Protocol Link provides white papers on management, compliance, and technical aspects of operating in an FDA regulated environment. These papers are intended to guide the decision making process and assist in selecting a course of action.
WHITE PAPERS
The primary goal of this white paper is to identify and present alternative practices for performing leak detection of filled, finished product containers produced using a blow-fill-seal (BFS) manufacturing process.
Combination product compliance has been a recent priority for the FDA, starting with the issuance of the cGMPs for Combination Products (21 CFR Part 4) in 2013. The final guidance for cGMP requirements for Combination Product was issued on January 10, 2017.
“Data Integrity” is an item which has garnered FDA and industry attention year over year. This buzz-word first received notoriety with respect to the inspection of laboratories based on their implementation of computerized systems having the ability to generate records with no apparent means of tracebility.
The primary goal of this white paper is to identify and present alternative practices for performing leak detection of filled, finished product containers produced using a blow-fill-seal (BFS) manufacturing process.
Combination product compliance has been a recent priority for the FDA, starting with the issuance of the cGMPs for Combination Products (21 CFR Part 4) in 2013. The final guidance for cGMP requirements for Combination Product was issued on January 10, 2017.
“Data Integrity” is an item which has garnered FDA and industry attention year over year. This buzz-word first received notoriety with respect to the inspection of laboratories based on their implementation of computerized systems having the ability to generate records with no apparent means of tracebility.