Data Structure for This Category
The quality traceability data for pharmaceutical preparations production comes from approved formulation processes, material batch ledgers, MES electronic batch records, equipment and environmental monitoring data, LIMS test records, and quality management systems. Daily associated documents include master production documents, batch production, packaging, and cleaning records, deviation, CAPA, and change records, and batch release review forms. Data is updated per production batch, key process steps, and monitoring plans. Fields include material batch numbers, process parameter values, test results, deviation numbers, and more. Records must be stored synchronously with production operations, and comply with GMP requirements for document and operation consistency.
Constraints Imposed on Tool Calling and Plugins Workflow
Data sources for this category are scattered, and must strictly meet GMP compliance requirements. Tool calling must connect to multiple system data sources to complete cross-document associated queries. Data updates occur at high frequency, and must synchronize with production links. This requires plugins to support low-latency real-time data pulling. Batch records and associated documents have a large number of fields and strict formats. Tool calling must accurately extract specific fields such as material batch numbers and deviation numbers for traceability. Additionally, quality traceability requires aggregating multi-dimensional data for audit judgments. The tool calling context window must accommodate the full set of associated documents to avoid information truncation.
Configuration Settings
The following configurations are based on FastGPT v4.17.0.
| Configuration Item | Recommended Setting | Rationale |
|---|---|---|
| Maximum Tool Calls per Run | First 8 entries | Matches the number of deviations and test records that need to be associated for a single traceability |
| Tool Call Timeout | 120–180 seconds | Matches the time requirements for aggregating multi-source data |
| Workflow/API tool selection | auto | Supports automatically selecting the appropriate tool to complete quality problem traceability queries |
| Workflow/API function-call configuration | Enabled | Used for structured extraction of key compliance fields from batch records |
| Maximum Context Window | 8000–12000 token | Accommodates full batch production records and associated documents |
| Result Rearrangement | Sort by relevance | Prioritizes displaying test data directly related to the current quality problem |
Common Configuration Mistakes
- The tool calling module continuously outputs redundant operation logs, leading to context overflow. This occurs when the detailed operation log output switch for tool calling is not disabled.
- After calling a tool, the traceability results for the current batch include data from historical batches. This occurs when the context window is not reset before each call, leaving historical conversation data intact.
- Tool call response time exceeds 15 seconds, triggering a timeout error. This occurs when the timeout setting is not adjusted appropriately, or too many scattered data sources are called simultaneously.
How to Verify Correct Configuration
- Submit a simulated quality problem traceability request. Verify that the tool calling output only includes structured results, with no redundant operation logs.
- Submit calls for quality problems from two different batches. Confirm that the fields in the two results do not have cross-batch data overlap.
- Run five or more consecutive tool calls. Confirm that response times meet the preset timeout settings, with no frequent timeout errors.
- Verify that the
functionCallfunction correctly extracts compliance fields such as material batch numbers and deviation numbers from batch records.
The values provided are common starting points and should be measured against the reader's own samples.