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Artificial Intelligence (AI) and Software as Medical Device
Artificial Intelligence and Medical Devices With all of the discussion around artificial intelligence (AI) and its effects on the pharmaceutical and medical device industry, it is good to understand the thinking of the FDA on this topic. AI is an exciting field but is still very new to most in the industry. It is the…
Read MoreDSCSA Pharmaceutical Serialization Updates and New Guidance
The Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013. Title II of this act was the Drug Supply Chain Security Act (DSCSA) to enhance the FDA’s ability to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The requirements also included improvements for the…
Read MoreSupplier Risk Assessment Essentials
Supplier Risk Assessments The FDA and ICH Q10 have provided direction on the need to risk assess suppliers as a part of the Quality System. Way back in 2011 the following slide was presented at the Pharmaceutical Quality System ICH Q10 Conference. The Supplier Identification Model or better known as the Supplier Quality Management Lifecycle…
Read MoreSurgical Mask Guidance
Surgical Mask EUA During the COVID-19 pandemic, the FDA issued Emergency Use Authorizations (EUA) for certain Personal Protective Equipment (PPE), including Surgical Masks. Normally a FDA 510K Premarket Notification is required prior to marketing a mask as a Surgical Mask. This is still a long term requirement. However, due to the issuance of the Umbrella…
Read MorePain is Weakness Leaving the Body!
Pain is Weakness Leaving the Body! I love this old military mantra! Or then there’s “No pain no gain!” Sometimes a little bit of pain goes a long way for ultimate success! We accept this mantra at Quality Audit Consulting (QAC)! We can help you get through your growing pains with a gap assessment for…
Read MoreN95 Respirator Test Requirements for NIOSH Submission
N95 Respirator Test Requirements for NIOSH Submission NIOSH requires that N95 manufacturers follow the guidelines in the Code of Federal Regulations (CFR), 42 CFR Part 84. 42 CFR Part 84 provides the test procedures, requirements, and documentation needed to file an application with NIOSH Before respirators can be submitted to NIOSH for certification, manufacturer’s must…
Read MoreNIOSH and N95 Respirator Certification Steps
The FDA defines N95 Respirator as a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. The edges of the respirator should be designed to form a seal around the nose and mouth. Surgical N95 Respirators are commonly used in healthcare settings and are a subset…
Read MoreQuality System Requirements, N95 NIOSH Approved Respirators
Quality System Requirements, N95 NIOSH Approved Respirators is required by the FDA. FDA enforcement of normal requirements for Face Masks and N95 Respirators has relaxed during the COVID-19 Global Pandemic. On April 2020 (revised on May 2020) the FDA issued Guidance “Enforcement Policy for Face Masks and Respirators During the Corona Virus Disease (COVID-19) Public…
Read MoreTop Tips for Moving from COVID-19 Manufacturing to Permanent – A Quality Perspective
The COVID-19 pandemic has forced companies to change the way they do business and has also encouraged new business growth. Two of the areas where we have seen an increase in new growth has been in the Personal Protective Equipment (PPE) area, particularly face/surgical masks, and in the hand sanitizer area. Each of these areas…
Read MoreHand Sanitizer Requirements, COVID-19
The COVID-19 Pandemic has brought the issue of hand sanitizer requirements and their regulation to the national forefront. Because of the public health emergency, the FDA has stated that they do not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs…
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