Suspension

Product: Active Ingredient:
Reg.No: Product specs: USP specs

Mfg Lic. No: Pack size: 1’s
WENOVO PHARMACEUTICAL
Sr no Document Name Status Prod. OfficerQA officer

1. Request for line clearance for dispensing
2. Dispensing of raw materials
3. Supplementary issue
4. Request for swab test(mixing)
5. Request for line clearance for mixing
6. Mixing
7. Request for sampling for analysis
8. Request for line clearance for filling
9. Weight variation sheet
10. Control form for filling and sealing
11. Batch reconciliation filled bottles
12. Analytical report (filled bottles)
13. Packing material order
14. Product over printing
15. Request for line clearance for packing
16. Packing instruction
17. Online packing inspection
18. Transfer to finish good store
19. Packing material reconciliation sheet
20. Disposal/destruction
21. Yield statement
22. Request for analysis of finished product
Doc # RP/PR/BMR/DS 001 Page #: 1/31

BATCH
MANUFACTURING
RECORD
_____________________

Instructions:
1. Before starting filling of entries make sure that BMR is issued by authorized person.
2. BMR should be available in the relevant area/ section of process.
3. Fill all the blanks neat & clean.
4. Never leave fields blank; write “NA” in case of not applicable entry.
5. Never over write mistakes or errors.
6. In case of mistake draw line like in bracket (Strike through), write the corrected entry & put
your signature.
7. Use only black/blue ink to fill entries.
8. Entries must be done by the relevant personnel only.
9. Fill the entries right at the time of activity is performed; fake entries strictly prohibited.
10. In the name entries always write the full name.
11. Follow strictly approved SOPs/ Instructions displayed or available in section.
12. The manufacturing process must be carried out strictly according to this process sheet. The
production manager and Quality Assurance manager must authorized any deviation from this
process sheet and should be recorded in the BMR (Batch Manufacturing Record)
13. All equipments and machinery should be neat and should bear status label.
14. All rejected material (product rejection) (if any) should be disposed off properly and recorded.
15. All operations from dispensing to Filling and Sealing must be conducted at a specified relative
humidity and temperature.
16. The % age formula should be calculated on the basis of assay results of active ingredients.
17. All in- process and bulk material should be properly labeled and should be kept in Quarantine
area.
18. Personal working in the manufacturing area must wear the suitable protective clothing i.e.
masks, gloves, and goggles at all times.
19. All the production personals must be trained regularly to minimize the production losses.
20. Authorized personnel (W/H pharmacist & QAI) are present at the time of dispensing of Raw
material & also packing material.
Step 1. Request for Line clearance for Dispensing

Send by: Date : Time: Rec. by: Date: Time:
Pre- Dispensing GMP Checks Report
Remains of previous product ________________________Batch No _______removed. Yes NO
Dispensing area (floor, door, window, walls, ceiling, tube lights, buffers properly cleaned.
Yes NO
Quantities of the raw materials have been checked to be correct as per their potency against
the quantities of standard batch size. Yes NO
Related documents of the product to be dispensed are properly filled and available.
Yes NO
Raw materials to be dispensed have been approved by quality assurance department.
Yes NO
All Relevant Equipment / Machine (scales/weighing balances, scoops etc.) to be used for dispensing
are, clean and clear from the remains of previous product. Yes NO
Air conditioning and exhaust system is working properly and temperature and relative humidity are controlled.
Temperature (NMT 30OC) ______________Humidity (NMT 40%)_____________. yes NO
Uniforms, masks and gloves of staff are available and properly worn.
Yes NO
Plastic bags and containers required for dispensing material are clean and labeled.
Yes NO
The weighing balance / scale is calibrated and working properly.
Yes NO
Dispensing Personnel posses’ sound health suffering from common cold and any other respiratory
infection, Bronchitis, sore throat, skin infections rashes open wounds, or skin abrasions, eye Yes NO
infection, diarrhea or Stomach upset.
Remarks:
Date/Time: ________________
QA Inspector
Step 2. Ingredients Qty/ Qty/

