OR WAIT null SECS
October 02, 2015
Managing change and overcoming employee resistance and fear requires a proactive approach.
An integrated approach can improve the efficiency of cleaning validation studies.
September 28, 2015
The agency releases guidance on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.
The agency releases guidance on controlled correspondences related to generic-drug development.
September 16, 2015
Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.
The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.
September 09, 2015
FDA publishes the final Q3D Elemental Impurities guidance.
September 08, 2015
The agency releases guidance on the nonclinical evaluation of endocrine-related drug toxicity.
A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)
As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available. Will more excipient suppliers, and drug manufacturers, use them?