Data Profile for This Category
Data for pharmaceutical dosage form manufacturing originates from approved formulation processes, MES systems, electronic batch records, equipment and environmental monitoring data, LIMS systems, and quality management systems. Daily reviewed documents include master production files, batch production records, batch packaging records, cleaning records, inspection records, deviation/CAPA/change documents, and batch release review forms. Data updates occur per production batch, each critical process step, and per established monitoring plans. Data fields include material batch numbers, process parameters, test results, deviation records, and additional relevant fields. These must adhere to GMP-compliant formatting requirements.
Constraints Imposed on Tool Calling and Plugin Workflows
Multi-source heterogeneous data integration requires plugins to adapt to the interface formats of different systems. This prevents review errors caused by incompatible data formats. Frequent updates tied to batches and critical steps require tool calling to support incremental synchronization and batch processing. This avoids performance losses from full data scans. GMP compliance requirements for documentation mandate that tool calling parameters strictly match document fields. This ensures cross-review content accurately maps to the same production batch. Mandatory unique identifier fields prevent incorrect association of data across different batches. This avoids compromising the accuracy of review results.
Configuration Settings
These configurations are adapted for FastGPT v4.17.0.
| Configuration Item | Recommended Setting | Rationale |
|---|---|---|
| Chunk Length | 800–1200 characters | Adapts to the single-page content length of batch production records, prevents incorrect merging of cross-batch data |
| Overlap Length | 100–200 characters | Preserves associated process step information across pages in batch records |
| Single Search Limit | Top 8 entries | Matches the number of key review items for GMP audits, avoids interference from redundant data |
| Maximum Context | 60000 characters | Adapts to the total length requirement of complete batch records for a single batch |
| Workflow/API tool selection | auto | Automatically selects appropriate tool calling logic, supports complex cross-document cross-review requirements |
| Workflow/API function-call configuration | Enabled | Ensures results returned by tools are correctly integrated into the review response workflow |
Three Common Configuration Mistakes
- After calling an interface to create a CSV file collection, the data displayed in the interface does not match the results returned by the interface. The cause is that the interface does not specify a batch number as the associated field. This leads to material data from different production batches being merged into the same collection.
- When configuring plugin previews, content can be retrieved, but the final output is empty. The cause is that the
functionCallparameter is not enabled. This leads to results returned by tools not being correctly integrated into the response workflow. - After using chunk mode to call the pushdata API to upload data, the interface always shows an indexing status. The cause is that the unique identifier field matching batch records is not configured. This leads to the system being unable to complete data association verification.
How to Verify Configurations Are Correct
- Upload complete batch production records for a single batch. Confirm that chunked content includes full process steps and material weighing data.
- Submit a cross-review request. Confirm that results returned by tool calling only include associated document data for the current batch, with no content from other batches included.
- Trigger the pushdata API to upload test data. Confirm that the interface indexing status completes updates within 120 seconds.
- Verify that when the
toolChoiceparameter is set to auto, the system automatically calls corresponding tools to complete cross-checking of deviation and batch release records.
The values provided here are common starting points. They should be evaluated against the reader’s own samples.