Showing posts with label ISO. Show all posts
Showing posts with label ISO. Show all posts

Contract Pharmaceutical Packaging Company Offers ISO Class 8 Capabilities for Potent Compounds

Compass Pharma Services today announced that it has completed a capital investment project to upgrade its contract pharmaceutical packaging capabilities to include “ISO Class 8” specifications

CLIFTON, N.J.-To provide contract pharmaceutical packaging services for certain high-potency pharmaceutical products, Compass Pharma Services, LLC today announced that it has completed a capital investment project to upgrade its production capabilities to include “ISO Class 8” (ISO 14644) specifications.

“These capital improvements now allow us to provide cGMP contract packaging services for select potent pharmaceutical compounds such as enzymes, antibiotics, antifolates, antimetabolites and some hormones,” said Tony Fenno, Chief Operating Officer. “Compass Pharma investments continue to position the company as a responsive contract pharmaceutical packaging partner for sophisticated, high-demand contract packaging services for the pharmaceutical industry.”

In February 2009, Compass Pharma added Micro and Nanofill packaging capabilities to its growing list of cGMP contract packaging capabilities. Micro and Nanofill technologies allow filling small volumes (less than one gram) of powders into blister packaging, vials or pouches.

The capital improvements for ISO-Class 8 certification comprise a fully integrated production suite where the primary packaging area has negative differential air pressure relative to surrounding gowning and secondary packaging areas. High-Efficiency Particulate Air (HEPA) filters are deployed in the primary packaging area.

Manufacturing Automation Corporation of Princeton, NJ assisted Compass Pharma with the engineering/design and validation of the ISO Class 8 area. Whitehouse Analytical Laboratories, Inc. (Whitehouse, NJ) has been retained to provide Compass Pharma with ongoing analytical services.

ENCO Pharmaceutical Development Announces Addition of Keith Hurley as Vice-President of Sales and Marketing

Jacksonville, FL, - Mr. Hurley joins the growing pharmaceutical contract organization as the company continues its expansion plans. “We are delighted to have someone with Keith’s background in the pharmaceutical and medical device industries join our team”, said Mr. Rick Camp, President of Enco Pharmaceutical Development, Inc. “He brings a wealth of knowledge and has already proven to be a great asset to the company.”

Mr. Hurley has 25 years of experience in the field of science, including 14 years directly in the pharmaceutical industry. He has extensive experience in both laboratory and business operations. “Keith’s broad exposure to so many disciplines within the pharmaceutical industry gives us a multi-faceted resource for our company. We are leveraging these resources not just in business but also in the technical and regulatory areas as well”, said Mr. Camp.

Prior to joining ENCO, Mr. Hurley founded Aspire Pharmaceutical Consulting, Inc., a successful consulting firm where he serves as President. He also has held key positions at Cardinal Health, where he was Global Head of Marketing for the Inhalation Division and at other contract organizations where he has held a variety of positions from Director to Vice-President. Mr. Hurley has also worked at Aradigm, Novartis and Proctor and Gamble. Mr. Hurley has been actively involved in a wide variety of pharmaceutical conferences around the world where he has either presented, chaired or led discussion forums. He is also a member of AAPS.

ENCO Pharmaceutical Development, Inc. provides technical outsourcing assistance to the pharmaceutical industry, including analytical product development with services that range from raw materials testing to full Phase III stability studies following cGMP standards. The company also provides comprehensive testing on medical devices. ENCO is FDA registered, an ISO accredited analytical laboratory and holds registration with the DEA to handle the development of controlled drug substance for pharmaceutical use. ENCO Pharmaceutical Development, Inc. operates two locations – the corporate headquarters at 4810 Executive Park Ct., Suite 110, Jacksonville, FL and a second location at 102-E Woodwinds Industrial Ct, Cary, NC 27511

ENCO Analytix, Inc, Announces Name Change to ENCO Pharmaceutical Development, Inc.

Jacksonville, FL, - The articles governing the amendment to change the company name were officially received in the offices of ENCO from the state of Florida on April 30, 2009. “We are very excited about the name change as it more accurately reflects our sole focus on the pharmaceutical industry”, said Rick Camp, President of ENCO Pharmaceutical Development, Inc. “We have worked hard over the past 5 years to develop a very positive reputation with our customers within the pharmaceutical and medical device industries and we believe that this change in name will make it easier for new customers to understand our service offerings”, Camp said.

The name change will be evident immediately on all ENCO Analytix, Inc. corporate documents, signage and references. “ENCO Pharmaceutical Development, Inc. is a better descriptor of the services that our company offers” said, Keith Hurley, Vice-President of Sales and Marketing. “We are a dynamic and growing company offering a unique service approach to the pharmaceutical outsourcing industry”, Hurley said. “It’s part of the marketing plan, we want to make sure those companies that are in search of an outsourcing partner to handle their analytical development needs, know that we are here to work with them”, said Hurley.

