GLP implementation on form Nov 1, 2010

GLP implementation on form Nov 1, but many units unaware of key norms
November 17, 2010, 0800 IST – Source : Pharmabiz News

Even as the drug authorities in the country are gearing up to implement the Good Laboratory Practices (GLP) for the pharmaceutical sector, most of the pharma units, especially the small and medium pharma units, are unaware about the requirements regarding the premises and equipments which should be upgraded as per the Schedule L-1 of the Drugs and Cosmetics Act, 1940.

Though the drug authorities have issued circulars to the pharma units asking them to comply with the GLP, which has become mandatory for the pharmaceutical units in the country from November 1 this year, the drug authorities did not mention any information about the requirements of premises and equipments as per the Schedule L-1 of the Drugs and Cosmetics Act.

Faced with lack of such information, the Madhya Pradesh Pharmaceutical Manufacturers Organization (MPPMO) has asked the state drug controller to provide the information in this regard to the pharma units so that they will be able to follow the norms set by the union health ministry. The MPPMO has asked the drug department to circulate the necessary information in this regard to the pharma units so that they can take steps towards implementation of Schedule L-1.

Besides, the MPPMO has also asked the state drug authorities to prepare a GLP-compliant model drug testing laboratory by the government so that the companies can send their quality control head to the government laboratory to get the proper guidance for upgrading their units as per GLP guidelines.

Earlier, the Drug Controller General of India (DCGI) Dr Surinder Singh had asked the state drug controllers to begin implementation of the GLP from November 1 this year. The DCGI directive in this regard was given to the state drug controllers at the Drugs Consultative Committee (DCC) meeting held on October 28 this year which also discussed several important issues that have been pending for some time.

The government decision to implement the GLP from November 1 has put the industry in real difficulty as a large number of units, especially the small and medium players, have not yet complied the GLP norms due to the huge financial burden involved in it. The GLP standards mandated through the revised Schedule L-1 under the Drugs and Cosmetics Rules, Third Amendment, 2008, demands setting up of costly machines like FTIR (Fourier Transform Infrared Spectroscopy), HPLC, AAS, HSGC, IR machines in every pharma units. Adherence to these norms would require a considerable investment from the small scale units, which are struggling for survival.

In fact, the industry has been under the hope that the government will further extend the deadline fixed by the government two years ago. Several industry associations, including, IDMA SPIC and CIPI, have been urging the government to extend the deadline by at least another two years.

DCGI issues guidance on clinical trial inspection

Source : Pharmabiz.com

November 03, 2010, 0800 IST

Aiming to provide direction to inspectors and other CDSCO officers for conducting inspection of clinical trial sites, sponsor or CROs’ facilities involved in clinical trial and information to investigators, sponsors or CROs about procedures for inspection and follow-up of action, the Drug Controller General of India (DCGI) has issued guidance on clinical trial inspection.

The guidance covers the entire gamut of issues involved in the clinical trial inspection. It aims to verify GCP compliance to protect the rights, safety and well being of the subjects involved in clinical trial; to verify the credibility and integrity of clinical trial data generated; and to verify the compliance with various regulatory provisions as per Drugs & Cosmetics Rules.

The scope and extent of the programme covers all clinical trial sites and sponsor/CRO’s facilities involved in clinical trial of drugs including biological and medical device covered under Drugs & Cosmetics Act.

As per the guidance, inspection can be conducted before, during or after a clinical trial is completed. Inspection can be carried out as a routine surveillance or for any specific cause(s). Study may be selected for inspection based on, but not restricted to the criteria like: Nature of study; for regulatory decision based on clinical trial data; Data irregularities; Complaints; Vulnerability of subjects; and Number of CT including number of subject enrolled at a particular site.

The CDSCO HQ will issue instruction to the CDSCO Officers /Inspectors to conduct the inspection identifying the clinical trial, name, address, contact number of clinical trial site, sponsor/CRO’s facilities to be inspected. It may also identify the type and purpose of the inspection and provide background materials like study protocol, CRF, etc.

According to the new guidance, inspection of clinical trial site would generally be pre-announced to ensure availability of the investigator/sub- investigator and other personnel along with study records at the time of the inspection. The date of inspection and other arrangements would be finalised by the CDSCO Officers/Inspector(s) in coordination with the investigator /sponsor/CRO. Under some specific circumstances unannounced inspection of clinical trial sites can be carried out as per the direction of CDSCO HQ and the inspection of CRO/sponsor can be conducted without prior notice.

The inspection includes verification of essential documents to determine whether the trial related activities were in accordance with the protocol, GCP guidelines published by DGHS, Govt. of India and Schedule Y as well as other applicable regulatory requirements. When inspection is carried out after completion of the clinical trial, it will include comparison of data generated by the sponsor with source documents at the clinical trial sites and Case Record Form (CRF) in the investigator’s files. If it is a routine surveillance or “for cause” inspection of an ongoing clinical trial, the comparison will generally include source documents and CRF

DCGI asks state DCs to enforce GLP from Nov 1, rejects industry plea for extension

Source : Pharmabiz.com

November 01, 2010, 0800 IST

The Union health ministry has decided not to extend the Good Laboratory Practices (GLP) and it will become mandatory for the pharmaceutical units in the country to comply the GLP norms set by the health ministry from November 1, 2010. The decision to implement GLP in the country was taken by the government more than two years ago and the ministry had given the pharma industry two years time to comply it.

Accordingly, the Drug Controller General of India (DCGI) Dr Surinder Singh has asked the state drug controllers to begin implementation of the GLP from November 1 this year. The DCGI directive in this regard was given to the state drug controllers at the Drugs Consultative Committee (DCC) meeting held on October 28 which also discussed several important issues which have been pending for some time.

