Drugsformulations

CARBOPLATIN INJECTION 150MG/15ML

CARBOPLATIN  is a chemotherapy drug. It targets fast-dividing cells, like cancer cells, and causes these cells to die. This medicine is used to treat ovarian cancer and many other cancers.

Carboplatin  Injection is an anticancer medicine that is used in the treatment of ovarian cancer (cancer of the ovary, part of the female reproductive organs that produces eggs) and lung cancer. This medicine works by preventing the growth of cancer cells by damaging the genetic material (DNA and RNA) which is required for their growth and development.

Carboplatin  Injection causes side effects like nausea, vomiting, temporary hair loss, pain, and weakness. This medicine may decrease the number of blood cells (red and white blood cells) in your body, making you more susceptible to infections or bleeding. Inform your doctor if you experience a fever, sore throat, chills, unusual bleeding or bruises, or dark urine.

Carboplatin  Injection is given by a qualified medical practitioner, therefore do not self-administer. Your doctor will determine the appropriate dose and duration of the therapy. This can vary depending on the severity of your condition. It may take many weeks or months for you to notice or feel the effects, but do not stop taking it until your doctor advises you to do so. Carboplatin  Injection can affect your heart, liver, and kidney adversely. Inform your doctor if you have any heart, liver, or kidney problems before starting this medicine. You should also inform your doctor if you are pregnant, planning a pregnancy, or breastfeeding.

Product: CARBOPLATIN INJECTION

Generic Name: CARBOPLATIN BP

Strength :150MG/15ML

Lot size: 1500 units

Claimed Volume: 15ml

Solution To be Filled:  15.2ml

Label Claim:  Each ml contains:

• Carboplatin BP equivalent to Carboplatin – 150mg
• WFI   (IP)  –  Q.s.

Shelf Life:   2 Years

Storage:   Store Between 15¡ to 20¡.Protect from light. Do not freeze.

Dosage Form:   As directed by the physician.

Dosage Form:

Liquid for Injection  ( For IV Use ).

Operating Parameters:Room Temperature :   25 + 2°C and  Relative Humidity  :   60 + 5 % .

MANUFACTURING FORMULA 

Calculations

(Lot size) X  (Strength per ml) X (Volume per unit) X 100 x 100 X Overages / 1000 X Assay (on an anhydrous basis)  X (100 – % of Water/LOD).

PACKING MATERIALS

BEFORE MANUFACTURING PROCESS INSTRUCTIONS:           

Clean thoroughly all the glassware with purified water and finally rinse with WFI. Cleaning of the compounding vessel, filling vessels, filtration equipment, and stirrer used earlier for products other than Active ingredients should be counter-checked and documented.  Rinse water samples should be checked by Q.C. for the absence of active ingredients of the previous product handled.

PRECAUTIONS:    

a) All parts in contact with the product must be of inert material.

b) Wear proper dress and accessories while handling raw materials.

c) Check that the manufacturing vessel is thoroughly cleaned.

d) Keep the sample solution collected at each stage separately till the batch manufacturing is Completed.

e) Check integrity of sterile membrane filter using bubble test before & after the filtration.

f) Check autoclave load indicators (chemical) of sterile loads before using every individual.

 MANUFACTURING PROCESS

Stage – 01: After the Q.C approval for chemical and BET testing, collect freshly prepared WFI into a manufacturing vessel.

Stage – 02:      Add the Carboplatin to the Manufacturing vessel with WFI.

Stage – 03:      Agitate for 15mins to ensure complete dissolution.

Stage – 04:      Flush Nitrogen gas throughout the manufacturing process.

Stage -05;       Check and Adjust the pH.

Stage – 06:       Inform to QC department to collect the sample for bulk analysis.

Stage – 07:       Start the filtration after getting results from QC.

STERILIZATION OF EQUIPMENT

1. Sterilize the membrane holder with 0.22µ member filter and 2micron filter,50ltr SS filling vessels filtration assembly, and filling assembly in steam sterilizer at 121°C and 15 PSI for 30 minutes before filtration.

2. Sterilize the filtration vessel in a steam sterilizer at 121°C and 15 PSI for 30 minutes before filtration.

FILTERATION PROCESS:

Previously Filter the solution through a 2.0-micron pre-filter with the help of filter housing aseptically in filtration zone and finally filter through  0.22 membrane filter ( MDI ) and take the pre integrity. Filter the solution in the aseptic area aseptically using 1.0 – 1.5 kg/cm² pressure of filtered (0.2µ) Nitrogen.

Collect the filtrate in a sterilized and nitrogen-purged glass bottle. After filtration performs the post integrity test .

VIAL  WASHING AND STERILIZATION

Wash the glass vial on the vial washing machine as per the standard washing cycle using highly purified water.

Pass into sterilization tunnel above 300°C having conveyor speed 120 mm/min & then vials are Depyrogenated.

FILLING AND SEALING

After sterilization, the vials pass from the cooling stabilization zone and fill the approved solution in sterilized and Depyrogenated vials under LAF and seal with a rubber plug and F/O aluminum seal. Carry out filling with an automatic filling machine with the help of SS316 filling pump as per SOP After filling place the rubber plug on the filled vial. Seal the vial with the help of an Automatic sealing machine as per SOP. Transfer the filled vials for Visual inspection.

VISUAL INSPECTION:

Inspect each of the vials by manually with the help of visual inspection board containing white and black backgrounds with illumination for particulate matter, less volumes and sealing quality by trained inspector (workman).Check the filled vials for presence of any foreign particles. Keep good vials separate with a label containing product name, Lot.No,Mfg .Dt & Exp.Dt. Keep the rejected vials in separate box with their type of rejection. Transfer the good vials to the quarantine area. QC  chemist does the random sampling of products for final analysis.

LABELLING AND PACKING 

Label and pack the visually inspected and passed vials using the labeling and packing machine as per approved technical direction. Take the dispensed packaging materials i.e, label, carton, literature, inner C-Box Outer C box, etc. Take the passed vials from the quarantine area for labeling. Paste the pre-printed labels on the vials with the help of a labeling machine. Check the initial coding on labels for batch no., Mfg.Dt, Exp.Dt and MRP. The packing supervisor and QA chemist shall randomly inspect the quality of labeling and coding. Pack the final product in corrugated boxes. After the QC approval transfer the finished product to the store for dispatch.

Storage:    Finished goods are to be stored at room temperature below 25⁰ C. Protect from light and Keep out of reach of children.

STANDARDS AND INPROCESS CHECK

YIELDS   

EQUIPMENT, MACHINERY AND ACCESSORIES

ANALYSIS:

Bulk solution analyzed and released by Q.C for filling.

Filled Vials are drawn online for analysis by QC.

CONTROL SAMPLES 

03 labeled and duly packed Vials are collected online by IPQA Incharge 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 

Checked and duly signed by authorized production and 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 complete analysis and release by QA.  Distribution records are maintained at finished goods stores.

TECHNICAL DIRECTION   

Generic name:  CARBOPLATIN BP                           

Claim      : 150MG/15ML

Description of Product: Carboplatin for Injection

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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