Quality Management

Quality is ingrained in our DNA
Our unwavering dedication to compliance with the latest regulations and the highest quality standards builds trust with clients and regulatory agencies alike. With a track record of inspections that speaks for itself (free from FDA 483 observations in over 20 years), we have earned a reputation for reliability, consistency, and quality.

Our pharmaceutical quality systems are built around internationally recognized cGMP principles and support every stage of GMP pharmaceutical manufacturing, from raw material qualification through commercial production.

Our Quality System is based on the cGMPs and adheres to the relevant quality guidelines such as ICH & ISPE and allows us to meet high compliance standards while implementing continuous improvement processes.

These pharmaceutical quality systems include standardized procedures, quality risk management, controlled documentation, change management and continuous monitoring to ensure manufacturing consistency and regulatory compliance.

We keep enhancing our quality system also by digitalization such as eBR (electronic Batch Record) as the first pharmaceutical manufacturer applying eBR in Spain. It provides real-time production execution, continuous monitoring and alerts of critical parameters whilst ensuring compliance requirement fulfilment and data integrity.

The integration of digital manufacturing technologies strengthens our cGMP manufacturing services by improving process traceability, reducing manual intervention and supporting electronic data management throughout production.

We adhere to the highest quality standards in every aspect of our processes, ensuring the safety, efficacy and compliance of your Small Molecule APIs and Intermediates. Our commitment ensures Top Pharma Quality.

Our facilities are regularly inspected by Health Authorities (FDA, European Authorities, PMDA, among others) and customers. With a track record of inspections that speaks for itself (free from FDA 483 observations in over 20 years), we have earned a reputation for reliability, consistency, and quality.

More than 20 years without FDA Form 483 observations reflects the effectiveness of our pharmaceutical quality systems and our commitment to maintaining inspection readiness every day, not only during regulatory inspections.

Regular inspections by international regulatory agencies, together with customer audits, verify that our GMP pharmaceutical manufacturing operations consistently meet global regulatory expectations.

Internal quality reviews, standardized procedures and continuous employee training help ensure that our manufacturing operations remain aligned with evolving GMP requirements and international quality guidelines.

Our comprehensive analytical departments span the entire product lifecycle, ensuring precision and quality at every stage.

Our analytical laboratories play a critical role in supporting GMP pharmaceutical manufacturing by providing reliable testing, method verification and scientific expertise throughout development and commercial manufacturing. Robust pharmaceutical quality systems and strict data integrity practices ensure that analytical results remain accurate, traceable and fully compliant with regulatory expectations.

Our key capabilities include:

• Development of new analytical methods.
• Optimization of existing analytical methods.
• Verification, validation and transfer of analytical methods.
• Analysis and release of raw materials, intermediates and APIs.
• Support the cleaning validation activities.
• Stability studies to define retest/expiry period of the intermediates and APIs.
• Characterization of standards and impurities.
• Elemental impurities evaluation.

Analytical testing is performed under controlled GMP procedures, ensuring reliable release decisions, product consistency and complete traceability throughout manufacturing operations.

Our team of regulatory experts play a crucial role throughout the entire project lifecycle, ensuring seamless preparation and delivery of all necessary registration documentation for intermediates and APIs.

They provide comprehensive support, ensuring compliance with the latest regulations and standards, and facilitating a smooth path to market approval for your products.

We handle submissions to global regulatory authorities, including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), European Directorate for the Quality of Medicines (EDQM), Japan PMDA, China FDA (CFDA), etc.

Our regulatory teams work closely with Quality Assurance, Manufacturing and Analytical Services to ensure that regulatory documentation accurately reflects manufacturing processes and complies with current international requirements.

Our services include:

• Drug Master Files for the EU, USA, Japan, China as well as other worldwide markets.
• Complete CMC documentation (Module 3.2.S) for approval applications.
• EP-Certificates of Suitability (CEP).
• Notifications of change.
• Assessment reports according to ICH Guidelines (genotoxic and mutagenic assessment, elemental impurities, residual solvents…)

Quality is not a static objective. At AGC Pharma Chemicals, continuous improvement is embedded within our pharmaceutical quality systems through ongoing process monitoring, periodic internal audits and continuous review of manufacturing performance.

For more than 20 years, our Operational Excellence Program, based on Lean and Six Sigma methodologies, has supported operational excellence across manufacturing, quality and laboratory activities.

Regular internal audits, management reviews, CAPA processes and employee training help ensure that our GMP pharmaceutical manufacturing operations continue to meet evolving regulatory expectations while identifying opportunities for further improvement.

This culture of continuous improvement contributes directly to our long-standing regulatory track record, including more than 20 years without FDA Form 483 observations.