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: Erythromycin Ointment||BATCH SIZE: 300 KG|
|PRODUCT REFERENCE CODE:||UNIT SIZE: 20 g|
|GENERIC NAME: N.A.||PACK SIZE: 24 ´ 12 ´ 20g|
|DOSAGE FORM: OINTMENT||STRENGTH: N.A.|
|DEPARTMENT: OINTMENT DEPARTMENT||EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING|
|Erythromycin||I. P.||3% w/w|
EQUIPMENTS TO BE USED:
|SR. NO.||NAME OF EQUIPMENT||CLEANING
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||ERYTHROCIN COLOUR||1.500||1.500 GM|
|2||ERYTHROMYCIN BASE||I.P.||9.000||5.00||9.450 KG|
|3||GULAB OINTMENT FLAVOUR||2.000||2.000 LTR|
|4||PEG – 4000||I.P.||93.999||93.999 KG|
|5||PEG – 400||I.P.||189.999||189.999 KG|
|S.NO.||NAME OF THE MATERIAL||THEORETICAL QUANTITY REQ.||FOR
|TOTAL QUANTITY USED|
|1||ADHERE TAPE ROLL BROWN||2.000||2.000 NOS|
|2||CELLO TAPE||2.000||2.000 NOS|
|3||CORRUGATED BOXES T – 10||52.000||52.000 NOS|
|4||ALUMINIUM TUBES||15000.000||15000.000 NOS|
|5||UNIT CARTON||15000.00||3.00||15003.000 NOS|
|6||OUTER CARTON||1250.000||2.00||1252.000 NOS|
Average fill of each Tube is 20 grams.
Weight variation limit allowed in each filled Tube is + 200 mg.
Melt the waxes at the maintained temperature 70˚ C.
The temperature of primary area should not exceed 30˚C.
Theoretical Yield is 15000 Tubes.
Expected Practical Yield is 15000 + 2% Tubes.
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 12 tubes in each outer carton.
Seal the outer carton with cello tape.
Pack the 24 outer cartons in specified corrugated box to give a pack size of 24 x 12 x 20g tubes.
Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label
Melt 93.990 kg of PEG- 4000 and 150.000kgs of PEG-400 in a Steam Heat Wax Melting Vessel by operating it as per its SOP. at temperature 70˚
Filter and transfer the melted waxes through Stainless Steel Sieve no. 100 to the mixing vessel and start the machine as per its SOP.
Transfer half the quantity to the mixing vessel.
Cool second half of PEG-400 TO 40 C and mix 9.450 kg of Erythromycin Base gradually and pass it through Colloidal Mill to achieve the slurry of uniform particle size by operating it as per its SOP and transfer it to the bulk batch.
Mix 5.000 kg of Propylene Glycol (P.G.), 1.5 g of Erythrocin Colour and 2.000 liters of Gulab Ointment flavour together and shift it to the mixing vessel.
Mix for 2.5 hours and cool it to room temperature while running the water in the jacket of mixing vessel.
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 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.