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



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


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



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



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




Dr. Ludwig Huber



Labcompliance News, January 2009

New FDA Guidance for Clinical Investigators and Sponsors

On Jan 14 the FDA published the "Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs - Improving Human Subject Protection". It is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the institutional review board (IRB).  Specifically, the guidance provides recommendations for sponsors and investigators conducting  investigational new drug (IND) trials to help them differentiate between those adverse events that are unanticipated problems that must be reported to an IRB and those that are not.  The guidance also makes suggestions about how to make communicating adverse events information to IRBs more efficient.

FDA, EU and GAMP 'Advice' on Using Excel®

Excel is frequently used in laboratories, offices and manufacturing as sophisticated  calculator.  Some companies stay away from using Excel and other spreadsheets in FDA regulated because such Out-off-the-Box software does not comply with all FDA requirements. However, with the necessary controls Excel can be brought into compliance. For example, the FDA has developed two internal Information Bulletins on developing and using spreadsheets in regulated environments. Useful advice also is received from FDA inspection reports. The new Annex 11 for EU GMP's and GAMP®5 also include chapters on Spreadsheets. To learn everything about FDA's and other regulatory expectations and enforcement practices for using Excel click here.

  FDA Opens Three Offices in China

It had been announced since long time, but now it happened: According to a US governmental press release  from 18 November 2008 the FDA has officially opened three offices in China: Beijing, Guangzhou and Shanghai. Eight senior experienced FDA officials have been selected to work in the offices in China. The employees are inspectors and senior technical experts in foods, medicines and medical devices. According to an article published by GMP NEWS the inspections will focus on API manufacturers. "Whereas during the 1980's, the major part of active pharmaceutical ingredients was still manufactured in Europe and the USA, today it is assumed that up to 80% of the active ingredients come above all from China and India. What experts had suspected for many years now seems to become apparent: Many active pharmaceutical ingredients manufacturers in China and India are not GMP compliant and are furthermore a starting point for counterfeits". the article states.

ICH Finalizes Annex to Q8 With Principles of Quality by Design

This guideline has been released under Step 4 of the ICH process in November 2008. Q8 as originally released in 2005 is intended to provide guidance on Pharmaceutical Development for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH guideline M4). In November 2008 ICH released a new Annex to this guideline that 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.

New PIC/S Brochure Published

PIC/S' mission is "to lead the international development, implementation and maintenance of harmonized Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products. There are currently 36 Participating Authorities from all over the world with more on the applications list, for example the US FDA. Some of the GMP guidelines have been signed into local regulations of member countries and inspection guides and joint inspection programs will help to harmonize global inspections. Now PIS/S has published a new brochure that describes all activities such as training programs, expert circles, and joint GMP inspection programs.

"Incomplete Risk Analysis" Cited in FDA Warning Letter

Risk analysis is expected to be conducted for medical devices through FDA's Quality System Regulation 21 CFR Part 820 and for pharmaceutical and API manufacturing through the FDA Guide: "Quality Systems Approach to Pharmaceutical CGMP Regulations". While in the past risk analysis and risk management was hardly enforced this seems to change now.  This became obvious through a Warning Letter for a medical device company. For example, the letter states: "Risk analysis is incomplete. The risk analysis for the hazard of linking PET/CT scans to the incorrect patient was performed after an xxx incident. The risk analysis has not been re-assessed/updated for increased probability given the three subsequent incidents. Your firm's Standard Operating Procedure directs risk analysis be reviewed and updated upon receipt of safety-related complaints. However, no risk analysis was performed for complaints related to incorrect normalization values in xxx scanners.". The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 212).  To learn everything risk analysis and management, and to receive a risk management master plan and SOPs, 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: Handling Deviations from Standard Operating Procedures . To download your free copy, go to the GLP Tutorial, scroll down and click on the corresponding ICON on the left (offer expires on Feb 1, 2009). Labcompliance offers more than 100 SOPs. For titles and ordering, click here.

ISO 17025 Workshop at Analytica Vietnam

Analytica Conference
Understanding and Implementing ISO 17025
March 20, 2009, Hanoi, Vietnam
One day workshop with Dr. Ludwig Huber
Learning through examples: 50% of the time will be dedicated to case studies
Very attractive pricing: $50, includes 10+ Best Practice Documents

New Audio Seminars - Updated Schedule

  1. Requirement Management for Equipment and Computer Systems
    Strategies for Development, Documentation and Updating Requirement Specifications
    February 4, 2009
  2. Validation and Use of Excel® Spreadsheets in Regulated Environments
    Comply with GxPs, Part11, HIPAA, SOX and other regulations.
    February 12, 2009

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