Posts by QAC Principal Consultant
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 MoreCosmetic GMPs and MoCRA
Updated Requirements for Cosmetic Companies MoCRA enacts the most significant expansion of the US FDA to regulate cosmetics since 1938. After 85 years of being effective, the Modernization of Cosmetics Regulation Act of 2022 , also known as “MoCRA” has been updated. It was enacted by Congress as part of the 4,155 pages of the Consolidated…
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 MoreSupplier Management and Auditing
REQUIREMENTS ICH Q10 Pharmaceutical Quality System , Section G provides guidance on the Management of Outsourced Activities and Purchased Materials. “Pharmaceutical companies are responsible for ensuring processes are in place to assure the control of outsourced activities and quality of purchased materials.” HOW? Assess PRIOR to outsourcing operations or selecting material suppliers the suitability and…
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 Mask Sampling Requirements
NIOSH 42 CFR Part 84 provides the standards for the approval of N95 respiratory protective devices. The approval of N95 respiratory protective devices requires that there be a Quality Control Plan in place. Part 84.41 describes the Quality Control Plan. One of the parts of the Quality Control Plan which must be in place in…
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…
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