Standard Operating Procedure for Recording Parameters in Batch Manufacturing Record (BMR)
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/069/2025 |
| Supersedes | SOP/ELX/069/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the procedure for accurately recording all process parameters, observations, and verification steps in the Batch Manufacturing Record (BMR) during the manufacturing of elixirs.
2. Scope
This SOP applies to all manufacturing stages of elixirs in the Elixir Department, including dispensing, mixing, heating/cooling, filtration, and filling, where critical data must be documented in the BMR.
3. Responsibilities
- Production Operator:
- Record parameters such as temperature, speed, time, and volume in the respective BMR fields.
- Sign and date each entry immediately after recording.
- Production Supervisor:
- Verify entries for correctness, completeness, and legibility.
- Ensure any corrections follow GMP-compliant documentation practices.
- QA Officer:
- Review completed BMRs before batch release.
- Ensure no critical parameters are missed or falsified.
4. Accountability
The Production Head is accountable for maintaining the accuracy, integrity, and compliance of all recorded parameters in the BMR.
5. Procedure
5.1 General Instructions
- Use only indelible black or blue ink for all handwritten entries.
- Do not use correction fluid or overwrite any entry.
- If an error occurs, strike a single line through the incorrect entry, write the correct value, and sign with date and reason.
5.2 Recording Process Parameters
- Record the following parameters in the BMR:
- Dispensed quantities and batch numbers of raw materials.
- Mixing speed (RPM), temperature, and duration.
- Heating and cooling cycles with start and stop times.
- pH readings and adjustments, if applicable.
- Volume adjustments and final volume check.
- Filtration start and end times, filter type used.
- Sampling time points and personnel initials.
5.3 In-Process Observations
- Note any unusual observations (e.g., foaming, odor, color change) along with action taken.
- Record deviations with reference to the deviation report number, if applicable.
5.4 Verification and Review
- Supervisor must verify entries within the same shift and sign with date.
- QA review should be done after process completion and documented in the QA review section of the BMR.
5.5 Archival
- After final QA release, BMRs must be archived in the QA documentation room as per document retention policy.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
7. Documents
- BMR Template (Annexure-1)
- Correction Log Sheet (Annexure-2)
- QA Review Form (Annexure-3)
8. References
- 21 CFR Part 211.188 – Batch Production and Control Records
- WHO TRS 986 Annex 2 – GMP Documentation Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: BMR Template
| Section | Parameter | Recorded Value | Date/Time | Initials |
|---|---|---|---|---|
| Mixing | RPM | 60 | 11/04/2025 – 10:30 AM | RK |
Annexure-2: Correction Log Sheet
| Date | Original Entry | Corrected Entry | Reason | Corrected By |
|---|---|---|---|---|
| 11/04/2025 | 85°C | 58°C | Typo | Rajesh Kumar |
Annexure-3: QA Review Form
| Date | Batch No. | Reviewed By | Remarks | Status |
|---|---|---|---|---|
| 11/04/2025 | ELX-1013 | Sunita Reddy | Complete and correct | Approved |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added Correction Log and QA Review Form | GMP Documentation Update | QA Head |