What are the steps to ensure your R&D lab is licensed and certified?

Following major steps are necessary: 1. QMS to follow up the entire working environment 2. Risk Management 3. Environmental Health and Safety

In my Experience, Before embarking on the journey to license and certify your Pharma R&D lab, it's crucial to identify the specific requirements mandated by regulatory bodies. In a biopharmaceutical R&D facility, we had to meticulously identify the requirements set by the FDA (Food and Drug Administration) and other relevant regulatory bodies. This involved understanding the Good Laboratory Practice (GLP) guidelines and ensuring our lab met or exceeded those standards.

Im my opinion lab's certification process, we focused on creating a detailed document repository. This included a validation master plan, outlining how each piece of equipment was validated. You should also document procedures for handling and disposing of hazardous materials, ensuring that every aspect of our operations was transparent and compliant.

Especially for certifications: please have a look who accredited your certification body. 1. The certification body is not accredited -> forgeth him, the certificate will not be accepted. 2. The certification body is accredited by a dubious organization -> forgeth him, the certificate will not be accepted. 3. The certification body is accredited by an ILAC/IAF accreditation body -> this is your choice to go as your certificate should be accepted worldwide.

Initiating the application process for licenses and certifications, This typically involves submitting your documentation to the relevant regulatory authority and undergoing an inspection or audit. Be prepared to address any queries or concerns raised during this evaluation. For example, after thoroughly preparing the documentation, You need to submit the application for GLP certification to the FDA. This involved a rigorous on-site inspection where inspectors scrutinized the lab's processes, facilities, and documentation. Addressing their queries promptly and transparently was key to a successful inspection.

Securing licenses and certifications is not a one-time effort. Regularly review and update your documentation to ensure continuous compliance with evolving regulations. Schedule periodic internal audits to identify and rectify any deviations from established standards. This proactive approach is essential for maintaining a compliant and efficient R&D lab.

Here are the few other aspects that can be considered Quality Management System (QMS): Implement a QMS to ensure a systematic approach to processes and continuous improvement. Risk Management: Develop a comprehensive risk management plan to identify and mitigate potential risks to lab operations. Environmental Health and Safety (EHS): Prioritize EHS considerations to create a safe working environment and comply with environmental regulations.

Get certified for Laboratory Management Standards, ISO 17025. Systems that ensures integrity and Business Continuity.On course factors you are advised to ensure a comprehensive risk framework based on ISO 31000