MASTER FORMULA OF Clobetasol and Gentamicin Ointment
PURPOSE: This Master Formula is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.
SCOPE: This MFR is performed and is applied during the manufacturing of dosage form.
RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, 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 Pharmacist
3. Copy No. 2: Manager Quality Control
4. Copy No. 3: Ointment Section
Clobetasol and Gentamicin Ointment
|BATCH SIZE: 200 KG|
|PRODUCT REFERENCE CODE:||UNIT SIZE: 10 g|
|GENERIC NAME: N.A.||PACK SIZE: 36 ´ 12 ´ 10g|
|DOSAGE FORM: OINTMENT||STRENGTH: N.A.|
|DEPARTMENT: OINTMENT DEPARTMENT||EXPIRY DATE: AFTER 18 MONTHS FROM THE DATE OF MANUFACTURING|
|Clobetasol Propionate||I. P.||3% w/w|
|(Added as Gentamicin Sulphate I.P.)|
|Miconazole Nitrate||I. P.||2.00% w/w|
SPECIMEN OF UNIT CARTON:
EQUIPMENTS TO BE USED:
|SR. NO.||NAME OF EQUIPMENT||ASSEMBLING
AS PER SOP NO.
AS PER SOP NO.
|5||Storage Container-I (500 Kg)|
|6||Semiautomatic Aluminium Tube Filling & Crimping Machine|
|S.NO.||INGREDIENTS||STD||Theoretical Quantity Req.||Overages %||Total Quantity Used|
|1.||CETO MACROGOL – 1000||I.P.||6.667 KG||6.667 KG|
|2.||CETOCETYL ALCOHOL||I.P.||20.000 KG||20.000 KG|
|3||CLOBETASOL PROPIONATE||I.P.||100.000 GM||5.00||105.000 GM|
|4.||GENTAMYCIN SULPHATE||I.P.||0.340 KG||30.00||0.442 KG|
|5||LIQUID PARAFFIN LIGHT||I.P.||10.000 KG||10.000 KG|
|6||MICONAZOLE NITRATE||I.P.||4.000 KG||5.00||4.200 KG|
|7||PARA CHLORO METAL CRESOL||I.P||0.200 KG||0.200 KG|
|8||SODIUM METABISULPHITE||I.P.||0.680 KG||0.680 KG|
|9||WHITE PETROLEUM JELLY||I.P.||32.000 KG||32.000 KG|
PACKING MATERIAL: –
|S.NO.||NAME OF THE MATERIAL||THEORETICAL QUANTITY REQ.||FOR
|TOTAL QUANTITY USED|
|1.||ADHESIVE TAPE ROLL||1.000||1.000 NOS|
|2.||CELLO TAPE||2.000||2.000 NOS|
|4.||UNIT CARTON||20000.000||3.000||20003.000 NOS|
|5.||OUTER CARTON 12 X 10 GM||1666.000||2.000||1668.000 NOS|
|6.||ALUMINIUM TUBE – 10 GM||20000.000||20000.000 NOS|
|7||CORRUGATED BOX C – 37||46.000||46.000 NOS|
Average fill of each Tube is 10 grams.
Weight variation limit allowed in each filled Tube is + 200 mg.
Melt the waxes at the maintained temperature 70˚ C.
Use accurate and weighed quantity of water to make up the final weight of cream.
Colloid the cream till uniform particle size is achieved.
The temperature of primary area should not exceed 30˚C.
Theoretical Yield is 20000 Tubes.
Expected Practical Yield is 20000 + 2% Tube.
Transfer the cream from storage tank to Semiautomatic Aluminium Tube Filling & Crimping Machine and start filling and then Crimping of the tubes as per its SOP.
Pack the filled tubes in unit carton.
Pack such 12 tubes in each outer carton.
Seal the outer carton with cello tape.
Pack the 36 outer cartons in specified corrugated box C-37 to give a pack size of 36 x 12 x 10g Tubes.
Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label.
Melt 6.667 kg of Ceto Macrogol- 1000, 20.0 kg of Cetocetyl Alcohol, 10.0 kg of Liquid Paraffin Light and 32 kg White Petroleum Jelly in a Steam Heat Wax Melting Vessel by operating it as per its SOP at temperature 60˚ C.
Heat the 126 kg of water at 65˚ C in Water Vessel by operating it as per SOP.
Filter and transfer the melted base through Stainless Steel Sieve no. 100 to the mixing vessel and start the machine as per its SOP.
Dissolve 0.680 kg of Sodium Metabisulphite in 2 kg of water and add to the bulk.
Slowly add 72 kg of hot water to the Mixing Vessel.
Dissolve 0.200 kg of P.C.M.C. (Para-chloro-meta-cresol) in 2 kg of water it and transfer it to the bulk batch.
Dissolve 4.2 kg of Miconazole Nitrate in 45 kg of water with temperature of 35˚C and gradually and pass it through Colloid Mill to achieve the slurry of uniform particle size by operating it as per its SOP and transfer it to the bulk batch.
Cool the cream to the temperature at 35˚ C while running the water in the jacket of mixing vessel.
Dissolve 0.442 kg of Gentamicin Sulphate in 5 kg of water and add to the bulk batch.
Triturate and dissolve 0.105 kg of Clobetasol Propionate in 2 kg of Liquid Paraffin Light in mortar–pestle and add to the bulk batch.
Mix the whole batch for 1 hour while running the water in the jacket.
Send the sample to Quality Control Department for bulk testing.
After approval from Quality Control Department, transfer the cream to the storage tank.
The following in-process controls should be maintained during the processing:
Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
All weighed Raw materials should be counter-checked by Assistant Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.
Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
The total weight of bulk ointment / cream should be checked in the presence of Assistant Manufacturing Chemist and record the same in Batch Manufacturing Record.
pH of the bulk should be checked and it should be with in specified limits.
Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.
While the tube filling operation is on, the Assistant Manufacturing Chemist should check weight of net filled quantity per tube at the interval of 30 minutes by checking the tare weight of empty tube and gross weight of the filled tube. Record for the same should be kept in Batch Manufacturing Record.
The ‘fill weight’ of ointment or cream per tube should not be less than the labelled amount.
Limit for Weight Variation: Weight claimed on the carton + 200 mg
Manufacturing Chemist will also ensure that the crimping of the filled Aluminium tubes, sealing of plastic tubes is appropriate and embossing of batch number and manufacturing date is conspicuous. Also the quality of embossing will be controlled by adjusting pressure exerted by the jaws, so that pinholes are not developed on the embossed letters / numbers.
The inner and outer cartons should be checked thoroughly for proper batch coding.
Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of inner cartons are being packed in each outer cartons and also the correct number of outer cartons in each shipper is exactly the same as that shown in proof.
Intimation should be sent to Quality Control Department for finished product sampling and testing.
After the completion of filling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Maintain the destruction of the same in the Batch Manufacturing Record.
It will be ensure that filling or packaging equipment has been properly cleaned.
Filling or packaging of next product should be commenced only after getting the ‘Line Clearance’ of the previous product, from the IPQA.