Dispensing of Raw material DISPENSING
Bottle Batch
QC # Actual Weighed Checked by Received
(mg) (Kg)
Date: Batch No: weight By
Batch Size: Bottles By
(W.H
(prod.
(Kg) Pharmaci QAI
S.No Officer)
st)
Assay: - % Overage=
Totalweight = KG weight/bottle=
__________________ ________________ ______________ _____________ _____________

Prepared by Checked by Verified by Approved by Authorized by
Production Officer warehouse officer QA officer Production Manager QA Manager
Step 2. Dispensing of Raw material DISPENSING

Qty/ Qty/ Received
Checked by By
Date: Ingredients Batch
Bottle No:Batch Actual
BatchWeighed
Size: Bottles
S.No (mg) (Kg) QC # weight (W.H
By (prod.
(Kg) Pharmaci QAI
Officer)
st)

Assay: - % Overage=
Totalweight = KG weight/bottle=
__________________ ________________ ______________ _____________ _____________

Prepared by Checked by Verified by Approved by Authorized by
Production Officer warehouse officer QA officer Production Manager QA Manager
Step 3 Packing Material Order Batch no:
Batch Size: 5000 bottles

Date:
Item Qty/ Analysis Vendor/ Qty Qty Issued by Checked Received

Pack No Purchaser Required Issued by by

HDPE pet bottles

90mL with
orange line
CRC Caps with
orange seal
__________________ _______________________
Reviewed by checked by:
Production Officer QA Inspector
Step 3 Packing Material Order Batch no:
Batch Size: 5000 bottles

Date:

Item Qty/ Analysis Vendor/ Qty Qty Issued by Checked Received

Pack No Purchaser Required Issued by by
HDPE pet bottles

90mL with
orange line
CRC Caps with
orange seal
__________________ _______________________
Reviewed by checked by:
Step 5. Request for Line clearance for mixing
Initiated by Production Officer : Date: Time: Received By QAI: Date: Time:

Pre Mixing GMP Checks Report
Remains of previous product_______________________ Batch No _______removed.

Yes NO
Manufacturing area (floor, door, window, walls, ceiling, tube lights, buffers properly cleaned.
Yes NO
Relevant machinery cleaned
Yes NO
Container of active material are available in area are properly cleaned , labeled
and QC released. Yes NO
All Relevant Machine working properly
Yes NO
Pressure, Temperature and Humidity parameters controlled.
Temperature (NMT 30oC) _________________Humidity (NMT 40%) _________________. Yes NO
Uniforms, masks and gloves of staff are available and properly worn.
Yes NO
Is pressure in room negative?
Yes NO
Personnel entering into the area posses sound health suffering from
common cold and any other respiratory infection, Bronchitis, sore throat, skin Yes NO
infections rashes open wounds or skin abrasions, eye infections diarrhea or
Stomach upset.
Remarks:
Date/time: ______________
Q.A Inspector
Step 6 Mixing
Sr# Instructions Time Time Performed Checked By

start Finish By Prod. QAI

Officer
1. Pass Fine sugar (Standard grade) through sieve

# 20.
a) _______ Kg
2 Then add the following materials in a polythene

bag and mix thoroughly then pass through mesh
#40
a) ________kg
b) ______ Kg
c) ______ Kg
d) _____ Kg
e) ____________ Kg
3 Divide the Sugar in 6 polythene bags and mix
portion wise of step 2 powder in each polythene
bag and mix thoroughly one by one polythene
bag and then add to double cone mixer.
Mix for about 30 minutes
Step 7 Request For Sampling for Analysis ( Final Mix bulk powder))
Initiated by Production Officer : Date: Received By QAI: Date: Time:
Time:
Send request to QA Department for sampling of filled Send by Sampled By Received

Bottles & then send to QC department for QC testing. (PRO) (QAI) By (QCA)
Analytical Report (Final Mix bulk powder)

Test Standard Result
Q.C. No.: ______________
Appreance
Remarks:-
Identification
Loss on Drying
Assay
FillWeight
Analyzed By: ___________ Date: ____________

QC analyst ________________________
Verified by ___________________ Approved by:
Deputy QCM Quality Control Manager
Step 8 Batch Reconciliation (Mix Bulk powder)

