Dextromethorphan hydrobromide Syrup

Dextromethorphan hydrobromide Syrup

PURPOSE:  This Master formula record (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This MFR is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: ItIt is the responsibility of  Manufacturing Chemist to follow and adhere to this MFR. The Production Pharmacist, The QA Manager, The QC Manager and cGMP Administrator 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 : cGMP Administrator

Copy No. 4 : Liquid Section

PRODUCT NAME: Dextromethorphan hydrobromide. BATCH SIZE:  2000 LTRS.
PRODUCT REFERENCE CODE:  UNIT SIZE:  100 ML
GENERIC NAME: N.A. PACK SIZE:  6 x 16 x 100 ml
DOSAGE FORM: SYRUP STRENGTH: N.A.
DEPARTMENT:  LIQUID DEPARTMENT EXPIRY DATE: AFTER 24 MONTHS     FROM THE DATE OF MANUFACTURING

 COMPOSITION:

 Each 5 ml contains:

Dextromethorphan hydrobromide       I.P.            5 mg

Phenylpropanolamine HCl                  U.S.P.       12.5 mg

Chlorphenarmine Maleate                   I.P.           2mg

EQUIPMENTS TO BE USED

SR. NO. NAME OF EQUIPMENT ASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1 Sugar Syrup Manufacturing Tank
2 Sugar Storage Tank
3 Charging Tank – V – 3500 Ltrs.
4 Filter Press
5 Storage Tank – III – 3500 Ltrs
6 Linear Bottle Washing Machine
7 Digipack Bottle Filling and Sealing Machine
8 Automatic Bottle Labelling Machine
9 Shrink Packing Machine

RAW MATERIAL:-

S.NO. INGREDIENTS STD Theoretical Quantity Req. Overages % Total Quantity Used
1. ASPARTUM I.P. 2.000 2.000 KGS
2 ASPARTUM (P) I.P. 4.000 4.000 KGS
3 C.P.M I.P. 0.800 10.00 0.880 KGS
4 CARMOSINE COLUR I.P. 200.000 200.000 KGS
5 CITRIC ACID I.P. 2.000 2.000 KGS
6 DEXTROMEHORPHAN HBR I.P. 2.00 5.00 2.100 KGS
7 LIQUID GLUCOSE I.P. 400.00 400.000 KGS
8 METHYL PARABEN SODIUM I.P. 2.00 2.000 KGS
9 MENTHOL I.P. 0.400 0.400 KGS
10 PROPY PARABEN SODIUM I.P. 0.500 0.500 KGS
11 PHENYL PROPANOLAMINE HCL I.P. 5.000 5.00 5.250 KGS
12. RASPBERRY FLAVOUR I.P. 4.00 4.00 KGS
13 SODIUM BENZOATE I.P. 10.00 10.00 KGS
14 SPIRIT CHLOROFORM I.P. 20.00 20.000 KGS
15 SUGAR F.G. 1400.00 1400.00 KGS

 PACKING MATERIAL

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

RECORD

TOTAL QUANTITY USED
1. 100 ML AMBER ROUND BTLS 20000.000 20000.000
2. CORRUGATED BOX  T – 10 208.333 208.333
3 ADHESIVE TAPE ROLL BROWN 3.000 3.000
4 UNIT CARTON 20000.000 2.000 20002.000
5 LABEL 20208.333 3.000 20211.333
6 GUM ACCACIA 2.000 2.000
7 PILFER PROOFS 20000.00 20000.00
8 SHRINK FILM 240 X 220 MM 3333.333 3333.333

MANUFACTURING SPECIFICATION:

Average fill of each Bottle is 100 ml.

Volume variation limit allowed in each filled Bottle is 100 ml to 101 ml.

Make up the final volume of the syrup accurately.

Filter the completely charged batch using Filter Press  by operating it as per its SOP .

Transfer the syrup from charging tank  to storage tank  after complete charging of batch.

Mix the batch, Fill the bottles and also perform the primary packing of bottles at temperature not more than 250 C and Relative Humidity not more than 40.

Yield:

Theoretical Yield is 20000 Bottles.

Expected Practical Yield is 20000 + 2% Bottles.

Packing Details:

Wash the bottles on Linear Bottle Washing Machine and operate it as per its SOP.

