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FDA Compliant Transfer of Analytical Methods

Prepare your Lab for the NEW USP General Chapter

December 10, 2009


Computer System Validation: Step-by-Step

With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation

January 14, 2010


How to Efficiently Build a GLP Laboratory
Step-by-step from design to cost-effective implementation



FDA Compliant and Efficient HPLC Qualification and Testing
Learn how to select, conduct and document the right tests in the right sequence



New  release on
August 25, 2009 

with 200 + eirs/483sb / warning letters



Labcompliance News, November 2009

FDA Continues to Enforce Part 11

FDA is working on a new revision for Part 11. In the meantime FDA officials refer to the Part guidance "Scope and Applications" from 2003. According to the guidance FDA allows enforcement discretion for some requirements, such as validation and electronic audit trail. FDA inspectors frequently used enforcement discretion from 2003 to 2006 and there was hardly any warning letter related to Part 11 requirements. This has changed. In the last couple years there were at least 30 warning letters with reference to requirements as stated in Part 11, but the letter did not mention Part 11 itself. It seems that  industry cannot always rely on enforcement discretion. An example is a Warning Letter as a result from a clinical study inspection with deviations related to missing electronic audit trails. The letter states: "All study data are handled and controlled by your Study Coordinator, who enters the data into an electronic data base. There is no audit trail or log of data changes that are made to the information in the database". The the warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 224). To prepare your organization for FDA inspections, and to avoid FDA warning letters related to Part 11, attend the upcoming Audio seminar: FDA's New Enforcement of 21 CFR Part 11.

USP General Chapter Allows more Flexibility for Method Changes

In December 2007 USP has updated chapter <621> with parameters and limits on what and how much a method can be adjusted before revalidation is required. For example limits have been defined for  column length ( 70%), column diameter ( 25%), particle size (can be reduced by as much as 50%), and  flow rate ( 50%). In the meantime it has been recognized that the chapter does not provide the necessary flexibility to change the chromatographic column to accommodate columns with lower internal diameters for significant solvent savings or to use ultrafast HPLC without revalidation through packing material with lower particle size. Starting December 1, 2009, as a first step USP will allow additional changes in 32-2. For example, the  column diameter can be changed freely provided that the linear velocity is kept constant by also adjusting the flow rate. This makers it easier to save solvents by going to columns with smaller diameters. In a new Stimuli Paper USP also indicates to allow flexibility in other areas, for example, to reduce particle size. In theory some of these changes will allow to transfer methods from standard HPLC to (ultra)fast HPLC For more information on practical implementation, attend the audio seminar: FDA Compliant Transfer of Analytical Methods 

"Missing Method Validation Electronic Raw Data" Cited in FDA Warning Letter

FDA's inspection focus is on electronic records. This became clear during an inspection of an API manufacturer in March 2009. The company has lost raw data when migrating to a new computer system. The letter states: "Your quality unit failed to maintain complete laboratory control records for the analysis of your APIs (including graphs, charts, and spectra from laboratory instrumentation derived from all tests conducted) to ensure compliance with established specifications and standards. For example, raw data, e,.g. chromatograms, standard and sample weights, calculations, standards, reagents, and instrument information for xxx. method validation were not available during inspection. Your quality unit personnel informed the investigators that the computer software was upgraded and the raw data was lost during the software upgrade, We have serious concerns about your firms  implementation of changes to your computer system (E.g., software upgrade). It is your responsibility to provide the means of ensuring data protection (e.g., back-up system) for your computerized system to prevent the permanent loss of records". This is an other example for recent enforcement of Part 11. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 222). To prepare your organization for FDA inspections, and to avoid FDA warning letters related to Part 11, attend the upcoming Audio seminar: FDA's New Enforcement of 21 CFR Part 11.

USP Plans General Chapter on Transfer of Analytical Methods

In Pharmacopeial Forum 35 (6) USP has published a 'Stimuli' paper: "Transfer of Analytical Procedures: A Proposal for a New General Information Chapter". The purpose of the transfer process is to qualify the receiving laboratory to perform an analytical procedure that was developed in another laboratory. This concept is similar to the verification process described in USP General Chapter Verification of Compendial Procedures. A section in the paper describes differences and similarities between verification and transfer. This Stimuli article aims "to initiate discussion and solicit stakeholder comments". For a detailed discussion on the transfer process and to get a transfer master plan, an SOP and a case study, attend the audio seminar: FDA Compliant Transfer of Analytical Methods 

15 New SOPs from Labcompliance

FDA and ISO 17025 require routine activities to follow written procedures. Healthcare professionals typically use Standard Operating Procedures (SOPs) to address this. Since more than 10 years Labcompliance has been offering example SOPs that help user firms to get started or to confirm their SOPs with external resources. Now we have added 15 more SOPs. Examples are "Internal Audits - Preparation, Conduct, Follow-up", "Training for GLP Compliance", "Responding to 483 Inspectional Observations", "Measurement Traceability in Chemical Analysis", "Conducting Laboratory Management Reviews", "Allocating Analytical Instruments to USP <1058> Categories", "Validation of Software and Computer Systems for ISO 17025" and "Measurement Uncertainty in Chemical Analysis " In the meantime over 120 example SOPs are available from Labcompliance to develop and maintain your own SOPs. They help you to comply with FDA and equivalent international regulations: GLP, GCP, GMP, Part11, PIC/S and with ISO 17025. For a complete list and ordering, click here.

Should Computer Based Training Record Systems Comply with Part 11?

Electronic training management and record systems systems may have to comply with Part 11. This became obvious from a Warning Letter citation: "Training Database software validation used to document employee training was deficient in that the test scripts were not available to show the execution of the software validation protocol."
Validation is one of the Part 11 requirements. Other requirements are even more important, e.g., limited and authorized access and e-audit trail. Let's assume a department has all training records on a Laptop PC, no paper back-up. The Laptop and the records are not secured in any way, so everybody can go in and make changes, e.g., if required trainings have not been provided in time. Or the lab supervisor could go in and change training dates just before the next inspection is coming without leaving a trace through electronic audit trail. If the computer database is the only way to document trainings, the system should comply with Part 11. The situation is different if originally all training records are available and maintained on paper and data are just entered into a computer data base to easier search and find training information. This system does not need to comply with Part11.
This situation is discussed as one of many case studies in the upcoming Audio Seminar: FDA's New Enforcement of 21 CFR Part 11. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview
excerpts (scroll down to 206).

Free Primer on Analytical Instrument Qualification and System Validation

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 qualification and system validation at minimal extra cost.  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

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: Disaster Recovery of Computer Systems. To download your free copy, go to the Computer System Validation Package website.  Scroll down and click on the corresponding ICON on the left (offer expires on December 2,  2009). Labcompliance offers more than 100 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

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