March 14th 2025
The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
FDA Prepares for New DTC User Fee Program
November 1st 2007In accordance with the US Food and Drug Administration Amendments Act of 2007, FDA is asking companies to notify the agency within 30 days whether they intend to participate in FDA?s direct-to-consumer user-fee program during fiscal year 2008.
FDA Committees Recommend Ban on Cough and Cold Medications for Young Children
October 24th 2007After a whirlwind of negative press this fall regarding the safety of cough and cold medications for children under age 6, the US Food and Drug Administration?s Nonprescription Drugs and Pediatric Advisory Committees have recommended such over-the-counter drugs no longer be used for young children.
The Application of Quality by Design to Analytical Methods
October 2nd 2007To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has therefore been developed to meet these needs. This article features a downloadable template on which to conduct a failure mode effect analysis (FMEA).
Materials of Construction Based on Recovery Data for Cleaning Validation
October 2nd 2007The material of construction is a factor in the recovery of residue in cleaning validation. An analysis of existing recovery data showed that recovery factors for drug products on various materials of construction may be categorized into several groupings.
Acceptance Limits for the New ICH USP 29 Content-Uniformity Test
October 2nd 2007Revisions to the United States Pharmacopeia's (USP) uniformity test require manufacturers to establish new acceptance limits. The authors present their method for calculating acceptance limits consistent with USP's revised content-uniformity test requirements.
Research initiatives to support science-based pharmaceutical manufacturing
October 1st 2007Recent regulatory initiatives have emphasized the need to improve pharmaceutical manufacturing. PAT marked the beginning of a number of regulatory efforts to encourage innovation and a transition towards science-based manufacturing. This article reviews the progress of the regulatory initiatives and describes two significant research initiatives to develop a future pharmaceutical manufacturing environment based on scientific understanding of pharmaceutical materials and processes.