Transfer the Syrup from storage tank to Digipack Bottle Filling and Sealing Machine  for filling and then Sealing of the bottles as per its SOP.

Fill 100 ml syrup in amber glass bottle and use 25 mm PP Cap to seal the bottle mouth.

Inspect the each filled and sealed bottle for proper sealing and presence of the foreign particles, if any.

Label every inspected bottle by using the Automatic Bottle Labelling Machine.

Pack each filled and sealed bottle in unit carton individually.

Make a group of 6 bottles packed in unit cartons.

Wrap this bundle in the thermoplastic film and shrink pack it by operating Shrink Packing Machine as per its SOP .

Pack such 16 shrinked packets in the Corrugated box. Thus each corrugated box contains 6 x 16 x 100 ml filled and sealed bottles.

Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.

MANUFACTURING PROCESS:

Preparation of Sugar Syrup:

Take purifed water 450 Ltrs into Stainless Steel Steam Jacketed Sugar Syrup Preparation Tank.

Run the steam into the jacket so as to heat the water.

Add 1400 kgs of sugar into the tank and start stirring by operating the tank .

Heat continuously till the sugar dissolves completely to give uniform Sugar Syrup.

Transfer the prepared Sugar Syrup to Sugar Syrup Storage Tank  through transfer pump.

Transfer the 200 kgs Liquid Glucose to the Sugar Syrup Storage Tank and stir it vigrously for half an hour to dissolve it in the Sugar Syrup completely.

Transfer the prepared Syrup from Sugar Syrup Storage Tank to Charging Tank  through transfer pump.

Addition of Ingredients into the Charging Tank  while stirring continuously:

Dissolve 2.0 kgs of Methyl Paraben Sodium and 0.500 kgs of Propyl Paraben Sodium in 10 Litres of  purifed water and add to the bulk batch.

Dissolve 10.0 kgs of Sodium Benzoate in 25 Litres of  purified water and add to the bulk batch.

Dissolve 2.0 kgs of Citric Acid in 10 Litre of purified water and add to the bulk batch.

Dissolve 2.0 kgs of  Aspartame in 10 Litres of  purified water and add to the bulk batch.

Dissolve 4.0 kgs of  Aspartame (P) in 20 Litres of  hot purified water and add to the bulk batch.

Dissolve 0.880 kgs of C.P.M. in 4 Litres of water and add add to the bulk batch.

Dissolve 2.1 kgs of Dextromethorphan HBr in 14 Litres of hot purified water and add add to the bulk batch.

Dissolve 5.25 kgs of Phenyl Propanol Amine in 15 Litres of purified water and add to the bulk batch.

Dissolve 0.400 kgs of Menthol in 20 x 450 ml of Spirit Chloroform and add to the bulk batch.

Dissolve 60 gms of Amaranth in 1 Litre of hot purified water and add to the bulk batch.

Dissolve 70 gms of Carmoisine colour in 1 litre of hot purified water and add to the bulk batch.

Add 2.0 Litres of Raspberry Flavour to the bulk batch

Make up the volume with purified water and mix until homogeneous.

Check the pH of Solution to be in between 4.5 – 5.5.

Filter the batch through Filter Press by operating it as per its SOP and transfer it to the Storage Tank .

Send the sample to Quality Control Department for bulk testing.

IN-PROCESS CONTROLS:

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  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.

Final volume should be made as per MFR using correct dipstick in the Manufacturing Chemist.

pH of the bulk should be checked and it should be with in specified limits.

Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.

Intermittently filled volume should be checked at 30 minutes interval by the Manufacturing Chemist and record for the same should be kept in Batch Manufacturing Record.

The net volume should be checked for all the filling nozzles and in no case, net volume should be less than volume claimed on the label.

Limit for Volume Variation:  Volume claimed on the label + 2ml

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.

Suspensions should be filled under constant slow speed stirring to maintain uniformity of contents.

The labels and cartons should be checked thoroughly for proper batch coding.

Intimation should be sent to Quality Control Department for finished product sampling and testing.

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.

It will be ensure that filling or packaging equipment has been properly cleaned.

Filling or packaging of next product should not commence until the ‘Line Clearance’ has been given by the IPQA.

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