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Labcompliance News, April 2003

April 22, 2003

Interactive Video Training and Worksheets for Computer Validation

Validation of computer systems is a requirement of all regulations and quality standards that are applicable. Well validated and qualified software, computer systems and networks help to increase system uptime and improve consistent and reliability of analytical results. A good understanding of the principles and practices of computer validation is important for everybody who develops and uses software and computer systems in regulated environments. Labcompliance has updated the CD entitled "Validation of Computerized Analytical and Networked Systems". The information has been increased by more than 30% and it has all you need to make the validation process most efficient
An interactive multimedia video presentation provides all the background information for developers, managers and users
SOPs, worksheets, templates, examples and gap analyses help for quick and efficient implementation

The CD also includes more than 50 predicate rules and guidance documents from the US FDA and EU. They help to learn about regulatory requirements and the current thinking of agencies. For more information and ordering, click here.

April 22, 2003

FDA Published Guidance on Electronic Common Technical Document Specification

The Electronic Common Technical Document Specification (eCTD) has been developed by the ICH M2 EWG Expert Working Group. It is defined as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission. The eCTD specification lists the criteria that will make an electronic submission technically valid. The focus of the specification is to provide the ability to transfer the registration application electronically from industry to a regulatory authority.

April 9, 2003

Establishment Inspection Reports More Valuable than 483's and Warning Letters

483-Form inspectional observations are written right after the inspections. They can be very short, don't give much explanation and only list deviations. Depending on the nature and extent of deviation the FDA may send the company a waning letter. Once again, they don't give a complete picture as they also only list deviations.
Between the 483 and the warning letter inspectors write Establishment Inspection Reports (EIR). They describe very much in detail how the inspection went, what the inspectors were looking at, what they were asking and what the firm's response was. EIR's will be reviewed, e.g., by the regional headquarter office and will be used as input to issue a warning letter or not. Most useful is to have the 483, the EIR, and the warning letter from the same inspection. This information is ideal to prepare firms for inspections. Most useful are the type of questions and whether the firm's answer was successful, so they not only help to avoid FDA warnings but also avoid to overreact.
Labcompliance has started to put EIR's on the Usersclub websites. At the start we did put a complete sequence of a 483, EIR, warning letter AND the EIR of the follow up inspection. In the later one the inspector describes the firm's corrective actions that have been accepted by the FDA. Original citations were related to employee training, investigation of OOS, inadequate validation of spreadsheets, security of computerized systems and integrity of data, incomplete process validation. The documents can be can be downloaded from the Labcompliance Users Club, W-107. For preview and ordering the Usersclub, click here

April 1, 2003

Update on FDA's New Initiative on Drug Product Quality

On March 3 the director of FDA's Center for Drug Evaluation and Research, Janet Woodcock, gave an update presentation entitled: Pharmaceutical GMP’s for the 21st Century: FDA’s New Initiative on Drug Product Quality. She talked about the common goal shared by public, the FDA and the pharmaceutical industry to make 'High Quality Products" using "High Quality Processes". Validity and integrity of laboratory data was high on the list. One other common goal is efficiency. Why efficiency? Why would public or FDA care? "We live in a world of limited resources. Inefficient processes direct resources to areas that are not completely necessary. Inefficiency diminishes agility, creates shortages and raises barriers to innovation" she said. She also talked about how these goals can be achieved. The presentation can be downloaded from the Labcompliance Users Club, G-006. For preview and ordering the Usersclub, click here

April 1, 2003

Do we Really Need a Design Qualification for Equipment and Computer Systems?

There are lots of discussions whether a design qualification (DQ) is required for commercial software and computer systems. The only official document that requires a DQ is Annex 15 of the EU GMP directive. It states: The first element of the validation of new facilities, systems or equipment could be design qualification (DQ). The question is: what does this mean? A really good definition of DQ came from the UK Pharmaceutical Analytical Science Group: Design qualification (DQ) defines the functional and operational specifications of the instrument and details the conscious decisions in the selection of the supplier“. The FDA glossary on Computer Systems has no mention of DQ, but this does not mean that FDA inspectors will not ask for documents usually developed in the DQ phase. They will ask for user requirement specifications, for functional specifications, for performance specifications of equipment hardware and if it is a complex computer system also for 'your conscious decision in the selection of the supplier'. Detailed written information on DQ with checklists and templates is available in two validation reference books on "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems".