Raw Material Testing
Testing raw materials ensures that any components to be used in the production and manufacture of pharmaceutical products are suitable for their intended use. Conducting raw materials analysis using the appropriate test and compendial methods can prevent costly production problems and delays.
The rules governing medicinal products in the European Union require that:
“The selection, qualification, approval and maintenance of suppliers of starting materials, together with their purchase and acceptance, should be documented as part of the pharmaceutical quality system. (Chapter 5, Clause 27)”.
Tepnel offers a comprehensive raw material testing, pharmacopoeial testing and microbiology testing of pharmaceutical excipients and ingredients service. Our raw material testing services can be used to meet a wide range of different purposes, such as prequalification, acceptance of consignments;
Batch release testing, in-process control, special controls, inspection for customs clearance, deterioration or adulteration or for obtaining a retention sample.
We can provide assurance that any constituent used in your process or product has not been changed and is fit for its intended purpose, with over thirty years’ experience in both pharmacopoeial testing and raw material testing, including acting as an Official Medicines Control Laboratory on behalf of the then Medicines Control Agency of the UK.
Our raw material testing supports formulation development within research and development, release of excipients and active pharmaceutical ingredients used in finished product manufacturing and the qualification of raw material vendors:
- Complete compendial analysis (BP, EP, JP and USP)
- A range of CMC techniques including; USP <467> residual solvent testing, HPLC, GC and IC analyses, spectrophotometric analyses (FTIR, UV/VIS), heavy metals testing, purified water and sterile water for Injections testing, Karl Fisher analyses, wet chemistry analyses
- Client-supplied or vendor-defined methods
- The complete suite of microbiological tests and assays
