PURPOSE: This Standard Operating Procedure is written for Glucosamine Sulphate to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.
SCOPE: This procedure is performed for Glucosamine Sulphate 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 MFR. 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: CARTILION CAPSULES||BATCH SIZE: 1.0 LAC|
|PRODUCT REFERENCE CODE: 238||UNIT SIZE: 6 ´ 1|
|GENERIC NAME: GLUCOSAMINE & CHONDROITIN CAPSULE||PACK SIZE: 100 ´ 6 ´ 1|
|DOSAGE FORM: CAPSULE||STRENGTH: N.A.|
|DEPARTMENT: NON β-LACTAM DEPARTMENT||EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING|
Each Capsule contains:
Glucosamine Sulphate 500 mg
Chondroitin Sulphate 200 mg
EQUIPMENTS TO BE USED:
|SR. NO.||NAME OF EQUIPMENT||ASSEMBLING
AS PER SOP NO.
AS PER SOP NO.
|2||Roto Cube Blender|
|3||Automatic Capsule Loading Machine|
|4||Semiautomatic Capsule Filling Machine|
|5||Feeder, Sorter & Capsule Polishing Machine With A.D.U.|
|6||Single Track Blister Machine|
|S.NO.||INGREDIENTS||STD||Theoretical Quantity Req.||Overages %||Total Quantity Used|
|1||CHONDROITIN SULPHATE||–||21.640||21.640 KGS|
WHITE / WHITE (0)
|3||GLUCOSAMINE SULPHATE SODIUM||–||29.760||29.760 KGS|
|4||GLUCOSAMINE SULPHATE POTTASIUM||–||29.610||29.610 KGS|
|S.NO.||NAME OF THE MATERIAL||THEORETICAL QUANTITY REQ.||FOR
|TOTAL QUANTITY USED|
|1||ADHESIVE TAPE ROLL BROWN||1.000||1.000 NOS|
|2||CELLO TAPE||2.000||2.000 NOS|
|3||CORRUGED BOX B – 03||167.000||167.000 NOS|
|5||ALUMNIUM FOIL||3.500||3.500 KGS|
|6||84 mm CLEAR PVC||16.000||16.000 KGS|
|7||CARTILION INSERT||16667.000||16667.000 NOS|
- Use number zero size White / White.
- Moisture content of powder should be less than 2.0 %.
- Average fill of each capsule is 810 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 18.100 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%.
- Theoretical Yield is 1.0 LAC capsules.
- Expected Practical Yield is 1.0 LAC ± 2% capsules.
- Blister Pack the filled and polished capsules by using Single Track Blister Packing Machine as per its SOP.
- Put 1 strip each containing 6 capsules into the carton.
- Seal the unit carton from both ends with cello tape.
- Pack the 100 unit cartons in specified corrugated box B-03 to give a pack size of 100 x 1 x 6 capsules.
- Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label.
- Fit the mesh # 40 Stainless Steel Sieve on the Sifter as per its SOP No. and place Stainless Steel Container below the discharge hopper.
- Sift the 21.640 kgs of CHONDROITIN SULPHATE through 40 mesh Stainless Steel Sieve on the sifter and collect in the container kept below the discharge hopper.
- Sift the 29.760 kgs of GLUCOSAMINE SULPHATE SODIUM through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
- Sift the 29.610 kgs of GLUCOSAMINE SULPHATE POTTASIUM through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
- Transfer all the sifted ingredients to Roto Cube Blender and blend together for 1 hour by operating it as
per its SOP.
- Weigh the whole batch. The weight of whole batch should be in range between 81.000 kg – 81.010 kg.
- Send the sample to Quality Control Department for bulk testing.
- Start filling of Empty Hard Gelatin capsules, 810 miligrams 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
- Blister pack the filled capsules by using Blister Packing Machine as per its SOP.
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:
- 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
|MAXIMUM PERCENTAGE DIFFERENCE ALLOWED|
|Less than 300 mg||10|
|300 mg or More||7.5|
b) Take the weight of individual Capsules and check if all the Capsules are lying with in the limits.
c) 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.
10. Capsules taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and cross-contamination.
11. Inspection, sorting and polishing of filled capsules should be done as per SOP.
12. Disintegration of filled capsules should be done using Disintegration Testing Apparatus.
i) 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.
ii) The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.
iii) Place the capsules in each of 6 tubes along with a plastic disc over the capsules.
iv) 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.
v) 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.
vi) Switch on the apparatus to move the basket assembly containing the capsules up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute. Start the stopwatch.
vii) When the capsules have disintegrated i.e. when no particles remain on the wire mesh at the bottom of tube, stop the stopwatch. Note the time taken for disintegration of the capsules and record the same in Batch Manufacturing Record.
Disintegration Time of filled capsules = Not more than 15 minutes
13. The strips and cartons should be checked thoroughly for proper batch coding
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