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Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with GxPs, Part11, HIPAA, SOX and other regulations.

Available on demand

 

Understanding and Implementing ISO 17025

Requirements, Strategies and and Tool Kits for Laboratory Accreditation

Available on demand

 

Validation of Analytical Methods and Procedures

Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance

February 28, 2008

 

Understanding USP Documents and Reference Standards

General Chapters, General Notices, Monographs, Forum, Reference Standards

March 13, 2008

 

Understanding the New USP <1058> for Analytical instrument Qualification

With SOPs, Templates and Examples for Easy Implementation

March 27, 2008

 

 

NEW BOOK EDITION

Dr. Ludwig Huber

 

 

Labcompliance News, January 2008

January 12, 2008

New Annex to Q8:  Pharmaceutical Development

This guideline has been released for consultation under Step 2 of the ICH process on 1 November 2007.
This guideline provides further clarification of key concepts outlined in the core guideline. In addition, this annex describes the principles of quality by design (QbD). The annex is not intended to establish new standards: however, it shows how concepts and tools (e.g., design space) outlined in the parent Q8 document could be put into practice by the applicant for all dosage forms. Where a company chooses to apply quality by design and quality risk management (Q9: Quality Risk Management), linked to an appropriate pharmaceutical quality system, then opportunities arise to enhance science- and risk-based regulatory approaches (see Q10: Pharmaceutical Quality System). .

January 12, 2007

FDA Uses Excel® Spreadsheets in Its Own Laboratories

Some companies don't want to use Excel® and other spreadsheets in FDA regulated environments. Concerns are that such spreadsheets are not accepted by the FDA. However, FDA professionals made it clear that Excel can be used in FDA regulated environments if specific procedures and technical controls are implemented. As a matter of fact FDA is using Excel® in its own laboratories to comply with their own regulations. The FDA has developed two internal Information Bulletins that guide single and multiple users of spreadsheets through the process. Controls include: User ID/Password for secure log-on, MS NTFS to limit access to files, storage of spreadsheets on write protected server directories, validation of spreadsheet applications, control and archive of spreadsheets for internal audits, standardizing design of templates (use of colors, cell protection). To learn more about using Excel® in FDA regulated environments and to receive 10+ good practices documents for easy implementation, click here.

January 12, 2008

No Validation of Excel Spreadsheets Draws FDA Warning Letter

The Excel Spreadsheets have been used to create and maintain non-conformance records, product return records, internal audit records and corrective action records. The letter stated that electronic records are used but there was no software validation. For example, no procedures were established to validate for its intended purpose the Microsoft Excel software. The Warning Letter can be downloaded from the Labcompliance Usersclub. (Scroll down to W-189). Non members can preview excerpts. To learn everything about Excel Spreadsheet validation attend the labcompliance audio seminar on February 7, 2008. 

January 12, 2008

Argentina and Malta new PIC/S Members

The Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S) announced in a press release that Argentina's and Malta's authorities have been invited to join PIC/S as new members as of Jan 1, 2008. With these new additions PIC/S now has 33 members. The committee also noted that Cyprus 'Pharmaceutical Services has applied for PIC/S membership. Furthermore authorities of Indonesia and New Zeeland announced their intention to apply membership by 2008. The committee also reviewed the progress made in the assessment of applications submitted by France's Agency for Veterinary Medicinal products' and by authorities from Israel, Thailand and the US FDA. On-site assessment visits to France, Israel and Thailand are scheduled to take place in 2008.

January 12, 2007

Labcompliance.com Gets Second Highest Score as The Most Relied Website

41% of Laboratory Decision-makers and Users of equipment ranked Labcompliance the most relied on website. This came out of recent blind survey mailed to LCGC subscribers. The survey question was ""What resources do you use to keep up-to-date with the regulatory compliance?". Labcompliance.com was only beaten by fda.gov. It is difficult to beat the US FDA in the area of compliance.

January 12, 2007

US FDA Laboratories follow ISO 17025 Standard Procedures

Laboratories of the FDA Office of Compliance follow ISO17025 Standard procedures to ensure quality, consistency, and efficiency throughout the field. The Laboratory Manual (LM) is entirely based on ISO17025 management and technical controls. As stated in the LM it  is the primary source for communicating to laboratory staff the manner in which business is to be conducted within the regulatory framework while carrying out the Agency's  public health mission. ISO17025 is not only an excellent Standard to prepare for and maintain Laboratory accreditation but also to assist pharmaceutical and API laboratories for GLP and GMP compliance. Learn everything about ISO 17025 in a new Audio Seminar from Labcompliance and receive 10+ Best Practice documents for easy implementation. 

January 12, 2007

GMP Draft from 1996 Discontinued

With the publication of the new and revised text of 21 CFR Part 211 in December 2007 the FDA announced to withdraw the draft for an updated 21 CFR Part 211 from 1996 (see Labcompliance News Dec 2007)

January 12, 2007

U.S. to Help India with Building an FDA Equivalent to the US

The U.S. Department of Health and Human Services Secretary Mike Leavitt and  Commissioner of FDA Andrew C. von Eschenbach visited Hyderabad, Indi, in the week of Jan 10. According to a report from Validation Times on Jan 10, 2008, India would receive technical assistance from the U.S. in developing a Centre for Food and Drug Administration, aimed at assuring the safety of medicines and vaccines produced in the country, Michael Leavitt said this week."We will be discussing ways by which we can work together to assist India in developing a Centre for Food and Drug Administration to assure that the drugs, vaccine and other foods produced in India are safe not only for the US but also for India". The US is interested to get lower cost drugs but at the same quality as drugs manufactured in the US. According to the Online edition of India's National Newspaper THE HINDU the FDA has no plans to open an office in India

New Audio Seminars - Schedule for Q1/2008

  1. Validation and Use of Excel® Spreadsheets in Regulated Environments
    (187)

    Comply with GxPs, Part11, HIPAA, SOX and other regulations.
    February 7, 2008
  2. Understanding and Implementing ISO 17025 (189)
    Requirements, Strategies and Tool Kits for Laboratory Accreditation
    February 14, 2008
  3. Validation of Analytical Methods and Procedures (190)
    Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance
    February 28, 2008
  4. Understanding USP Documents and Reference Standards (191)
    General Chapters, General Notices, Monographs, Forum, Reference Standards
    March 13, 2008
  5. Understanding the New USP <1058> for Analytical Instrument Qualification
    With SOPs and Case Studies for Easy Implementation
    March 27, 2008
  6. Learning from Recent FDA Warning Letters Related to Computer Validation
    and Part 11

    With Clear Recommendations for Corrective and Preventive Actions
    Thursday, April 3, 2008

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