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

 

Validation and Use of Excel® Spreadsheets in Regulated Environments
Comply with GxPs, Part11, HIPAA, SOX and other regulations.
February 11, 2009

 

Master Planning for Software and Computer Validation
With examples for master and several project plans
January 15, 2009

 

Requirement Management for Equipment and Computer Systems
Strategies for Development, Documentation and Updating Requirement Specifications
February 4, 2009

 

Bioanalytical Method Validation
Conduct and Document for Efficiency and FDA and EMEA compliance

Recorded

 

Raw Data in FDA Regulated Environments
FDA/EU compliant recording, maintenance and archiving

Recorded

 

Residual Solvent Analysis According to USP <467>
Understanding and implementing the revised chapter

Recorded

 

NEW BOOK EDITION

Dr. Ludwig Huber

 

 

Labcompliance News, December 2008

Handbook for Requesting Special Information and Records from FDA

FDA makes certain documents such as press releases, consumer publications, speeches, and congressional testimony available on www.fda.gov. In addition many other documents not published on the FDA website are available through the Freedom of Information Act (FOIA). Now the FDA has published a handbook for requesting such information and records from FDA. The guidance given in this handbook is intended to facilitate requests for both public information and records not originally prepared for distribution by FDA. Examples are Establishment Inspection Report and 483 form inspectional observations. The handbook has been published on the FDA website

FDA Publishes New Guidance on Genotoxic and Carcinogenic Impurities

On Dec 15, 2008, the Food and Drug Administration (FDA) has published a new draft guidance for industry entitled "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches." This guidance provides recommendations on how to evaluate the safety of these impurities during clinical development (investigational new drug applications (INDs)) and for marketing applications (new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs)). The guidance provides recommended exposure thresholds on the clinical exposure to genotoxic or carcinogenic impurities. Also provided are additional testing and exposure threshold recommendations for situations where there are known or theoretical safety concerns based on available data, structural alerts, and/or assessment of the synthetic pathway.

More Regulatory Agencies to Join PIC/S

A joint Committee meeting of the Pharmaceutical Inspection Convention (PIC) and the
Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) took place in Geneva
(Switzerland) on 11-12 November 2008. Currently the organization has 34 members with more in the application process. Meeting delegates have been informed about the status of new membership applications. For example, Slovenia has just applied for membership, The US Food and Drug Administration (US FDA) is more close to become a member. The application was made two years ago and the on-site assessment visit will take place in January 2009.

FDA Warning Letter Issued for not Validating a Planning System

Computer systems used for regulated activities should be validated. This became obvious when the FDA inspected a system that was was used for managing inventory, distribution of inventory, scheduling, engineering change orders, recalls, complaints, reworks, device master records, product return, procurement, production and sales processes. The FDA inspector wrote: "No software validation or verification was available for the planning system. You provided some documented “scenarios”; however there was no protocol or summary included with those scenarios and no evidence that the tasks listed in the scenarios were ever performed". The company also failed to perform bioburden determination, to implement sampling plans and to train QA employees. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 211). 

Top Five FDA Citations related to Biological Drugs, Intermediates and Substances

Mary Malarkey, Director, FDA Office of Compliance and Biologics Quality gave a compliance update at the joint PDA/FDA meeting on September.  She talked about CBER priorities, internal and external quality systems, CBER review of submitted risk assessments, and about the status of the amendments to CGMP regulations for finished drugs. Most interesting was a hit list of top five citations in FDA Warning Letters and 483's resulting from inspections of biological drugs, biological drug intermediates and substances.  Incomplete failure investigations, inadequate quality control, not following procedures, and no or inadequate production and process controls. The presentation can be downloaded from the Labcompliance Usersclub,. For preview and ordering, click here, scroll down to G-277 

50 New Documents in the Labcompliance Usersclub

We have added 50 new documents to the Labcompliance Usersclub. They include 11 new SOPs, 11 checklists/ templates/examples, FDA presentations and guidance documents and FDA warning letters/483's related to GMP/GLP or GCP. To see the new titles, click here. User club members can instantly download the new additions. To see the list and ordering the users club, click here, and scroll down to 'new additions'. With these additions, the Usersclub has more than 400 documents ready for download.

"Investigations and CAPA Records not Maintained" Draws FDA Warning Letter

No or incomplete failure investigations and corrective and preventive action plans are amongst the most frequently found deviations in FDA and other regulatory inspections. This became obvious during an inspection of a a device distributor. Examples for deviations include: "Failure to maintain a record of an investigation of a complaint by a formally designated unit that includes any corrective action taken", "Failure to establish and maintain procedures for acceptance of incoming product, and to inspect, test, or otherwise verify incoming product as conforming to specified requirements". and " Failure to establish and maintain procedures for implementing corrective and preventive action that include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problem",  The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 210).  To learn everything about FDA compliant electronic records, click here

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 SOP: Scanning of Paper Records for GxP Compliant Archiving . To download your free copy, go to the 21 CFR Part 11 Tutorial, scroll down and click on the corresponding ICON on the left (offer expires on Jan 1, 2009). Labcompliance offers more than 100 SOPs. For titles and ordering, click here.

2 Day Interactive Workshop by Dr. Ludwig Huber

  1. ECHO Consulting Group
    Computer System Validation and Part 11 Compliance for (Bio)Pharmaceutical and Device Industry
    Jan. 20/21, 2009 San Juan, PR, USA
    Learning through examples: 50% of the time will be dedicated to case studies

New Audio Seminars - Updated Schedule

  1. Master Planning for Software and Computer Validation
    With examples for master and several project plans
    January 15, 2009
  2. Requirement Management for Equipment and Computer Systems
    Strategies for Development, Documentation and Updating Requirement Specifications
    February 4, 2009
  3. Validation and Use of Excel® Spreadsheets in Regulated Environments
    Comply with GxPs, Part11, HIPAA, SOX and other regulations.
    February 11, 2009

Conferences

  1. Conference Calendar Echo Consulting

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