MASTER FORMULA OF AMPICILLIN DRY SYRUP
PURPOSE: This Master 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 , 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 : β – Lactam Dry Syrup
| PRODUCT NAME: AMPICILLIN DRY SYRUP | BATCH SIZE: 200 KGS |
| PRODUCT REFERENCE CODE: | UNIT SIZE: 40 GMS |
| GENERIC NAME: AMPICILLIN ORAL SUSPENSION | PACK SIZE: 96 ´ 100 ML |
| DOSAGE FORM: DRY SYRUP | STRENGTH: N.A. |
| DEPARTMENT: β – LACTAM DEPARTMENT | EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING |
COMPOSITION:
Each 5 ml of prepared suspension contains:
Ampicillin Trihydrate B.P.
Equivalent to Ampicillin 125 mg
SPECIMEN OF LABEL:
EQUIPMENTS TO BE USED:
| SR. NO. | NAME OF EQUIPMENT | ASSEMBLING
AS PER SOP NO. |
CLEANING
AS PER SOP NO. |
| 1 | Sifter | ||
| 2 | Double Cone Blender (200 kgs) | ||
| 3 | Air Jet Bottle Cleaning Machine | ||
| 4 | Automatic Double Head Dry Powder Filling & Single Head Screw Capping Machine | ||
| 5 | Automatic Bottle Labelling Machine | ||
| 6 | Shrink Packing Machine |
RAW MATERIALS:
| S.NO. | INGREDIENTS | STD | Theoretical Quantity Req. | Overages % | Total
Quantity Used |
| 1 | AEROSIL | B.P. | 1.250 | 1.250 KGS | |
| 2 | AMPICILLIN TRIHYDRATE | B.P. | 14.380 | 5.00 | 15.100 KGS |
| 3 | CMC SODIUM | B.P. | 3.130 | 3.130 KGS | |
| 4 | CARMOISINE COLOUR | F.C.F. | 13.350 | 13.350 GMS | |
| 5 | METHYL PARABEN SODIUM | B.P. | 0.500 | 0.500 KGS | |
| 6 | PROPYL PARABEN SODIUM | B.P. | 0.127 | 0.127 KGS | |
| 7 | PHARMA GRADE SUGAR | B.P. | 175.670 | 175.670 KGS | |
| 8 | SODIUM BENZOATE | B.P. | 2.500 | 2.500 KGS | |
| 9 | SUNSET YELLOW SUPRA | F.C.F. | 26.670 | 26.670 GMS | |
| 10 | VANILLA DRY POWDER | F.G. | 2.500 | 2.500 KGS |
PACKING MATERIALS:
| S.NO. | NAME OF THE MATERIAL | THEORETICAL QUANTITY REQ. | FOR
RECORD |
TOTAL QUANTITY USED |
| 1. | 130 ML AMBER RING BOTTLES | 3000.000 | 3000.000 NOS | |
| 2 | ADHESIVE TAPE ROLL BROWN | 2.000 | 2.000 NOS | |
| 3 | LABEL (AMPICILLIN – 100 ML) | 3000.000 | 3.000 | 3000.000 NOS |
| 4 | UNIT CARTONS
(AMPICILLIN – 100 ML) |
3000.000 | 2.000 | 3002.000 NOS |
| 5 | GUM ACCACIA | 0.300 | 0.300 KGS | |
| 6 | CORRUGATED BOX T-10 | 31.200 | 31.200 NOS | |
| 7 | PILFER PROOF CAPS – 25 MM | 3000.000 | 3000.000 NOS | |
| 8 | SHRINK FILM 240 X 220 MM | 500.400 | 500.400 NOS |
MANUFACTURING SPECIFICATION:
1. Moisture content of powder should be less than 2.0 %.
2.Use Amber glass bottle of 130 ml capacity with mark at 100 ml.
3.Fill 40 g of powder in each bottle within range of 200 mg.
4.Mix the batch, fill and seal the bottles at temperature not more than 250 C and Relative Humidity not more than 40.
5.Yield:
·Theoretical Yield is 5000 bottles.
· Expected Practical Yield is 5000 + 2% bottles.
Packing Details:
1.Label the filled and sealed bottles using Automatic Labelling Machine as per its SOP and pack the bottles in unit carton individually.
2.Make a group of 8 bottles packed in unit cartons.
3. Wrap this bundle in the thermoplastic film and shrink pack it by operating Shrink Machine as per its SOP.
4.Pack such 12 shrinked packets in the Corrugated box T-10. Thus each corrugated box contains 12 ´ 8 filled and sealed bottles.
5.Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label.
MANUFACTURING PROCESS:
1.Fit the 30 No. Stainless Steel Sieve on the Sifter as per its SOP and place Stainless Steel Container below the discharge hopper.
2. Sift the 15.100 Kgs of Ampicillin Trihydrate through 30 No. Stainless Steel Sieve on the sifter and let it to collect in the container kept below the discharge hopper.
3.Sift the 1.000 Kgs of Aerosil through 30 No. Stainless Steel Sieve on the sifter and collect in the same container.
4.Sift the 3.130 Kgs of Sodium Carboxy Methyl Cellulose through 30 No. Stainless Steel Sieve on the sifter and collect in the same container.
5.Sift the 0.500 Kgs of Methyl Paraben Sodium through 30 No. Stainless Steel Sieve on the sifter and collect in the same container.
6.Sift the 0.127 kgs of Propyl Paraben Sodium through 30 No. Stainless Steel Sieve on the sifter and collect in the same container.
7.Sift the 2.500 Kgs of Sodium Benzoate through 30 No. Stainless Steel Sieve on the sifter and collect in the same container.
8.Mix the Sunset Yellow Colour 26.670 Gm and 0.0081 kg of Carmoisine with 13.350 Kg of Aerosil and sift through 30 No. Stainless Steel Sieve on the sifter and collect in the same container.
9.Sift the 2.500 Kgs of Vanilla Dry Powder through 30 No. Stainless Steel Sieve on the sifter and collect in the same container.
10. Sift the 175.670 Kgs of Pharma grade Sugar through 30 No. Stainless Steel Sieve on the sifter and collect in the separate container.
11.Transfer the above sifted ingredients to Double Cone Blender and mix it for 1 hour as per its SOP.
12. Send the sample to Quality Control Department for bulk testing.
13. After receiving the Bulk Test Report from Q.C. Dept. start filling and sealing 40g of powder in clean, amber bottles by using Automatic Double Head Dry Powder Filling And Single Head Screw Capping Machine as per its SOP.
14.Label the filled bottles by using Automatic Bottle Labelling Machine as per its SOP.
IN-PROCESS CONTROLS:
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 Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production 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+2oC
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 + 200mg
9.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.
10.The labels and cartons 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 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.
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’.