AMOXYCILLIN CLAVULANATE FOR INJECTION
PRODUCT INTRODUCTION
AMOXYCILLIN- CLAVULANATE FOR INJECTION is a penicillin-type of antibiotic that helps
your body fight infections caused by bacteria. It is used to treat infections of the lungs
(e.g., pneumonia), ear, nasal sinus, urinary tract, skin, and soft tissue. It will not work for
viral infections such as the common cold.
Amoxycillin- Clavulanate for Injection is generally administered by a healthcare professional
and should not be self-administered. Depending on the severity of your underlying illness,
your doctor will decide the precise dose and schedule as per which this injection is to be
given. It is strictly advised to be used as per the doctor’s prescription.
Common side effects of this medicine include nausea, vomiting, and diarrhea.
Additionally, you may notice some injection site reactions like pain, swelling, or redness.
Please consult your doctor if these do not get better or persist for a longer
duration of time. In cases of patients with severe liver or kidney disease, consult
your doctor before you start the treatment.
Before using it, you should tell your doctor if you are allergic to any antibiotics or
have any kidney or liver problems. Your doctor may change the dose or prescribe
a different medicine. This medicine is generally regarded as safe to use during pregnancy
and breastfeeding if used under a doctor’s supervision.
Generic Name: Amoxycillin- Clavulanate for Injection
Strength:600 MG
Lot size:70500 units
Average Filled Weight:666 mg/vial
Label Claim: Each vial contains:
Amoxycillin Sodium & Clavulanate Potassium USP
Equivalent ___________ 600 mg
Shelf Life: 2 Years
Dosage Form: Dry powder for Injection ( For IM / IV Use ).
OPERATING PARAMETERS:Room Temperature : 23 + 2°C , Relative Humidity: 25 + 5 %.
MANUFACTURING FORMULA
| S.No | Ingredient | Standard Quantity | Compensation Factor | Required Quantity |
| 01 | Amoxycillin sodium & Clavulanate Potassium USP | 42.30 KG | 11.00% | 46.953 KG* |
* Exact Required Quantity depends upon Assay and Moisture / LOD content of Raw Materials.
Calculations:
Required Quantity of Amoxycillin sodium& Clavulanate Potassium
= Lot Size in No. X 0.60 gm X 10 / Assay on an anhydrous basis X (100 – Moisture)
PACKING MATERIALS
| Item | Specification |
| Vials | 10 ml Vial White Type I |
| Seal | 20mm F/O -Black[CODE-C] |
| Plugs | Rubber Plugs 20mm Bromo Butyl |
GMP CHECKLIST
The area is free from unwanted material as well as the material from the last batch/ product.
All equipment and containers used in processing in this batch are cleaned to the required standard.
The wash water analysis report is available in case of product change over.
The product is labeled at all stages with all details such as the name of the product, Lot no.,
and Mfg. date, Exp. date.
All the instructions of manufacturing procedure are strictly followed and any deviation is made
only after consultation of manager Q.A and recorded.
The temperature and relative humidity of the manufacturing area is 23 + 2°C &
20% – 30% respectively and these parameters are checked and recorded
every 1 hour by operation and 2 hours by QA during the process.
A sterile dress is worn during the manufacturing process.
All the critical parameters are to be recorded as per BMR.
PRECAUTIONS:
All parts in contact with the product must be of inert material.
Wear proper dress and accessories while handling raw materials.
Keep the sample collected at each stage separately till the batch manufacturing is Completed.
Check autoclave load indicators (chemical) of sterile loads before using every individual
Check all prints out of equipment.
EQUIPMENT CHECKLIST
| S.No. | Equipment | Previous product |
| 1 | SS Hopper | |
| 2 | Linner vial machine | |
| 3 | Vial filling and stoppering machine | |
| 4 | Vial sealing machine | |
| 5 | SS Treys | |
| 6 | Sterilization and depyrogenation Tunnel | |
| 7 | Autoclave | |
| 8 | Electronic balance |
DISPENSING PROCESS
Manufacturing chemist shall punch material requisition slip in ERP and take a
printout Signed and shall give it to store in charge .
Store In charge dispenses the approved raw material in the presence of the
production person and IPQA person.
IPQA person shall tally the weighed quantity with requisition slips and shall sign
on dispensing sheet and BMR.
The storekeeper shall fill the issued quantity and analytical control number on BMR
and sign it & transfer the dispensing raw material to the filling section.
Issue the required quantity of primary packing material from the store.
