Ginseng Powder 200 mg
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 Assistant 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 : Non-β Lactam Capsule Section
| PRODUCT NAME:Vitamin with Ginseng 200 mg Capsules | BATCH SIZE: 1.0 LAC |
| PRODUCT REFERENCE CODE: NA | UNIT SIZE: 5 X 10 |
| GENERIC NAME: N.A. | PACK SIZE: 80 ´ 5 ´ 10 |
| DOSAGE FORM: CAPSULE | STRENGTH: N.A. |
| DEPARTMENT: NON β-LACTAM DEPARTMENT | EXPIRY DATE: AFTER 12 MONTHS FROM THE DATE OF MANUFACTURING |
COMPOSITION:
Each Capsule contains:
Ginseng Powder J.P. 200 mg Vitamin C I.P. 50 mg
Vitamin A (as Acetate) 2500 I.U. Vitamin E I.P. 10 mg
Cholecalciferol I.P. 200 I.U. (as Alpha Tocopheryl Acetate)
Thiamine Mononitrate I.P. 2 mg Dibasic Calcium Phosphate I.P. 25 mg
Riboflavin I.P. 2 mg Dried Ferrous Sulphate I.P. 30 mg
Niacinamide I.P. 25 mg Magnesium Oxide Light I.P. 10 mg
Pyridoxine HCl I.P. 1.5 mg Manganese Sulphate I.P. 2 mg
Calcium Pantothenate I.P. 5 mg Copper Sulphate I.P. 1 mg
Folic Acid I.P. 0.1 mg Zinc Sulphate I.P. 1 mg
Vitamin B12 I.P. 1 mcg
EQUIPMENTS TO BE USED:
| SR. NO. | NAME OF EQUIPMENT | ASSEMBLING AS PER SOP NO. | CLEANING AS PER SOP NO. |
| 1 | Tray Drier Machine | ||
| 2 | Sifter | ||
| 3 | Roto Cube Blender | ||
| 4 | Automatic Capsule Loading Machine | ||
| 5 | Semiautomatic Capsule Filling Machine | ||
| 6 | Feeder, Sorter & Capsule Polishing Machine With A.D.U. | ||
| 7 | Triple Track Blister Packing Machine |
RAW MATERIALS:
| S.NO. | INGREDIENTS | STD | Theoretical Quantity Req. | Overages % | Total Quantity Used |
| 1 | AEROSIL | B.P. | 0.100 | 0.100 KGS | |
| 2 | COPPER SULPHATE | I.P. | 0.100 | 20.00 | 0.120 KGS |
| 3 | DI CALCIUM PHOSPHATE | I.P. | 2.500 | 10.00 | 2.750 KGS |
| 4 | CALCIUM PANTOTHENATE | I.P. | 0.500 | 10.00 | 0.550 KGS |
| 5 | DRIED FERROUS SULPHATE | I.P. | 3.000 | 10.00 | 3.300 KGS |
| 6 | EDTA | I.P. | 0.100 | 0.100 KGS | |
| 7 | E.C. Black\Black (Size:0) BLACK / BLACK (0) | – | 100000.000 | 100000.000 KGS | |
| 8 | FOLIC ACID | I.P. | 0.010 | 50.00 | 0.015 KGS |
| 9 | GINSING POWDER | J.P. | 20.000 | 20.000 KGS | |
| 10 | MAGANESE SULPHATE | I.P. | 0.200 | 20.00 | 0.240 KGS |
| 11 | MAGNESIUM OXIDE LIGHT | I.P. | 1.000 | 5.00 | 1.050 KGS |
| 12 | NIACINAMIDE | I.P. | 2.500 | 10.00 | 2.750 KGS |
| 13 | SODIUM BENZOATE | I.P. | 0.170 | 0.170 KGS | |
| 14 | S.M.B.S | I.P | 0.100 | 0.100 KGS | |
| 15 | SPIRIT CHLOROFORM | I.P. | 0.450 ML | 0.450 ML | |
| 16 | STARCH | I.P. | 5.000 | 5.000 KGS | |
| 17 | VITAMIN A – ACETATE POW. | – | 0.500 | 15.00 | 0.575 KGS |
| 18 | VITAMIN – B2 (PLAIN) | I.P. | 0.200 | 20.00 | 0.240 KGS |
| 19 | VITAMIN – B1 (MONO NITRATE) | I.P. | 0.200 | 20.00 | 0.240 KGS |
| 20 | VITAMIN – B6 HCl | I.P. | 0.150 | 20.00 | 0.180 KGS |
| 21 | VITAMIN – C (COATED0 | I.P. | 5.000 | 10.00 | 5.500 KGS |
| 22 | VITAMIN – D3 | I.P. | 0.500 | 50.00 | 0.750 GMS |
| 23 | VITAMIN – B12 | I.P. | 0.100 | 100.00 | 0.200 GMS |
| 24 | VITAMIN – E (COATED – 50%) | I.P. | 1.000 | 140.00 | 2.400 KGS |
| 25 | ZINC SULPHATE | I.P. | 0.100 | 20.00 | 0.120 KGS |
Packing materials:
| S.NO. | NAME OF THE MATERIAL | THEORETICAL QUANTITY REQ. | FOR RECORD | TOTAL QUANTITY USED |
