Betamethasone Neomycin EYE /EAR DROPS

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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:

  1. Master Copy : Manager Quality Assurance
  2. Copy No. 1 : Production Manager
  3. Copy No. 2 : Manager Quality Control
  4. 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