Comprehensive Data Management for Pharmaceutical Drug Development

Comprehensive Data Management for Pharmaceutical Drug Development

Groups involved in drug development

Pharmaceutical drug development requires management of large numbers of samples which in turn generate large datasets of process and analytical data. Managing drug development data using paper-based systems has proven inadequate and most development organizations have progressed to electronic solutions. The current challenge is to integrate the various electronic files and systems, and therefore avoid transcriptions and manual interactions, which can introduce errors and quality concerns.
On the surface, it would seem simple for different electronic tools to communicate. The reality is often – transcriptions and copy/paste. In some cases, information is siloed in the various groups which comprise a development organization. A typical development team can include the following functional divisions each responsible for a slice of the information pie:

  1. Formulation/Manufacture with responsibility for process records, measurements, and operating parameters
  2. Sample Management is tasked with sample definition, labeling, tracking location, inventory, and task scheduling & assignment
  3. Analytical will define methods, generate compliant processes, and release data with heavy reliance on instrument software
  4. Quality is responsible for review and approval of documentation
  5. Stability manages study samples and generates shelf-life prediction reports

Designed for pilot scale manufacture, this solution supports flexible definition of the manufacture process including formulation and procedural steps


Drug Development Process


Formulation

Formulation or manufacture batch records are an important source of project information and implementation of an electronic batch record (EBR) solution is key gaining access to this information:

    • Process operating parameters can include the bill of materials, equipment used, and procedural steps. An EBR solution will verify equipment calibration, link to material libraries, and assure the process is executed as defined. The EBR will also support scanning materials to accurately identify lots and expiration.
    • Process Measurements can originate from both manual and automated sources. Examples: amount of a material, temperature, timings. In addition to capturing this information electronically, an EBR can flag excursions, maintain data files, and abstract critical measurements from process instrumentation.
    • Samples are typically predefined by the batch protocol to characterize both in-process and final product. A batch or formulation record will include the information required to identify a sample allowing an EBR to automatically create and label samples. Additionally, the EBR can add the required testing to each sample in the form of a task list, enhancing communications with the analytical group.
Sample Management
Accurate sample definition provides the structure required for making sense of project information. An optimal sample management solution will:

    • Assist with sample definition using structured input techniques to avoid inconsistent metadata.
    • Print barcoded labels to reliably identify and record samples when used across the organization/
    • Track inventory and sample location. Additionally, provide chain of custody for controlled substances.
    • Organize the testing and tasks required for each sample.

A sample management solution will assure reliable association of information and sample.


Analytical

Generating quality analytical data is supported electronically by LIMS (Lab Information Management) and ELN (Electronic Lab Notebook) solutions.

    • Samples must be well defined and labeled (see sample management). Scanning barcode labels in a LIMS/ELN avoids errors linking samples and results.
    • Templating functionality in LIMS/ELN dramatically reduces the effort required to document complex procedures such as APSD/NGI and will increase compliance for regulated applications. Templating can perform validated calculations and reduce both recording and review effort.
    • LIMS/ELN assists definition of Resources such as reference standards, working standards, instruments, solutions, methods/SOPs. Once defined, a resource can be labeled and referenced to avoid duplicate documentation.  Usage logs to identify all instances where a resource was used assist when investigating excursions.
    • Recording attributable data is supported by LIMS/ELN and provides a mechanism to track analytical variability to a specific analyst or environment. LIMS/ELN also flags result excursions, either from expected analytical technique or from specifications.
    • The instrument interface functionality of a ELN can record instrument measurements automatically avoiding transposition or substitution.
    • LIMS/ELN can collate information for an analytical run and allow a scientist to make sense of the information at the test level and spot excursions.
Quality Reviews

The overall quality of data and efficiency of the review and approval process can be dramatically enhanced by introduction of a LIMS solution.  LIMS can reduce the effort required for documentation reviews by 30%.

    • LIMS makes all information accessible electronically and avoids tracking down notebooks, instrument records, or data files in cabinets or on file shares
    • Templated processes supported by LIMS/ELN support validated calculations and avoid time consuming verifications. Templated processes also define consistent layout contributing to detection of errors and data inconsistencies.  Finally, compliance is built into templates elimination the need for verification against checklists.
    • LIMS/ELN enforces good documentation practices. All entries are stamped with analyst name and date recorded.  Changes to data are fully documented with reason for the change.  Calibration and expiration dates are documented at the time of use.
    • Communication during the review process is optimized by LIMS/ELN using electronic sticky notes to facilitate a conversation between reviewer and analyst.

Improve your compliance using validated formulas to eliminate calculation errors and assure adherence to SOPs.


    • Electronic signatures and sign off by analyst, reviewer, and approver avoid delays transmitting documents between staff.
Stability

Drug development stability is often more complex due to orientation and packaging considerations. LIMS is a key solution to manage the complexity.

    • LIMS will manage specifications to define the testing required and the criteria used to judge the results.
    • Protocol definition in LIMS reduces the effort required to setup a study based on the protocol.
    • Study definition in LIMS automatically defines and labels samples for each condition & time point. The testing requirements for each sample are specified by LIMS.  Inventory requirements and schedules for set, pull, and delivery of stability samples should also be automatic.
    • LIMS provides data entry capability for analytical stability results.
    • Reporting and shelf life predictions are provided by LIMS.


CONCLUSIONS


Pharmaceutical drug development is conducted across multiple work groups.  To manage the intrinsic complexity of development and to be most efficient & compliant, each work group should implement an electronic solution – Electronic Batch Records (EBR), Sample Management, Lab Information Management (LIMS), and Electronic Lab Notebook (ELN).  These electronic systems, together comprise the data warehouse for a drug development project and ideally, the information stored in these electronic systems is combined in a visualization tool such as Spotfire or JMP to ascertain the state and viability of a drug project.

Implementing up to 4 different solutions across the organization is difficult and ‘patching’ the solutions together to communicate and share data would require a great deal of effort to coordinate.  Additionally, regular maintenance and upgrades across multiple ‘patched’ solutions will introduce additional risk and effort.

The ideal solution is a single vendor solution capable of providing benefit to each work group in the drug development team and seamlessly combining project information.   Additionally, the vendor solution should support the flexibility required for early formulation & method development and the structure required for GMP manufacture & analytical testing.

 


SciCord is a hybrid ELN/LIMS, featuring a spreadsheet paradigm, that combines the compliance and structured aspects of a Laboratory Information Management System (LIMS) with the flexibility of an Electronic Laboratory Notebook (ELN). The ELN and LIMS functions integrate seamlessly and enable your company to quickly reap the benefits of enhanced data and time efficiencies as you continue to meet compliance standards and follow GLP.

If you’d like to learn more about how you could use SciCord ELN/LIMS in your laboratory, please request a demo. Provide us your contact information, and we’ll share a helpful demo that will show you how our ELN/LIMS could boost the productivity of your lab and enhance the quality of your data.