P3 Manufacture
P3 Manufacture
P3 Manufacture
Ibuprofen
PART II QUALITY DOCUMENT
P3: MANUFACTURE
P3 MANUFACTURE
1- Applicant’s:
2- Manufacturer’s*:
Name : Briell pharmaceuticals (Pvt.) Ltd.
Address : 538-C,Sundar Industrial Estate, Multan Road, Lahore-Pakista n
Phone : 042-35297545
E-mail : info@briellpharm.com
Page 1 of 11
Bril Suspension (90 ml)
Ibuprofen
PART II QUALITY DOCUMENT
P3: MANUFACTURE
P 3.1 Batch Formula
The batch formulation for Bril Suspension is provided below:
MASTER FORMULATION
Composition Quantity
Sr.
Ingredients (Each 5 ml Per Batch Specs. Function
No
Contains) 2000 Liter
ACTIVE INGREDIENT
1.
Ibuprofen * 100 mg 40.00 kg USP API
EXCIPIENTS
2. Sucralose 35 mg 14.00 Kg BP Sweetener
4. Sodium Benzoate
5mg 2 Kg BP Preservative
5. Methyl Paraben Sodium 3mg 1.2Kg BP pH stabilizer
Page 2 of 11
Bril Suspension (90 ml)
Ibuprofen
PART II QUALITY DOCUMENT
P3: MANUFACTURE
Note:
* Final quantity of API to be added depends on the analytical assay as per QC results
Page 3 of 11
Bril Suspension (90 ml)
Ibuprofen
PART II QUALITY DOCUMENT
P3: MANUFACTURE
Preparation of ibuprofen
dispersion
Mesh # 40
Filter sorbitol solution
Sieve Ibuprofen through
Bottle blowing
Suspension filling
Labelling
Packing
Page 4 of 11
Bril Suspension (90 ml)
Ibuprofen
PART II QUALITY DOCUMENT
P3: MANUFACTURE
MANUFACTURING INSTRUCTIONS
Process
Equipment’s Used Capacity
Stage
Weighing Balance (Top Loading) 1200gm
Dispensing Weighing Balance (Platform) 150.00 Kg
Dispensing Hood N/A
Preparation of Silverson Homogenizer with Mixing
2000L
Simple Syrup Tank
Barrel Pump 3 HP
Preparation of
Muslin Cloth N/A
Ibuprofen
Dispersion Sieve Mesh Size#40 Mesh Size# 40
Page 5 of 11
Bril Suspension (90 ml)
Ibuprofen
PART II QUALITY DOCUMENT
P3: MANUFACTURE
Dispensing
Dispense the materials as per manufacturing order in the presence of QA, production
and raw material store representatives.
Ensure the proper protective measure of personals like mask, gloves etc.
Check the temperature & humidity of area and balance calibration.
For weighing purpose, ensure that there are no chances of cross contamination.
Ensure the use of separate scoop, spoon, and spatula for weighing purpose.
Precautions:
Manufacturing process must be carried strictly according to the Standard
Manufacturing Procedure and any deviation from the process must be authorized by
the Production Manager & Quality Control Manager.
Prior to start the manufacturing process check that manufacturing area and equipment
are cleaned and ensure that Area Approval and Line Clearance Certificate are issued
by the Quality Assurance Department.
All equipment to be used must be cleaned and absolutely dry and have the cleaned
status and labeled with Product Name, Batch Number, stage and date.
Before going to start manufacturing process ensure that all active and inactive raw
materials must be checked and weighed.
Prior to start manufacturing process ensure that personnel hygiene wearing area
uniform, face mask and surgical gloves.
Pre-processing Operations:
Before manufacturing process ensure area and machine cleaning, LOG Book completion
and environmental conditions.
Before manufacturing process ensure the availability of Area Approval and Line
Clearance Certificate issued by Quality Assurance Department.
Page 6 of 11
Bril Suspension (90 ml)
Ibuprofen
PART II QUALITY DOCUMENT
P3: MANUFACTURE
MANUFACTURING PROCEDURE
Materials Quantity
Methyl Paraben Sodium 1.20 kg
Propyl Paraben Sodium 0.6 kg
Sucralose 14.00 kg
Sodium benzoate 2.0 kg
Sodium saccharine 0.6 kg
Sodium EDTA 2.0 kg
Citric Acid Monohydrate 4.0 kg
Tween-80 2.00 Kg
Color Sunset Yellow 0.3Kg
1.1 Take Purified water in S.S.container and run silverson mixer in it.
1.2 Slowly add methyl paraben sodium at and mix it.
1.3 Then Slowly add propyl paraben sodium to solution and mix it.
1.4 Now add sucralose to solution and mix it.
1.5 Add sodium benzoate into the above solution and mix it well.
1.6 Add Tween 80, Sodium EDTA and sunset yellow color into the solution
obtained at step 1.5 and continues mix it until it dissolves completely.
Materials Quantity
Aerosil-200 1.5 Kg
Materials Quantity
Ibuprofen 41.19 Kg
4. Then add following materials with continuous stirring and mix for 20 minutes.
Material Quantity
Xanthan Gum 4.0 Kg
Page 7 of 11
Bril Suspension (90 ml)
Ibuprofen
PART II QUALITY DOCUMENT
P3: MANUFACTURE
CMC 5.30 Kg
3.1 Slowly add xanthan gum in glycerin and mix it completely till homogeneous
dispersion is obtained.
5.
Material Quantity
Orange Flavor 2.7 kg
Purified water 2000.00 L
5.1. Transfer the solution after filtration through muslin cloth into the S.S.
manufacturing tank with continuous mixing.
7. Filling:
7.1 Intimate QA department for sampling and get release for filling.
7.2 After receiving QC approval, transfer the bulk in filling area.
7.3 Set filling and labelling machine according to product specification. After
getting line clearance from QA department, start filling
7.4 Perform all the In-Process Quality Control Tests (Volume variation, cap sealing,
label pasting etc).
7.5 Fill the batch as per filling specifications.
8. Packaging:
8.1 Generate the packing material requisition for cartons and shippers.
8.2 After getting line clearance from Q.A department and packing pharmacist, start
printing of cartons.
8.3 Now pack bottles in cartons and then in shippers.
Page 8 of 11
Bril Suspension (90 ml)
Ibuprofen
PART II QUALITY DOCUMENT
P3: MANUFACTURE
To check the raw material and packing components to make sure that
complies with standard specifications.
Page 9 of 11
Bril Suspension (90 ml)
Ibuprofen
PART II QUALITY DOCUMENT
P3: MANUFACTURE
IN-PROCESS SAMPLING
Sr.
Tests Specifications
No.
Orange colored smooth suspension with
1. Description
orange flavor and sweet taste.
2. pH 3.6 - 4.6
3. Density 1.060 – 1.085 g/ml at 20°C
Page 10 of 11
Bril Suspension (90 ml)
Ibuprofen
PART II QUALITY DOCUMENT
P3: MANUFACTURE
Page 11 of 11