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Drug Product Development

Overview​

Drug Product Development in Labii provides a structured workspace for transforming a product concept into an evaluated formulation. It connects product requirements, formulation versions, material records, specifications, analytical methods, prototype batches, test results, and stability data so development teams can make decisions from a traceable body of evidence.

The application is designed for formulation scientists, analytical scientists, process development teams, project leads, and quality reviewers. Before beginning, define user permissions, standardize units and naming conventions, and prepare the material and analytical methods your program requires. Available through the Labii products catalog, Drug Product Development integrates development work with Labii's inventory, storage, chain-of-custody, consumption, and reporting capabilities.

Use Cases​

Formulation Design and Screening​

  • Define target product characteristics and compare formulation candidates.
  • Evaluate excipients, active ingredients, and material attributes.
  • Preserve formulation versions and the rationale for development decisions.

Prototype Batch Development​

  • Convert selected formulations into controlled development batch records.
  • Track material lots, containers, storage conditions, and consumption.
  • Compare manufacturing observations and analytical results across prototypes.

Analytical and Stability Evaluation​

  • Define product specifications and associate validated testing methods.
  • Record results against acceptance criteria for each development batch.
  • Monitor stability studies across conditions, intervals, and test points.

Development Reporting and Review​

  • Assemble formulation, batch, test, and stability evidence into reports.
  • Support technical reviews with linked, time-stamped source records.
  • Maintain data integrity and traceability for regulated development programs.

Getting Started​

Install Drug Product Development from Settings → Applications → Add application → Add from a template. See Add from a template for application installation instructions.

Confirm that the application includes the following tables:

  • dp_product
  • dp_formulation
  • im_material
  • dp_specification
  • testing_method
  • dp_batch_record
  • core_batch
  • core_container
  • core_storage
  • core_chain_of_custody
  • core_consumption
  • dp_specification_result
  • dp_stability_study
  • core_report

Review table permissions and assign suitable access to formulation, analytical, inventory, quality, and project team members.

Standardize material names, units, specification terminology, batch numbering, and stability conditions before entering development data.

Create or import material and testing method records needed for the first product development program.

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Use controlled terminology and consistent units from the start. This makes formulation comparisons, specification checks, and stability trend reviews more reliable.

Define the Drug Product​

Create the development target and its quality expectations before comparing formulations.

Create a record in Drug Products (dp_product) and enter the product name, dosage form, strength, intended route of administration, and development stage.

Document the target product profile, including critical quality attributes, performance goals, packaging assumptions, and storage requirements.

Create records in Specifications (dp_specification) for the product's identity, potency, purity, physical properties, performance, and microbiological requirements as applicable.

Associate each specification with the appropriate analytical procedure in Testing Methods (testing_method) and define its acceptance criteria.

Design and Compare Formulations​

Build traceable formulation candidates and use material evidence to select prototypes.

Review or create source records in Materials (im_material) for active ingredients, excipients, processing aids, and packaging components.

Create a candidate in Formulations (dp_formulation), link it to the drug product, and assign a unique version or development code.

Add the materials, target quantities or concentrations, functional roles, processing sequence, and relevant formulation assumptions.

Record the scientific rationale, known risks, and expected effect of each candidate on critical quality attributes.

Compare formulation candidates and select those that should advance to prototype batch production.

tip

Create a new formulation version when composition or processing assumptions change so earlier experimental results remain attributable to the formulation that produced them.

Prepare and Track Prototype Batches​

Convert a selected formulation into an executable development batch with material-level traceability.

Create a development record in Batch Records (dp_batch_record) and link the approved formulation version, planned scale, protocol, and responsible team members.

Create or link the corresponding batch in Batches (core_batch) and assign the batch identifier, dates, status, and yield targets.

Select the material lots and source containers in Containers (core_container), then record each quantity used in Consumption (core_consumption).

Document dispensing, mixing, granulation, drying, compression, coating, filling, or other applicable operations in the batch record, including actual process parameters and observations.

Place retained and test samples into defined locations in Storage (core_storage) and use Chain of Custody (core_chain_of_custody) to document transfers.

Reconcile actual yield and material consumption, then record deviations and conclusions before closing the prototype batch.

Evaluate Specifications and Test Results​

Capture analytical evidence consistently and assess each prototype against predefined criteria.

Select the product specifications and testing methods required for the batch's development stage.

Create a record in Specification Results (dp_specification_result) for each test and link the product, formulation, batch, specification, method, analyst, and test date.

Enter the observed result, units, supporting data, and any calculation or instrument references.

Compare the result with its acceptance criteria and record the disposition, review status, and investigation reference when a result does not meet expectations.

Review results together to determine whether the formulation should be advanced, revised, repeated, or discontinued.

Manage Stability Studies​

Track product performance over time under defined storage conditions.

Create a study in Stability Studies (dp_stability_study) and link the drug product, formulation version, and representative batch.

Define study conditions, packaging configuration, orientation when relevant, pull intervals, tests, acceptance criteria, and protocol dates.

Assign study samples to monitored locations in Storage (core_storage) and document sample movement through Chain of Custody (core_chain_of_custody).

At each interval, perform the scheduled tests and add linked records in Specification Results (dp_specification_result).

Review trends, excursions, missed pulls, and changes from initial results, then document the study conclusion and recommended shelf life or further work.

Advanced Features​

End-to-End Traceability​

Link products, formulation versions, materials, consumed lots, batches, samples, specifications, methods, results, and stability studies. These relationships let reviewers move from a reported conclusion back to its source evidence.

Risk-Based Development​

Use structured fields and linked sections to record critical material attributes, critical process parameters, and critical quality attributes. Prioritize experiments and controls according to their potential effect on product quality.

Controlled Reporting​

Use Reports (core_report) to assemble approved development summaries from linked records. Include the evaluated formulations, batch execution details, analytical results, stability trends, deviations, conclusions, and approvals.

warning

Application records support a controlled development process, but your organization remains responsible for validating its configuration, procedures, electronic signatures, and regulatory controls for the intended use.

Troubleshooting​

A specification result cannot be evaluated​

Symptoms: A test result has no acceptance status or cannot be compared with its specification.

Confirm that the result links to the correct specification and testing method.

Verify that the result and acceptance criterion use compatible units and data types.

Check that the specification version was effective for the tested batch and date.

Material consumption is not traceable to a batch​

Symptoms: A prototype batch does not show the material lot or container used.

Confirm that the consumption record links both the development batch and the source container.

Verify that the container links to the correct material lot and that the consumed quantity has a unit.

Review user permissions if the source container or consumption record is not visible.

A stability pull is missing or overdue​

Symptoms: A scheduled interval has no sample or associated test results.

Review the study schedule, condition, and target pull date.

Locate the sample through storage and chain-of-custody records.

Document the missed or delayed pull according to your procedure and reschedule testing when scientifically justified.