What this category of data looks like
Daily documents for pharmaceutical preparations production include master production documents, batch production records, batch packaging records, cleaning records, deviation/CAPA reports, and batch release review forms. Data sources include approved formulation processes, MES electronic batch records, LIMS laboratory information management systems, quality management systems, and equipment and environmental monitoring data. Data is updated with each batch production, key process step, and execution of monitoring plans. Document structures include standardized fields such as material batch numbers, equipment numbers, environmental temperature and humidity values, deviation descriptions, and CAPA measures. All fields carry units required by production specifications.
What constraints these characteristics impose on the "citation sourcing and traceability" link
Multi-source and heterogeneous data sources require retrieval results to accurately associate fields from different systems, to avoid traceability confusion. High-frequency batch-level updates require the retrieval link to support real-time calls to the latest data, ensuring the timeliness of citations. Good Manufacturing Practice (GMP) compliance requirements require complete retention of the original data path and generation time of citations, to meet audit traceability needs. The large volume of data associated with a single batch production requires limiting the retrieval scope while ensuring coverage, to avoid missing key traceability information.
How to set the configurations
| Configuration Item | Recommended Setting | Rationale for This Setting |
|---|---|---|
| Similarity Threshold | 0.75–0.85 | Matches the precision requirements for process parameters and batch records |
| Single Search Limit | Top 8 entries | Covers the associated data volume of a single batch production |
quoteMaxToken | 1200–1500 token | Accommodates complete batch record and deviation report content |
responseData | Includes file path, batch number, generation time | Meets the field requirements for GMP traceability |
detail | Enabled | Displays the complete citation chain of original data |
| Maximum Context | 8000–10000 characters | Carries associated data from multiple systems |
Three common mistakes
- Phenomenon: Only citation identifiers are returned after matching data is retrieved, and complete traceability content is not displayed. Cause: The
responseDataparameter is not configured correctly, and the traceability fields to be returned are not specified. - Phenomenon: An error is triggered in the code execution stage after calling knowledge base retrieval in the workflow, prompting that the input field is empty. Cause: The output fields of the retrieval result are not mapped to the input parameters of code execution in the plugin configuration.
- Phenomenon: The number of retrieval results is far lower than expected, and cannot cover all associated data of a single batch production. Cause: The single search limit is set too low, and does not match the associated data volume of a single batch production.
How to confirm the configuration is correct
- Initiate a query for process parameters of a single batch production, and check whether returned results include preset traceability fields such as material batch numbers and equipment numbers.
- View the details of each citation, confirm that the chain points to the storage path and generation time of the original data, with no missing links.
- Simulate an exception report drafting scenario, and verify whether retrieval results cover associated deviation, inspection, and cleaning records.
- Test workflow plugin calls in the FastGPT v4.17.0 environment, and confirm that retrieval results can be correctly passed to downstream code execution nodes.
Note: The values listed above are common starting points. They should be evaluated against the reader's own samples.