Container Gross Weight Tare Weight Net Weight Date Operator Supervised
#. Kg. Kg. Kg. By
1

Total
a) Theoretical Yield: _____________________________ Kg.

b) Actual Yield: _________________________________ Kg.
c) Unaccountable Loss (a-b): _____________________ Kg.
d) %age unaccountable loss c x 100: _____________________ %
e) (Limit NMT 1%) a
f) Given explanation if the reconciliation is outside the stated limits.
_________________ _________________ _______________

Prepared by: Reviewed by: checked by:
Mixer Operator Production Officer Q.A Inspector
Step 9 Transfer Of mixed bulk powder for Filling and Sealing
Qty Transferred No Of Shippers Transferred By Received By

Step 10 Request for Line Clearance for Filling and Sealing

Imitated by Production Officer : Date: Received By QAI: Date: Time:
Time:
Pre-Filling and Sealing GMP Checks Report

Remains of previous product _______________________Batch No ____________removed.
Yes NO
Sachet filling area(floor, door, window, walls ,ceiling, tube lights, buffers properly
Cleaned. Yes NO
Relevant machinery cleaned
Yes NO
Container of material are available in area are properly cleaned ,labeled
And QC released. Yes NO
Sachet filling Machine ,scoops and, weighing balances are cleaned are
Working properly. Yes NO
Temperature and Humidity parameters controlled.
Temperature (NMT 30oC) ________________Humidity (NMT 50%) _______________ Yes NO
Uniforms, masks and gloves of staff are sterilized and properly worn.
Yes NO
Personnel entering into the area posses sound health suffering from
common cold and any other respiratory infection, Bronchitis, sore throat, skin Yes NO
infections rashes open wounds or skin abrasions, eye infections diarrhea or
Stomach upset.
Remarks
Date/Time: __________________
QA Inspector

Step 11 Control Form (Filling and sealing)

Date: Objective Fill Weight: __________ gm/bottle
Machine:
Lower Limit:
Operator: Upper Limit:
In-process check list
Date Time 1 2 3 4 5 RH% TOC Induction Checked By
PROD.
sealing PHARMACIST
Remarks
Step 12. Batch Reconciliation (Filled Bottles)
a) Theoretical Yield: __________________________Bottles

b) Actual Yield: ______________________________Bottles

c) Unaccountable Loss (a-b): ___________________Bottles.
d) %age unaccountable loss c x 100: _____________ %
e) (Limit NMT 1%) a
f) Given explanation if the reconciliation is outside the stated limits.
_____________________________________________________________________-
___________ ______________ _
Prepared by: Reviewed by: Checked by:
Operator Production Officer Q.A Inspector
Step 13 Transfer Of Bottles to IPQ
Qty Transferred No Of Shippers Transferred By Received By
___________ ______________ _
Prepared by: Checked by: Received by:
Operator Production Officer IPQ In-charge
Step 14. Analytical Report (filled Bottle)
Date:
Send request to QA Department for sampling of filled Send By(PRO) Sampled By Received By
Bottles & then send to QC department for QC testing. (QAI) (QCA)

Analytical Report (filled Bottle)
Parameter Standard Result

Q.C. No.: ______________
Appearance
Remarks :-
Identification
Average Weight
Weight Variation
Bottle size
Assay
Analyzed By:_______________ Date: _______________

QC analyst
Verified by -------------------------------
Deputy QCM _________________________
Approved by:
Quality Control Manager
Step 15 Packing Material Order

Date: Batch No.:
Item Analysis Overage Qty./Batch Qty Issued Checked By
No Warehouse QAI Rec by
officer

Labels 10% 5500
Unit Carton 1% 5050

Commercial
Leaflet 1% 5050
Oral Spoon (5mL) 1% 5050
Master Cartons 1% 84
60 packs/ carton
Code: N-82
__________________ ___________________ ______________ _____________

Prepared by Reviewed by Verified by Approved by
Production Officer QA Officer Production Manager QA Manager
Step 15 Packing Material Order

