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BATCH MANUFACTURING FORMULATION PROCESS FOR AN ANTIMALARIAL DRUG PRODUCT
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BATCH MANUFACTURING RECORDPLOT 32, LYNSON CHEMICAL AVENUE, KM 38, LAGOS-ABEOKUTA EXPRESSWAY, SANGO-OTA, OGUN STATE Page 1 of 51
PRODUCT INFORMATIONPRODUCT NAME ACTPRO AL DRY SYRUP
NAFDAC REG. NO.A4-2664
DOSAGE FORMDRY SYRUP
PACKAGING SPECIFICATION60mL
SHELF LIFE2 YEARS
LABEL CLAIMEach 60mL containsARTEMETHER 180mgLUMEFANTRINE 1080mg
BATCH INFORMATION
JOB NO.004
BATCH NO.3B004001
BATCH SIZE0.458kg(50 BOTTLES)
DATE OF MANUFACTURE
02/2013
DATE OF EXPIRY
01/2015AUTHORISATION
QUALITY ASSURANCE MANAGER
SIGN & DATE
PRODUCTION MANAGER
SIGN & DATE
COMPOSITION
BATCH MANUFACTURING RECORD Page 2 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
Item No.
DESCRIPTION CODE SPEC.Standard mg/60mL Overage Actual
1. Artemether ERM0063 BP 9.0gm 10% 9.9gm
2. LUMEFANTRINE ERM0062 BP 54.0gm 10% 59.4gm
3. CITRIC ACID ERM0103 BP 3.75gm - 3.75gm
BATCH MANUFACTURING RECORD Page 3 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
4. SODIUM CITRATE ERM0001 BP 5.0gm - 5.0gm
5. ASPARTAME ERM0010 BP 3.75gm - 3.75gm
6. AVICEL RC 581 ERM0194 BP 16.3gm - 16.3gm
7. XANTHAN GUM ERM0097 BP 2.5gm - 2.5gm
BATCH MANUFACTURING RECORD Page 4 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
8. AVICEL PH 112 ERM0032 BP 325.0gm - 325.0gm
9. TARTRAZINE YELLOW ERM0031 BP 35.0mg - 35.0mg
10. STRAWBERRY FLAVOUR ERM0054 BP 12.5gm - 12.5gm
11. AEROSIL ERM0019 BP 20.0gm 20.0gm
BATCH MANUFACTURING RECORD Page 5 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
BATCH MANUFACTURING RECORD Page 6 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
WEIGHING PRECAUTIONEnsure that area is clean and clearance given Ensure that only “Approved” materials are used Ensure that personnel are properly dressedEnsure that balances are calibrated and clean Ensure that dispensed materials are properly identified Ensure that dispensing equipments are clean
Weigh into appropraitely labelled polythene bags: DATE COMMENCED DATE COMPLETEDWEIGHING BALANCE EQUIPMENT NUMBER:Item DESCRIPTION AR. NO. EXP. DATE ACTUAL TOTAL WEIGHT WEIGHT CHECK
BATCH MANUFACTURING RECORD Page 7 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
No. WEIGHT TAKEN STORES PROD. PROD.PHARM
QA
1. ARTEMETHER 9.9gm
2. LUMEFANTRINE 59.4gm
3. CITRIC ACID 3.75gm
BATCH MANUFACTURING RECORD Page 8 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
4. SODIUM CITRATE 5.0gm
5. ASPARTAME 3.75gm
6. AVICEL RC 581 16.3gm
7. XANTHAN GUM 2.5gm
8. AVICEL PH 112 325.0gm
BATCH MANUFACTURING RECORD Page 9 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
9. TARTRAZINE YELLOW 35.0mg
10. STRAWBERRY FLAVOUR 12.5gm
11. AEROSIL 20.0gm
BATCH MANUFACTURING RECORD Page 10 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
BLENDING PRECAUTIONEnsure that area is clean and clearance given Ensure that personnel are properly dressedEnsure that equipment is clean Confirm name and weight of materials before processingEnsure that humidity and temperature are within limits
EQUIPMENT CHECK
S.No. EQUIPMENT EQUIPMENT NUMBER CAPACITY CLEANED BY CHECKED BY REMARK
BATCH MANUFACTURING RECORD Page 11 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
1. SS DRUM BLENDER2. SS SIFTER3. SS BUCKETS4. SCOOPS, SPATULA
DATE COMMENCED DATE COMPLETED
BATCH MANUFACTURING RECORD Page 12 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
Step No.
