Drugsformulations

AMOXYCILLIN CLAVULANATE  FOR INJECTION

PRODUCT INTRODUCTION

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

* 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

GMP CHECKLIST

1. The area is free from unwanted material as well as the material from the last batch/ product.
2. All equipment and containers used in processing in this batch are cleaned to the required standard.
3. The wash water analysis report is available in case of product change over.
4. The product is labeled at all stages with all details such as the name of the product, Lot no., and Mfg. date, Exp. date.
5. All the instructions of manufacturing procedure are strictly followed and any deviation is made only after consultation of manager Q.A and recorded.
6. 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.
7. A sterile dress is worn during the manufacturing process.
8. 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 print out of equipment.

 EQUIPMENT CHECKLIST

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 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

YIELDS

EQUIPMENT, MACHINERY, AND ACCESSORIES

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 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.

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field.
During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube