๐Ÿงช BCR Generator โ€” Precision Pharma

Select product ยท Lots default to last used ยท Calculated weights from CoA assay % ยท Print 2-page BCR

1 Batch Details

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PRECISION PHARMA

555 Heritage Drive, Lab 143 โ€ข Jupiter, FL 33458
Tel: 561-941-3900 โ€ข orders@precisionpharma.org
USP <797> Category 3 โ€ข ยง503A โ€ข FL Permits: PH35541, PH35823

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MFR: โ€”
Page 1 of 2
BATCH COMPOUNDING RECORD
1. BATCH IDENTIFICATION
Product Nameโ€” Batch Dateโ€”
BCR Lot # โ€” Target Vialsโ€”
Compounding Techโ€” Lead Techโ€”
Director of ComplianceMarcia Walker, PharmD PICStewart Edington, RPh
2. EQUIPMENT USED
Balance IDBAL-001 Balance Last Calโ€”
pH Meter IDPHM-001 pH Meter Last Calโ€”
Mixing Vessel ID PEC-1 Hood IDLAF-001
PEC-2 Hood IDLAF-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 โœ“ Lead โœ“
4. CONTAINER & CLOSURE LOT VERIFICATION
Component Lot # Expiry Cert / Depyrogenation Ref Tech โœ“ Lead โœ“
0.22ฮผm Filter Type โ€” Filter Lot # โ€”
5. PRE-COMPOUNDING CHECKS
Checkโœ“ Pass / โœ— FailTechLead
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
BCR: โ€” | MFR: โ€” PRECISION PHARMA โ€” CONFIDENTIAL โ€” Retain minimum 4 years โ€” Page 1 of 2

PRECISION PHARMA

555 Heritage Drive, Lab 143 โ€ข Jupiter, FL 33458

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MFR: โ€”
Page 2 of 2
BATCH COMPOUNDING RECORD โ€” PAGE 2
6. SOLUTION PREPARATION
Compounding Start Time SWFI Temperature at Use (ยฐC)
Excipients Added (EDTA/Antioxidant) โ€” TimeFully Dissolved โ€” Time
API Added โ€” TimeAPI Fully Dissolved โ€” Time
Preservative Added โ€” TimeMixed โ€” Time
โš  CRITICAL โ€” pH Adjustment. Target 6.5 ยฑ 0.3 (range 6.2โ€“6.8). 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 / TimeBulk Appearance โ€” Pass / Fail
Final Bulk Volume (mL)Final pH Confirmed (6.2โ€“6.8)
Tech InitialsLead Initials
7. FILTRATION & FILL
โš  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 TypePost-Use Result โ€” PASS / FAIL
Filtration Start TimeFill Start Time
Fill CheckVial #Weight (g)Target (g)Pass/FailTech โœ“
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 โ€” Sterile Haz (ยฐC) Room Temp โ€” Sterile Non-Haz (ยฐC) Room Temp โ€” Ante-Room (ยฐC)
Differential Pressure (inH2O) Humidity %RH Time of Reading
NVPC โ‰ฅ0.5ยตm (inside hood) NVPC โ‰ฅ5.0ยตm (inside hood) NVPC Pass / Fail
All EM Within Limits? โ˜ Yes โ€” all readings within USP <797> action limits     โ˜ No โ€” 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 โ€” Tech 1 Name Left Hand CFU Right Hand CFU Pass/Fail
GFT โ€” Tech 2 Name Left Hand CFU Right Hand CFU Pass/Fail
GFT Media Lot # Plates In โ€” Date/Time Incubator ID Incubator Temp Set
Post-Compound SS โ€” Sites Sampled โ˜ SS3  โ˜ SS4  โ˜ SS5  โ˜ SS6  โ˜ SS7  โ˜ SS8  โ˜ SS9  โ˜ SS10  โ˜ SS11 SS Plates In โ€” Date/Time
11. RELEASE RESULTS โ€” complete when ARL report received
TestSpecificationResultPass/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.
BCR: โ€” | MFR: โ€” PRECISION PHARMA โ€” CONFIDENTIAL โ€” Page 2 of 2
BCR Ready โ€” โ€”