Articles by Mark Durivage
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FDA: Postapproval CMC Changes To Be Documented In Annual Reports
2/18/2022
New CDER guidance represents the FDA's thinking regarding the changes that BLA holders for specified biological products must document in an annual report. The products include therapeutic DNA plasmid products, therapeutic synthetic peptide products of 40 or fewer amino acids, mAb products for in vivo use, and therapeutic recombinant DNA-derived products.
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Clinical Trials: FDA Proposes Benefit-Risk Assessment For New Biologics
2/11/2022
The FDA's draft guidance illustrates how a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions. Communication between the sponsor and the FDA regarding the benefit-risk assessment is typically conducted at the end of the Phase 2 study, which can help influence the design of Phase 3 studies.
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FDA Proposes Inspection Of Injectable Products For Visible Particulates
2/1/2022
FDA and CDER have released a draft guidance addressing the development and implementation of a holistic, risk-based approach to visible particulate control incorporating product development, manufacturing controls, visual inspection, particulate identification, investigation, and corrective actions. The public comment period ends Feb. 15, 2022.
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EMA Publishes Guideline On Quality Documentation For Medicinal Products
8/2/2021
This new EMA guideline will become effective on January 1, 2022. It describes the information that should be presented in the quality part of a marketing authorization dossier for a medicinal product when it is used with a medical device and/or as part of a medical device. Medicinal products are similar to "combination products" referred to by the US FDA.
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FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products
7/14/2021
At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.
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FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities
5/3/2021
On April 14, 2021, the FDA released a new guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance, and shares how to submit public comments for FDA consideration.
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Establishing An Effective Calibration Program
3/15/2021
Calibration is the comparison of inspection, measuring, and test equipment against a traceable reference device to determine if accuracy and precision limits are met. It is one of the fundamental, yet often neglected requirements for GMP. Several international standards, regulations, and guidances provide requirements for an effective calibration program.
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7 Rules For Properly Interpreting Control Charts
2/15/2021
It is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements.
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Using Production And Postmarket Data To Validate FMEA Assumptions
1/15/2021
One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and postmarket surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings.
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How To Implement Continuous Process Monitoring Of Validated Processes
10/28/2020
It is time to consider augmenting your validated pharmaceutical, medical device, and tissue production processes, including processing, packaging, and labeling, with continuous process monitoring to ensure continued compliance with established specifications and requirements if you do not want to be cited by the FDA.