<span class="archive__title-prefix>Posts Categorized:</span> Blog

Brassica Pharma Pvt. Ltd. (Brassica) is an India-based Contract Development & Manufacturing Organization (CDMO) that specializes in sterile semi-solids such as eye ointments and gels, pre-filled syringes, and dermatological and liquid oral products. Its past customers include Cipla and Cadila Pharma. According to the company website, Brassica manufactures 250 different formulations, has been manufacturing sterile […]

At the PDA/FDA Joint Regulatory Conference 2024 held in Washington, DC, September 9-11 2024, Associate Commissioner of Regulatory Affairs (ACRA) in the FDA Office of Regulatory Affairs (ORA), Michael Rogers discussed his office – which will be renamed Office of Inspections and Investigations on October 1 – and the attrition FDA has been experiencing in […]

How does an expert FDA investigator conduct a manufacturing inspection? While each inspection and each investigator is different, what thought processes might they use as they walk through a facility? At the 48th annual International GMP Conference held in early March 2024 at the University of Georgia in Athens, Georgia, FDA national expert pharmaceutical investigator […]

An eleven-day FDA inspection in early 2023 of a contract manufacturer of homeopathic and over-the-counter (OTC) drug products, including those intended for infants and children, revealed serious lapses in the firm’s manufacturing, deviation, laboratory, and complaint investigation systems. This is an analysis of that Denison Pharmaceuticals 483, which turned into a Warning Letter. The FDA […]

This is a guest post by Independent Consultant Sarah Boynton, with Quality Executive Partners When it comes to manufacturing life-saving biologics and CGT (cell and gene therapy) products, compliance is the core of market authorization and sustained operational success. However, beyond the regulations themselves, it is the human factors—the intricacies of human performance—that often […]

Blatant data manipulation – for example, falsifying visual inspection particle counts for finished parenteral products – was highlighted in a Form 483 from a 2023 drug manufacturing facility inspection. In addition, observations from a different 2023 inspection cataloged egregious data integrity lapses, including the use of shared passwords and erasable markers to record GMP data. […]

How should your firm find culturally compatible outsourcing partners? To talk through it with the Redica Systems community, Stephanie Gaulding stopped by our virtual studios for a webinar she titled: “Cultivating Successful Outsourcing Partnerships — The Power of Cultural Fit.” With 25 years of experience in quality management systems and leadership roles in the regulated […]

What actions should a pharma company take upon receiving a form 483 from FDA after a manufacturing facility inspection? What are key elements in submitting a response to the 483 that the agency will find acceptable? How important are these actions in avoiding additional enforcement actions by FDA? At the 48th annual International GMP Conference […]

In September 2022, an FDA inspection found that a company in Puerto Rico had released numerous batches of an infusion product – i.e., destined to be put directly into the human bloodstream – even though microbiological plate testing showed the product contained high levels of a microbiological contaminant, designated Too Numerous to Count (TNTC). The […]

How does Health Canada conduct regulatory compliance and enforcement? What different offices carry out its compliance and enforcement function? Health Canada’s Regulatory Operations and Enforcement Branch (ROEB) is responsible for oversight and inspections to ensure compliance with acts and regulations. It conducts inspections, compliance verifications, product sampling, enforcement measures, and investigations. The Regulatory Operations and […]