MFR OF DICLOFENAC GEL 25GM
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 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: DICLOFENAC GEL 25GM | BATCH SIZE: 300 KG |
| PRODUCT REFERENCE CODE: | UNIT SIZE: 25 g |
| GENERIC NAME: N.A. | PACK SIZE: 30X12X25GM |
| DOSAGE FORM: OINTMENT | STRENGTH: N.A. |
| DEPARTMENT: OINTMENT DEPARTMENT | EXPIRY DATE: AFTER 36 MONTHS FROM THE DATE OF MANUFACTURING |
COMPOSITION:
| Diclofenac Diethyl Ammomium equivalent to Diclofenac Sodium | B. P. | 1.16%w/w
1.00%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 MATERILAS: –
| S.NO. | INGREDIENTS | STD | Theoretical Quantity Req. | Overages % | Total Quantity Used |
| 1 | CARBOPOL–934 | I.H | 3.600kgs | 3.600 KGS | |
| 2 | DICLOFENAC DIETHYL AMMO. | B.P. | 3.480 | 5.0 | 3.654 KGS |
| 3 | EDTA | B.P. | 0.300 | 0.300 KGS | |
| 4 | ISO PROPYL ALCOHOL | B.P. | 30.000 | 30.000 KGS | |
| 5 | M.P.B.S. | U.S.P. | 0.300 | 0.300 KGS | |
| 6 | P.P.B.S. | U.S.P. | 0.074 | 0.074 KGS | |
| 7 | PEG-400 | U.S.P | 15.000 | 15.000 KGS | |
| 8 | S.M.B.S. | B.P. | 0.600 | 0.600 KGS | |
| 9 | TRIETHANOLAMINE | B.P. | 6.400 | 6.400 KGS |
PACKING MATERIALS: –
| S.NO. | NAME OF THE MATERIAL | THEORETICAL QUANTITY REQ. | FOR
RECORD |
TOTAL QUANTITY USED |
| 1 | ADHESIVE TAPE ROLL | 2.000 | 2.000 NOS | |
| 2 | CELLO TAPE (PLAIN) | 4.000 | 4.000 NOS | |
| 3 | ALUMINIUM TUBE | 12000.000 | 12000.00 NOS | |
| 4 | UNIT CARTON | 12000.000 | 3.000 | 12003.000 NOS |
| 5 | OUTER CARTON | 1000.000 | 2.000 | 1002.000 NOS |
| 6 | CORRUGATED BOXES | 34.000 | 34.000 NOS |
MANUFACTURING SPECIFICATIONS:
- Average fill of each Tube is 25 grams.
- Weight variation limit allowed in each filled Tube is + 200 mgs.
- Melt the waxes at the maintained temperature 700
- Use accurate weighed quantity of the water to make up the final weight of cream.
- The temperature of primary area should not be more than 30˚C.
Yield:
- Theoretical Yield is 16666 Tubes.
- Expected Practical Yield is 16666+2% Tube.
Packing Details:
- 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 30 outer cartons in specified corrugated box to give a pack size of 30 x 12 x 25g tubes.
- Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.
MANUFACTURING PROCESS:
- PREPARATION OF GEL:
- Add 240 kg of water, to water vessel and operate it as per its SOP.
- Under constant stirring add 0.300 kg of Methyl Paraben Sodium, 0.074kg of Propyl Paraben Sodium, 0.300 kg of E.D.T.A. and 3.600 kg of Carbopol- 934,0.600KG S.M.B.S to the same water vessel and allow the stirring to achieve uniform smooth gel.
- Add and mix constantly 11.627kg of Triethanolamine to the same water vessel to get a transparent gel having pH between 5.3 to 5.6.
- Transfer the gel to mixing vessel and stir it as per its SOP to the mixing vessel and check the pH.
- Now perform the Following:
- Dissolve 3.654 kg of Diclofenac Diethylamine in I.P.A in Stainless Steel Containers.
- Check the pH. It must be between 5.3 to 5.6.
- Shift the solution to the mixing vessel.
- Add 15.00kg of PEG–400 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 Assistant Manufacturing Chemist and record the same in Batch Manufacturing Record.
- pH of the bulk should be checked and it should be within 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.