Out of specification investigations
Concept Life Sciences’ extensive experience of GMP and GLP analytical method validation and testing is invaluable in executing out of specification investigations.
What is an Out of Specification (OOS) Result?
An out of specification result is an atypical analytical result for an active ingredient or product batch, test item or similar, whereby the result obtained does not meet the agreed product specification (e.g. within the product registration, drug master file, marketing authorisation, pharmacopoeial monograph, internal specifications etc).
This could encompass:
- Batch release testing for finished products or active ingredients (AI)
- Testing of starting materials, raw materials, inactive ingredients
- In certain circumstances, In-Process Control testing
- Stability studies on finished products and or active ingredients (marketed products)
- Batches manufactured for clinical trials
- Release testing for product registration (e.g. 5 batch analysis)
Carrying out the investigation
Applying the most up-to-date regulatory guidance, Concept Life Sciences use their expertise to carry out a detailed laboratory investigation, with the objective of discriminating between an OOS result with an assignable cause and a genuine OOS batch or test item.
We can support your manufacturing and quality teams in carrying out extensive and timely hypothesis testing, root cause analysis, appropriate retesting and resampling / testing, and provide a detailed analytical dossier plus OOS investigation document to include with your batch records.
The investigation involves several stages, from the initial laboratory assessment through to a detailed manufacturing investigation (undertaken by the manufacturing site). Our quality assurance team, plus appropriately skilled and experienced technical reviewers, have oversight of every step of the process.
Bioanalysis and biomarkers
Cleaning validation and verification
Clinical and commercial manufacturing
Contaminants and foreign bodies
GXP analytical method development, validation and transfer
Process research and development and pre-clinical API manufacture
QC release and GMP release testing
Storage stability studies