Drug Product

May 30, 2019
Published by Meranda Parascandola at May 30, 2019

Need to Know about CMC Regulatory Affairs? Consider What Makes a Great Philly Cheesesteak!

what makes a drug development program? Much like a Philly cheesesteak, the pursuit of greatness is the assurance that any given compound meets requisite technical and quality elements in each stage of development to allow for the ultimate successful commercialization of the drug.
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June 23, 2020
Published by Meranda Parascandola at June 23, 2020

The Odd Couple – Part 2: Authoring the Manufacture of Drug Substance and Drug Product Modules (S2, P3)

An overview of the quality assurance aspects of the manufacturers may provide insight into the viability of the process. Although not required to be included in the application, a request for the report of the most recent cGMP manufacturing inspection from the US Food and Drug Administration (FDA) and/or European Union (EU) agencies enable a broad overview of the cGMP compliance aspects of the facilities.
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July 2, 2020
Published by Meranda Parascandola at July 2, 2020

The Odd Couple – Part 3: Authoring the Control of Excipients Modules

The acceptance criteria and tests conducted for the excipients should be reviewed relative to the preformulation experimental results. The acceptance criteria for the excipients should consider those qualities critical to the drug product performance and manufacturing operation as described earlier in formulation development.
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July 14, 2020
Published by Meranda Parascandola at July 14, 2020

The Odd Couple – Part 4: Authoring the Analytical Control and Analysis and Reference Standards Modules

Perhaps the most consequential specification input is analytical method capability. The attribute of interest must, after all, be assessable. Thus specifications depend on the method’s specificity, sensitivity, variability, and accuracy.
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July 23, 2020
Published by Meranda Parascandola at July 23, 2020

The Odd Couple – Part 5: Authoring the Container Closure Systems for Packaging of Drug Substance and Product Modules

Container closure systems refer to the sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. The packaging information in the chemistry, manufacturing, and controls section usually includes a description of the components, the assembled packaging system and any precautions needed to ensure the protection and preservation of the drug substance and drug product during their use.
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August 13, 2020
Published by Meranda Parascandola at August 13, 2020

The Odd Couple – Part 7: Authoring the Composition and Pharmaceutical Development Modules

Pharmaceuticals (both Synthetically and Biotechnology-derived) are being developed by many sponsors whose management teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging products.
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August 5, 2021
Published by Meranda Parascandola at August 5, 2021

Why and When Filter Validation is Key to Bringing a Product to Market

Bringing a product to market is a long and complex one, even more so when developing a sterile product, such as injections, ophthalmic preparations, irrigation fluids, dialysis solutions, among others. The only method for removing microorganisms without adversely affecting the product is sterile filtration, and those processes need to be assessed through filter validation to ensure that the filter used to eliminate any microorganisms is the right one.
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September 2, 2021
Published by Meranda Parascandola at September 2, 2021

Planning, Preparing and Crafting the Drug Development Report

DSI has seen a lot of pharmaceutical development reports ranging from several hundred pages to a summary of conclusions attached to stacks of data. The latter can make things difficult when it’s time to put a regulatory filing together. It’s become clear that capturing development decisions and data from the outset in a living document is good practice and whether the data collected thus far is supporting development goals. It’s a reference point for what has been completed and what still has to be done.
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April 6, 2022
Published by Meranda Parascandola at April 6, 2022

Nitrosamine Assessment

The FDA has been investigating the presence of nitrosamine impurities in certain drug products. Since 2018, several drug products including ARBs, ranitidine, nizatidine, and metformin have been found to contain unacceptable levels of nitrosamines. Nitrosamines are classified as probable human carcinogens based on animal studies and there has been a pressing need to remove the risk to patients.
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