OPERATION PROCEDURE START FINISH PROCESS CHECKDATE TIME DATE TIME OPERATOR CHECKED BY
1. WEIGHT CHECK Verify that the indicated weight on each ingredient tag corresponds to weight as per BMR.
2 DRYING Dry the following materials in the Tray drier at about 80°C -90°C for 4 – 5 hrs.2.5gm of Xanthan gum, 16.3gm of Avicel RC 581,3.75gm
BATCH MANUFACTURING RECORD Page 13 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
of Citric acid, 325.0gm of Avicel pH 112, 5.0gm of Sodium citrate
3. SIEVING Charge 9.9gm of Artemether, 59.4gm of Lumefantrine, Citric acid, Sodium Citrate, Aspartame, Avicel RC 591, Xanthan gum, Avicel PH 112, Tartrazine Yellow, Aerosil and Strawberry Flavour into the Drum Blender and blend for 10 minutes.
4. Discharging Discharge the powder mixture into an SS drum lined with
BATCH MANUFACTURING RECORD Page 14 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
two polyethylene bags. Tie properly and label appropriately.
5. IN-PROCESS SAMPLING
Fill the In-Process Analysis Request form and forward to QA for sampling and analysis.
Sampled by: Attach the completed In-Process Analysis Request form
7. DISCHARGING On QA approval, discharge the powder blend into SS drums lined with double polyethylene bags. Tie properly and label appropriately. Determine and record weight of the blend.
8. WEIGHT CHECK No. of containers: Weight of Blend: Operator: Pharmacist:
BATCH MANUFACTURING RECORD Page 15 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
BATCH MANUFACTURING RECORD Page 16 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
BATCH MANUFACTURING RECORD Page 17 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
BATCH MANUFACTURING RECORD Page 18 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
FILLINGCAPPING
PRECAUTIONEnsure that area is clean and clearance given Ensure that personnel are properly dressedEnsure that equipment is clean Confirm name and weight of materials before processing
BATCH MANUFACTURING RECORD Page 19 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
Ensure that humidity and temperature are within limits
EQUIPMENT CHECK
S.No. EQUIPMENT EQUIPMENT NUMBER CAPACITY CLEANED BY CHECKED BY REMARK
1. SINGLE-HEAD FILLING MACHINE2. CAPPING MACHINE3. LABELLING MACHINE
BATCH MANUFACTURING RECORD Page 20 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
DATE COMMENCED DATE COMPLETED
Step No.
OPERATION PROCEDURE START FINISH PROCESS CHECKDATE TIME DATE TIME OPERATOR CHECKED BY
1. FILL WEIGHT FILL WEIGHT TARGET: 9.16g
UPPER LIMIT: 9.39g
BATCH MANUFACTURING RECORD Page 21 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
LOWER LIMIT: 8.93g2. FILLING &
CAPPING1. Obtain line clearance from QA.2. Load the approved powder blend into the hopper.3. Operate the machine as per SOP to set the fill weight.4. Set the threading of the capping machine5. Once weight and capping is approved, commence with
the filling.6. Start capping of the bottles immediately.
BATCH MANUFACTURING RECORD Page 22 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
7. Check the weight of the bottles every 15minutes.8. Continue filling and capping until powder is exhausted
or until fill weight remains out of limit.3. DUSTING Collect the bottles into suitable containers. Clean each
bottle with a moist cloth to remove powder from bottle.4. LABELLING Set the product batch coding stereo on the labelling
machine using the batch details on page 1 of BMR.
BATCH MANUFACTURING RECORD Page 23 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
Confirm the information.Mount some labels on the machine and label some few bottles for QC approval of the batch coding and neatness of labelling.Obtain line clearance.On QC approval, start the labelling of the bottles.Check regularly to ensure that the batch coding is
BATCH MANUFACTURING RECORD Page 24 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
clearly printed.Affix a QA approved sample of label to the BMR.
5. OVERPRINTING Prepare the overprinting machine as per SOP.Set the product batch coding stereo using the batch details on page 1 of BMR. Confirm the information.Mount the stereo on the overprinting machine.Operate the machine to obtain a few coded packs and
BATCH MANUFACTURING RECORD Page 25 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
check the batch coding for legibility and correctness of information.Obtain line clearance from QA.Affix a QA approved sample of pack to the BMR.Start coding of packs.
6. PACKAGING 1. Clear the packaging line of any previous product.2. Obtain line clearance from QA and start the
BATCH MANUFACTURING RECORD Page 26 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
packaging.3. Rejects detected during packaging should be
processed immediately.
