Resuming Foreign GMP Inspections in Philippine Professional Services
September 30, 2024
With the Foreign GMP Inspections Resumption under Advisory No. 2024-0542, the Philippines FDA is once again conducting overseas Good Manufacturing Practice (GMP) inspections, marking a critical period for drug manufacturers. Ensuring compliance with regulatory standards is essential to maintaining market access and avoiding potential delays or penalties. Triple I specializes in guiding pharmaceutical companies through the complexities of these inspections, offering expert support in documentation, regulatory requirements, and compliance strategies. Our team is dedicated to helping you streamline the inspection process, address any potential gaps, and maintain high operational standards to meet FDA expectations.
With the World Health Organization’s declaration that COVID-19 is no longer a public health emergency, the Foreign GMP Inspections Resumption is now underway. The FDA has announced that inspection schedules will be issued starting in March 2024, with on-site inspections set to commence in April. This marks a crucial moment for pharmaceutical and manufacturing companies to demonstrate their commitment to quality, safety, and regulatory compliance. Preparing in advance will be key to ensuring a smooth inspection process and maintaining global market access. Don’t miss this opportunity to reinforce your dedication to industry standards.
Our expert team will assist you in various aspects such as documentation practices of your GMP credentials, ensuring:
Cleanliness and maintenance
Equipment calibration and maintenance
Personnel training and hygiene
and Quality control processes that align with FDA standards.
We’ll help you establish effective communication with the FDA and address any compliance concerns proactively. Foreign GMP Inspections Resumption is a critical step in ensuring your manufacturing processes meet regulatory standards. Our team of experts is ready to guide you through the necessary steps to maintain compliance and avoid potential disruptions. Contact us through any of the following channels below to schedule an initial consultation with one of our FDA experts:
