In recent years, the Chinese pharmaceutical industry has experienced remarkable growth and has become a significant player on the global stage. As the industry expands, meeting international standards and regulations has become of utmost importance. GMP audits play a vital role in ensuring compliance with these. However, conducting effective GMP audits in Chinese pharmaceutical companies presents a distinct set of challenges. In this article, we will explore some of these challenges and discuss potential solutions.
Language Constraints and Cultural Barriers
One of the primary difficulties encountered during GMP audits in Chinese pharmaceutical companies is the language barrier. Many auditors from Western countries may not be proficient in Mandarin or other Chinese dialects. This language gap can impede effective communication, understanding, and interpretation of regulatory documents and procedures. Additionally, disparities in cultural norms and business practices can lead to misunderstandings, further complicating the audit process.
Diverse Interpretations of Regulatory Requirements
Pharmaceutical regulations and guidelines are open to interpretation, and different interpretations can result in compliance discrepancies. Chinese pharmaceutical regulations may differ from those of Western countries, leading to varying expectations during GMP audits. These differences in interpretation can encompass quality management systems, documentation practices, data integrity, and more.
Audit Approach and Risk Management
Chinese pharmaceutical companies more often adopt a traditional “checklist” approach to GMP audits. Their focus is usually more on ticking off specific compliance requirements without necessarily considering the broader risks associated with their processes. In contrast, in Europe and the US, GMP audits are typically more risk-based. Auditors prioritize identifying and assessing the critical risks within a company’s operations and supply chain. This risk-based approach tends to concentrate on areas that have the most significant impact on product quality and patient safety.
At the same time the risk management approach of Chinese pharmaceutical companies tends to be more reactive than proactive. While they are often adept at problem-solving, they may have limited experience or emphasis on comprehensive risk assessment and management. This reactive approach could lead to non-compliance with GMP standards. Many Chinese pharmaceutical firms can find it challenging to build a robust risk assessment framework in accordance with the newly revised ICH Q9 (R1) Risk Assessment that requires the removal of subjectivity and to identify hazards in the process and ways of working. Thorough risk assessments throughout the entire manufacturing process, supply chain and distribution channels will enable them, to identify potential risks and implement preventive measures to mitigate those risks effectively.
Slow Adaptation of Data Integrity and Computer Validation Practices
Data integrity and computer validation are critical aspects of GMP compliance, ensuring that data generated throughout the manufacturing process is accurate, complete, and reliable. However, the Chinese pharmaceutical industry has been slower in adopting robust data integrity and computer validation practices compared to Western counterparts. Only in the last few years we have seen improvements in these areas.
Complex Supply Chain and Outsourcing
The Chinese pharmaceutical industry often relies on a complex network of suppliers and outsourced manufacturing processes. Auditing these suppliers and ensuring compliance throughout the entire supply chain poses significant challenges. Lack of transparency and oversight in the supply chain can give rise to quality issues and regulatory non-compliance. Implementing a robust supplier qualification program is essential for ensuring the quality and safety of pharmaceutical products. Establishing clear guidelines for supplier audits and conducting regular inspections can help mitigate risks associated with outsourcing. Utilizing technologies such as track-and-trace systems can improve supply chain transparency and facilitate effective auditing.
Evolving Regulatory Landscape
The regulatory landscape in China’s pharmaceutical industry is continually evolving. New regulations and guidelines are being introduced, and compliance expectations are being heightened. Keeping up with these changes and implementing necessary updates in a timely manner can be challenging for both pharmaceutical companies and auditors.
Pharmaceutical companies must establish effective regulatory intelligence systems to monitor and stay updated on regulatory changes. Regular training and educational programs should be conducted to ensure employees and auditors are aware of the latest regulatory requirements. Engaging with regulatory authorities and industry associations can provide valuable insights and help navigate the evolving landscape.
At PNR Pharma, we recognize the significance of overcoming language and cultural barriers by utilizing experienced local QA personnel who are fluent in both Mandarin and English. They accompany the QPs during GMP audits, bridging the communication gap and enhancing the effectiveness of the audits. Our experienced auditors have conducted numerous audits in the region and possess a deep understanding of the local culture and business practices, enabling them to navigate the cultural landscape more effectively. This enables us to provide consistent and fair assessments of compliance, effectively addressing varying interpretations. Following successful completion of the required GMP audits, PNR’s EU QPs and UK QPs can issue QP declarations for commercial supplies and IMPs.