Category — Operations

Thomas Rossnagel - former head of Sunrise’s Europe business and operations has been promoted to President and CEO of Sunrise Medical. Michael N. Cannizzaro - former CEO will continue as Chairman of the Board of Directors.

Rossnagel who worked out of the companies German operations is recognised in Europe for his leadership - and his most notable performance in driving efficient and effective operations for Sunrise Europe over the past several years.

With this latest move Sunrise continues to demonstrate it’s ability to take a global management perspective to it’s business.

The full press release is here.

May

There is no doubt that the economic recession which has now touched all parts of the world is taking it’s toll on most industries.

One of the most resilient however is the healthcare industry. Sibaya LifeScience! recently interviewed several companies supplying services to “big pharma” in the form of contract manufacturing - especially drug delivery - at ICSE, P-Mec, Cphi - Frankfurt, Germany. While this was not a scientific study, anecdotally we were told that it was business as usual, in fact for some, business was clearly on the increase as manufacturing was being outsourced to contract manufacturers.

Not the case though for small and medium sized biotech companies according to this report in the IHT which lists companies in the Biotech hub in Massachusetts struggling for cash and laying off employees. Biotech companies need cash to fund research while waiting for their revenues to hopefully arrive one day, but in the US biotech companies have only been able to raise about half of what they did in the prior year.Technorati Tags: biotech, contract manufacturing

The United States FDA has just issued a new

Guidance for Industry: Process Validation: General Principles and Practices

This is an important new proposed guideline document and the FDA is inviting comments within 60 days of it being published in the register.

Our initial observations at Sibaya LifeScience! are:

Aligning process validation activities with the product lifecycle concept and with existing FDA guidance, this guidance now includes biological products and active pharmaceutical ingredients.

It also specifically provides recommendations with the Risk-Based Approach for technological advances in pharmaceutical manufacturing.

It clearly defines process validation ‘as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products’

From our perspective one of the most interesting guidance points is the consideration of having an integrated team composed of a variety of specialties to cover process knowledge, facility design and equipment selection among others.

The full text is available from the FDA or it is available as a PDF file from their site.

We would be interested in your views which you can add below by clicking on the comments link.

Bruno Cocheteux is a Managing Partner at Sibaya LifeScience!

Sialkot is an area in Pakistan that is noted for the production of medical products, most notably surgical instruments. Over the years there has been an increasing number of manufacturers from this region leading to a higher degree of competition as well as higher quality performance.

There is a high degree of interest from Sialkot surgical product manufacturers in search or international distributors and international distributors looking for surgical products on this blog.

We are therefore creating this separate post which hopefully will become a central point for both manufacturers from Sialkot and international distributors to meet.

If you would like to post your information please simply click on the “comment” tab below and enter your details. Please be aware that your details will then be available on the internet.

Sibaya China Joint Venture

Aluminum Manufacture Extrusions, Parts, Assemblies

• Company founded in 1960
• ISO 9001:2000 Certified
• 5 Extrusion machines from 690 - 2100 tons
• Fully integrated mold manufacture, CNC milling, bending, punching capability
• Served industries, industrial, construction, healthcare mobility, bicycle frames, electronic, various parts all industries
• International specifications for Aluminum

Quality Capability

 Microstructure Analysis

 Spectrometer

Extrusion Capability

 2100 Ton Extrusion Press

 Extrusion Press Workshop

CNC Capability

 CNC Machine Center

 CNC Lathe

Punching Capability

 Punching Workshop

 Punching Workshop

Drilling Capability

 Heat Sink Drilling

Assembly Capability

 Wheel Rim Workshop

Mold Capability

 Mold Center

 Mold Maintenance

Contact Frank Barlin at Sibaya Healthcare

International Trading Group, Inc. (ITG) is a full service trading and consulting firm located in Philadelphia Pennsylvania, U.S.A. Established in 1990; ITG is actively involved in the development and expansion of business opportunities in Pharmaceuticals and Food in the global market.

For more than 15 years ITG has enjoyed an extensive business relationship with China. This is one of ITG’s key strengths, allowing the company access to FDA/GMP approved pharmaceutical plants throughout China. ITG has had a long term relationship with Sinopharm. Sinopharm is the largest Pharmaceutical and Medical Device company in China.

ITG’s business portfolio includes a wide range of clients within the Pharmaceutical, Nutraceutical and Medical Device Industry - from GSK (GlaxoSmithKline) to Delavau.

For additional information, please check our website:
www.itradinggroup.com