| 1 | 225 MM CLEAR PVC | 50.000 | 50.000 KGS | |
| 2 | ADHESIVE TAPE ROLL BROWN | 1.000 | 1.000 NOS | |
| 3 | CELLO TAPE | 4.000 | 4.000 NOS | |
| 4 | CORRUGATED BOX K -13 | 25.000 | 25.000 NOS | |
| 5 | OUTER CARTON | 2000.000 | 2.000 | 2002.000 NOS |
| 6 | ALUMINIUM FOIL | 10.000 | 10.000 KGS |
MANUFACTURING SPECIFICATION:
Use number zero size Black – Black Capsules.
Moisture content of powder should be less than 2.0 %.
Average fill of each capsule is 455 milligrams.
Weight Variation Limit for average weight of 20 Capsules is +5 %
Disintegration time for each Capsule is not more than 15 minutes.
Average weight of twenty filled capsules is 11.0 grams.
Mix the batch, Fill and Polish the Capsules and also perform the primary packing of Capsules at temperature not more than 270 C and Relative Humidity not more than 45 %.
Yield:
Theoretical Yield is 1.0 LAC capsules.
Expected Practical Yield is 1.0 LAC ± 2% capsules
Packing Details:
Blister Pack the filled and polished capsules by using Blister Packing Machine as per its
Put 5 strips each containing 10 capsules into the carton.
Seal the unit carton from both ends with cello tape.
Pack the 80 unit cartons in specified corrugated box K-13 to give a pack size of 80 x 5 x 10 capsules.
Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label
MANUFACTURING PROCESS:
Fit the mesh # 40 Stainless Steel Sieve on the Sifter as per its SOP and place Stainless Steel Container below the discharge hopper.
Sift the 0.100 kgs of Aerosil through 40 mesh Stainless Steel Sieve on the sifter and let it to collect in the container kept below the discharge hopper.
Dry 0.120 kgs of Copper Sulphate in tray drier at 60°C for 45 minutes and sift it through 40 mesh Stainless Steel Sieve on the sifter and let it to collect in the container kept below the discharge hopper.
Sift the 0.550 kgs of Calcium Pantothenate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Sift the 3.300 kgs of Dried Ferrous Sulphate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Sift the 0.100 kgs of EDTA through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Sift the 0.015 kgs of Folic Acid through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Sift the 20.0 kgs of Ginseng Powder through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Sift the 3.300 kgs of Dried Ferrous Sulphate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Sift the 0.240 kgs of Manganese Sulphate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Sift the 1.050 kgs of Magnesium Oxide Light through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Dry 2.750 kgs of Niacinamide in tray drier at 60°C for 45 minutes and sift it through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Sift the 0.170 kgs of Sodium Benzoate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Sift the 0.100 kgs of Sodium Meta bi-sulphite through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container
Sift the 0.240 kgs of Vitamin B1 Mono Nitrate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Sift 0.240 kg of Vitamin B2 through 40 mesh and collect in same container.
