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Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug SubstancesThe authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.
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Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug SubstancesThe authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.
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Appendix: Common Deficiencies Related to Solution NMR in the Type-II DMFsAppendix to Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs, Part I: Solution Nuclear Magnetic Resonance Spectroscopy
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Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug SubstancesThe authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.
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FT-IR Identification: the Expertise Required To Ensure ComplianceBy providing an information "fingerprint", infrared red spectroscopy is a useful tool for identifying counterfeit pharmaceuticals. The authors identify best practices for ensuring compliance.
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Choosing Containment Strategies For Highly Potent APIsSafe handling of HPAPIs requires determining exposure potential and selecting appropriate containment strategies.
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Contamination: Invisible And AirborneMillions of pounds worth of products are at risk if contamination occurs in a cleanroom environment. According to an independent consultant (Cleanroom Management Associates Inc) for our company, contamination from personnel and equipment, such as wheeled carts and tanks, is a major concern in cleanrooms and controlled environments.
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Best Practice: Testing Softgel CapsulesTexture analyzers can be used to evaluate wall hardness and elasticity of softgel capsules.
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Best Practice: Testing Softgel CapsulesTexture analyzers can be used to evaluate wall hardness and elasticity of softgel capsules.
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Testing the Integrity of Lyophilized Product ContainersNon-destructive container closure integrity testing allows 100% inspection of all ampoules, syringes, vials, and cartridges.
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Updates on Container Closure Integrity Testing for Sterile InjectablesChanges in CCIT testing have followed the evolution of regulatory guidance, and this article examines different possible CCIT strategy approaches.
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Specimen Logistics: The Rx for a Better DxUsing best practices in specimen preparation, packaging, and shipping can improve efficiency for diagnostic laboratories.
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Concept Design for Establishing an Eco-Friendly Pharmaceutical Production Facility in MaltaThe authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.
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Concept Design for Establishing an Eco-Friendly Pharmaceutical Production Facility in MaltaThe authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.
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Concept Design for Establishing an Eco-Friendly Pharmaceutical Production Facility in MaltaThe authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.
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Concept Design for Establishing an Eco-Friendly Pharmaceutical Production Facility in MaltaThe authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.
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Best Practice: Choosing Glass Or Polymer For Parenteral PackagingConsider the 3 Ps (product, process, and patient) when choosing a parenteral packaging material.
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Controlled Crystallization During Freeze-DryingThe authors discuss the preparation of lipophilic drug nanocrystals by controlled crystallization during freeze-drying.
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Early Development GMPs for Drug-Product Manufacturing of Small Molecules: An Industry Perspective (Part III)IQ Consortium representatives explore industry approaches and practices for applying GMPs in early development.
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Public Health Organizations Pen Letter to House and Senate CommitteesNine public health organizations submitted a letter to US House and Senate committees citing concerns about Section 11 of the FDA and NIH Workforce Authorities Modernization Act.
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New Lab Instruments Tackle Workflow ChallengesA sampling of new laboratory equipment showcases streamlined operations.
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Addressing Segregation of a Low-Dosage Direct BlendThe authors modified equipment and the manufacturing process to re-establish content uniformity among tablets.
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Futureproofing the Pharmaceutical Industry through TechnologyBy focusing on laying strong technology foundations, pharmaceutical businesses can make informed decisions, equip themselves with the capabilities to eliminate threats, and future-proof operations.
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Determination of Sodium Chloride in Yeast Extract by Ion ChromatographyDetermination of sodium chloride level is critical for assessment of purity of yeast extracts. This case study demonstrates the validation of an ion chromatography method as a suitable analytical approach.
