Lonza Increases HPAPI Manufacturing With New cGMP Facility In China
Lonza recently completed a laboratory expansion at its API manufacturing plant in Nansha, China. The focus of the expansion is on improving the capabilities and capacities of labs and cGMP manufacturing labs to supply HPAPI or highly-potent APIs. HPAPIs are a major part of the growing small molecules business with specific requirements for process safety, […]
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FDA Proposes Rule To Change Device cGMP Requirements
Last month, FDA issued a proposed rule called Medical Devices; Quality System Regulation Amendments. It would feature an international standard that is specific for device quality management systems that are overseen by ISO. Specifically, it would incorporate the 2016 version of ISO 13485, which is considered the international standard for device companies. FDA states it […]
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How Pharmaceutical Packaging Can Lead to Product Recalls
Pharmaceutical manufacturers generally pay close attention to ensure they are compliant with GMP standards and FDA regulations when manufacturing drug. But sometimes, the packaging of the pharmaceutical can be an afterthought. It is estimated that as many as 50% of drug recalls are because of errors with product labeling and artwork on the packaging. This […]
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Why Do You Need a Quality Agreement?
A quality agreement provides precise details of what is expected from both parties and who will be responsible for all of the aspects of the pharmaceutical project. There is a misconception that a quality agreement is only needed for CMOs operating in a different type of regulatory environment. This is not the case. Any outsourcing […]
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Canada Has Completed Its Transition to MDSAP
Most of the medical device companies in the Canadian market were able to meet the deadline of Jan. 1 2019 to complete a transition to the Medical Device Single Audit Program or MDSAP. According to Health Canada’s Medical Devices Bureau, the organization was flooded early this year with the transition packages from many companies. The […]
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FDA Audit Shows Data Manipulation at Immunonedics Plant
Immunomedics received a complete response letter from FDA last month that related to cGMP issues in manufacturing regarding its breast cancer antibody drug conjugate. When they were pressed by pharma analysts, executives for the pharma company dodged questions about if it was related to a preapproval inspection last year. How to Survive Your Next FDA […]
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You Can’t Change That: FDA Reiterates Risk of Delegating Responsibility in Quality Agreements
In the span of three weeks, the Food and Drug Administration issued Warning Letters to two dietary supplement companies, in part, for relying, to their detriment, on quality agreements. We discussed another similar Warning Letter in a recent Bulletin. Regardless of the type of FDA-regulated product, the agency made clear that, despite an agreement, a […]
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You Can’t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter
Companies can’t sign quality agreements and then say “we’re done.†This message was brought home with a recent Warning Letter issued by the Food and Drug Administration to a pharmaceutical company for violating current good manufacturing practice requirements for combination products, drugs, and medical devices. The Warning Letter included a myriad of quality-related concerns, including inadequate […]
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Anyone Can Enter Into a Quality Agreement, It’s the Hold: FDA Issues a Warning Letter Referencing Lack of Quality Oversight
Many of us remember the classic comedy bit on the Seinfeld television show where Jerry was unable to secure the rental car for which he had made a reservation. He tells the agent: See, you know how to ‘take’ the reservation, you just don’t know how to ‘hold’ the reservation and that’s really the most […]
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Federal Judge Issues Consent Decree for OTC Tennessee Drug Manufacturer
A federal court has issued an order to an over the counter drug company in Tennessee to cease the sale of OTC products until such time it is compliant with the FD&C Act. According to CDER, Americans both deserve and expect high quality OTC drug products. Although the company in question was given several warnings, […]
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