Clinical Research Solutions
FDA Draft Guidance Addresses Increase in Data Integrity Violations
In mid-April 2016, the FDA published a draft guidance clarifying the role of data integrity in current good manufacturing practice (cGMP) for drug products, as required under 21 CFR parts 210, 211,...
Clinical Research Solutions
Everything you to need to know about Audit Trails
In today’s validated lab environment, knowing the importance of an audit trail in computerized laboratory systems is just one of the integral qualification tasks that the ProPharma’s Computer System...
Clinical Research Solutions
FDA’s CBER Announces Invitation to Participate in the Regulatory Site Visit Training Program
On February 2, 2016, the FDA’s Center for Biologics Evaluation and Research (CBER) published its annual invitation for biologics facilities to participate in the Regulatory Site Visit Training...
Clinical Research Solutions
Supplier Qualification in the Pharmaceutical Supply Chain
The Food and Drug Administration Safety and Innovation Act (FDASIA), was signed into law on July 9, 2012. This law significantly expanded the FDA’s authority and strengthened its ability to safeguard...
Clinical Research Solutions
The FDA’s Enforcement of Section 503B of the Federal Food, Drug, and Cosmetic Act
The FDA publishes weekly enforcement reports highlighting drugs that have been recalled during the previous week. Over the past several months these reports have been littered with hundreds of...
Clinical Research Solutions
FDA Provides Recommendations on Injectable Drug Dose Labeling
On October 21, 2015, FDA released a draft guidance entitled “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose,...