bioburden analysis – harmonised absence of and total viable counts, microbial identification, preservative efficacy Testing, microbiological antibiotic assay, specialist microbiological method development and validation
- Complete compendial analysis (BP, EP, JP and USP) API, IMP, FP batch release testing and lot release testing for small molecules, inhaled products and biopharmaceuticals Method transfer and analyst exchange
Following Good Manufacturing Practice
With over 20 years of continuous cGMP accreditation from the MHRA, Tepnel supports testing for both certification and release.
Tepnel is a UK based MHRA certified Quality Control testing laboratory. As part of a leading global healthcare and diagnostics company, we strive to provide quality control laboratory analysis and biomarker research and development which helps advance the realisation of precision medicine and a value healthcare system which improves patient outcomes. We believe that it is our responsibility to provide our customers with high quality, regulatory compliant data.
Our customers gain access to our knowledge, experience and ability to help them simplify their studies which facilitates outsourced solutions that can work to achieve both incremental and transformational progress towards improving patients’ lives. We are successful because of our People. We are Progressive in our way of thinking. We believe in our Principles.
We recognise that outsourcing should be a continuum rather than a destination therefore as Vested Outsourcing practitioners we look to innovate and develop a different way of working with our partners in supporting the delivery of their desired outcomes. Vested is a new way in working in partnership, it requires a systematic change in mind-set, where by the partners are wholly committed to each other’s success creating a true win – win outcome.
Our Commitment to You
Tepnel’s triple A seal ensures Accountability, Affordability and Adaptability on all you IMP release testing requirements. As an advocate of Vested Outsourcing our focus is on delivering outcomes that add economic value.
Why should you talk to Tepnel?
- We have over 20 years of experience in batch release testing for a wide range of pharmaceutical companies.
- Our cGMP compliant facilities are located in Scotland, UK part of an innovative and world recognised Life Sciences Destination.
- We service a wide range of formulation types.
- We have particular experience in tablets/capsules, parenteral, inhaled and complex peptide formulations.
- Our laboratories cater for both chemical and microbiological analysis
- We can handle Schedule 1 through 4 licensed plus OEB/OEL category 2/3 materials.