PURPOSE: This Mater 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, 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 : External Preparation Section
|PRODUCT NAME: POVIDONE-IODINE SOLUTION||BATCH SIZE: 1000 LTRS.|
|PRODUCT REFERENCE CODE:||UNIT SIZE: 100ml|
|GENERIC NAME: POVIDONE-IODINE SOLUTION U.S.P.||PACK SIZE: 72 x 100 ML|
|DOSAGE FORM: SEMI LIQUID||STRENGTH: N.A.|
|DEPARTMENT: LIQUID DEPARTMENT||EXPIRY DATE: AFTER 36 MONTHS FROM THE DATE OF MANUFACTURING|
Povidone – Iodine U.S.P. 5% w/v
(Available Iodine 0.5 % w/v)
EQUIPMENTS TO BE USED:
|SR. NO.||NAME OF EQUIPMENT||ASSEMBLING
AS PER SOP NO.
AS PER SOP NO.
|2||Storage Tank – III|
|3||Manual Bottle Filling Machine|
|4||Semi Auto Bottle Sealing Machine|
|5||Semi Auto Labelling Machine|
|6||Shrink Packing Machine|
|S.NO.||INGREDIENTS||STD||Theoretical Quantity Req.||Overages %||Total Quantity Used|
|1.||BENZYL ALCOHOL||U.S.P.||20.0000||20.000 KGS|
|2||POVIDON IODINE||U.S.P.||50.000||10.00||55.000 KGS|
|S.NO.||NAME OF THE MATERIAL||THEORETICAL QUANTITY REQ.||FOR
|TOTAL QUANTITY USED|
|1||100 ML AMBER RD. BOTLS||10000.000||10000.000 NOS|
|2||ADHESIVE TAPE ROLL BROWN||4.000||4.000 NOS|
|3||CORRUGARED BOX E-24||152.000||152.000 NOS|
|4||GUM ACCACIA||1.100||1.100 KGS|
|5||P.P CAPS 25 MM||10000.000||10000.000 NOS|
|8||SHRINK FILM 240 X 220 MM||1667.000||1670.000|
|9||HANDLE WITH CARE STICKER||138.000||145.000|
Average fill of each Bottle is 100 ml.
Volume variation limit allowed in each filled Bottle is 100 ml to 102 ml.
Make up the final volume of the solution accurately.
Transfer the solution from charging tank to storage tank 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 100 ml of solution in 100ml Amber colored 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 manually.
Pack such 72 labeled bottles in a specified Corrugated box .
Seal each corrugated box with adhesive tape on both side
To the charging tank add 55.0 kgs of Povidone Iodine.
Add 300 Ltrs of Purified water to it and let it to wet for overnight.
Add 20.0 kgs of Benzyl Alcohol to it.
And stir well for 90 minutes.
Transfer this to the Storage tank .
Send the sample to Quality Control Department for bulk testing.
The following in-process controls should be maintained during the processing:
Check Raw materials used for manufacturing purpose are all approved 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.
Final volume should be made as per Standard Operating Procedure using correct dipstick in the 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 + 2ml
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.
Suspensions should be filled under constant slow speed stirring to maintain uniformity of contents.
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 labeling 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’.