5 Ways to Avoid cGMP Problems With FDA
Latest FDA and cGMP Compliance News Everyone fears getting a 483 or warning letter. These sanctions can lead to serious problems for pharmaceutical companies. cGMP violations are very costly in terms of public image and repairing the damage. We find that most problems can be avoided by following these steps: Ensure full compliance with cGMP […]
Read More »Category : Compliance Tips
Writing Effective SOPs for Pharma
This is Part II of our article on ensuring effective SOPs in the pharmaceutical industry. A strong SOP program has a solid technology platform that works well with current technologies and can handle the following functions: SOP distribution Validation Testing Recording keeping in formats ready for audit SOPs have to be revised when there is […]
Read More »Category : Compliance Tips
Ensuring Effective SOPs in the Pharmaceutical Industry
Latest FDA and cGMP Compliance News Every year, FDA hands out plenty of 483s and warning letters, and many of them center on the failure to have or to properly utilize their SOPs, which is really the most fundamental aspect of cGMP rules. The purpose of SOPs in the pharmaceutical industry is clear – to […]
Read More »Category : Compliance Tips
How Well Do Drugmakers Understand Informed Consent?
Latest FDA and cGMP Compliance News Mark Hochhauser, who is a community member on the North Memorial Medical Center IRB in Robbinsdale, MN, provides some details about problems that he sees with informed consent forms: #1 Be Sure to Proofread Your Consent Many consent forms come into IRBs that have not been carefully proofread. IRBs […]
Read More »Category : Compliance Tips
Tips to Vacuum Your Cleanroom
Latest FDA and cGMP Compliance News As most pharmaceutical professionals know, every inch of your cleanroom has to be completely pristine to avoid contamination problems and cGMP violations. You need to regularly decontaminate your: HEPA filtration devices Sprinkler heads Ceiling panels Lighting units Glass surfaces Piping systems Floors Manufacturing equipment You also should monitor […]
Read More »Category : Compliance Tips
FDA Data Reveals More Warning Letters to Medical Device Companies
Latest FDA and cGMP Compliance News FDA medical device inspectors have been issuing more warning letters since 2005, as an inspection of recent FDA records indicates. The increase in 483s and warning letters is coming along with an increase in QSR inspections in the last 5 years. FDA did 1423 QSR inspections of medical device […]
Read More »Category : Compliance Tips
Readying for a US FDA Inspection
If your company produces drugs, medical devices or nutraceuticals that fall under US cGMP regulations, your facility is eventually going to be inspected by the U.S. Food and Drug Administration (FDA). The Federal Food, Drug and Cosmetic Act states that domestic drug establishments can be inspected at least one time every two years. The inspections […]
Read More »Category : Compliance Tips
How To Create and Staff Your FDA Inspection War Room
Latest FDA and cGMP Compliance News To have a successful FDA inspection, your company really should create a war room in advance of the FDA visit. This is a strategic office that should be entirely devoted to giving all of the needed evidence that is requested by an FDA inspector during an audit. Having […]
Read More »Category : Compliance Tips
Court Tells FDA That FSMA Deadlines Are Required
Latest FDA and cGMP Compliance News The Food Safety Modernization Act, or FSMA, has made major changes in how FDA and the government is monitoring food safety. FSMA has science based standards and controls on food companies, and it directs companies to do hazard analysis and to create strong, preventive control plans. FDA also has […]
Read More »Category : Compliance Tips
How To Improve Your CAPA System
Latest FDA and cGMP Compliance News FDA reports that more than 50% of the top FDA 483 citations and warning letter observations are always related to CAPA, or corrective and preventive actions. A strong CAPA system is set up to ID and correct faulty processes that cause a nonconformance, and will prevent such a nonconformance […]
Read More »Category : Compliance Tips