Date: Batch No.:
Item Analysis Overage Qty./Batch Qty Issued Checked By
No Warehouse QAI Rec by
officer
Labels 10% 5500
Unit Carton 1% 5050

Commercial

Leaflet 1% 5050
Oral Spoon (5mL) 1% 5050
Master Cartons 1% 84
60 packs/ carton
Code: N-82
__________________ ___________________ ______________ _____________

Prepared by Reviewed by Verified by Approved by
Production Officer QA Officer Production Manager QA Manager
Step 16 Product Over-Printing

Status: Quantity:
Machine setting by: Mfg. Date:
Printed by: Exp. Date:
P.O. Available: Yes No M.R.P.Rs.:
Equipment / Operation clearance
Previous Product: Clearance Granted
Batch No.:
_______________ _______________
Ensure that there should not be any remains
Production Officer Date/ Time
Of the previous batch.
_______________ ________________
Q.A.I Date/Time
Affix Specimen
__________________ __________________
Checked by: Verified by:
Step 17 Request for Line Clearance for Labeling
Send by: Date : Time: Rec. by: Date Time:
Pre-Labeling GMP Checks Report
Remains of previous product_____________________ Batch #_________Removed. Yes NO

Labeling area (floor, door, window, walls, ceiling, tube lights,) properly cleaned.. Yes NO

Product to be Label is properly identified and approval has been taken from the Yes NO
Quality Assurance Department
Labeling machine is clean and cleared from the remains of previous product. Yes NO
Properly printed Labels have been verified and cross checked as per the Yes NO
Quantity mentioned in the packing order.
Related documents of the product to be labeled are available on the belt. Yes NO
Uniforms of staff are properly worn. Yes NO

Remarks:-
Date/time: ____________
Q.A Inspector
Step 19 Request for Line Clearance for Packaging
Send by: Date : Time: Rec. by: Date Time:
Pre-Packaging GMP Checks Report
Remains of previous product_____________________ Batch #_________Removed. Yes NO

Packing area (floor, door, window, walls, ceiling, tube lights, conveyer belt properly cleaned.. Yes NO
Product to be packed is properly identified and approval has been taken from the Yes NO
Quality Assurance Department

Conveyer belt is clean and cleared from the remains of previous product. Yes NO
All packaging components have been verified and cross checked as per the Yes NO
Quantity mentioned in the packing order.
Related documents of the product to be packed are available on the belt. Yes NO
All equipment required for packing i.e. Conveyer Belts, are clean and cleared from the Yes NO
Remains of previous product.
Material printed properly Yes NO
Uniforms, of staff are properly worn. Yes NO
Remarks:-
Date/time: ____________
Q.A Inspector
Belt In-charge
Date Process Performed by
Auto-labelling
Label sorting
Unit Cartons sorting
Bottle sorting
Bottle placement
Leaflet Insertion
Purified water placement
Oral syringe Insertion
Unit carton closing

Weighing ( Pack of 6)
Final Master Carton
ID tags writing
Step 21 A On Line Packing Inspection
Date Stamp Unit Carton leaflet Spoon Purified Pack Price Checked Remarks
Time Printed (C/P)/(P/S) water Size Rs./= by

Step 22 Q.C Retaining Samples record

Pack Size: No. of packs taken:
Date:- Time:-
_____________ __________________ _____________

Send by Checked by Received by
Packing Officer Q.A Inspector Q.C Analyst
Step 33 Final Weighing Record
Shipper Weight Shipper Weight Shipper Weight Shipper Weight Shipper Weight
No (kg) No (kg) No (kg) No (kg) No (kg)
1 31 61 91 121
2 32 62 92 122
3 33 63 93 123
4 34 64 94 124
5 35 65 95 125
6 36 66 96 126
7 37 67 97 127
8 38 68 98 128
9 39 69 99 129

