Betamethasone Neomycin EYE /EAR DROPS
PURPOSE:
This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.
SCOPE:
This procedure is performed and is applied during the manufacturing of dosage form.
RESPONSIBILITY / ACCOUNTABILITY:
It is the responsibility of Assistant Manufacturing Chemist to follow and adhere to this SOP. The Production Manager, QC/QA Manager are accountable for the strict adherence to the master formula.
COPY ISSUED TO:
- Master Copy : Manager Quality Assurance
- Copy No. 1 : Production Manager
- Copy No. 2 : Manager Quality Control
- Copy No. 3 : Small Volume Parenteral Section
| PRODUCTNAME:Betamethasone Neomycin EYE /EAR DROPS | BATCH SIZE: 100 LTRS. |
| PRODUCT REFERENCE CODE: 301 | UNIT SIZE: 10 ml VIAL |
| GENERIC NAME: N.A. | PACK SIZE: 24 x 24 X 10 ML |
| DOSAGE FORM: OPTHALMIC DOSAGE FORM | STRENGTH: N.A. |
| DEPARTMENT: STERILE PREPARATION | EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING |
COMPOSITION:
| Neomycin Sulphate | IP | 0.5% w/v | |
| Betamethasone Sodium Phosphate | IP | 0.1% w/v | |
| Benzalkonium Chloride (as preservative) | IP | 0.02% v/v | |
| Aqueous buffered vehicle | q.s | ||
EQUIPMENTS TO BE USED:
| SR. NO. | NAME OF EQUIPMENT | ASSEMBLING AS PER SOP NO. | CLEANING AS PER SOP NO. |
| 1 | Auto Clave with SS Transfer trolley | SOP/ SV/006/MO/II | SOP/ SV/010/MC/II |
| 2 | Multi Column Distillation Still | SOP/ SV/016/MO/II | SOP/ SV/020/MC/II |
| 3 | Distill Water Storage Tank | — | SOP/ SV/003/MC/II |
| 4 | SS Batch Mixing Tank | — | SOP/ SV/001/MC/II |
| 5 | SS Pressure Vessel – 100 Ltr. | — | SOP/ SV/004/MC/II |
| 6 | SS Membrane Filteration Assembly (293 mm) | SOP/ SV/002/MO/II | SOP/ SV/005/MC/II |
| 7 | SS Filling Vessel – 100 Ltr | — | SOP/ SV/006/MC/II |
| 8 | Auto Liquid Vial Filling, Stoppering & Sealing Machine | SOP/ SV/010/MO/II | SOP/ SV/014/MC/II |
| 9 | Auto Vial Labelling Machine | SOP/ SV/015/MO/II | SOP/ SV/019/MC/II |
RAW MATERIALS:
| S.NO. | INGREDIENTS | STD | Theoretical Quantity Req. | Overages % | Total Quantity Used |
| 1. | BORIC ACID | I.P. | 0.200 | – | 0.200 KGS |
| 2. | BORAX | I.P. | 0.320 | – | 0.320 KGS |
| 3. | BETAMETHASONE SODIUM PHOSPHATE | I.P. | 100.000 | 15.000 | 115.000 GMS |
| 4. | BENZYLKONIUM CHLORIDE | I.P. | 0.02 | – | 0.02 KGS |
| 5. | EDTA | I.P. | 0.040 | – | 0.040 KGS |
| 6. | DI SODIUM HYDROGEN ORTHOPHOSPHATE | I.P. | 0.280 | – | 0.280 KGS |
| 7. | NEOMYCIN SULPHATE | I.P. | 0.500 | 20.000 | 0.600 KGS |