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What are the best practices for mitigating GMP risks in emerging markets?

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Emerging markets offer great opportunities for pharmaceutical and biotech companies, but they also pose significant challenges in terms of quality management and compliance. Good Manufacturing Practice (GMP) is a set of standards and guidelines that ensure the quality, safety, and efficacy of drugs and medical devices. However, GMP regulations and enforcement vary widely across different regions and countries, creating potential risks for manufacturers and distributors. How can you mitigate these risks and ensure your products meet the highest quality standards in emerging markets? Here are some best practices to consider.

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Mustafa Kayyali

HE Higher Education Ranking
Md. Saddam Nawaz

Senior Manager @ ACI HealthCare Ltd | Leading Site QMS | Championing Global Compliance & Operational Excellence |…

1 Assess the local GMP landscape

Before entering an emerging market, you need to conduct a thorough assessment of the local GMP landscape. This includes understanding the regulatory requirements, the level of enforcement, the availability of qualified personnel and suppliers, the infrastructure and logistics, and the cultural and ethical norms. You also need to identify the potential gaps and risks between your own GMP standards and those of the target market, and develop a plan to address them. For example, you may need to adjust your product specifications, packaging, labeling, or testing methods to comply with local regulations or customer preferences.

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Mustafa Kayyali

HE Higher Education Ranking
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Mitigate Good Manufacturing Practice (GMP) risks in emerging markets by: 1. Local Expertise: Utilize local experts familiar with regulatory landscapes. 2. Robust Training: Implement extensive training programs for staff on GMP principles. 3. Supplier Oversight: Thoroughly vet and monitor suppliers for compliance. 4. Regular Audits: Conduct frequent and rigorous internal and external audits. 5. Adaptability: Stay abreast of evolving regulatory requirements and adapt processes accordingly. 6. Technology Integration: Employ advanced technologies for data monitoring and reporting. 7. Cross-functional Collaboration: Foster collaboration between regulatory, quality, and production teams.

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2 Implement a robust quality management system

A quality management system (QMS) is a set of policies, procedures, and processes that ensure your products meet the quality objectives and expectations of your stakeholders. A robust QMS should cover all aspects of your product lifecycle, from design and development to manufacturing and distribution. It should also be aligned with the international standards, such as ISO 9001 or ICH Q10, and incorporate the principles of quality risk management, continuous improvement, and customer focus. A QMS can help you monitor and control your GMP performance, identify and resolve quality issues, and prevent quality deviations or non-compliances.

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3 Train and empower your staff and partners

Your staff and partners are the key to your GMP success in emerging markets. You need to ensure they have the necessary skills, knowledge, and awareness to follow your QMS and GMP standards. This means providing regular and comprehensive training, coaching, and feedback to your employees and contractors, as well as verifying their competencies and qualifications. You also need to empower them to make quality decisions, report quality problems, and suggest quality improvements. Moreover, you need to foster a culture of quality that values collaboration, communication, and accountability across your organization and supply chain.

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Fernando Palacios Sanchez

Customer Experience CX Expert | MicroMaster Corporate innovation | Desing Thiking | Marketing Digital | UX |
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La capacitación al personal y a los socios puede significar el éxito sostenido o fracaso de la implementación de SGC y GMP. En mi experiencia es necesario realizar diversas rondas de capacitación previa a la implmentación de los estandares y por lo menos una vez al verificar las competencias mediante herramientas ya sean de evaluación tradicional o ludicas (apoyadas en herramientas online). Basados en los resultados de las evaluaciones podremos identificar que aspectos se deben reforzar en el equipo o que aspectos no han sido lo suficientemente desarrollados. También es importante fomentar la capacidad de decisión ya que esto permite liberar cuellos de botella o gestionar acciones de calidad en el momento que se presenta el desvió.

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4 Conduct frequent and thorough audits and inspections

Audits and inspections are essential tools for verifying your GMP compliance and performance in emerging markets. You need to conduct frequent and thorough audits and inspections of your own facilities, processes, and products, as well as those of your suppliers, distributors, and customers. You need to use a risk-based approach to prioritize your audit and inspection activities, and follow the relevant guidelines, such as ISO 19011 or ICH Q9. You also need to document and communicate your audit and inspection results, findings, and recommendations, and implement corrective and preventive actions (CAPAs) to address any quality issues or gaps.

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5 Leverage technology and innovation

Technology and innovation can help you enhance your GMP capabilities and efficiency in emerging markets. You can leverage various technologies, such as cloud computing, data analytics, artificial intelligence, blockchain, or internet of things, to improve your QMS and GMP processes, such as data management, document control, quality monitoring, risk assessment, or traceability. You can also adopt innovative approaches, such as quality by design, process analytical technology, or lean manufacturing, to optimize your product quality, reliability, and productivity. However, you need to ensure that your technology and innovation solutions are compatible with your GMP standards and requirements, and that they are validated and verified before use.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Md. Saddam Nawaz

Senior Manager @ ACI HealthCare Ltd | Leading Site QMS | Championing Global Compliance & Operational Excellence | Advancing Pharmaceutical Quality Through Robust Data Governance Program | Lead Auditor | Mentor | Father
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Building relationships with local regulatory bodies goes beyond mere compliance—it's a strategic imperative. Open communication channels with health authorities foster a collaborative approach. Proactive engagement proved invaluable during regulatory updates, ensuring a seamless transition to new requirements. Cultivating such partnerships is foundational in emerging markets, creating a symbiotic environment where industry practices align with evolving regulatory landscapes. This not only enhances compliance but also positions organizations to anticipate and navigate regulatory changes adeptly, fostering long-term success in dynamic markets.

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What are the best practices for mitigating GMP risks in emerging markets?

1

2

3

4

5

6

1 Assess the local GMP landscape

2 Implement a robust quality management system

3 Train and empower your staff and partners

4 Conduct frequent and thorough audits and inspections

5 Leverage technology and innovation

6 Here’s what else to consider

Quality Management

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What are the best practices for mitigating GMP risks in emerging markets?

1

2

3

4

5

6

1 Assess the local GMP landscape

2 Implement a robust quality management system

3 Train and empower your staff and partners

4 Conduct frequent and thorough audits and inspections

5 Leverage technology and innovation

6 Here’s what else to consider

Quality Management

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