Sift the 0.180 kgs of Vitamin B6 HCl through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Sift the 5.50 kgs of Vitamin C Coated through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Sift the 0.575 kgs of Vitamin – A Acetate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Sift the 2.4 kgs of Vitamin E (coated 50%) through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Sift the 0.120 kgs of Zinc Sulphate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
Triturate and dissolve 0.200 Gms of Vitamin B12 in 225ml of spirit chloroform in a stainless steel container.
Similarly dissolve 0.750 gm of Vitamin D3 in 225 ml of spirit chloroform in a stainless steel container
Sift 2.750 kgs of D.C.P. through 40 mesh Stainless Steel Sieve on the sifter and collect it in another stainless steel container and perform the following:
To this add the solution of Vitamin B12 prepared in the step no. 23 and mix it thoroughly with a stainless steel spatula until uniform.
Also add the solution of Vitamin D3 prepared in the step no. 24 and mix it thoroughly with a stainless steel spatula until uniform.
Dry it in the tray drier at 60°C for 30 minutes.
Sieve it through 40 mesh and add to the Roto Cube Blender.
Transfer all the sifted ingredients to Roto Cube Blender. Mix 5.0 kg of Calcium Sulphate granules to these ingredients and blend it together for 1 hour by operating it as per its SOP
Weigh the whole batch. The weight of whole batch should be in range of 43.230 kg – 45.50
Send the sample to Quality Control Department for bulk testin
Start filling of Empty Hard Gelatin capsules, 455 milligrams of blended powder in each capsule shell by using Automatic Capsule Loading Machine and Semiautomatic Capsule Filling Machine as per their SOP
Polish the filled capsules by using Feeder, Sorter & Capsule Polishing Machine with A.D.U. as per its
SOP
Blister pack the filled capsules by using Triple Track Blister Packing Machine as per its SOP .
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 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.
Humidity and temperature should be maintained during the manufacturing, filling, polishing and packaging of the capsules.
Relative Humidity – Less than 45 %
Temperature – 25 0C ± 2 0C
The total weight of blended powder should be checked in the presence of Assistant Manufacturing Chemist and record the same in Batch Manufacturing Record.
Bulk sample should be sent for analysis to Quality Control Department before starting the filling of hard gelatin capsules.
Intermittently the Assistant Manufacturing Chemist should check weight variation of filled capsules at interval of 30 minutes and record for the same should be kept in Batch Manufacturing Record.
Detect out of limit capsules by Weight Variation Method as follows:
The glass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C through out the test by suitably setting the thermostat.
Introduce a tube assembly unit into glass beaker in such a way that wire mesh at the base of each tube is atleast 2.5cm below the surface of liquid when the basket is at highest position.a) Take the average weight of 20 Capsules on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP:
Detect out of limit capsules by Weight Variation Method as follows:
a) Take the average weight of 20 Capsules on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP:
| AVERAGE WEIGHT OF CAPSULES (in mg) | MAXIMUM PERCENTAGE DIFFERENCE ALLOWED |
| less than 300 mg | 10 |
| 300 mg or More | 7.5 |
Take the weight of individual Capsules and check if all the Capsules are lying with in the limits.
Select the Capsules only if no more than two Capsules are out of percentage limit and if none Capsule differs by more than 2.5 times the percentage limit, otherwise reject the Capsules.
Capsules taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and cross-contamination.
Inspection, sorting and polishing of filled capsules should be done as per SOP
Disintegration of filled capsules should be done using Disintegration Testing Apparatus.
Disintegration is the time required for the group of capsules to disintegrate. Disintegration Test should be carried out at regular interval of 1 hour by using Disintegration Test Apparatus.
The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.
Place the capsules in each of 6 tubes along with a plastic disc over the capsules.