MFR OF AMOXYCILLIN DRY SYRUP

MFR OF AMOXYCILLIN DRY SYRUP

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  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:

  1. Master Copy : Manager Quality Assurance
  2. Copy No. 1 : Production Pharmacist
  3. Copy No. 2 : Manager Quality Control
  4. Copy No. 3 : β – Lactam Dry Syrup
PRODUCT NAME: AMOXYCILLIN DRY SYRUPBATCH SIZE:  120 KGS
PRODUCT REFERENCE CODE: UNIT SIZE:  12 GMS
GENERIC NAME: AMOXYCILLIN ORAL SUSPENSION I.P.PACK SIZE: 144 ´ 30 ML
DOSAGE FORM: DRY SYRUPSTRENGTH: N.A.
DEPARTMENT: β – LACTAM DEPARTMENTEXPIRY DATE: AFTER 18 MONTHS FROM THE DATE OF MANUFACTURING

 COMPOSITION: 

Each 5 ml of prepared suspension contains:

Amoxycillin Trihydrate                  I.P.

Equivalent to Amoxycillin              125 mg

   EQUIPMENTS TO BE USED: 

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1 Sifter
2Double Cone Blender (200 kgs)
3Air Jet Bottle Cleaning Machine
4Automatic Double Head Dry Powder Filling & Single Head Screw Capping Machine
5Automatic Bottle Labelling Machine
6Shrink Packing Machine

RAW MATERIALS: 

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total

Quantity Used

1AEROSILB.P.0.7500.750 KGS
2AMOXYCILLIN TRIHYDRATEI.P8.6255.009.056 KGS
3CMC SODIUMI.P.1.8751.875 KGS
4ERYTHROCIN COLOURFCF8.0008.000 GMS
5METHYL PARABEN SODIUMI.P.0.3000.300 KGS
6PROPYL PARABEN SODIUMI.P.0.0750.075 KGS
7PHARMA GRADE SUGARI.P.105.400105.400 KGS
8SODIUM BENZOATEI.P.1.5001.500 KGS
9SUNSET YELLOW SUPRAF.C.F.16.00016.000 GMS
10VANILLA DRY POWDERF.G.1.5001.500 KGS

PACKING MATERIALS:

S.NO.NAME OF THE MATERIAL THEORETICAL QUANTITY REQ.FOR

RECORD

TOTAL QUANTITY USED
1.46 ML AMBER RING BOTTLES10000.00010000.000 NOS
2ADHESIVE TAPE ROLL BROWN2.0002.000 NOS
3LABEL10070.003.00010073.000 NOS
4UNIT CARTONS10000.0002.00010002.000 NOS
5GUM ACCACIA1.0001.000 KGS
6CORRUGATED BOX70.00070.000  NOS
7PILFER PROOF CAPS – 25 MM10000.00010000.000 NOS
8SHRINK FILM     220 X 220 MM834.000834.000 NOS

MANUFACTURING SPECIFICATION:

  1. Moisture content of powder should be less than 2.0 %.
  2. Use Amber glass bottle of 46 ml capacity with mark at 30 ml.
  3. Fill 12 g of powder in each bottle within range of 200
  4. Mix the batch, fill and seal the bottles at temperature not more than 250 C and Relative Humidity not more than 40.
  5. Yield:
  • Theoretical Yield is 10000 bottles.
  • Expected Practical Yield is 10000 + 2% bottles. 

Packing Details:

  1. Label the filled and sealed bottles using Automatic Labelling Machine as per its SOP and pack the bottles in unit carton individually.
  2. Make a group of 12 bottles packed in unit cartons.
  3. Wrap this bundle in the thermoplastic film and shrink pack it by operating Shrink Machine as per its SOP.
  1. Pack such 12 shrinked packets in the Corrugated box N-08. Thus each corrugated box contains 12 x 12 filled and sealed bottles.
  2. Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label.

MANUFACTURING PROCESS: 

  1. Fit the 30 No. Stainless Steel Sieve on the Sifter as per its SOP and place Stainless Steel Container below the discharge hopper.
  2. Sift the 9.056 Kgs of Amoxycillin Trihydrate through 30 No. Stainless Steel Sieve on the sifter and let it to collect in the container kept below the discharge hopper.
  3. Sift the 0.650 Kgs of Aerosil through 30 No. Stainless Steel Sieve on the sifter and collect in the same container.
  4. Sift the 1.875 Kgs of Sodium Carboxy Methyl Cellulose through 30 No. Stainless Steel Sieve on the sifter and collect in the same container.
  5. Sift the 0.300 Kgs of Methyl Paraben Sodium through 30 No. Stainless Steel Sieve on the sifter and collect in the same container.
  6. Sift the 0.075 kgs of Propyl Paraben Sodium through 30 No. Stainless Steel Sieve on the sifter and collect in the same container.
  7. Sift the 1.5 Kgs of Sodium Benzoate through 30 No. Stainless Steel Sieve on the sifter and collect in the same container.
  8. Mix the Sunset Yellow Colour 0.016Kg and 0.008 kg of Erythrosine with 0.100 Kg of Aerosil and sift through 30 No. Stainless Steel Sieve on the sifter and collect in the same container.
  9. Sift the 1.5 Kgs of Vanilla Dry Powder through 30 No. Stainless Steel Sieve on the sifter and collect in the same container.
  10. Sift the 105.4 Kgs of Pharma grade Sugar through 30 No. Stainless Steel Sieve on the sifter and collect in the separate container.
  11. Transfer the above sifted ingredients to Double Cone Blender and mix it for 1 hour as per its SOP.
  1. Send the sample to Quality Control Department for bulk testing.
  2. After receiving the Bulk Test Report from Q.C. Dept. start filling and sealing 12g of powder in clean, amber bottles by using Automatic Double Head Dry Powder Filling And Single Head Screw Capping Machine as per its SOP.
  3. Label the filled bottles by using Automatic Bottle Labelling Machine as per its SOP. 

IN-PROCESS CONTROLS: 

The following in-process controls should be maintained during the processing:

  1. Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
  2. All weighed Raw materials should be counter-checked by Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.
  3. Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
  4. Humidity and temperature should be maintained during the manufacturing, filling and sealing.
  • Relative Humidity –   35+5%
  • Temperature –   25+2oC 
  1. The total weight of blended powder should be checked in the presence of Manufacturing Chemist and record the same in Batch Manufacturing Record.
  2. Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.
  3. Intermittently the  Manufacturing Chemist should check weight of filled powder at the interval of 30 minutes and record for the same should be kept in Batch Manufacturing Record.
  4. The net weight should be checked for both the filling nozzles and in no case, net weight should be less than weight claimed on the label.
Limit for Weight Variation:  Weight claimed on the label + 200mg 
  1. Visual inspection of filled and sealed bottles should be done as per SOP and the record of the same should be kept in the Batch Manufacturing Record.
  1. The labels and cartons should be checked thoroughly for proper batch coding.
  2. Intimation should be sent to Quality Control Department for finished product sampling and testing.
  3. After the completion of labelling and packaging, the coded labels and cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Maintain the destruction of the same in the Batch Manufacturing Record.
  4. It will be ensure that filling or packaging equipment has been properly cleaned.
  5. Filling or packaging of next product should not commence until the IPQA has given the ‘Line Clearance’.

MFR OF AMPICILLIN DRY SYRUP

About 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

Check Also

CEFADROXIL DRY SYRUP 125 mg

CEFADROXIL DRY SYRUP 125 mg PURPOSE: This Master formula is written to describe the formulae, manufacturing procedure, …