Quality by Design
Where Scientific Rigor and Manufacturing Excellence Converge for Reliable, High-Performance Results
Quality
Quality Management
Sinopep is fully committed to providing the highest quality products and services. The Sinopep "Quality Manual" is established based not only on the requirements of regulatory agencies such as NMPA, US FDA, EMA, ICH, and regulatory guidelines such as 21 CFR Part 210/211/820 and ICH Q7/Q8/Q9/Q10, but also on Sinopep's top management's strong commitment to ensuring our operation and control of processes in CMC (Chemistry, Manufacturing and Controls) are conducted in full compliance meeting the highest level of global quality requirements.
Sinopep’s Quality System spans the entire product lifecycle, encompassing all phases of clinical development, commercial launch, and post-launch activities.
- Quality System
- Laboratory Control System
- Material Management System
- Production Management
- Facility & Equipment Management
- Packaging & Labeling System
These elements are effectively implemented across all stages of the product lifecycle, with consideration given to the specific objectives and requirements of each phase. Opportunities for quality improvement and efficiency enhancement through innovative solutions are carefully assessed and introduced at appropriate timepoints, ensuring full regulatory compliance.
Established based on ICHQ7 requirements
Quality Systems: Four Layers of Support
Sophisticated Quality Control Document System
| Quality System Area | What It Covers |
|---|---|
| Master Documents / Quality Manual / SOPs | Documentation hierarchy governing all GMP operations |
| Raw Material & Finished Product Release | Testing and release criteria ensuring every batch meets specification before use or shipment |
| Equipment Calibration & Qualification | IQ/OQ/PQ protocols and routine calibration to maintain validated, audit-ready equipment |
| Change Control | Structured review and approval process for any change affecting product quality or compliance |
| Deviation / OOS Investigation | Root cause investigation and resolution for any deviation or out-of-specification result |
| Product Quality Review | Periodic trend analysis confirming consistent process performance and product quality |
| CAPA Management | CAPA management — corrective and preventive action system closing the loop on quality issues |
| Training Programs | Documented, role-based training ensuring staff competency on GMP procedures |
In-House Release Testing
CGMP Specifications
Our CGMP specifications and testing procedures include the following:
- Appearance: Solid, off-white to white
- Solubility: Clear solution at specified concentration
- Purity (HPLC/UPLC): 95–98% (phase-dependent)
- Molecular Weight (MS) / AAA: Within ±10% of theoretical value
- Peptide Content: ≥70%
- Counter-Ion Content: Report
- Elemental Impurities (ICP-MS): Report Sb, As, Bi, Cd, Cu, Pb, Hg, Mo, Ag, Sn
- Endotoxin: Report LAL (Gel Clot) per USP
- Bioburden: Report aerobic and spore counts per USP
- Residual TFA: ≤0.1%
- Residual Solvents: GC-MS, report
- Moisture (Karl Fischer): ≤10%
Regulatory affairs
IND & NDA Regulatory Support
Sinopep delivers end-to-end regulatory expertise for U.S. and global IND and NDA submissions, ensuring seamless compliance and successful approval of your peptide APIs.
- Full batch record review and certification
- Secure document management and version control
- Deviation investigations and root-cause analysis
- CAPA development, implementation, and tracking
- Complaint handling and resolution
- Final product release and CoA issuance
- Phase-appropriate quality system design and consulting
- CMC section drafting and technical writing
- CDMF preparation, compilation, and eCTD submission
- Annual Product Quality Reviews (APQR)
Regulatory
Inspection History
Since 2014, Sinopep’s GMP manufacturing facilities have successfully passed four (4) inspections conducted by the U.S. FDA, demonstrating our strong commitment to global regulatory compliance and product quality. In addition to these FDA audits, Sinopep has also undergone inspections by the Korean MFDS and has successfully completed 20 regulatory audits conducted by the NMPA in China.
| Date | Inspected Product | Inspection Type | Result |
|---|---|---|---|
| Apr 2014 | Peptide API (Eptifibatide) | FDA CGMP | Pass |
| Apr 2016 | Peptide API (Eptifibatide, Lanreotide acetate) | FDA CGMP | Pass |
| Jan 2019 | Peptide API (Eptifibatide, Lanreotide acetate, Bivalirudin, Octreotide acetate) | FDA CGMP | Pass |
| Nov 2023 | Small Molecule & Peptide API | MFDS CGMP | Pass |
| Sep 2024 | Peptide API (Tirzepatide, Semaglutide, Liraglutide, Cetrorelix acetate, Eptifibatide, Octreotide acetate, Bivalirudin, Lanreotide acetate, Desmopressin Acetate) - Unannounced Inspection | FDA CGMP | Pass |
| July 2025 | Semaglutide & Liraglutide | ANVISA CGMP | Pass |
