PRECISION PHARMA
555 Heritage Drive, Lab 143 โข Jupiter, FL 33458
Tel: 561-941-3900 โข orders@precisionpharma.org
USP <797> Category 3 โข ยง503A โข FL Permits: PH35541, PH35823
BATCH COMPOUNDING RECORD
1. BATCH IDENTIFICATION
| Product Name | โ |
Batch Date | โ |
| BCR Lot # |
โ |
Target Vials | โ |
| Compounding Tech | โ |
Lead Tech | โ |
| Director of Compliance | Marcia Walker, PharmD |
PIC | Stewart Edington, RPh |
2. EQUIPMENT USED
| Balance ID | BAL-001 |
Balance Last Cal | โ |
| pH Meter ID | PHM-001 |
pH Meter Last Cal | โ |
| Mixing Vessel ID | |
PEC-1 Hood ID | LAF-001 |
| PEC-2 Hood ID | LAF-002 |
PEC Certs Current Y/N | |
3. MATERIALS โ 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 โ |
Lead โ |
4. CONTAINER & CLOSURE LOT VERIFICATION
| Component |
Lot # |
Expiry |
Cert / Depyrogenation Ref |
Tech โ |
Lead โ |
| 0.22ฮผm Filter Type |
โ |
Filter Lot # |
โ |
5. PRE-COMPOUNDING CHECKS
| Check | โ Pass / โ Fail | Tech | Lead |
|---|
| All materials quarantine-released and within expiry | | | |
| PEC-1 and PEC-2 certifications current (confirm above) | | | |
| EM compliance verified โ prior week/month within action limits | | | |
| Balance calibrated today (daily USP weights) โ reading: ________ | | | |
| pH meter calibrated today (pH 4 + pH 7 buffer) โ slope: ________ | | | |
| Previous batch of same product reviewed and released | | | |
| Sterile garbing complete, glove fingertip sampling performed | | | |
PRECISION PHARMA
555 Heritage Drive, Lab 143 โข Jupiter, FL 33458
BATCH COMPOUNDING RECORD โ PAGE 2
6. SOLUTION PREPARATION
| Compounding Start Time | |
SWFI Temperature at Use (ยฐC) | |
| Excipients Added (EDTA/Antioxidant) โ Time | | Fully Dissolved โ Time | |
| API Added โ Time | | API Fully Dissolved โ Time | |
| Preservative Added โ Time | | Mixed โ Time | |
โ CRITICAL โ pH Adjustment. Target 6.5 ยฑ 0.3 (range 6.2โ6.8). Record each reading with time. Out of range = stop and investigate.
| Pre-Adjustment pH / Time | |
Adjusting Agent (NaOH / HCl) | |
| Volume Adjusting Agent Added (mL) | | Post-Adjustment pH / Time | |
| Final pH after Preservative / Time | | Bulk Appearance โ Pass / Fail | |
| Final Bulk Volume (mL) | | Final pH Confirmed (6.2โ6.8) | |
| Tech Initials | | Lead Initials | |
7. FILTRATION & FILL
โ CRITICAL โ Post-use filter integrity failure = IMMEDIATE BATCH REJECTION. No vials to be released from a failed batch.
| Pre-Use Integrity Test Type | |
Pre-Use Result โ PASS / FAIL | |
| Post-Use Integrity Test Type | | Post-Use Result โ PASS / FAIL | |
| Filtration Start Time | | Fill Start Time | |
| Fill Check | Vial # | Weight (g) | Target (g) | Pass/Fail | Tech โ |
|---|
| Start | | | | | |
| Mid | | | | | |
| End | | | | | |
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
| Room Temp (ยฐC) | |
Differential Pressure (inH2O) | |
Humidity (%) | |
| EM Within Limits Y/N | |
Time of Environmental Reading | |
10. ARL SUBMISSION & CHAIN OF CUSTODY
| Vials Sent to ARL (qty) | |
ARL Submission Date | |
Packaged By | |
| Shipped By | |
Tracking Number | |
ARL Report # | |
11. RELEASE RESULTS โ complete when ARL report received
| 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
Name: โ
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> ยง503A. 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.