10 40 70 100 130
11 41 71 101 131
12 42 72 102 132
13 43 73 103 133
14 44 74 104 134
15 45 75 105 135
16 46 76 106 136
17 47 77 107 137
18 48 78 108 138
19 49 79 109 139
20 50 80 110 140
21 51 81 111 141
22 52 82 112 142
23 53 83 113 143
24 54 84 114 144
25 55 85 115 145
26 56 86 116 146
27 57 87 117 147
28 58 88 118 148
29 59 89 119 149
30 60 90 120 150
_______________
Weight by Checked By
Step 23 Transfer to finish Good Store
Date: Date
Qty. Deliver to Store (Sales)
Pack size: _______________________ Qty. Deliver to Store
Packs/carton:____________________ Pack size: _______________________
No of full cartons:_________________ Packs/carton:____________________
Packs in loose carton:_____________ No of full cartons:_________________
Total packs:______________________ Packs in loose carton:_____________
Total packs:______________________

Delivered ByPacking OfficerChecked ByQ.A.IReceived byWarehouse Officer
______________________ ________________ _____________________
Step 23 Transfer to finish Good Store
Date: Date:
Qty. Deliver to Store (Sales)
Pack size: _______________________ Qty. Deliver to Store
Packs/carton:____________________ Pack size: _______________________
No of full cartons:_________________ Packs/carton:____________________
Packs in loose carton:_____________ No of full cartons:_________________
Total packs:______________________ Packs in loose carton:_____________
Total packs:______________________
Delivered ByPacking OfficerChecked ByQ.A.IReceived byWarehouse Officer
______________________ ________________ _____________________
Step 24 Batch Consumption Record
Filled/ Weight 16.60gm/bottle Date

No of Units Produce
Raw Material
Sr.No Item Name Units Required Issued/used Returned Rejected Overage
01 Kg
02 Kg
03 Kg

04 Kg
05 Kg
06 Kg
Packaging Material
Sr.No. Item Name Units Required Issued/used Returned Rejected Overage
1 Pet Bottles 100ml NOS 3%

2 CRC Caps NOS 3%
3 Labels NOS 10%

4 Unit Cartons NOS 5%
5 leaflets NOS 1%
6 Spoon (5mL) NOS 1%
7 Master cartons NOS 1%
_______________ ____________ ________________

Prepared by Reviewed by Checked by
Production Officer Production Manager QA Manager

No of Units Produce
Raw Material
01 Kg
02 Kg
03 Kg
04 Kg
05 Kg

06 Kg
Packaging Material

2 CRC Caps NOS 3%
3 Labels NOS 10%

5 leaflets NOS 1%
_______________ ____________ ________________


No of Units Produce
Raw Material
01 Kg
02 Kg
03 Kg
04 Kg
05 Kg
06 Kg

Packaging Material

2 CRC Caps NOS 3%
3 Labels NOS 10%

5 leaflets NOS 1%
_______________ ____________ ________________

Step 25 Re-workable Recovered material

Product: Batch No.:
Batch Size:
Mfg. Date:
Date: Exp. Date:

Date Operator Supervised
By
Give detail of reworking left.
S. No. Product B. No Status . Quantity/Weight
1
2
3
__________
Requested by: Reviewed by: Approved by:

Step 26 Yield Statement
Date: Batch Size:

Theoretical Yield
Actual yield
%age Yield
_____________ ________________ ______________

Prepared by: Reviewed by: Checked by:
Production Officer Production Manager QA Manger
Step 27 Disposal/Destruction Note
Sr. no. Product Name Qty Rejection %age Rejection

issued/used
1 Pet Bottles 100ml
2 Plastic Caps
3 Labels
4 Cartons
5 Inserts
6 Spoon
7 Master cartons N-82
________________ __________________
Belt In-charge Production Officer
________________ Authorization __________________

QA Manager Production Manager
________________ Destruction Witness _________________

QAI Production Officer
Step 28 Request For Analysis of Finish Product (Final Product)
Product: Batch No.:

Batch Size: Mfg. Date: Exp. Date:
Send By: Date: Time: Received By: Date: Time:
Product Specifications
Packing Status Observation Specification
Physical appearance
Color of Product
Dosage from

Packaging Specification
Pack Size
Observation Specification
Sale/Sample Box
Inner Pack
Master Pack
Mfg Date:- Exp Date
Manufacturing Lic No:- Reg. No
M.R.P.Rs Batch /Lot No
Assay ----------------------------------------------------------------------------------------------------
Remarks-------------------------------------------------------------------------------------------------
Analyzed By: __________ Checked by: _______________

