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Labcompliance News, May 2006

May 11 , 2006

An Inspector’s Perspective on Computerized Systems Validation

It rarely happens that EU inspector give presentations at public conferences. However this happened at the conference “Recent FDA/EU Requirements on Laboratory Computers and Records” sponsored by the European Compliance Academy (ECA) on March 9 in Copenhagen with Ludwig Huber as chair person. EU inspector Jan Anton Norder of the Dutch Health Care Inspectorate presented a European Inspector’s Perspective on Computerized Systems Validation (CSV) for Laboratory Computer Systems. Mr. Jander made it very clear that EU inspectors are focusing more and more on computer system validation. He presented lists with questions typically asked during inspections and most frequently found deviations and finally concluded the presentations with recommendations. The top deviation was a missing computer system validation master plan. To develop such a master plan was also his first recommendation.

May 11 , 2006

36 New Documents in the Labcompliance Users Club

We have added 36 new documents to the Labcompliance UsersClub. They include eight SOPs, four checklists/ templates/examples, two reference papers, eight FDA presentations, three FDA guidance documents and 12 FDA warning letters/483's related to GMP/GLP or GCP. User club members can instantly download the new additions.. To see the list and ordering the users club, click here. With these additions, the UsersClub has >400 documents ready for download.

May 11, 2006

FDA Publishes a Guidance for Nonclinical Safety Evaluation of Drug or Biologic Combinations

This new guidance provides recommendations on nonclinical approaches to support the clinical study and approval of fixed-dose combination products (FDCs), co-packaged products, and some adjunctive therapies. The intent of this guidance is to delineate general guiding principles. To receive more detailed advice regarding a particular drug or biologic combination development program, sponsors should contact the appropriate review division before submitting an investigational new drug application (IND). In addition, the Food and Drug Administration (FDA) is in the process of publishing more specific guidance for certain categories of drug combinations.

May 11, 2006

New Preamble and Economic Analysis in 'New' Part 11

When the Part 11 Guidance on scope and applications was published in 2003 the FDA also announced to revise Part 11 itself. The first draft was expected to be released in 2005 but has been delayed to 2006. At the annual meeting of ISPE GAMP America on March 17 George Smith, FDA's national Part 11 expert, gave an excellent overview on Part 11 and and also an update on the amendment process. The title of the presentation was: "Where we were, where we are and where we are going". Most interesting was the third part. Mr. Smith listed in detail industry comments and suggestions that will be considered for the amendment. He told the audience that the new Part 11 will need a new preamble and an economic analysis based on the approaches taken. Time frame for the draft was 2006 with no more details. UsersClub members can download the presentation. For preview and ordering the Users Club, click here.

May 11, 2006

New Publication on Analytical Balances

 Weighing is a critical operation in all analytical laboratories. This article written by Chris Burgess and Bob McDowall gives practical advise on how to improve accuracy and stability of balances. Factors that have been considered include temperature effects, electrical and electromagnetic interference, flat surface, magnetic effects, static electricity and vibration. The article also includes chapters on good calibration and maintenance practices. The article has been published in LCGC Europe and as of April 2006 is available on the publishers website. Copyright rests with the publisher.

May 11, 2006

"Supervisor Signature Does not Give Sufficient Level of Accountability", FDA Warning Letter Says.

Just recently an Indian drug and API manufacturer has been hit with an FDA warning letter. Deviations have been related to documentation such as procedures, protocols, batch records and installation records. Documentation either was not available, incomplete, developed from the memory of an employee, not accurate or not followed. The inspector also found that some documents have not been signed by persons who performed the operation but by the supervisor. "The logbook did not contain complete and/or accurate documentation. We expect that all entries in logbooks, batch records, laboratory documentation and all other documentation be signed by the person who performed the operation". The warning letter further noted: "Complete, true and accurate records are the foundation for good GMPs. Reliable documentation is a control which raises assurance of the quality of the product manufactured". The Warning Letter can be downloaded from the Labcompliance Users Club. Non members can preview excerpts. Labcompliance has just conducted a seminar on GxP compliant Documentation for GxP Compliance: what documents are required and what the formats and content should be.