Inspection Results: FDA inspections (Form 483 and Material Findings) have established an excellent quality control system with no complaints for more than 20 years.
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Drive Digitalization: Our eBR (Electronic Batch Record) is integrated with the plant’s DCS (Distributed Control System), automatically extracting data synchronized with the plant equipment, ensuring accuracy and reliability in records, ensuring robust data management.
Regulatory application support: We will prepare reports of various application forms according to the production of APIs and intermediates at our company and support the customer’s regulatory affairs application.
Quality assurance
AGC Pharma Chemicals has a rich track record of inspections by the FDA, PMDA, and EMA, and has conducted more than 23 inspections since 2001. We have a proven track record of handling commercial and late-stage development projects that require a higher level of cGMP management.
FDA inspections (Form 483 and Material Findings) have resulted in excellent quality control systems with no nominations for more than 20 years.
AGC Pharma Chemicals is committed to supporting our customers in the manufacturing and development of APIs and intermediates while adhering to the highest quality standards.
Inspections & Audits
We manufacture with the latest cGMP compliant quality control system. By committing to continuous improvement, we have won high trust from FDA, PMDA, EMA, and customers.
Summary of Health Authority inspections
USA, FDA
1999 |
2002 |
2004 |
2009 |
2015 |
2017 |
2023 |
Europe, AEMPS
2012 |
2015 |
2018 |
2024 |
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Japan, PMDA
2007 |
2012 |
2018 |
2023 |
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Quality Control
AGC Pharma Chemicals’ analytical department ensures high quality at every step from development to manufacturing. Key services include:
- Development of new analysis methods
- Optimization of existing analysis methods
- Verification, validation, and transfer of analysis methods
- Analysis and shipment of raw materials, intermediates, and APIs
- Support for cleaning validation
- Stability testing for retesting intermediates and APIs/setting quality expiration dates
- Characterization of reference materials and impurities
- Evaluation of elemental impurities
Main Analytical Instruments:
- HPLC
- UPLC
- GC-HS
- HPLC-MS
- GC-MS
- RAMAN
- DSC
- Analytical Techniques for particle size measurements
- Laser diffraction
- XPRD
Regulatory Application Support Service
AGC Pharma Chemicals provides intermediate and API data required for various applications from preclinical studies to commercial manufacturing, and provides a report in the form of an application.
We ensure compliance with the latest regulations and standards, and support regulatory submission procedures with regulatory authorities worldwide, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Japan PMDA, and China FDA (CFDA).
Service Overview:
- Drug Master File (DMF) for the EU, US, Japan, China and other global markets.
- CMC documents for approval application.
- EP Certificate of Conformity (CEP).
- Change Notices.
- Evaluation report based on ICH guidelines (genotoxicity and mutagenicity assessment, elemental impurities, residual solvents, etc.).
