CHPA supports the U.S. Food and Drug Administration's (FDA) federal regulations ensuring and enforcing product quality for over-the-counter (OTC) medicine and dietary supplement manufacturers.
CHPA member companies continuously monitor the quality and manufacturing processes of their OTC medicines and dietary supplements. Federal regulations issued by FDA provide the regulatory framework for ensuring product quality, starting with the ingredients in these products and continuing through manufacturing, distribution, and the product’s expiration date. Compliance with federal regulations is evaluated by FDA via regular manufacturing facility inspections. Individual states may also have laws and regulations that impact manufacturing and set standards for product quality. A number of organizations also provide guidelines or standards for ensuring product quality. Taking all these laws and regulations into consideration, a manufacturer develops internal standard operating procedures to document their processes and ensure consistently high-quality products are produced for the marketplace.
Our member companies support the concept that well-designed metrics are critical in driving and measuring continuous improvement activities in both quality systems and improving manufacturing processes.
CHPA is generally supportive of the revision proposal to update and clarify the Chapter. We would however request that the implementation be delayed for 24 months.
Letter to Mr. Brown regarding U.S. Pharmacopeia draft publication, "General Chapter <909> Uniformity of Dose from Oral Suspensions in Multi-Unit Containers."
CHPA strongly supports USP's efforts to address impurity control in drug substances and products. Overall the newly revised chapters provide reasonable guidance and direction for controlling organic impurities.
These comments are primarily focused on the use of Ultra-High Performance Liquid Chromatography as the method of choice for assay and organic impurities.
Because of FDA's safety concerns regarding the control and monitoring of levomethorphan, CHPA supports the control of levomethorphan as an impurity and respectfully submits the following comments regarding the proposed updates to the DXM monograph as proposed in the IRA published in PF 40(3).