QC Analyst Q.C Manager

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Product: Active Ingredient:

Reg.No: Product specs: USP specs

Sr no Document Name Status Prod. OfficerQA officer

Doc # RP/PR/BMR/DS 001 Page #: 1/31

Doc # RP/PR/BMR/DS 001 Page #: 2/31

Step 1. Request for Line clearance for Dispensing

Doc # RP/PR/BMR/DS 001 Page #: 3/31

Send by: Date : Time: Rec. by: Date: Time:

Pre- Dispensing GMP Checks Report

Remains of previous product ________________________Batch No _______removed. Yes NO

Step 2. Ingredients Qty/ Qty/

__________________ ________________ ______________ _____________ _____________

Step 2. Dispensing of Raw material DISPENSING

Doc # RP/PR/BMR/DS 001 Page #: 5/31

__________________ ________________ ______________ _____________ _____________

Step 3 Packing Material Order Batch no:

Batch Size: 5000 bottles

Item Qty/ Analysis Vendor/ Qty Qty Issued by Checked Received

Doc # RP/PR/BMR/DS 001 Page #: 6/31

HDPE pet bottles

Step 3 Packing Material Order Batch no:

Batch Size: 5000 bottles

Doc # RP/PR/BMR/DS 001 Page #: 7/31

Item Qty/ Analysis Vendor/ Qty Qty Issued by Checked Received

HDPE pet bottles

Step 5. Request for Line clearance for mixing

Initiated by Production Officer : Date: Time: Received By QAI: Date: Time:

Doc # RP/PR/BMR/DS 001 Page #: 8/31

Pre Mixing GMP Checks Report

Remains of previous product_______________________ Batch No _______removed.

Doc # RP/PR/BMR/DS 001 Page #: 9/31

start Finish By Prod. QAI

1. Pass Fine sugar (Standard grade) through sieve

2 Then add the following materials in a polythene

Initiated by Production Officer : Date: Received By QAI: Date: Time:

Send request to QA Department for sampling of filled Send by Sampled By Received

Analytical Report (Final Mix bulk powder)

Analyzed By: ___________ Date: ____________

Step 8 Batch Reconciliation (Mix Bulk powder)

Doc # RP/PR/BMR/DS 001 Page #: 11/31

a) Theoretical Yield: _____________________________ Kg.

_________________ _________________ _______________

Step 9 Transfer Of mixed bulk powder for Filling and Sealing

Qty Transferred No Of Shippers Transferred By Received By

Doc # RP/PR/BMR/DS 001 Page #: 12/31

Step 10 Request for Line Clearance for Filling and Sealing

Pre-Filling and Sealing GMP Checks Report

Doc # RP/PR/BMR/DS 001 Page #: 13/31

Step 11 Control Form (Filling and sealing)

Step 12. Batch Reconciliation (Filled Bottles)

a) Theoretical Yield: __________________________Bottles

b) Actual Yield: ______________________________Bottles

Step 13 Transfer Of Bottles to IPQ

Qty Transferred No Of Shippers Transferred By Received By

Step 14. Analytical Report (filled Bottle)

Doc # RP/PR/BMR/DS 001 Page #: 15/31

Analytical Report (filled Bottle)

Parameter Standard Result

Analyzed By:_______________ Date: _______________

Step 15 Packing Material Order

Doc # RP/PR/BMR/DS 001 Page #: 16/31

Labels 10% 5500

Unit Carton 1% 5050

Remains of previous product __________________Batch No _removed. Yes NO

__________ _ _______

__________ _ _______

Remains of previous product_________________ Batch No _removed.

Analyzed By: _ Date: __

_________ _ _______

Analyzed By:_ Date: _

________ _ _______

________ _ _______

Remains of previous product_____________ Batch #_Removed. Yes NO

Remains of previous product_____________ Batch #_Removed. Yes NO

_ ___

__ _

__ _

_ __

_ __

_ __

_ __

Authorization __