PURPOSE: This Master formula Records (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, QA Manager, QC 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: External Preparation Section
|PRODUCT NAME:||BATCH SIZE: 200 KGS|
|PRODUCT REFERENCE CODE:||UNIT SIZE: 20g / 18 ml|
|GENERIC NAME: N.A.||PACK SIZE: 160 x 20 gm / 18 ml|
|DOSAGE FORM: solution||STRENGTH: N.A.|
|DEPARTMENT: EXTERNAL LIQUID DEPARTMENT||EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING|
Iodine B.P. 1 g
Potassium Iodide B.P. 2 g
Tannic Acid B.P. 1.5 g
Menthol B.P. 0.25% w/v
Camphor B.P. 0.20% w/v
Thymol B.P. 0.25% w/v
Glycerin B.P. 70% w/v
Purified Water 100 g
EQUIPMENTS TO BE USED:
|SR. NO.||NAME OF EQUIPMENT||ASSEMBLING|
AS PER SOP NO.
AS PER SOP NO.
|1||Charging Tank E-02 (1200 Lts)|
|3||Manual Bottle Filling Machine|
|4||Semi Automatic Bottle Sealing Machine|
|5||Semi Automatic Bottle Labelling Machine|
|6||Shrink Packing machine|
|S.NO.||INGREDIENTS||STD||Theoretical Quantity Req.||Overages %||Total Quantity Used|
|5||POTASSIUM IODIDE||B.P.||4.000||10||4.400 Kgs|
|6||SPIRIT CHLOROFORM||B.P.||45.000||45.000 Lts|
|7||TANNIC ACID||B.P.||3.000||10||3.300 Kgs|
|Sr.No.||NAME OF THE MATERIAL||THEORETICAL QUANTITY REQ.||FOR |
|TOTAL QUANTITY USED|
|1.||20 ML AMBER ROUND BTLS||10000.000||10000.000 Nos.|
|2.||ADH. TAPE ROLL BROWN||2.000||2.000 Nos.|
|3.||GUM ACCACIA||1.000||1.000 Nos.|
|4.||C. BOX||62.500||62.500 Nos.|
|5.||PL. INNER PLUG (DRY SYRUP)||10000.000||10000.000 Nos.|
|6.||P.P. CAPS 25 MM (RUBBER)||10000.000||10000.000 Nos.|
|7.||SHRINK FILM 220 X 220 MM||500.000||500.000 Nos.|
TOOTH HEAL 18 ML
|9.||LABELS TOOTH HEAL 18 ML||10062.500||3.000||10065.500 Nos.|
Average fill of each Bottle is 18 ml.
Volume variation limit allowed in each filled Bottle is 18 ml to 19 ml.
Make up the final volume of the solution accurately.
Transfer the solution from charging tank E – 02 to storage tank E-03 after complete charging of batch.
Theoretical Yield is 10000 Bottles.
Expected Practical Yield is 10000 + 2% Bottles.
Wash the bottles manually.
Transfer the lotion from charging tank to manual bottle filling machine E-04 for filling of the bottle as per its SOP
Fill 18 ml of solution in 20ml Amber coloured glass bottles.
Sealing of filled bottle is done on semi-automatic bottle sealing machine E-05 as per its SOP
Label each filled and sealed bottle by Labelling machine as per its SOP
Make a group of 20 bottles packed in unit cartons.
Wrap this film in thermoplastic film and shrink pack it by operating shrink packing machine E-06 as per its SOP
Pack such 8 shrinked packets in the Corrugated box K-25. Thus each corrugated box contains 8 X 20 X 20 gm/18 ml filled and sealed bottles.
Seal each corrugated box with adhesive tape on both side and label it properly by affixing the specified label.
To 140 kg of Glycerin in Charging Tank Start stirring.
Dissolve 4.40 kg of Potassium Iodide in 25 Ltrs of Purified water and add 2.2 kg of Iodine to it. And let it. Mix well. Add this to the above tank.
Dissolve 3.30 kg of Tannic Acid in 25 ltrs of Purified water and to the bulk batch.
Dissolve 0.500 kg of Camphor, 0.600 kg of Thymol, 0.600 kg of Menthol in45 ltrs of Spirit Chloroform.
And stir well for 30 minutes.
Send the sample to Quality Control Department for bulk testing.
Transfer this to the Storage tank E-03 for filling.
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.
Final volume should be made as per Standard Operating Procedure using correct dipstick in the Assistant Manufacturing Chemist.
pH of the bulk should be checked and it should be with in specified limits.
Only after receiving the Bulk Test Report from Q.C. Dept. start filling and sealing stage.
The Manufacturing Chemist should check intermittently filled volume at 30 minutes interval and record for the same should be kept in Batch Manufacturing Record.
The net volume should be checked for all the filling nozzles and in no case, net volume should be less than volume claimed on the label.
Limit for Volume Variation: Volume claimed on the label + 1.0 ml
Visual inspection of filled and sealed bottles should be done as per SOP and the record of the same should be kept in the Batch Manufacturing Record.
The labels and cartons should be checked thoroughly for proper batch coding.
Intimation should be sent to Quality Control Department for finished product sampling and testing.
After the completion of labelling and packaging, the coded labels and 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 not commence until the IPQA has given the ‘Line Clearance.