Choline Salicylate Ointment
PURPOSE: This Master formula record (MFR) 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:
Master Copy : Manager Quality Assurance
Copy No. 1 : Production Pharmacist
Copy No. 2 : Manager Quality Control
Copy No. 3 : Ointment Section
| PRODUCT NAME: Choline Salicylate Ointment | BATCH SIZE: 300 KG |
| PRODUCT REFERENCE CODE: | UNIT SIZE: 10 g |
| GENERIC NAME: N.A. | PACK SIZE: 21 ´ 20 ´ 10 g |
| DOSAGE FORM: OINTMENT | STRENGTH: N.A. |
| DEPARTMENT: OINTMENT DEPARTMENT | EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING |
COMPOSITION:
| Choline Salicylate Solution (equivalent to Choline Salicylate) | B. P. | 8.7% w/w |
| Lignocaine Hydrochloride | B. P. | 2.0% w/w |
| Benzalkonium Chloride Solution | B. P. | 0.01% w/w |
EQUIPMENTS TO BE USED:
| SR. NO. | NAME OF EQUIPMENT | ASSEMBLING AS PER SOP NO. | CLEANING AS PER SOP NO. |
| 1 | Wax Vessel | ||
| 2 | Water Vessel | ||
| 3 | Mixing Vessel | ||
| 4 | Storage Container-I (500 Kg) | ||
| 5 | Semiautomatic Aluminium Tube Filling & Crimping Machine |
RAW MATERIALS:-
| S.NO. | INGREDIENTS | STD | Theoretical Quantity Req. | Overages % | Total Quantity Used |
| 1 | ASPARTUM | B.P. | 0.060 | 0.060 KGS | |
| 2 | ASPARTUM (P) | B.P. | 0.450 | 0.450 KGS | |
| 3 | BENZALKONIUM CHLORIDE SOLUTION | B.P. | 0.030 | 0.030 LTRS | |
| 4 | CARBOPOL – 934 | I.H | 5.400 | 5.400 KGS | |
| 5 | CHOLINE SALICYLATE SOLUTION | B.P. | 52.200 | 5.06 | 54.841 KGS |
| 6 | EDTA | B.P. | 0.300 | 0.300 KGS | |
| 7 | GLYCERINE | B.P. | 40.000 | 40.000 KGS | |
| 8 | LIGNOCAINE HYDROCHLORIDE | B.P. | 6.000 | 10.00 | 6.600 KGS |
| 9 | METHYL PARABEN SODIUM | B.P. | 0.300 | 0.300 KGS | |
| 10 | PROPY PARABEN SODIUM | B.P. | 0.075 | 0.075 KGS | |
| 11 | PIPPERMENT OIL | B.P. | 0.600 | 0.600 LTR | |
| 12 | P.G. | B.P. | 16.500 | 16.500 KGS | |
| 13 | SPIRIT CHLOROFORM | B.P. | 27.000 | 27.000 BTLS | |
| 14 | TRIETHANOLAMINE | B.P. | 4.800 | 4.800 KGS |
PACKING MATERIALS: –
| S.NO. | NAME OF THE MATERIAL | THEORETICAL QUANTITY REQ. | FOR RECORD | TOTAL QUANTITY USED |
| 1 | ADHESIVE TAPE ROLL BROWN | 300.000 | 300.000 NOS | |
| 2 | CELLO TAPE | 2.000.000 | 2.000 NOS | |
| 3 | ALUMINIUM TUBE | 30000.000 | 30000 NOS | |
| 4 | UNIT CARTON | 30000.000 | 3.00 | 3003.000 NOS |
| 5 | OUTER CARTON | 2500.000 | 2.00 | 2502.000 NOS |
| 6 | CORRUGATED BOXES | 70.000 | 70.000 NOS |
MANUFACTURING SPECIFICATION:
Average fill of each Tube is 10 grams.
Weight variation limit allowed in each filled Tube is + 200 mg.
Use accurate weight quantity of water to make up the final weight of the cream.
The temperature of primary area should not exceed 30˚C.
Yield:
Theoretical Yield is 30000 Tubes.
Expected Practical Yield is 30000 + 2% Tubes.
Packing Details:
Transfer the Ointment from storage tank to 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 20 tubes in each outer carton.
Seal the outer carton with cello tape.
Pack the 21 outer cartons in specified corrugated box to give a pack size of 21 x 20 x 10g tubes.
Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label.
MANUFACTURING PROCESS:
PREPARATION OF GEL:
Add 135 kg of water, to water vessel and operate it as per its SOP.
Under constant stirring add 0.300 kg of Methyl Paraben Sodium, 0.075 kg of Propyl Paraben Sodium, 0.300 kg of E.D.T.A. and 5.4 kg of Carbopol- 934 to the same water vessel and allow the stirring.
Add and mix constantly 4.80kg of Triethanolamine to the same water vessel to get a transparent gel having pH between 5.3 to 5.6.
Add 30 kg of Glycerin to the same water vessel.
Transfer the gel to mixing vessel and stir it as per its SOP.
Add 54.841kg of Choline Salicylate solution to the mixing vessel and check the pH.
Now perform the Following:
Dissolve 6.6 kg of Lignocaine Hydrochloride in 30 kg of water in Stainless Steel Containers.
Add 16.5 kg of Propylene Glycol and 12.15 liters of Spirit Chloroform i.e. 27 bottles to the Lignocaine HCl
Check the pH. It must be between 5.3 to 5.6.
Shift the solution prepared in step no. 6 to the mixing vessel.
Dissolve 0.060 kg of Aspartum in 1 kg of water and add to the bulk batch.
Dissolve 0.450 kg of Aspartum (P) in 4 kg of hot water and add to the bulk batch.
Add 0.060litres Peppermint Oil to the bulk batch.
Add 0.030 liters of Benzalkonium Chloride Solution to 1.0 kg of water and add to the bulk batch.
Mix for 60 minutes till uniform gel is achieved.
Send the sample to Quality Control Department for bulk testing.
After approval from Quality Control Department, transfer the gel to the storage tank.
IN-PROCESS CONTROLS:
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 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 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 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.
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