Now that the DCGI has given his directive to implement the GLP, the state drug controllers will start inspections of the pharma units to verify the situation.

The government decision will put the industry in real difficulty as a large number of units, especially the small and medium players, have not yet complied the GLP norms due to the huge financial burden involved in it. The GLP standards mandated through the revised Schedule L-1 under the Drugs and Cosmetics Rules, Third Amendment, 2008, demands setting up of costly machines like FTIR (fourier transform infrared spectroscopy), HPLC, AAS, HSGC, IR machines in every pharma units. Adherence to these norms would require a considerable investments from the small scale units, which are struggling for survival.

In fact, the industry has been under the hope that the government will further extend the deadline fixed by the government two years ago. Several industry associations, including, IDMA, SPIC and CIPI, have been urging the government to extend the deadline by at least another two years. “Considering the financial situation of the small scale units after compliance of the revised Good Manufacturing Practices (GMP) and the increasing competition in the market, the government should relax the GLP norms so that some of the laboratory activities could be outsourced by these companies in GLP complied third party labs. The government should also consider extending the deadline for implementation, to help the small scale units to survive,” the industry argues with the ministry.

More U.S. Medical Laboratories Ready to Step up to ISO 15189 Accreditation

Source : http://www.darkdaily.com

October 14, 2010

North America’s three ISO 15189 accreditation bodies will be at Lab Quality Confab, along with most of the nation’s ISO-15189 accredited clinical pathology laboratories

In the United States and Canada, acceptance and use of ISO 15189:2007 Medical Laboratories has been limited to a handful of clinical pathology laboratories—except in the Canadian province of Ontario, where, starting almost eight years ago, ISO 15189 became the basis of the province’s mandatory clinical laboratory accreditation program.

But now more pathologists and clinical laboratory managers south of the U.S.–Canadian border are asking a fundamental question: “Is ISO 15189 accreditation an effective way to move my laboratory organization to higher levels of analytical quality while continuously reducing or eliminating errors that affect patient safety and clinical outcomes? More senior medical lab leaders are answering this question with a “yes.”

Clinical Laboratories Turning to ISO 15189

Evidence of the growing interest in ISO 15189 will be highly visible at a medical laboratory conference in San Antonio, Texas, that takes place on November 2-3, 2010. All three of the major ISO 15189 accrediting bodies in the United States will be at the Lab Quality Confab and Process Improvement Institute. Joining them will be the leaders from most the U.S. clinical laboratories currently accredited to the standards of ISO 15189.

Gathering together all these experts and lab users of ISO 15189 in one place at one time gives pathologists and clinical laboratory managers a cost-effective opportunity to learn how adopting ISO 15189 can put their own laboratory on the fast track to improved market share, lower costs, and increased clinical quality.

The three ISO 15189 accrediting bodies will conduct these sessions:

SO 15189’s Essential ‘Do’s and Don’ts’: Lessons from Early-Adopter Laboratories, conducted by Georgene Cooke, CAP 15189 Market Manager, College of American Pathologists (CAP) and Trace Custer, Senior Director Regulatory Compliance, Genzyme Genetics

QMS in the ISO World: What You Need to Know about ISO 9001 Certification and ISO 15189 Accreditation, led by Daniel Tholen, Technical Consultant, American Association for Laboratory, Accreditation (A2LA)

Eight Years of ISO 15189 in Ontario Give Both Labs and Med Techs a Top Reputation and Better Access to Resources and Funding, given by Julie Coffey, Quality Manager, Quality Management Program-Laboratory Services (QMPLS)
To share the successes and lessons learned by the nation’s first ISO 15189-accreditated laboratories, also speaking at Lab Quality Confab will be the leaders from these medical laboratories: Spectra Laboratories, Inc. of Rockleigh, New Jersey; Genzyme Genetics, Santa Fe, New Mexico; and Avera McKennan Health System Laboratories, Sioux Falls, South Dakota.

How Labs and Pathology Groups Are Using Lean and Six Sigma

These sessions will be among the more than 40 presentations and speakers who will take the podium at this fourth annual Lab Quality Confab. It is a comprehensive range of information, knowledge, and case studies about how clinical labs are using Lean, Six Sigma, and rapid process improvement methods to great advantage.

Poster sessions will take place, and national awards and prizes totaling $3,000 will be awarded. To see topics, speakers, and all the events at Lab Quality Confab, visit http://www.labqualityconfab.com.

To register for Lab Quality Confab, visit http://www.labqualityconfab.com/register

With more than 250 participants expected from as many as 10 different countries, Lab Quality Confab not only continues to be the most important meeting about performance improvement methods as used by innovative medical laboratories, but the large size of this meeting provides strong evidence that quality management and process improvement is now an established part of laboratory medicine. Interested lab managers and pathologists are encouraged to register today to guarantee their place at the Fourth Annual Lab Quality Confab.

Related Information:

•Full program information and speaker agenda for Lab Quality Confab:

•Complete Details About the Lean-Six Sigma Poster Presentations, National Trophies, and Cash Awards, along with Poster Presentation Application and Abstract forms:

Four Easy Ways to Register:

1. Register ONLINE
2. Call 800-560-6363. Our friendly staff can register you quickly and easily, as well as answer any questions you may have.
3. Fax this complete registration form to 512-264-0969
4. Mail the one page form with payment to:
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Genzyme Laboratory Recognized for Quality—December 09, 2009

Ontario’s Mandatory Accreditation to ISO:15189:2003, Quality Management Program—Laboratory Services, Ontario Laboratory Accreditation

ISO 15189:2007 Medical laboratories—Particular requirements for quality and competence