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
REMARKS *All additional information regarding the production process should be documented on this page*
BATCH MANUFACTURING RECORD Page 28 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
DESCRIPTION OF DEVIATION STAGE OF PROCESS DEVIATION OCCURRED JUSTIFICATION
BATCH MANUFACTURING RECORD Page 29 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
OPERATION LOG
PROCESS EQUIPMENT(S) LABOUR TIME DURATION
BATCH MANUFACTURING RECORD Page 30 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
WEIGHING
BLENDING
FILLING
BATCH MANUFACTURING RECORD Page 31 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
CAPPING
DUSTING
LABELLING
BATCH MANUFACTURING RECORD Page 32 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
DOCUMENT CONTROL *Every personnel that has to document any information into BMR should fill this section*
NAME OPERATION PERFORMED DATE SIGNATURE
1.
BATCH MANUFACTURING RECORD Page 33 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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PRODUCT NAME BATCH N0.
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MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
2.
3.
4.
5.6.7.
BATCH MANUFACTURING RECORD Page 34 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
8.9.10.
11.12.13.
BATCH MANUFACTURING RECORD Page 35 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
14.
15.
BATCH MANUFACTURING RECORD Page 36 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
OVERPRINTING PRECAUTIONEnsure that area is clean and clearance given Ensure that the batch coding on packaging materials corresponds to BMREnsure that overprinting machine is clean and operational Ensure that personnel are properly dressed
PACKAGING SPECIMEN DATE COMMENCED DATE COMPLETED
BATCH MANUFACTURING RECORD Page 37 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
Paste specimens of over print here of initial overprint Paste specimens of over print here of final overprint
BATCH MANUFACTURING RECORD Page 38 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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MFG. DATE
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QA MANAGER
PRODUCTION MANAGER
PACKAGING MATERIALS RECORDITEM CODE AR. No. REQUIRED FIRST ISSUE STORES
(sign)PRODUCTION(sign)
SUPPLEMENTARY ISSUE*
STORES (sign)
PRODUCTION (sign)
1. Actpro Al dry syrup inner EPM0210
BATCH MANUFACTURING RECORD Page 39 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
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Cartons2. 60ml Bottles
3. ROPP Caps; 28mm,
4. Actpro Al dry syrup Labels EPM0211
5. Leaflets
BATCH MANUFACTURING RECORD Page 40 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
6. Dosage Cup
*Request for additional pages from QA for more supplementary issue
BATCH MANUFACTURING RECORD Page 41 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
PACKAGING MATERIALS RECONCILIATIONITEM CODE TOTAL ISSUED TOTAL USED TOTAL REJECTS REASON FOR REJECT PRODUCTION
(sign)SURPLUS RETURNED
STORES(sign)
1. Actpro Al dry syrup inner Cartons
EPM0210
2. 60ml Bottles
BATCH MANUFACTURING RECORD Page 42 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
3. ROPP Caps; 28mm,
4. Actpro Al dry syrup Labels EPM0211
5. Leaflets
6. Dosage Cup
PACKAGING YIELD To be completed by production Pharmacist
BATCH MANUFACTURING RECORD Page 43 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
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PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
THEORETICAL OUTPUT ACTUAL OUTPUT % YIELD
1. BLENDING2. PACKAGING 2,000 bottles3.
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PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
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QA MANAGER
PRODUCTION MANAGER
4.
QUANTITY SENT TO QUALITY CONTROL DEPARTMENT (Assay and reference sample): ………………………………………………………….
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JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
QUANTITY SENT TO STORE:
DATE QUANTITY PACK PRODUCT REPORT NO.
BATCH MANUFACTURING RECORD Page 46 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
TOTAL QUANTITY
Remarks ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….
BATCH MANUFACTURING RECORD Page 47 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
PRODUCTION MANAGER QUALITY ASSURANCE MANAGER FACTORY MANAGER
BATCH MANUFACTURING RECORD Page 48 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
OPERATION LOG
PROCESS EQUIPMENT(S) LABOUR TIME DURATION
OVERPRINTING
BATCH MANUFACTURING RECORD Page 49 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
PACKAGING
DOCUMENT CONTROL *Every personnel that has to document any information into BMR should fill this section*
NAME OPERATION PERFORMED DATE SIGNATURE
BATCH MANUFACTURING RECORD Page 50 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
1.2.
3.
4.
5.6.
BATCH MANUFACTURING RECORD Page 51 0f 15JOB NO. PRODUCT NAME BATCH N0. BATCH SIZE SHELF LIFE MFG. DATE EXP. DATE QA MANAGER PRODUCTION MANAGER004 ACTPRO AL DRY STRUP 3B004001 0.458kg
50 Bottles2 YEARS 02/2013 01/2015
JOB NO.
PRODUCT NAME BATCH N0.
BATCH SIZE
MFG. DATE
EXP. DATE
QA MANAGER
PRODUCTION MANAGER
7.8.
