PRECISION PHARMA
555 Heritage Drive, Lab 143 · Jupiter, FL 33458
Tel: 561-941-3900 · orders@precisionpharma.org
USP <797> Category 3 · §503A · FL Permits: PH35541, PH35823
MFR:
Page 1 of 3
BATCH COMPOUNDING RECORD
Document Status:
Data + hardcopy in SharePoint
Data in tracker, no hardcopy uploaded
Not yet captured
Manual entry required
1. BATCH IDENTIFICATION
| Product Name | |
| BCR Lot # | |
Batch Date | |
| Compounding Tech | |
Target Vials | |
| Lead Tech | |
PIC | Stewart Edington, RPh |
| Director of Compliance | Marcia Walker, PharmD |
Dir. of Compliance | Marcia Walker, PharmD |
2. EQUIPMENT USED
| Balance ID | BAL-001 |
Balance Last Cal | — |
| Mixing Vessel ID | |
PEC-1 Hood ID | — |
| PEC-2 Hood ID | — |
PEC Certs Current Y/N | — |
3. MATERIALS — LOT VERIFICATION & CALCULATED WEIGHTS
All materials must be quarantine-released and within expiry before use. Calculated weights correct for actual assay purity. Tech weighs; Lead Tech independently verifies each weight.
| Component |
Lot # |
Assay % ⚡ |
Expiry |
Calc. Target |
Actual Weight |
Tech ✓ |
Lead ✓ |
4. CONTAINER & CLOSURE LOT VERIFICATION
| Component | Lot # | Expiry | Cert / Depyrogenation Ref | Tech ✓ | Lead ✓ |
|---|
| Vials (10 mL sterile amber glass) | ___________ | | Depyrogenation cert ref: __________ | | |
| Stoppers (bromobutyl rubber) | ___________ | | Sterilization cert ref: __________ | | |
| Crimp seals (20mm aluminum) | ___________ | | | | |
| 0.22µm PTFE Filter |
___________ |
___________ |
Bubble point ≥50 PSI pre + post |
| |
PRECISION PHARMA
555 Heritage Drive, Lab 143 · Jupiter, FL 33458
MFR:
Page 2 of 4
BATCH COMPOUNDING RECORD — PAGE 2
5. PRE-COMPOUNDING CHECKS
| Check |
✓ Pass / ✗ Fail |
Tech |
Lead |
| All materials quarantine-released and within expiry | | | |
| PEC-1 and PEC-2 certifications current (confirm above) | | | |
| EM compliance verified — prior week/month within action limits | |
| Balance calibrated today (daily USP weights) — reading: ________ | | | |
| Previous batch of same product reviewed and released | | | |
| Sterile garbing complete, glove fingertip sampling performed | | | |
6. COMPOUNDING PROCEDURE
PRECISION PHARMA
555 Heritage Drive, Lab 143 · Jupiter, FL 33458
MFR:
Page 4 of 4
BATCH COMPOUNDING RECORD — PAGE 3
7. IN-PROCESS QC CHECKS
| Check | Specification | Method | Result | Pass/Fail |
|---|
8. YIELD & VIAL REJECTION LOG
| First Vial # | |
Last Vial # | |
Total Filled | |
| Vials Rejected | |
Rejection Reason(s) | |
| Vials Accepted | |
Quarantine Location | |
9. ENVIRONMENTAL CONDITIONS DURING COMPOUNDING ⚡ Auto-Fill from EdgeX
| Room Temp — Sterile Haz (°C) | |
Room Temp — Sterile Non-Haz (°C) | |
Room Temp — Ante-Room (°C) | |
| Differential Pressure (inH₂O) | |
Humidity %RH | |
Time of Reading | |
| All EM Within Limits? |
☐ Yes — all readings within USP <797> action limits ☐ No — see Excursion Log & initiate investigation |
10. ARL SUBMISSION & CHAIN OF CUSTODY
| Vials Sent to ARL (qty) | |
ARL Submission Date | |
Packaged By | |
| Shipped By | |
Tracking Number | |
ARL Report # | |
10b. GFT & POST-COMPOUND SURFACE SAMPLES
⏳ GFT and surface sample results pending — will auto-populate when uploaded via Universal Parser
| Personnel | Left Hand CFU | Right Hand CFU | Action Limit | Pass/Fail | Media Lot # |
|---|
| Post-Compound SS — Sites Sampled |
☐ SS3 ☐ SS4 ☐ SS5 ☐ SS6 ☐ SS7 ☐ SS8 ☐ SS9 ☐ SS10 ☐ SS11 |
SS Plates In — Date/Time | |
11. RELEASE RESULTS — complete when ARL report received
⏳ ARL results pending — will auto-populate when ARL report uploaded via Universal Parser
| Test | Specification | Result | Pass/Fail |
|---|
12. BUD ASSIGNMENT & FINAL SIGN-OFF
| BUD Assigned | |
Release Date | |
| Deviations? Y / N | |
Deviation Form Ref # | |
| Overall Batch Result | |
Batch Entered in BCR Register | |
Compounding Technician
Date: ______________ Time: ______
Director of Compliance (Batch Review)
Marcia Walker, PharmD
Date: ______________ Time: ______
Pharmacist-in-Charge (Final Release)
Stewart Edington, RPh
Date: ______________ Time: ______
Retain minimum 4 years per Florida BoP & USP <797> §503A. Alterations: single-line strikethrough + initials + date only. No correction fluid. This BCR must be reviewed and signed by the Director of Compliance before PIC release signature.