Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars



 

Online Audio Seminars come with 10+ Best Practice guides for easy implementation

 

Management and Validation of Computers for ISO 17025
Requirements, Recommendations and Tools for Implementation
Recorded

 

IT Infrastructure and Network Qualification
Introduction and Strategies for Compliance and System Uptime
Recorded

 

Traceability in Chemical Analysis
With strategies and tools for ISO 17025 and FDA Compliance
Recorded

 

Effective Verification of Compendial Methods
Understanding USP and FDA Requirements and get Tools for Implementation
Recorded

 

Auditing Laboratories for FDA and ISO 17025 Compliance
Preparation - conduct - follow up - documentation
Recorded, available on demand

 

Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
Comply with the FDA and international guidances
Recorded, available on demand

 

Validation and Use of Excel® Spreadsheets in Regulated Environments
With FDA's
Dennis Cantellops

Recorded

 

Labcompliance News, March 2009

New FDA Guidance on Anticancer Pharmaceuticals.

The Food and Drug Administration announced in a Federal Register notice of February 17, 2009, the availability of a draft guidance entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both drugs and biotechnology-derived products, intended to treat patients with advanced cancer. The recommendations describe the type and timing of nonclinical studies to support an investigational new drug application (IND) and the submission of a new drug application (NDA) or biologics license application (BLA). The guidance can be downloaded from the FDA website.

New Primer on Analytical Instrument Qualification and System Validation for Free

Agilent Technologies offers a 67 page primer on Analytical Instrument Qualification and Laboratory Computer System Validation. This primer written by Dr. Ludwig Huber, guides analysts, laboratory managers, quality assurance managers and IT and validation professionals through instrument and system validation at minimal extra cost. Following a literature and regulatory overview, this primer provides information on the entire qualification and validation process from planning, writing specifications as well as vendor qualification to installation, initial and on-going operation. Special focus is placed on getting a good understanding of and implementing USP chapter <1058>. After an introduction to the chapter’s approach for instrument qualification and system validation, this primer will lead you through individual qualification phases and give recommendations for implementation. For more information and ordering the free printed primer , click here

FDA Takes Regulatory Action Against Ranbaxy’s Plant in India

The U.S. Food and Drug Administration announced that a facility owned by India-based Ranbaxy Laboratories falsified data and test results in approved and pending drug applications. The facility, Paonta Sahib, has been under an FDA Import Alert since September 2008. To address the falsified data, the FDA has invoked its Application Integrity Policy (AIP) against the Paonta Sahib facility. The AIP is invoked when a company’s actions raise significant questions about the integrity of data in drug applications.  Under the AIP, the FDA has asked Ranbaxy to cooperate with the agency to resolve the questions of data integrity and reliability. This would include implementing a Corrective Action Operating Plan (CAOP) to provide assurance of the integrity and reliability of data from the Paonta Sahib facility.

Requirements of ISO 17025 for Computer Systems

There is a frequent question on how software and computer systems should comply with the ISO/IEC 17025 accreditation standard. The answer is written in the standard itself. For example the standard has 33 clauses that reference to computers, either directly or indirectly. Most of them are short and need further interpretation for implementation. Laboratories should have a clear general procedure on using computers in ISO 17025 environment. In addition procedures should be available for specific task such as validation, back-up, and secure authorized access to systems and data The effort to bring software into compliance depends on the software category and on the impact the system has on the test results. Attend the new Labcompliance audio seminar to learn what to do for different software categories and get necessary procedures for easy implementation.

President Barack Obama Announces New FDA Commissioner

In his weekly address, President Barack Obama announced the appointments of Dr. Margaret Hamburg as Commissioner of the Food and Drug Administration, and Dr. Joshua Sharfstein as the Principal Deputy Commissioner, as well as the creation of a new Food Safety Working Group. Dr. Hamburg is a nationally and internationally recognized leader in public health and medicine, and an authority on global health, public health systems, infectious disease, bioterrorism and emergency preparedness. In addition to the creation of a new Food Safety Working Group, the President also announced two other measures to protect the American people.

New FDA Guidance on Pharmacopoeial Texts - Dissolution Test

The Food and Drug Administration announced in a Federal Register notice the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7: Dissolution Test General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Dissolution Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance can be downloaded from the FDA website.

Readability Problems with 10 Year old PDF Files?

During a one day seminar on March 3, 2009 about Raw Data in Regulated Environments long term archiving and retrieval of electronic records has been discussed. When PDF as archiving format was suggested, a seminar attendee from a global pharmaceutical company reported readability problems with 10 year old PDF files using current reader software. Needless to say that this can cause big problems when working in regulated environments. Look at the recent Labcompliance audio seminar to learn about several alternatives and to get procedures for recording, long term archiving and retrieval in regulated environments. 

New FDA Guidance on Pharmacopoeial Texts - Uniformity of Dosage Units.

The Food and Drug Administration announced the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 6: Uniformity of Dosage Units General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Uniformity of Dosage Units General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance can be downloaded from the FDA website.

Free Document of the Month

As a 'Thank You' for our visitors Labcompliance offers every month one document for free. This month's document is the Validation Example: Requirements Specifications for HPLC Systems . To download your free copy, go to the  seminar page Understanding the New USP <1058> for Analytical Instrument Qualification (192), scroll down and click on the corresponding ICON on the left (offer expires on April, 2009). Labcompliance offers more than 100 Examples that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here

New Audio Seminar Schedule

  1. Management and Validation of Computers for ISO 17025
    Requirements, Recommendations and Tools for Implementation
    April 8, 2009
  2. IT Infrastructure and Network Qualification
    Introduction and Strategies for Compliance and System Uptime
    April 23, 2009
  3. Traceability in Chemical Analysis
    With strategies and tools for ISO 17025 and FDA Compliance
    April 30, 2009
  4. Effective Verification of Compendial Methods
    Understanding USP and FDA Requirements and get Tools for Implementation
    May 14, 2009
  5. Auditing Laboratories for FDA and ISO 17025 Compliance
    Preparation - conduct - follow up - documentation
    June 18, 2009
  6. Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
    Comply with the FDA and international guidances
    July 9, 2009

New or Updated Sites

Click here to tell others in your company about news