ASAPprime® uses experimental data at a range of highly accelerated conditions to model the shelf-life of products based on both chemical and physical stability in as little as four weeks. FreeThink is the leader in conducting such studies for many purposes including determining packaging and solving stability problems.
- Peptides and oligonucleotides
- Medical devices
- Oxygen sensitivity
cGMP ASAPprime® Studies
FreeThink offers ASAPprime® laboratory studies with three levels of quality review:
- Standard Level
- Analytical methods verified for use, but no formal method transfer or validation is conducted.
- Report includes details and recommendations.
- Quality Assurance Reviewed
- Maintains high scientific integrity provided at the Standard Level.
- Includes a Quality Assurance (QA) review and signature for all data in the report.
- A Full cGMP ASAPprime® Study and Report
- Recommended for regulatory filings with late-stage and post-approval applications.
- Analytical work is carried out according to FreeThink's SOPs, with customer prior approval. Analytical methods are transferred according to a formal protocol, often using co-validation.
- Samples are analyzed based on the protocol according to SOPs for each step.
- All instruments are certified based on their qualification (IQ/OQ/PQ) and calibration documentation.
- Software used has appropriate qualification documentation.
- All data used and reports generated are reviewed and signed by FreeThink's experienced QA staff.
ICH Stability Studies
When long-term stability studies are required, FreeThink laboratories can carry out the studies using a customer-agreed level of quality that can be fully cGMP based on agreed protocols and FreeThink's quality system.
- Qualified chambers store products at ICH long term and intermediate (25°C/60%RH, 30°C/65%RH), accelerated (40°C/75%RH), Zone IVb (30°C/75%RH) and refrigerated (5°C) conditions.
- Packaging of small-scale batches of products (bottles, blisters) for testing is available.
- Studies can be carried out for information only or under the FreeThink Quality Management System, using the most modern systems and risk management approaches:
- SOPs cover all operations
- All instrumentation fully validated
- All staff fully trained
- Analytical testing includes most standard techniques (e.g., HPLC, dissolution, KF)
- Experienced staff can assist with protocol design and report generation compliant with international regulations and guidelines
- Customers are invited to audit FreeThink’s quality systems and meet the scientists and QA professional staff