P Atlantic pharmaceuticals laboratories

89-D INDUSTRIAL ESTATE PESHAWAR- PAKISTAN

DEPARTMENT: PRODUCTION LOCATION: LIQUIDS
BATCH MANUFACTURING RECORD (FOR LIQUIDS)
TITLE: ACITRAL SYRUP DOCUMENT# REFERENCE:
PRD/LIQ/BMR/001 ATLANTIC INTERNAL
Sodium Acid Citrate BP1.25g/5ml
VERSION # EFFECTIVE DATE: NEXT REVISION DATE: PAGE #:
1ST Issue Feb 2018 FEBRUARY, 2020 1 of 4

RMO.NO: DATE:

BATCH NO: BATCH SIZE: 1000 Lit. QUANTITY: 8333 Bottles

MFG.DATE: EXP.DATE: PACK SIZE: 120ml

PRODUCT DESCRIPTION: Yellow color syrup with Lemon flavor.

STANDARD FORMULATION

S/NO. INGREDIENTS QCR.NO. UNITS STD.QTY. OVERAGE ACTUAL

100% %Age QTY.
1 Citric Acid Kg 200.00 5% 210.00
2 Sod. Carbonate Kg 100.00 5% 105.00
3 Sod. Benzoate Kg 2.50 NIL 2.50
4 Sod. Saccharine Kg 1.75 NIL 1.75
5 Flavor Lemon L 1.25 NIL 1.25
6 Color Yellow Kg 0.025 NIL 0.025
7 E.D.T.A. Sodium Kg 0.250 NIL 0.25
8 Water-De-Ionized (QS) L QS NIL QS

NOTE: To be printed in duplicate.

PREPARED BY (PROD INCHARGE): ____________________________________

ISSUED BY (STORE INCHARGE): ______________________________________

CHECKED BY (QA INCHARGE): _____________________________

Product name: ACITRAL SYRUP B.NO:____________ Page: 2 of 4

 MANUFACTURING PROCEDURE
1- DISPENSING:
1.1- Before starting dispensing check & ensure the line clearance for dispensing.

LINE CLEARANCE CERTIFICATE

DATE:____________

PRODUCT NAME: ___________________________________ BATCH NO.________________________

PREVIOUS PRODUCT:________________________________ BATCH NO.________________________

I Checked the Area, Line &Equipments. I found all these neat & clean & found no materials of the previous batch. So
the QAI issues the LINE CLEARANCE CERTIFICATE for DISPENSING of the above batch.

_________________
QA INSPECTOR

1.2- After dispensing as per above standard formulation precedes manufacturing as per following steps.

2- BATCH FORMULATION:

2.1- Wearing mask and gloves take 100L water and boil it in a tank. Dissolve Citric Acid in it.
2.2- Take some quantity of water in the main formulation tank and dissolve Sod. Carbonate in it. Then transfer the Citric Acid
solution to the main formulation tank and mix and leave over night.
2.3-On next day dissolve Sod. Benzoate, Sod. Saccharine, E.D.T.A. one by one in 10L of water &add into the main
formulation tank &mix.
2.4- Then dissolve the Color yellow in some quantity of hot water & add to the main formulation tank & mix.
2.5- Then add Flavor Lemon to the main formulation tank & mix.
2.6- Now adjust the volume to 1000litres.
2.7-And mix for about 1hour.
2.8- Request QC to take sample for analysis as per format
2.9- After release from QC transfer the batch to the filling area for filling & packing.
Batch formulation started Date &Time: _________________________
Batch formulation completed Date &Time: ______________________

Performed by: Checked By:

Operator name: _______________ Prod. Pharmacist: ________________
Date of Operation: _____________ QA. Inspector: _____________________

Product name: ACITRAL SYRUP B.NO:____________ Page: 2 of 4

3- FILLING & CAP SEALING:
Check & ensure the line clearance for Filling & cap Sealing.

