Excipients, Ingredients, API and Finished Products
Manufacturers take various approaches to raw materials testing compliance. Some manufacturers will qualify a raw materials supplier by performing a detailed vendor audit followed by an annual vendor qualification which may consisting of full pharmacopeial monograph testing on three lots of each of the materials that they procure. If the qualification lots test successfully, then subsequent material shipments will require only monograph identification testing.
However, not all manufacturers follow the vendor assurance route and many companies that take a more conservative approach to raw materials instituting a release testing approach which requires full monograph or specification testing for each lot of supplied material.
Tepnel is able to support our customers down which ever pathway they choose to follow.
In terms of the GMP’s, it is a requirement that excipients and ingredient suppliers should be controlled through quality agreements and a formalised risk assessment be made based on these results. Tepnel has extensive experience in excipient testing and work in partnership with approved vendors for extending our service capability to include flame atomic absorption, spectrophotometry, atomic absorption spectrophotometry, elemental analysis, differential scanning calorimetry and thermogravimetric analysis.
In terms of active substances, it is a GMP requirement that supply chain traceability should be established and that the associated risks, from active substance starting materials to the finished medicinal product, should be formally assessed and periodically verified.
Tepnel can assist in developing and executing any appropriate measures or plans that require to be put in place to reduce any risks to the quality of the active substance.
Sections in Raw Material Testing Service
- ICH Stability Testing Services
- Batch Release Services
- Raw Material Testing Service
- Method Development and Validation
All Raw Material Testing Service
- Pharmacopoeial Monographs
- Excipients, Ingredients, API and Finished Products
- Pharmaceutical Microbiology Services