MASTER FORMULA OF DERMIFRESH POWDER (SANDAL EFFECT)
PURPOSE: This Mater Formula 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:
1. Master Copy: Manager Quality Assurance
2. Copy No. 1: Production Pharmacist
3. Copy No. 2: Manager Quality Control
4. Copy No. 3: Dry Powder Preparation Section
|PRODUCT NAME:DERMIFRESH POWDER||BATCH SIZE: 750 KGS|
|PRODUCT REFERENCE CODE:||UNIT SIZE: 150 GMS|
|GENERIC NAME: N.A.||PACK SIZE: 6 X 12 X 150 gm|
|DOSAGE FORM: DRY POWDER||STRENGTH: N.A.|
|DEPARTMENT: DRY POWDER DEPARTMENT||EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING|
Chorphenesin I.P. ’85 1% w/w
Zinc Oxide I.P. 16% w/w
Starch I.P. 51% w/w
Talc Purified I.P. q.s.
SPECIMEN OF LABEL:
EQUIPMENTS TO BE USED:
NAME OF EQUIPMENT
AS PER SOP NO.
AS PER SOP NO.
|2||Double Cone Mixer (200 kgs)|
|S.NO.||INGREDIENTS||STD||Theoretical Quantity Req.||Overages %||Total
|2.||MYSORE SANDAL||F.G||8.750||8.750 KGS|
|3||STARCH (POWDER)||I.P.||431.750||431.750 KGS|
|4||TALCUM PURIFIED||I.P.||232.500||232.500 KGS|
|5||ZINC OXIDE||I.P.||120.000||120.000 KGS|
|S.NO.||NAME OF THE MATERIAL||THEORETICAL QUANTITY REQ.||FOR
|TOTAL QUANTITY USED|
|1.||150 GMS PL. BTLS DERMINIL POWDER||5000.000||5000.000 NOS|
|2||ADH. TAPE ROLL BROWN||5.000||5.000 NOS|
|3||CAPS PL. BTL. DERMINIL POWDER||5000.000||5000.000 NOS|
|4||CORRUGATED BOX D-42A||69.445||69.445 NOS|
|5||CORRUGATED BOX D-42A S (4 X 3 JALLY)||416.670||416.670 NOS|
|6||SIFTER PL. BTL. DERMINIL POWDER||5000.000||5000.000 NOS|
|7||STICKER DERMINIL (SANDAL EFFECT)||5070.000||3.000||5073.000 NOS|
|8||SHRINK FILM 240 X 220 MM||1667.000||1667.000 NOS|
1. Moisture content of powder should be less than 2.0 %.
2. Use Plastic bottle of 150 Gms capacity.
3. Fill 150 gms of powder in each bottle within range of + 2 g.
4. Mix the batch, fill and seal the bottles at temperature not more than 250 C and Relative Humidity not more than 40.
Theoretical Yield is 5000 bottles.
Expected Practical Yield is 5000 + 2% bottles.
1. Label the filled and sealed bottles manually
2. Make a group of 3 bottles wrap this bundle in the thermoplastic film and shrink pack it by operating Shrink Machine as per its SOP No. – SOP/EL/005/MO/II.
3. Pack such 4 shrinked packets in the Corrugated box D-42A S (4 X 3 JALLY). Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label. Thus each corrugated box contains 4 x 3 filled and sealed bottles.
4. Pack such 6 Corrugated box D-42A S (4 X 3 JALLY) in the Corrugated box D-42A. Thus each corrugated box contains 6 X 4 X 3 filled and sealed bottles.
5. Seal the each corrugated box D- 42A S (4 X 3 JALLY) with adhesive tape and label it properly by affixing the specified label.
The process is carried out in 5 lots of 150 kgs each. Manufacturing Process for one lot is as follows:
1. Dry the Starch in the FBD machine as per SOP No. – SOP/TB/008/MO/II.
2. Fit the 80 No. Stainless Steel Sieve on the Sifter as per its SOP No- SOP/BL/001/MO/II and place Stainless Steel Container below the discharge hopper.
3. Sift the Chlorphenesin 1.500 kg through 80 No. Stainless Steel Sieve on the sifter and let it to collect in the container kept below the discharge hopper.
4. Mix the Mysore Sandal 1.750 kgs in 10 kgs of Starch and keep aside for air-drying. Sift the dried mixture through 80 No. Stainless Steel Sieve on the sifter and collect in the same container.
5. Sift the balance Starch through 80 No. Stainless Steel Sieve on the sifter and collect in the same container.
6. Sift the Zinc Oxide 24.0 Kg through 80 No. Stainless Steel Sieve on the sifter and collect in the same container.
7. Sift the Talc Purified 46.5 kg through 80 No. Stainless Steel Sieve on the sifter and collect in the same container.
8. Transfer the above-sifted ingredients to Double Cone Blender and mix it for 1 hour as per its SOP/DP/002/MO/II.
9. And the process is carried out in same manner for the other lots.
10. Send the sample to Quality Control Department for bulk testing.
11. After approval of the bulk start filling and sealing 150 Gms of powder in clean, Plastic Bottles by using Machine as per its SOP/DP/003/MO/II.
12. Label the filled bottles manually.
The following in-process controls should be maintained during the processing:
1. Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
2. 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.
3. Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
4. Humidity and temperature should be maintained during the manufacturing, filling and sealing.
Relative Humidity – 35+5 %
Temperature – 25+2 oC
5. The total weight of blended powder should be checked in the presence of Assistant Manufacturing Chemist and record the same in Batch Manufacturing Record.
6. Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.
7. Intermittently the Assistant Manufacturing Chemist should check weight of filled powder at the interval of 30 minutes and record for the same should be kept in Batch Manufacturing Record.
8. The net weight should be checked for both the filling nozzles and in no case, net weight should be less than weight claimed on the label
Limit for Weight Variation: Weight claimed on the label + 3 g
9. Visual inspection of filled and sealed bottles should be done and the record of the same should be kept in the Batch Manufacturing Record.
10. The labels should be checked thoroughly for proper batch coding.
11. Intimation should be sent to Quality Control Department for finished product sampling and testing.
12. 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.
13. It will be ensure that filling or packaging equipment has been properly cleaned.
14. Filling or packaging of next product should not commence until the IPQA has given the ‘Line Clearance’