WASHING AND STERILIZATION PROCESS OF VIALS AND RUBBER PLUGS
Remove approved empty vials from the boxes in De-cartoning area and load
the vials on the conveyor of vial washing machine .
Wash the vials in automatic liner vial washing machine as per validation cycle and SOP .
Checking of washed vials done by production and IPQA In charge at frequent interval .
After washing vials are automatically transferred in sterilization and depyrogenation
tunnel for sterilization and depyrogenation . Check pressure of different zone of the tunnel,
and sterilization temperature and conveyor speed of tunnel at every hours .
After sterilization vials are automatically transferred in filling area .
If rubber stoppers are not Ready for use then wash and sterilized the rubber plug in
bung processor with HPW and transferred the washed and sterilized rubber plug to
the filling area.
FILLING AND SEALING
Maintain the temperature and relative humidity of the filling area before doing
filling process and recorded at frequent interval .
Take the Blended raw materials under sterile condition .
Fill the blended sterile powder in the hopper and starts filing operation .
Adjust the fill weight of the powder ( Range – 666 mg ± 2% )
After filling rubber plugs are automatically bunged on filled vial by automatic
plugging machine.
Seal the vials with the help of automatic vial sealing machine.
Check the weight variation , Temperature , RH % , Pressure differential and sealing
of vials after every hour .
VISUAL INSPECTION:
Check the filled vials for the presence of any foreign partials.
Keep the good vials separate with a label containing the product name,
lot No., Mfg.Date, Exp.Date.
Keep the rejected vials in separate tray labels of the type of rejection.
Transfer the good vials to the Quarantine Section.
IPQA In-charge does the random sampling of products for final analysis by QC.
LABELLING AND PACKING INSTRUCTION
The packing area is free from unwanted material as well as material
from the last batch/product.
The line equipment and containers are properly identified.
Care is taken to avoid mix up during all stages of packing.
PROCEDURE
Take the dispense packing material that is labeled, carton, literature, inner carton
box and outer carton box etc.
Take the vials from quarantine area for labeling, paste the printed labels on the vials
with the help of labeling machine.
Check the initial coding of labels for batch No. Mfg.Date, Exp.Date and MRP.
Check the labeled vial and packing carton with packing insert.
Packing supervisor and IPQA In charge shall randomly inspect the quality of labeling
and coding every two hours.
Pack the final product in corrugated boxes.
After the QA approval transfer the finish product to store .
STANDARDS AND IN-PROCESS CHECK
| S.No | Parameters | Standards | Frequency |
| 1 | Colour of reconstituted solution | Clear Colourless solution | At the time of reconstitution |
| 2 | Fill Weight Check | 666 mg ±2% | 2 Hours |
| 3 | Cleanliness of filled vial | Should be clean | 2 Hours |
| 4 | Seal Check | 20mm F/O Black | 2 Hours |
| 5 | Mould Defect | All the Vials should pass | 2 Hours |
| 6 | Overprinting on Labels and
other Packing material. |
At the time of packing | 2 Hours |
| 7 | pH | 8.0 – 10.0 | At the time of finished product testing |
| 8 | Assay | Between 90% to 110% of label claim | At the time of finished product testing |
| 9 | Water/LOD/Moisture | NMT 3.5 %w/w | At the time of finished product testing |
YIELDS
| S.No | Process | Theoretical | Permissible |
| 1 | Bulk | 100 % | 98 – 99.5% |
| 2 | Filling | 99.0% | 97 – 99.0% |
| 3 | After visual inspection and packing | 97% | 96 – 97% |
EQUIPMENT, MACHINERY, AND ACCESSORIES
| S.No. | Equipment | Make | Purpose |
| 1. | Weighing Balance | Citizen | Weight Adjustment |
| 2. | Vial Washing Machine | Laxmi Pharma | Washing of Vials |
| 3. | Sterilizing Tunnel | Fabtec | Sterilization & Depyrogenation of Washed Vials |
| 4. | Autoclave | Metal Chem | Sterilization of Dresses , filling item and accessories |
| 5. | Filling and sealing Machine | Fabtec | Filling of powder into Vials |
| 6. | External Vial Washing machine | N.K. Pharma Products | External washing of vial |
| 7. | Visual Inspection Table | Pragathi | Visual inspection |
| 8. | Labeling Machine | Ambica | Vial Labeling |
ANALYSIS
Raw material analyzed and released by Q.C for filling.
Filled Vials are drawn online for analysis by IPQA.
