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20 April 2015 | By Dave Elder, GlaxoSmithKline and JPAG
Increasing research and development costs, low productivity, reduced product life cycles, governmental pricing containment, convergence of technologies and increasing regulatory oversight are challenges that increasingly provoke pharmaceutical companies into making precompetitive collaborations with other organisations.
20 April 2015 | By Roger A. Stroud, R Stroud Pharmaceutical Quality Solutions Limited
Increasing numbers of pharmaceutical companies are considering outsourcing in the area of analytical and microbiological testing, from the very smallest start-up, virtual, or small company up to the largest multinational. This article will examine the factors that lead to a company deciding to outsource, and provides invaluable guidance on the…
20 April 2015 | By Guenther Gapp, Lachman Consulting Ltd/Independent Consultant
Several years ago, microbiologist Guenther Gapp created a new sterile risk assessment tool (based on a hazard operability analysis [HAZOP] approach) to identify and reduce the microbial contamination and compliance risk of aseptically-produced sterile products and production plants. The following article describes the operating principle of three risk analysis tools…
The methods for monitoring air in cleanroom environments: viable counting techniques (settle plates and biological air samplers) and particle counters, are long established technologies and have been widely used in pharmaceutical manufacturing environments for decades. Although innovations have taken place with both particle counters and biological air samplers, primarily in…
20 April 2015 | By Ivo Backx, Manager, Business & Project Development for the Pharmaceutical Industry, Siemens
Ivo Backx of Siemens discusses continuous processing in the context of the company’s Simatic PCS 7 system and PAT software...
20 April 2015 | By Ravendra Singh, Marianthi Ierapetritou and Rohit Ramachandran: Rutgers University
Continuous pharmaceutical manufacturing together with process analytical technology (PAT) provides a suitable platform for automatic feed-forward/feed-back (FF/FB) control of the end product quality as desired by quality by design (QbD)-based efficient manufacturing. The precise control of the quality of the pharmaceutical product requires proactive, corrective actions on the process/raw material…
7 April 2015 | By Victoria White
Patients with pneumonia can initially be treated with most common antibiotics, according to research carried out by University Medical Centre Utrecht...
27 March 2015 | By Victoria White
LEO Pharma has announced it submitted a MAA to 30 European Health Authorities for Enstilar cutaneous foam for the treatment of psoriasis vulgaris...
27 March 2015 | By Victoria White
While antibiotics boast a vast pipeline, the majority is dominated by generics, as weak financial incentives and high fail rates have discouraged innovation..
20 March 2015 | By Victoria White
Scientists should reduce antibiotic use in lab experiments - according to a researcher from UEA’s Norwich Medical School...
19 March 2015 | By Victoria White
Martindale Pharma, a leading speciality pharmaceutical company, announce the appointment of NiiX Holdings (Pvt.) Ltd as distribution partner in Sri Lanka...
CAMO Software will be arranging their 2015 User Meeting in Prague, Czech Republic on 16th – 17th April...
In Issue #1 2015: Regulatory Insight, Biologics, NIR in-depth focus, Raman in-depth focus, PAT, Drug Delivery, Microbiology Series and much more...
Aqueous, multiple-use, non-sterile drug products are susceptible to microbial contamination during their shelf life. To protect these products from this potential hazard to patients, they are formulated with antimicrobial preservatives. Other product attributes employed using the hurdle concept to prevent microbial contamination include: low pH, low redox potential, reduced storage…
13 February 2015 | By PatientView
An independent study by PatientView...