LINE CLEARANCE CERTIFICATE

DATE:____________

PRODUCT NAME: ___________________________________ BATCH NO.________________________

PREVIOUS PRODUCT:________________________________BATCH NO.________________________

I Checked the Area, Line &Equipments. I found all these neat & clean & found no materials of the previous batch. So
the QAI issues the LINE CLEARANCE CERTIFICATE for: Filling & cap Sealing of the above batch.

_________________
QA INSPECTOR

3.1- After washing &cleaning &receiving the line clearance Wear mask and gloves & adjust the volume on the filling
machine at .
3.2- Discard the first four bottles from each nozzle &then start filling in the bottles.
3.3- Both the Prod.Incharge & QAI should Check the Filling Volume, cap Sealing& optical checking at start & then at regular
intervals (i.e. least after every 30minutes) and record the reading as per In process record sheet:
Filled &Sealed by:
Filling started Date &time ______________ filling completed Date &time ______________ Operator name: __________
Sealing started Date& time ______________ Sealing completed Date &time _____________ Operator name: __________
Optical checking By--------------------

Checked By:
Prod. Pharmacist: ________________ QA. Inspector: _____________________

4- BATCH CODING, LABELLING & PACKING:

ISSUE OF PACKING MATERIALS FROM STORE (PMS):
Receive the Packing materials from the store as per PMO:
Check & ensure the line clearance Batch Coding (Batch Number Printing) & Packing.

LINE CLEARANCE CERTIFICATE

DATE:____________

PRODUCT NAME: ___________________________________ BATCH NO.________________________

PREVIOUS PRODUCT:________________________________BATCH NO.________________________

I Checked the Area, Line &Equipments. I found all these neat & clean & found no materials of the previous batch.
So the QAI issues the LINE CLEARANCE CERTIFICATE for: Batch Coding,Labeling & Packing of the
above batch.
_________________
QA INSPECTOR

4.1- After receiving the line clearance start the Batch coding (Batch Number Printing) & Packing.
4.2- Both the Prod.Incharge &QAI should check &sign the first LABEL & UNIT CARTON and then allow to start the printing.
Batch Coding:
Batch Coded by: Labels__________________________Unit Cartons: __________________________
Checked By: Production Incharge: _____________________ QA Inspector:__________________________

4.3- Both the Prod.Incharge &QAI should check at regular intervals (i.e. at least after every 30 minutes) the labeling &Packing line
For B.NO, Mfg.& Exp.Date etc as per In-process record sheet:
Labeling &Packing started Date&time: _________________ Completed Date & time:________________
Bottles Labeled by: ______________________________________________________________________
Unit cartons packed by ___________________________________________________________________
Master cartons packed by); ________________________________________________________________

Supervisor Name: ______________________________________ Prod. Incharge: ____________________________

4.4- After completions of packing, reconciliate the packing materials as per &transfer the packed
quantity to the finished goods store.
Total quantity transferred to FGS: ----------------------------------------------Date of transfer: ---------------------

Checked By: Prod. Incharge: ________________________ QA. Inspector: ______________________________

Received By: Store Incharge): __________________

Product name: ACITRAL SYRUP B.NO:____________ Page: 2 of 4

 COMPLETE BATCH ACCOUNT/RECONCILLIATION

DATE: ---------------

PRODUCT NAME: ACITRAL SYRUP BATCH NO:_______________

MFG.DATE: ________________ EXP.DATE:________________

BATCH SIZE: 1000 Liters STRENGTH: 8333 Bottles PACK SIZE: 120ml

S/NO. PARTICULARS QUANTITY

1 BATCH SIZE
2 THEORITICAL YIELD
3 PRACTICAL YIELD
4 QTY.OF SAMPLE GIVEN TO QC
5 QTY. TRANSFERRED TO STORE

%YIELD = PRACTICAL YIELD X 100 = _____________ %

THEORITICAL YIELD

%Gain/Loss (+ 3%) =____________%

REMARKS (IF ANY): _____________________________________________________________________

________________________________________________________________________________________

_____________________________
PRODUCTION INCHARGE