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Data Management and Electronic Publication Data Management and Electronic Publication Data Management and Electronic Publication Data Management and Electronic Publication (SDMS/VP)(SDMS/VP)
Chris Chris StumpfStumpf, Ph.D., Ph.D.Senior Product Marketing ManagerSenior Product Marketing Manager
Strategic Operational NeedsStrategic Operational Needsg pg p
Improve productivity/faster analysisImprove productivity/faster analysis Lower cost of analysisLower cost of analysis Lower cost of analysisLower cost of analysis Improve results qualityImprove results quality Make scientific information more accessible across Make scientific information more accessible across
Single system for storing and retrieving all analytical dataSingle system for storing and retrieving all analytical data— All discovery sites world-wide (both internal & external)
— Integration with existing informatics tools
Single requesting tool for specialized analytical analyses
Replace existing in-house Oracle-base storage system— Integrated with in-house chemical structure systems
Reference: Raju, G.K., New Opportunities for Pharmaceutical Manufacturing, a 2001 presentation to FDA’s Science Board, www.pharmamanufacturing.com/whitepapers/2004/118.html
Identifying the BottleneckIdentifying the Bottlenecky gy g
Reference: Raju, G.K., New Opportunities for Pharmaceutical Manufacturing, a 2001 presentation to FDA’s Science Board, www.pharmamanufacturing.com/whitepapers/2004/118.html
Consequences of Delayed Certificate Consequences of Delayed Certificate of Analysisof Analysisyy
Limited shelf life Limited shelf life— A 15 day COA delay represents 17% of a 90 day shelf life for a
pharmaceutical product
Late/Non-shipment May translate into millions of dollars of lost revenue per batch— May translate into millions of dollars of lost revenue per batch
— May allow competitors to build market share with similar products
Informatics Implementation Steps used to Informatics Implementation Steps used to StreamStream--line Certificate of Analysis Processline Certificate of Analysis Processyy
2009 Warning Letters Raw Data2009 Warning Letters Raw Datagg
February 2009February 2009— no raw data used to support the verification of the software
used in … device.
— Failure to store and retain all raw data documentation — Failure to store and retain all raw data, documentation, protocols, final reports …generated as a result of nonclinical laboratory studies. (21 CFR §§ 58.190(a) and 58.195(b)].
March 2009 March 2009— The inspection revealed the absence of supporting data for
these products, including raw data for sensitivity studies; accelerated and real-time stability study data and protocols; accelerated and real-time stability study data and protocols; reproducibility data; and cut-off testing data, interference, pH and specific gravity data. Likewise, gas chromatography/mass spectrophotometry data and method comparison data for the
p p y pDrugs of Abuse Screening Tests was missing.
2009 2009 Warning Letters Warning Letters Raw DataRaw Datagg
May 2009May 2009— Raw data for definitive trial … were changed by the
study director without explanation.
August 2009 August 2009— a. Raw data (e.g., chromatograms, standard and sample
weights, calculations, standards, reagents, and instrument information) for And related substances method validation information) for …. And related substances, method validation were not available during the inspection.
Significant Time Spent on QC Significant Time Spent on QC DocumentationDocumentation
Cycle Time ComponentsSTEPS
Process/Unit OperationInterruption of the process
Cycle Time ComponentsIN QC/QAIN THE PROCESS/PLANT
p pSecuring of sample from processHolding of sample in plantDocumentation and verification of samplingTransferring of samples to QC LabBatching of samples in QCPreparation of test samplesActual test-separationActual test-measurementTest data collection and processingDocumentation and verification of testingTransferring of results for reviewTransferring of results for reviewDecision regarding impact on process
Reference: Raju, G.K., New Opportunities for Pharmaceutical Manufacturing, a 2001 presentation to FDA’s Science Board, www.pharmamanufacturing.com/whitepapers/2004/118.html
Combine SOP and Data Entry by Combine SOP and Data Entry by using Electronic SOP Formsusing Electronic SOP Formsgg
Stock No. 123456
34 Maple Street, Milford MA 01757Phone: 1-800-252-4752 Fax: 1-508-482-2004
Stock PreparationStep 1: Weigh the following into a clean dry 100 mL class "A" volumetric flask
Case studies Achieved a Standardized Data Management OperationBased on Standardization of CDS SDMS and LIMS (for QC)— Based on Standardization of CDS, SDMS, and LIMS (for QC)
A Centralized SDMS Provides Standardized Data Management — Improves laboratory productivity
— Centralizes all data into one location and improves compliance
— Acts as a data integrator and connector for all scientific information -certificate of analysis eCTD submissions and Electronic Laboratory certificate of analysis, eCTD submissions, and Electronic Laboratory Notebooks
A Standardized CDS Platform A Standardized CDS Platform — provides standardized data format, reduces training effort, improves