For additional information on the name change of ENCO Analytix, Inc. to ENCO Pharmaceutical Development, Inc., please contact Keith Hurley, Vice-President of Sales and Marketing at 336.541.3270

About ENCO Pharmaceutical Development, Inc.

ENCO Pharmaceutical Development, Inc. provides technical outsourcing assistance to the pharmaceutical industry, including analytical product development with services that range from raw materials testing to full Phase III stability studies following cGMP standards. The company also provides comprehensive testing on medical devices. ENCO is FDA registered, an ISO accredited analytical laboratory and holds registration with the DEA to handle the development of controlled drug substance for pharmaceutical use. ENCO Pharmaceutical Development, Inc. operates two locations – the corporate headquarters at 4810 Executive Park Ct., Suite 110, Jacksonville, FL and a second location at 102-E Woodwinds Industrial Ct, Cary, NC 27511

Pharma cos adhere to EHS to attract global business

Globalisation seems to be driving the Indian pharma industry towards better environmental, health and safety (EHS) performances. In order to elevate their global image, several Indian companies are complying with EHS standards to widen their horizons and attract international players.
EHS auditing is becoming a global practice as organisations around the world develop audit standards. Big players across diverse industrial sectors especially from US and European countries are opting for EHS compliance as one of the key mandate in the process of manufacturing outsourcing.

Most pharma companies like Ranbaxy Laboratories, Alembic, Dr Reddy's Laboratories, Cadila Pharmaceuticals, Zydus Cadila, Arch Pharmalabs and USV, among others have ensured a proper EHS management system and other environmental initiatives to attract additional business opportunities in the global arena.

"The Indian pharma world has evolved around industrial development zones set up by various state governments. In earlier years, most of the units could take benefit of the then prevalent lax environmental laws. But now US and European customers are looking beyond our local compliance levels and want companies to adhere to their standards, which are quite exacting and taxing from an investment perspective. This has led to a big challenge for the Indian pharma industry, particularly small scale units, which either have investment concerns or limitations of growth beyond their allotted unit areas in these industrial zones. These developments are bound to result in various units getting disqualified for supplies leading to elimination and consolidation in the pharma world. With quality and cost efficiency as a given, it is only EHS compliance that will stand out for a vendor," says Ajit Kamath, chairman and managing director of Arch Pharmalabs, which has a standalone turnover of Rs 750 crore.

Kamath adds that at a macro level, both China and India have long been viewed as countries with suspect EHS compliance. Companies with orientation of exports to the Western world are faced with no choice but to adhere to EHS. Besides customer audits, many Indian companies have been proactively seeking out ISO14000 and ISO18000 standards to signal EHS compliance.

To be in sync with the green policy of the western world, Indian companies seem to be proactive in adopting a number of green initiatives, including a proper EHS management system.

For Alembic, EHS functions as a major focus are along with other green initiatives like water conservation, replacement of furnace oil by solid fuel bio-mass and stopping the use of ozone depleting chemicals. "Alembic is a 101 year old company and we put a lot of focus in EHS. At present we are working with a number of multinational pharmaceutical companies and this is an important pre-requisite for them in considering Alembic as a partner for their global outsourcing. A good EHS system such as the one we have at Alembic also helps us in terms of an accident free zone, awareness about the safety and periodically training our team and a pollution free environment. Besides, EHS has become a critical area for the leading Indian pharmaceutical companies as more people are investing in it due to the numerous benefits such as safety and health of employees as well as a commitment to the environment. This also results in the enhancement of productivity," says Pranav Amin, director and chief business development officer at Alembic Limited.

According to Amin, an environment-friendly policy could result in additional business opportunities which would affect the top line and bottom-line as an environmentally friendly policy is well respected by pharmaceutical companies all over the world.

The EHS guidelines were created by the International Finance Corporation in 1998. The objective of EHS is to safeguard life, property and the environment. It enables industries to manage risk better, reduce cost and improve health & safety of people in general. Most global pharma companies use environmental, health and safety performance criteria to assess and select contract manufacturers, key API suppliers, contract research and development labs and even logistics centers. This is primarily done to protect the reputation of the global pharma companies while they outsource to India.

Mumbai-based pharma major USV has invested significantly in resources to reduce the ecological footprint of its operations.

The company has put in place the integrated implementation of environmental, occupational health and safety management systems, popularly known as ISO 14001 and OHSAS 18001, at its manufacturing locations in Lote, Baddi and Daman. "In our business, we must also respond to the growing stringency of statutory EHS norms. In this respect, our environmental performance has consistently extended beyond the statutory requirements, like provision of RO plants for recycling of treated effluent to the maximum extent possible, safe solid waste disposal and emission reductions. To increase health and safety awareness across the organisation, we have created a detailed work flow for reporting accidents or incidents, enabling us to better track and analyse these incidents. All our manufacturing plants have fully equipped with occupational health centers. Also, this year all our manufacturing sites have achieved Zero LTA," says Debabrata Gupta, director and chief operating officer at USV.

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