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GMP
For Increased Patient Safety
Drug Safety - To fight the alarming increase of falsified medicinal products detected, the European Parliament and the Council of the European Union released the Directive 2011/62/EU in the middle of last year. From the pharmaceutical industry's perspective, the key measures described are a requirement for safety features that will allow to validate the authenticity of drugs and the introduction of a system to verify individual medicinal packs. more
7 Steps to GMP Compliance
Updating Chinese GMP Guidelines - The Chinese know that implementing good manufacturing practice (GMP) is a prerequisite for a certificate but in the past, the Chinese GMP system could not be compared to Western GMP standards. The first GMP manual in 1988 focused on cleanrooms and cleanroom technology.It appears as if the installation of such a cleanroom would constitute the whole GMP status. more
Vaccine Production: ‘Best-in-Class’
The production of pharmaceutical products requires strict compliance with specified ambient conditions. Since the building automation systems (BAS) must meet very special requirements and increasingly stringent official regulations. more
Flow Chemistry for Hazardous Reactions
Magic Pill? - The kick to expand flow chemistry into new application areas is a hot topic in chemistry and pharma. Driven by the vision of highly efficient processing, reputable players put enormous efforts into converting existing and new processes from batch to flow. Indisputably, the flow process has a potential but is it the pill to cure all headaches?Chemistry Between Flow and Batch
Continuous processes are work horses in the production of commodities such as petro and industrial bulk chemicals. more09.06.2011
Next-Generation Instrument Simplifies Sample Preparation
Hamilton Bonaduz is introducing the Microlab 600, the next generation of semi-automated laboratory diluters and dispensers for sample preparation. Based on Hamilton's leading syringe technology, the new Microlab 600 instrument has been designed for ease of use and offers flexibility for more routines and smaller sample volumes. Features more
Securing Each Step
Like nearly all aspects of public and private business, healthcare management organizations and national governments are feeling price pressure, and many look to mitigate this by saving money when it comes to drugs. This pressure gets passed along the value chain to the manufacturers of excipients, who strive to provide the highest-quality products to their customers in a world where the regulatory framework is unclear. Brandi Schuster asked some of this year's CPhI exhibitors the following questions:more15.06.2010
Turning Point
Sharp Focus - 2010 could be a watershed year for the excipient sector in Europe as amendments to the falsified medicines directive bring excipient quality and safety considerations to the fore. As the second decade in the 21st century gets underway, it is a pivotal time for excipient suppliers and users, with greater attention being paid than ever before to the quality and safety of materials used to manufacture pharmaceuticals. more
Improving Efficiencies And Compliance
Look Closer -Wockhardt UK experienced firsthand the economic and personnel advantages a Laboratory Information Management Systems (LIMS) can bring to a business. The company is a contract manufacturing organization (market capitalization $1.3 billion) with 12 coordinated facilities in Europe, Asia and USA. Wockhardt UK is a 16,000 m2 facility with European Medicines and Healthcare Products Regulatory Agency (MHRA) and U.S. more
Prosonix Succesfully Scales Up Umax Technology For Respiratory Medicines
Prosonix has announced the successful scale up of UMAX, its new particle engineering technology that is set to revolutionize respiratory medicine. The scaleup has now been demonstrated on multiple APIs in GMP facilities. more- Legal
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