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SEPTEMBER 2006 NEWS

 

International cGMP Training Offered by PTi International

PTi international is offering a training class titled, International GMPs: Complying with Requirements in the U.S., EU and Japan.

October 16-17, 2006 Boston, MA
December 11-12, 2006 New Brunswick, NJ
http://www.pti-international.com/IntlGMPs/index.xml

  • Clarify the similarities and differences among GMP requirements for the U.S., EU and Japan and create a globally compliant manufacturing process.
  • Comply with the guidelines of all regulatory bodies by understanding the process of harmonization and the implementation of ICH Q7 and Q7A guidance documents in each region.
  • Meet international requirements for production of commercial as well as clinical trial supplies and become fully prepared for inspections.
  • Examine mutual recognition procedures and the types of information-sharing allowed among international regulatory agencies.
  • Understand the role of Qualified Persons in a GMP-controlled environment.
  • Comply with Quality System Regulations and establish a thorough quality program that ensures manufacturing efficiency.
  • Ensure manufacturing operations located in the U.S. are compliant with international requirements.
  • Adjust to recent changes in the Japanese drug approval system to increase approval chances in the region.

 

Recent NABL Accreditations to Laboratories in India

The National Accreditation Board for Testing and Calibration Laboratories (NABL) has given accreditation to the Sophisticated Test and Instrumentation Centre (STIC) (http://sticindia.com/) at the Cochin University of Science and Technology. Cochin University of Science and Technology is located in Kerala, India.

The STIC has set up state-of-the-art calibration facilities for pressure, weight, and other mechanical parameters. The mechanical calibration laboratory at the centre is equipped with dead weight testers, weighing balances and standard weights of EI and FI class.

The STIC had earlier received NABL accreditation in the electro-technical and thermal areas. In the mechanical discipline, the centre has calibration and testing capabilities in pressure, weight, vacuum, liquid viscosity, material hardness, fatigue and material strength.

Suven Life Sciences Ltd has announced that the Company has received NABL (National Accreditation Board for Testing and Calibration Laboratories) Certificate by the Department of Science & Technology, India, to its Biopharmaceutical Research Lab facility at Hyderabad with the standard ISO / IEC /17025:2005 ("General Requirements for the Competence of Testing & Calibration Laboratories").

The Company is a Hyderabad based Life Sciences Company, pioneer in Contract Research and Manufacturing Services (CRAMS) since 1995, Drug Discovery and Development Support Services (DDDSS) since 2005 and a Collaborative Research Partner (CRP) with Global life Science Companies (2006).

The Company is awarded the "Partner of Choice in Drug Discovery for CNS" by Frost & Sullivan in 2005. With this NABL certification, the Company will be in a position to offer value added services within the business segment of CRAMS, DDDSS and CRP.

 

Bookham Qualification Labs Achieve International Standard ISO/IEC 17025

Bookham Inc., a provider of optical components, modules and subsystems, announced that it has achieved the International Standard ISO 17025 for testing and calibration.

The company said the achievement means that its reliability and qualification testing facilities can now provide independent test data on Bookham products and can offer an independent testing service to other companies.

The accreditation follows a third party audit of the Bookham reliability laboratory at Caswell, UK, which assesses all of the company's products for reliability and longevity. The audit, which was conducted by the British Standards Institute (BSI), confirmed that the quality and reliability data produced by the laboratory is impartial and satisfies the stringent standards required.

"Bookham has been assessed by a world-renowned, external authority, which has confirmed that our laboratory can be trusted, not only to produce authenticated results for our own products, but now for the products of other companies," said Reiner Breu, VP, Quality and Reliability at Bookham.

"This complements Bookham's existing TL9000 global accreditation and is another major step forward in the continuous enhancement of the services we offer our customers. It has only been possible through continuous commitment and investment in test equipment, facilities and expertise, and the benefits are already being seen, with a number of customer audits demonstrating the high quality of service provided by Bookham," added Breu.

To achieve the standard, Bookham has established a separate service, with its own organization and line management, that meets the requirements of ISO 17025. This involved the production and documentation of a quality management system and quality management procedures embracing the management and technical requirements that comprise the standard.

ISO 17025 is an International Standard (published by the International Organization for Standardization) that specifies the general requirements for the competence to carry out tests and/or calibrations. There are 15 management requirements and 10 technical requirements to achieve the standard. To gain accreditation a laboratory must document a quality management system and establish quality management procedures to ensure the system is maintained.

More information on Bookham, Inc. is available at www.bookham.com.

 

Cebu CITE Calibration Laboratory Meets ISO Standards

The Center for Industrial Technology and Enterprise (CITE) Electrical Standards and Testing Laboratory or CITE Calibration Laboratory has been validated to conform the requirements of the Philippine National Standard/ International Standard Organization/ International Electrotechnical Committee (PNS ISO/IEC) 17025:2000. The Philippine Accreditation Office (PAO) of the Department of Trade and Industry (DTI) issued the certificate of accreditation to CITE Electrical Standards and Testing Laboratory on August 22 at CITE.

DTI Undersecretary Zenaida Maglaya handed in the certificate of accreditation to CITE president Pedro Dimaculangan in a simple ceremony attended by Rene Burt Llanto, Department of Science and Technology-7 director; John Manzanas, National Program Manager of Private Enterprise Accelerated Resource Linkages (Pearl2) Project, Jens Funk of Deutcher Entwicklungsdienst (DED-Philippines); and members of the CITE board of trustees, management, and staff.

PAO evaluated the laboratory's capabilities, in both management and technical aspects, based on international standards through a rigorous laboratory accreditation scheme. CITE calibration laboratory was found to have complied with internationally accepted standards of quality, performance, technical expertise and competence.
CITE calibration laboratory, which is located in San Jose, Cebu City, has been servicing industry partner companies by providing them with a wide gamut of top-quality calibration services and fast turn-around time. Its management and staff have ensured that all activities are conducted in accordance with the company procedures and in compliance with the requirements of PNS ISO/IEC 17025:2000.

Visit CITE’s website at http://www.cite.edu.ph/ for more company details.

 

GMP Webinars Now Available As Recordable Webinars
The GMP webinars offered by the European Compliance Academy (ECA) since January have turned out to be a big success. Numerous attendees already take advantage of the opportunity to get the latest on topics and current developments relative to EU and FDA GMP requirements fast and easily without leaving their desk.

In addition to the big interest in currently offered webinars, ECA continuously received inquiries for past webinar topics. Therefore, the Academy extended its offer with recorded webinars. These recordings are 1:1 replays of live webinars, including questions from participants and answers from the speakers. They are thus a perfect alternative or an additional tool for receiving an update any time – sort of "on-demand".

All a viewer needs to play a recorded webinar is a high speed Internet connection (DSL), the (commonly pre-installed) Windows Media Player or the RealPlayer from Real Networks, a sound card and speakers.

The recording can be ordered via an Internet form in which potential buyers also have to specify when they plan on watching the recording. At the specified date, the recorded webinar is available via an access code – this code is active for 24 hours only.
More information on this new service and on the currently offered recorded webinars as well as an excerpt of a recording can be found here:

The next live GMP webinar on 28 September 2006 from 15.30 to 17.00 o'clock (CET) concentrates on the USP Draft General Chapter < 1058 >: Analytical Instrument Qualification and focuses on questions like:

  • What are the differences between qualification and validation?
  • What are the components of data quality?

To find this news item please visit http://www.gmp-compliance.org and access the News section article dated August 30, 2006.

 


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