All the analytical tests are performed by QC Chemist from Quality Control.
The batch is released after 14 days.
CONTROL SAMPLES
10 labeled and duly packed Vials are collected online by IPQA In charge during
packing and sent to QC for storage in the control sample room.
WASTAGE / REJECTION DISPOSAL
Control samples are destroyed 3 months after the expiry of the batch as per the
standard operating procedure. Destruction records are to be maintained.
Filled rejected Vials are first inactivated by using suitable chemicals and then
destroyed by crushing as per the standard operating procedure. Printed packing material is
destroyed by shredding it into small pieces.
DOCUMENTATION CHECK
All the documents are Checked by the department head or concerned person
and duly signed by authorized Q.A. personnel.
Batch records are to be preserved for 5 years after manufacturing in the record room.
TRANSFER
Packed finished goods are transferred to FGS after proper entry in ERP.
Dispatched after finished good inspection by IPQA and release by QA HEAD.
Distribution records are maintained at finished goods stores.
TECHNICAL DIRECTION
Generic name: Amoxycillin and Potassium Clavulanate for Injection
Party Name:
Claim: Each vial contains:
Sterile Amoxycillin Sodium to Amoxycillin……………………………………… 500 mg
Sterile Potassium Clavulanateeq. to Clavulanic acid ……………………….. 100mg
Description of Product:
White to pale yellow/cream colored crystalline powder filled in glass vials and
sealed with rubber plug and flip-off aluminum seal.
| S. No. | Component | Brief Description | Qty./Super
Master |
Packaging Instructions |
| 1. | Glass Vial 10 ml | 10 ml type- I Vial with 20 mm Neck, Neutral glass | 240 No. | Fill Sterile powder as per required weight aseptically. |
| 2. | Rubber plug | 20 mm Bromo Butyl | 240 No. | Plug the vial using a sterile rubber plug aseptically. |
| 3. | Flip-off seal
( Black ) |
20mm standard virgin flip-off aluminum seal with a black color plastic flip. | 240 No. | Seal the vial properly using flip-off aluminum seal. |
| 4. | Label
|
Sticker Label for vial printed as per the approved color, text & design on GSM 80 ± 10%.
Size : 70 x 28 mm ± 1 mm |
240 No. | Paste one label on each vial duly coded with batch No. Exp. date & Mfg. Date. |
| 5. | Unit carton
|
Unit carton made up of 300 GSM ± 10% laminated art card, printed as per approved text, color and design.
Size : 34 x 34 x 62 mm ± 1 mm |
240 No. | Put 1 vial in each unit carton duly coded with all batch details. |
| 6. | Literature | As per party artwork | 240 No. | Put 1 in each unit carton. |
| 7. | Shrink pack
|
Shrink pack made from 9-inch polythene roll | 24 Nos.
|
Pack 10 unit cartons in each shrink pack. |
| 8. | Master Corrugated box
|
Corrugated box made up of 3 ply as per approved design, color, and text,
Size: 220x 180 x 138 mm ± 3mm |
04 Nos. | Put 6 shrink packs in each master corrugated box. |
| 9. | Super Master corrugated box (Shipper Master ) | Corrugated box made up of 5 ply as per approved design, color, and text,
Size – 370 x 237 x 290 mm ± 3mm |
01 No. | Put 04 master Corrugated boxes in each super master corrugated box. |
| 10. | BOPP tape
Brown plain |
48 mm ±1 mm wide self-adhesive BOPP tape plain. | Qs. | Close the corrugated box flaps and seal them using BOPP tape |
BENEFITS OF AMOXYCILLIN- CLAVULANATE FOR INJECTION
In Treatment of Bacterial infections
Amoxycillin- Clavulanate for Injection contains two different medicines, Amoxycillin and
Clavulanic Acid, that work together to kill the bacteria that cause infections. Amoxycillin
works by stopping the growth of bacteria. Clavulanic Acid reduces resistance and
enhances the activity of Amoxycillin against bacteria.
This combination medicine can be used to treat many different bacterial infections
such as ear, sinus, throat, lung, urinary tract, skin, teeth, joints, and bones.
It usually makes you feel better within a few days, but you should continue taking
it as prescribed even when you feel better to make sure that all bacteria are killed
and do not become resistant.
SIDE EFFECTS OF AMOXYCILLIN- CLAVULANATE
POWDER FOR INJECTION
Common side effects of AMOXYCILLIN- CLAVULANATE
FOR INJECTION
- Vomiting
- Nausea
- Diarrhea