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Labcompliance News, April 2004

April 19, 2004

Macro&Spreadsheet Qualification Package - Product Update

Since April 1, 2004, the Labcompliance Marco&Spreadsheet Quality Package includes FDA's 40 page Laboratory Information Bulletin: Spreadsheet Design and Validation for the Multi-User Application for the Chemistry Laboratory.
The package helps to use spreadsheets like Excel in FDA regulated environments. It also includes a one hour interactive video presentation for a quick overview and SOPs, templates, example spreadsheets with and without VBA scripts for quick implementation. For more information, click here. Existing users of the package can get a free update.

April 09, 2004

FDA Announces Public Part 11 Meeting

On April 8 the Food and Drug Administration (FDA) announced a public meeting to discuss various topics concerning their intended re-examination of 21 CFR part11. The public meeting will be held on June 11, 2004, from 8 a.m. to 4:30 p.m.

April 09, 2004

Validation of Software and Computer Systems in Laboratories

Laboratory systems are amongst key targets of FDA inspections. They are considered high risk systems because they can have a high impact on product quality. Validation can be a challenge because laboratory computers become more and more automated. And automated systems are more and more networked so the question is how to validate networks. Last but not least programs are readily available for customization of workflows and reports such as Macro programs and spreadsheet applications, they need to be validated, too. On the other hand using risk based approaches can reduce the validation burden for standard functions, but such procedures need to be justified and documented. The question is how much validation is enough? Answers are provided in an audio online seminar. For information and registration,

April 03, 2004

New Article: Process Analytical Technology - Changing the Validation Paradigm

Implementation of Process Analytical Technology (PAT) for pharmaceutical manufacturing has continued to advance and enable operations that monitor, control, and analyze critical quality attributes of processes and products while manufacturing is in progress, i.e. continuous quality verification. Implementation of PAT challenges the current validation paradigm to change towards supporting quality by design so that a balance is maintained between compliance and innovation. Therefore, it is necessary to define PAT validation that is appropriate, commensurate with intended use of data, and practical for a risk-based approach to cGMPs. In a new article, a validation approach is described for PAT systems and methods intended for use with existing processes and products. 

April 03, 2004

FDA Warning Letter for Inadequate Method Validation

In a recent warning letter the FDA cited a firm for inadequate method validation. This warning letter has been reviewed by an FDA center and as FDA's David Horowitz, Director of CDER's Office of Compliance, said in a training session is not just the view of a particular investigator of a particular district or even of a particular region. It means that the center has determined that these are significant enough violations that if they are not corrected an enforcement action. Modifications of the method have not been documented, the reason for the change has not been identified and the accuracy and reliability of the method has not been verified after the change. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts.

April 03, 2004

Risk Based Computer Validation

As part of the 21st Century cGMP initiative the FDA promotes risk based approaches for compliance. 21 CFR Part 11 has been affected by this including scope and some of the controls such as electronic audit trail, archiving of records and validation of computer systems.

It has been stated in FDA guidance documents that the extent of validation of computer Systems depends on the the system complexity and on it's impact on product quality and data integrity. When implemented right, this risk based validation approach can save valuable resources. We recommend three steps for implementation:
1) Assess the risk of your computer systems, e.g., high, medium and low or just high and low.
2) Make a list with validation tasks for all validation phases, sorted by extent of validation.
3) Develop a matrix with validation tasks and GAMP categories or complexity and enter validation tasks as defined in 2) in the matrix.
For more information and to receive an SOP, attend the Labcompliance Audio Seminar or click here