1 Understand the GMP landscape

The first step to overcoming GMP differences across borders is to understand the GMP landscape and the main players involved. GMP is not a universal standard, but rather a set of guidelines and regulations that vary depending on the country or region where you operate, manufacture, or distribute your products. Some of the most influential GMP authorities are the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the World Health Organization (WHO), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). These authorities have their own GMP regulations, inspections, and certifications, but they also collaborate and harmonize their standards to some extent. For example, the ICH Q7 guideline provides a common framework for GMP for active pharmaceutical ingredients (APIs) that is accepted by the FDA, the EMA, and other regulators. However, there are still some differences and nuances that you need to be aware of and follow.

2 Assess your GMP compliance

The second step to overcoming GMP differences across borders is to assess your GMP compliance and identify any gaps or risks that you need to address. Depending on your business model, you may have to comply with multiple GMP standards, such as the ones from your home country, your target market, your suppliers, or your contract manufacturers. You need to conduct a thorough gap analysis and compare your current practices and procedures with the relevant GMP requirements and expectations. You also need to monitor any changes or updates in the GMP regulations that may affect your compliance status. You can use tools such as checklists, audits, risk assessments, and gap reports to help you with this process.

3 Implement GMP improvements

The third step to overcoming GMP differences across borders is to implement GMP improvements and close any gaps or risks that you have identified. This may involve revising or developing your GMP documentation, such as standard operating procedures (SOPs), quality manuals, validation protocols, batch records, and certificates of analysis (COAs). You may also need to train or retrain your staff, upgrade or validate your equipment, facilities, or systems, or modify or optimize your processes or methods. You should prioritize the most critical or urgent improvements and allocate sufficient resources and time to complete them. You should also document and track your progress and outcomes and verify that your improvements are effective and sustainable.

4 Communicate and collaborate with GMP stakeholders

The fourth step to overcoming GMP differences across borders is to communicate and collaborate with GMP stakeholders, such as regulators, customers, suppliers, or contract manufacturers. You need to establish and maintain good relationships with these stakeholders and ensure that you understand and meet their GMP expectations and requirements. You also need to communicate and share your GMP information and data with them, such as your GMP certificates, audits, inspections, deviations, corrective and preventive actions (CAPAs), or recalls. You should use clear and consistent communication channels and formats and avoid any misunderstandings or conflicts. You should also seek and provide feedback and support and work together to resolve any GMP issues or challenges.

5 Learn and adapt to GMP changes

The fifth step to overcoming GMP differences across borders is to learn and adapt to GMP changes and trends. GMP is not a static or fixed standard, but rather a dynamic and evolving one that reflects the latest scientific, technological, and regulatory developments and innovations. You need to keep yourself updated and informed about the GMP changes and trends that may affect your business and your compliance status. You also need to be flexible and adaptable and be ready to adjust your GMP practices and procedures accordingly. You should embrace continuous improvement and innovation and seek opportunities to enhance your GMP performance and competitiveness.

6 Seek GMP guidance and expertise

The sixth and final step to overcoming GMP differences across borders is to seek GMP guidance and expertise from external sources, such as consultants, trainers, auditors, or associations. These sources can provide you with valuable insights, advice, support, and resources to help you navigate the complex and diverse GMP landscape and achieve your GMP goals and objectives. They can also help you benchmark your GMP practices and procedures against the best practices and standards in the industry and identify areas for improvement or optimization. You should leverage their GMP knowledge and experience and use them as a reliable and trusted partner for your GMP success.

7 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?