18. March 2018
This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method. According to the modern requirements of the European Union’s Good Manufacturing Practice for Medicinal Products, a manufacturing authorization holder should guarantee the suitability of excipients included in the finished medicine. For this purpose, a formalized, documented assessment of risks associated with safety, quality,...
04. September 2017
Abstract Excipients are an integral part of practically all medicines. Historically, excipients have been regarded as pharmacologically and chemically indifferent within the formulation. However, nowadays excipients along with active pharmaceutical ingredients are the subject of strict monitoring and quality control in pharmaceutical manufacture. According to the current rules of European Union’s Good Manufacturing Practice of Medicinal Products excipients should be subjected to a thorough...
11. August 2016
Many pediatric patients require medications that are not available in age appropriate formulations, especially those with cardiovascular diseases. The use of a suitable vehicle is critical for the preparation of extemporaneous formulations with the expected effect. Considering that palatability is essential to treatment adherence in children, we analyzed the acceptance of extemporaneous formulations of Captopril and Furosemide prepared using a developed vehicle in three flavors: neutral,...
20. July 2016
ABSTRACT The goal of this study was to utilize risk assessment techniques and statistical design of experiments (DoE) to gain process understanding and to identify critical process parameters for the manufacture of controlled release multiparticulate beads using a novel disk-jet fluid bed technology. The material attributes and process parameters were systematically assessed using the Ishikawa fish bone diagram and failure mode and effect analysis (FMEA) risk assessment methods. The high risk...
10. July 2016
Abstract The current work outlines the application of an up-to-date and regulatory-based pharmaceutical quality management method, applied as a new development concept in the process of formulating dry powder inhalation systems (DPIs). According to the Quality by Design (QbD) methodology and Risk Assessment (RA) thinking, a mannitol based co-spray dried formula was produced as a model dosage form with meloxicam as the model active agent. The concept and the elements of the QbD approach...
05. October 2015
Highlights •First formal environmental risk assessment for pharmaceutical excipients. •Based on material balances of single galenical productions at two sites. •PEC/PNEC risk ratios for wastewater treatment plants and the receiving water. •No risk identified for wastewater treatment or receiving water (River Rhine). More
27. May 2015
By Patricia Van Arnum posted Tue, May 26, 2015 01:51 PM The IPEC Federation has issued a position paper on European Union (EU) guidelines for excipients based on quality risk management. Although supporting risk assessment, the organization raised concerns over timing for a March 2016 deadline for risk assessments as incomplete assessments may jeopardize the availability of excipients. IPEC issued the position paper earlier this month to put forth several issues for consideration in the...
06. May 2015
http://ipecamericas.org/content/ipec-federation-publishes-position-paper-eu-risk-assessment-guidelines-excipients-2015c-9502
24. April 2015
On march 21st 2015 the EU published new guidelines on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (2015/C 95/02). The manufacturing authorization holder should identify risk presented to quality, safety and function of each excipient. In addition, the excipient manufacturer’s risk profile should be determined using a gap analysis of the required GMP against the activities an capabilities of the...