QA Documentation Review Desk • Controlled Paper Record + Source Evidence
Batch Manufacturing Record — Granulation
Product: PQS Immediate-Release Tablets 100 mg
Batch: TX240906A • Page 14 of 36
6.2 Granulation Process Record
| Activity / Parameter | Recorded entry | Performed / checked |
|---|---|---|
| Granulator ID | GRN-02 | RK / 09:18 |
| Start time | 09:22 | RK |
| Binder addition complete | 09:48 | RK |
| Product temperature | 25.8 °C | RK / 09:52 |
| Mixing time | 35 min | RK / 10:05 |
| IPC sample ID | RK | |
| Yield result | 97.6 % | QA-JM / 10:02 |
| Deviation / event No. | N/A | RK / 10:12 |
6.3 Completion Review
| Operator comments | No abnormality observed |
| Second-person review | Reviewed: Date: |
IPC sample = IPC-GR-118-03
temp 25.3°C
note made during line activity
temp 25.3°C
note made during line activity
Source evidence — temperature recorder
Independent equipment printout retained with the batch packet.
GRN-02 TEMP LOG
09:51:47 25.3 C
09:52:17 25.3 C
Status: stable
09:51:47 25.3 C
09:52:17 25.3 C
Status: stable
Electronic equipment log
Time-stamped events generated by the granulator control system.
09:22:05 START
09:46:31 BINDER END
10:05:12 MIX END
09:46:31 BINDER END
10:05:12 MIX END
Controlled correction tools
Use only after you identify a correctable entry and supporting evidence.