Featured Pharma Online Editorial

  1. EMA Updates Guidance On Inhalation And Nasal Product Quality 5/29/2024

    The EMA has issued a new draft guideline, “Guideline On The Pharmaceutical Quality Of Inhalation And Nasal Medicinal Products.” The public comment period ends Oct. 31.

  2. A Holistic Approach To Container Closure Integrity 5/20/2024

    Regulations are pushing for an approach to container closure integrity that builds quality into the design and processes rather than testing/inspecting the manufactured item.

  3. Addressing Challenges In Serialization For Complex Therapeutics 5/7/2024

    The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.

  4. Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations 5/6/2024

    Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.

  5. Drug Labeling: 3 Pitfalls To Avoid And 8 Best Practices To Follow 12/7/2023

    You may have processes in place to prevent drug labeling errors, but they can still occur. Here are three common pitfalls and the eight best practices you should be employing to make sure they don't happen.

  6. Emerging Trends & Technologies In Anti-Counterfeit Pharmaceutical Packaging 11/21/2023

    Counterfeit medicines are rising at an alarming rate, with data showing that nearly 6,500 pharmaceutical crime incidents were recorded in 2021, ranging from innovator drugs to generics, and from antimalarials to blood pressure medicine to vaccines. What packaging and labeling strategies are pharma/biotech companies using to tackle this?

  7. Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems 11/16/2023

    With the expansion of serialization requirements, including the need for Drug Supply Chain Security Act compliance, many pharma/biotech companies are turning to serialization technology systems to help them manage those specifications. This article shares the key benefits of leveraging an application managed services (AMS) provider as well as key considerations for selecting a provider.

  8. FDA Seeks Comment On Quality Considerations For Topical Ophthalmic Drug Products Draft Guidance 11/2/2023

    As a response to recent observations regarding the contamination of eye drops, the FDA published draft guidance titled Quality Considerations for Topical Ophthalmic Drug Products on Oct. 13, 2023. In addition to addressing quality considerations, the guidance also provides recommendations about the CMC documentation. The deadline for submitting public comments is Dec. 12, 2023.

  9. FDA Announces 1-Year “Stabilization” Period For DSCSA Compliance — Don't Mistake It For An Enforcement Delay 10/4/2023

    On August 30 in a new guidance document, the FDA announced the establishment of a one-year stabilization period with regard to the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) that go into effect on Nov. 27, 2023. The FDA makes it clear that this is not an opportunity to delay implementation; rather, it is an opportunity to refine, improve, and stabilize your systems and processes.

  10. Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development 9/14/2023

    The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.