MASTER FORMULA OF ANTACID – 160 ML
PURPOSE: This Master Formula 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 , QC/QA Manager and cGMP Administrator are accountable for the strict adherence to the master.
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 : cGMP Administrator
5. Copy No. 4 : Liquid Section
|PRODUCT NAME: ANTACID 160 ML||BATCH SIZE: 1600 LTRS.|
|PRODUCT REFERENCE CODE:||UNIT SIZE: 160 ml|
|GENERIC NAME: N.A.||PACK SIZE: 36 x 160 ml|
|DOSAGE FORM: SUSPENSION||STRENGTH: N.A.|
|DEPARTMENT: LIQUID DEPARTMENT||EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING|
Each 5 ml contains:
Dried Aluminium Gel I.P. 400 mg
Magnesium Hydroxide I.P. 400 mg
Simethicone U.S.P. 50 mg
SPECIMEN OF LABEL :
EQUIPMENTS TO BE USED:
|SR. NO.||NAME OF EQUIPMENT||ASSEMBLING|
AS PER SOP NO.
AS PER SOP NO.
|1||Charging Tank 1300 Ltrs.|
|3||Charging Tank 3500 Ltrs.|
|4||Storage Tank 3500 Ltrs|
|5||Linear Bottle Washing Machine|
|6||Digipack Bottle Filling and Sealing Machine|
|7||Automatic Bottle Labelling Machine|
|S.NO.||INGREDIENTS||STD||Theoretical Quantity Req.||Overages %||Total Quantity Used|
|2.||ALUMINIUM HYDROXIDE (HYROXIDEGGGPASTE ASTE||I.P.||752.000||6.39||800.053 KGS|
|3||ANISE FLAVOUR||F.G.||2.400||2.400 LTRS.|
|6||CMC SODIUM||I.P.||4.000||4.000 KGS|
|7||MAGNESIUM HYDROXIDE PASTE||I.P.||610.000||6.56||650.016 KGS|
|9||PROPYLENE GLYCOL||I.P.||6.400||6.400 KGS|
|10||PROPYL PARABEN||I.P.||0.320||0.320 KGS|
|11||SODIUM CITRATE||I.P.||4.800||4.800 KGS|
|12||SORBITOL SOLUTION||I.P.||240.00||240.00 KGS|
|13||SPIRIT CHLOROFROM||I.P.||7.2 LTR||7.2 LTR|
|14||SIMETHICONE 30%||U.S.P||53.333||5.00||56.000 KGS|
|15||TARTRAZINE SUPRA||F.G.||0.560||0.560 KGS|
|S.NO.||NAME OF THE MATERIAL||THEORETICAL QUANTITY REQ.||FOR |
|TOTAL QUANTITY USED|
|1.||170 ML WHITE ROUND BTLS.||10000.000||1000.000 NOS|
|2.||CORRUGATED BOXES A – 01 WITH 6 X 6 JALI||278.000||278.000 NOS|
|3||ADHESIVE TAPE ROLL BROWN||4.000||4.000 NOS|
|4||160 ML YELLOW (LABEL)||10278.00||3.000||10281.000 NOS|
|5||GUM ACCACIA||1.000||1.000 KGS|
|6||PILFER PROOFS 25 MM||10000.000||10000.000 NOS|
1. Average fill of each Bottle is 160 ml.
2. Volume variation limit allowed in each filled Bottle is 160 ml to 162 ml.
3. Make up the final volume of the suspension accurately.
4. Colloid the completely charged batch using Colloidal Mill L-20 by operating it as per its SOP.
5. Transfer the suspension from charging tank L-10 to storage tank L-14 after complete charging of batch.
6. 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.
7.Dried Aluminium Hydroxide Gel contains 47.5% of Aluminium Oxide.
8.Aluminium Hydroxide Gel (Paste) contains 7.50 ± 0.25% of Aluminium Oxide.
9. Actual quantity of Aluminium Hydroxide Gel (Paste) required is:
400 x 1600 x 47.5
5 x Contents of Aluminium Oxide in x 1000
Aluminium Hydroxide Gel (Paste)
· Theoretical Yield is 10000 Bottles.
· Expected Practical Yield is 10000 + 2% Bottles.
1.Wash the bottles on Linear Bottle Washing Machine L-24 and operate it as per its SOP.
2.Transfer the Suspension from storage tank to Digipack Bottle Filling and Sealing Machine L-25 for filling and then sealing of the bottles as per its SOP.
3.Fill 160 ml suspension in 170 ml white glass bottle and use 25 mm PP Cap to seal the bottle mouth.
4.Inspect each filled and sealed bottle for proper sealing and presence of the foreign particles, if any.
5.Label every inspected bottle by using the Automatic Bottle Labelling Machine L-26 as per its SOP.
6.Pack 36 filled and sealed bottle in each corrugated box A-01.
7. Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.
1. Charge 240 kgs of Sorbitol to charging tank.
Addition of Ingredients into the Charging Tank L-09 while stirring continuously:
2.Dissolve 8.0 kgs of Sodium Benzoate in 50 Ltrs of DM water and add to the bulk batch.
3.Dissolve 1.60 kgs of Aspartum 10 Ltrs of DM water and add to the bulk batch.
4.Slowly transfer 924.0 kgs of Aluminium Hydroxide Paste to the bulk batch.
5. Add 200 Ltrs of Purified Water to the bulk batch.
6.Slowly transfer 140.8 kgs of Magnesium Hydroxide Powder to the bulk batch.
7. Add 1.6 kgs of Aerosil to the bulk batch.
8.Dissolve 1.28 kgs of Bronopol in 5 Ltrs of DM water and add to the bulk batch.
9.Slowly transfer 16.8 kgs of Simethicone to the bulk batch.
10.Dissolve 0.560 kgs of Tartrazine Supra in 5 Ltrs of Purified water and add to the bulk batch.
11.Mix the whole batch for 1 hour and then colloid the batch.
12. Colloid the batch through Colloid Mill L-20 by operating it as per its SOP and transfer it to the Charging Tank.
13.Dissolve 0.512 kgs of Menthol in 16 x 450 ml of Spirit Chloroform and add to the bulk batch.
14.Make up the volume with DM water to 1600 Ltrs and mix until homogeneous.
15.Leave the Suspension to settle for overnight or for minimum 8 hours.
16. Again check the volume and make up with DM water to 1600 Ltrs and mix until homogeneous.
17. Check the self pH of Solution to be in between 8.0 – 9.0
18.Send the sample to Quality Control Department for bulk testing.
19.Transfer it to the Storage Tank.
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 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 Standard Operating Procedure 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 Assistant 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.