Tips and Thoughts on Critical Process Cleaning Procedures
Latest FDA and cGMP Compliance News How hard can cleaning be? That is something that people who are not involved in the production of pharmaceutical products may ask, but not people in the industry. The general thought process in the industry is that cleaning and cleaning validation is a practice that is necessary and unpleasant […]
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No Device Complaints – No Problems? Think Again
Latest FDA and cGMP Compliance News FDA states that a complaint is any written, oral or electronic communication that is alleging there are deficiencies in a product related to the quality, durability, identity, safety, reliability, performance or effectiveness of a medical device after it is released to the market. Note that the ISO 13485 definition […]
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Tips to Qualify Your Pharmaceutical Ingredient Suppliers
Latest FDA and cGMP Compliance News As most of us know, the globalization of drug manufacturing and the move to the use of many overseas suppliers has greatly increased the complexity and vulnerability of the drug supply chain. That is why supplier and vendor cGMP compliance at all stages – purchasing, manufacturing and distribution […]
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Don’t Fight the FDA Auditor! FDA Issues Guidance on How to Avoid Inspection Problems
Latest FDA and cGMP Compliance News FDA has been ramping up its efforts to inspect drug facilities in the last three years or so. Some of the largest pharmaceutical companies have had cGMP inspectors at many of their sites. Drug compounding pharmacies are getting more scrutiny due to a very serious fungal meningitis scandal. FDA […]
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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 […]
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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 […]
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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 […]
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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 […]
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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 […]
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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 […]
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