Ensuring GMP Compliance: Consulting Services for a Japanese Pharmaceutical Company

Background:

Our client is a well-known Japanese pharmaceutical company with established subsidiaries across Europe, and the Americas, and collaborates extensively with multinational pharmaceutical partners. To enhance its market position and facilitate growth in Asian countries, including China, the client required a robust strategy for maintaining GMP compliance and ensuring product quality at its international manufacturing sites.

Client Needs:

The client required comprehensive GMP compliance solutions to address several critical needs:

• Ensuring consistent quality management at their manufacturing sites in China.

• Conducting thorough GMP inspections and audits to identify and rectify high-risk deficiencies.

• Providing bilingual GMP inspection reports to facilitate effective communication and understanding.

• Implementing actionable Corrective and Preventive Actions (CAPAs) to address identified issues promptly.

• Supporting the alignment of their global business strategies with regulatory requirements.

Scope of Services:

To meet these needs, AUSTAR provided tailored consulting services for the client's manufacturing site in China, including:

• Process validation audits

• Mock-up inspections and compliance consulting

• QC, validation and quality system audits

• GMP inspection consulting

• Quality agreement services

AUSTAR Contributions and Customer Benefits:

• Facilitated effective quality management at the client's manufacturing sites in China.

• Provided bilingual GMP inspection reports (Chinese and English), highlighting and addressing high-risk deficiencies.

• Developed and implemented efficient CAPA plans to ensure timely corrections.

• Supported the client's strategic goals and regulatory compliance across global markets.