Happy New Year! MWA is off and running to a busy 2018. Our feature article for January 2018 is a summary of FDA 483 observations from 2017. This information can help you focus your resources to ensure your company is in compliance with the current FDA regulations and concerns as well as enhance your training programs.
Here is the complete spreadsheet of observations from the FDA website (link will download as an Excel file) from Fiscal Year 10/1/2016 – 9/30/2017. It includes summaries for Biologics, Bioresearch Monitoring, Devices, Drugs, Foods, Human Tissue, Parts 1240 and 1250, Radiological Health and Veterinary Medicine.
MWA’s regulatory compliance consulting experts can help you formulate the correct response to FDA 483 observations. Our staff includes highly experienced subject matter experts who can help your firm craft a clear and accurate response to technical inquiries for GXP reviewers as well as warning letters and technical questions to Regulatory Agency centers. Responding to a Regulatory Agency is only the first step. MWA will also provide you with a clear remediation and corrective action plan and help you implement the specific actions quickly and efficiently.
For Drugs, the most common violations were related to Production Record Review; Organization and Personnel: The QC Unit and Personnel Qualifications; Laboratory Controls; Production and Process Controls: Written Procedures Deviations and Control of Microbial Contamination.
For Devices, the most common violations were Corrective and Preventive Action; Records: Complaint Files and Device History Records; Production and Process Controls, Process Validation; Design Controls, Design Validation; Quality System Requirements, Quality Audits; and Purchasing Controls.
The full summary can be found on the PDA website.
Recent News and Guidelines
- EMA Guidelines on GMP specific to Advanced Therapy Medicinal Products
- Revision of Annex 1 “Manufacture of Sterile Medicinal Products” published for Comments
- ICH Q12 Draft Guideline Nov 2017
- Annex 13: Detailed Commission Guideline on GMP for IMPs published
- Drastic Changes Ahead: New Medical Device Regulations