BATCH MANUFACTURING REVIEW

Annexure 1: Checklist for Draft BMR Review.

Sr. Reference
Check Points
No. Documents

STEP 1: INTRODUCTION OF  NEW PRODUCT (BMR Review)

1 Ensure that the availability of Approved MPS. Approved MPS

Approved
2 Ensure that the availability of Approved Change Control.
Change Control

3 Ensure that the availability of the Approved Bill of Material Master. Approved BOM

Ensure that the availability of Risk Assessment Report of SOP Approved

4
Granulation/ Compression and Coating (as required). MPS

License no, Form no, Generic name, Product name (Brand name) and FDA License
5
Label Claim/Category, product strength and type of dosages form. copy

Product Code, Description, Batch Size, BOM Code, Unit, Item Code,
Item Ref. Lot, Item Name/Manufacturer Code, Quantity (Lot Wise), Approved MPS
6
Material Potency, Minimum potency, Adjust potency, BOM valid up Approved BOM
to and BMR version No.

7 Product Shelf Life. Approved MPS

8 Product stability data. Approved MPS

Product description (core tablet /coated tablet /finished product

Approved MPS
specification).

Approved MPS
9 Grade (Pharmacopoeial status) of API and Excipients.
Master BOM

10 Overages in Raw materials added, (if any) Approved MPS

Product manufacturing and packing special precautions (if any).         

11 Approved MPS
(e.g. Light Sensitive and Hygroscopic)

12 Stage wise yield limits. IH

Bill of Material/Work order, pages, and space for entries/ instructions

13 NA
and UOM (Unit of Measurement)

14 Details of product equipment’s/utensils are used for manufacturing. IH

15 Equipment equivalency and occupancy as per batch size IH/SOP

Item codes for raw materials as per regulated /non- regulated market
16 Approved BOM
requirement
 BATCH MANUFACTURING REVIEW

17 Details of environmental conditions for product stage wise. Approved MPS

During Sifting and Milling process checks and ensures Mesh size/
18 Approved MPS
Screen size/ Co-sifting / Pre-mixing/Qty. and Ingredients used.

During Binder Preparation process checks and ensures Sieve/Binder

19 Approved MPS
preparation time and Temperature of Purified Water.

During Mixing and Granulation processes checks and ensure Material

20 Approved MPS
sequence/ Mixing time/ Agitator -Chopper speed and Ampere load.

During Drying process checks and ensure Operating parameters/

21 Approved MPS
LOD/Total drying time.

During Sizing and Milling checks and ensure Screen size/Mesh size/
22 Approved MPS
Direction of blades / Speed and Milling time.

During Lubrication (Blending) checks and ensure Blending time /

23 Approved MPS
Speed and LOD.

During Compression and Inspection checks and ensure Physical

parameters / Operating parameters/ Punch description (Drawing)
24 Approved MPS
/Tablet description, dimension / Machine type/ Machine speed/ Qty.
of defected tablets and Quantity of good tablets.

During Coating and Inspection checks and ensure Physical

parameters/ Operating parameters /Quantity/ Stirrer RPM / Time for
25 Approved MPS
milling/ Homogenization/ Qty. of defected tablets and Quantity of
good tablets.

Coating specifications like Appearance, Weight, Thickness,

26 Approved MPS
Diameter, DT, etc. shall be the part of BMR.

STEP 2: SITE TRANSFER PRODUCT (BMR Review)

1 Ensure that the availability of Site Transfer BMR. Approved BMR

Approved
2 Ensure that the availability of Approved Change Control.
Change control

3 Ensure that the availability of the Approved Master Bill of Material. Approved BOM

Ensure that the availability of Risk Assessment Report of Granulation/

4 IH/SOP
Compression and Coating (as required).

License no, Form no, Generic name, Product name (Brand name) and
5 FDA License
Label Claim/Category, product strength and type of dosages form.

6 Product Code, Description, Batch Size, BOM Code, Unit, Item Code, Approved BOM
Item Ref. Lot, Item Name/Manufacturer Code, Quantity (Lot Wise), Approved BMR
Material Potency, Minimum potency, Adjust potency, BOM valid up
 BATCH MANUFACTURING REVIEW

to and BMR version No.

7 Product Shelf Life. Approved BMR

8 Product Stability Data. Transfer Site

Product description (core tablet /coated tablet /finished product Approved BMR
9
specification). FP Specification

1 Batch size (Kg/No. of units), unit dosage weight/Lot division as per Approved BOM
0 batch size/ Overages in Raw materials added, (if any) Approved BMR

1 Approved BOM
Grade (Pharmacopoeial status) of API and Excipients.
1 Approved BMR

1 Product manufacturing special precautions (if any). (e.g. Light

Approved BMR
2 Sensitive and Hygroscopic)

1
Stage wise yield limits IH
3

1 Bill of Material/Work order pages and space for entries/ instructions

NA
4 and UOM (Unit of Measurement)

1
Details of product equipment’s/utensils are used for manufacturing. IH
5

1
Equipment equivalency and occupancy as per batch size IH/SOP
6

1 Item codes for raw materials as per regulated /non- regulated market Approved BOM
7 requirement Approved BMR

1
Product-related Stage wise Environmental Condition Approved BMR
8

1
Ensure that the availability of Tooling Drawing/Change Part IH
9

2
Ensure that the availability of the Site Product History/Flow Chart. From Site
0

2 During Sifting and Milling process checks and ensures Mesh size/
Approved BMR
1 Screen size/ Co-sifting / Pre-mixing/Qty. and Ingredients used.

2 During Binder Preparation process checks and ensures Sieve/Binder

Approved BMR
2 preparation time and Temperature of Purified Water.

2 During Mixing and Granulation processes checks and ensure Material

Approved BMR
3 sequence/ Mixing time/ Agitator -Chopper speed and Ampere load.

2 During Drying process checks and ensures Operating parameters/ Approved BMR
 BATCH MANUFACTURING REVIEW

4 LOD/Total drying time.

2 During Sizing and Milling checks and ensure Screen size/Mesh size/
Approved BMR
5 Direction of blades / Speed and Milling time.

2 During Lubrication (Blending) checks and ensure Blending time /

Approved BMR
6 Speed and LOD.

During Compression and Inspection checks and ensure Physical

2 parameters / Operating parameters/ Punch description (Drawing)
Approved BMR
7 /Tablet description, dimension / Machine type/ Machine speed/ Qty.
of defected tablets and Quantity of good tablets.

During Coating and Inspection checks and ensure Physical

2 parameters/ Operating parameters /Quantity/ Stirrer RPM / Time for
Approved BMR
8 milling/ Homogenization/ Qty. of defected tablets and Quantity of
good tablets.

2 Coating specifications like Appearance, Weight, Thickness, Diameter,

Approved BMR
9 DT, etc. shall be the part of BMR.

STEP 3: FORMULATION CHANGE

A.       MAJOR CHANGE (E.G. GRANULATION PROCESS CHANGE)

Approved
1 Ensure that the availability of Approved MPS.
MPS

Approved
2 Ensure that the availability of the Approved Master Bill of Material.
BOM

Approved
3 Ensure that the availability of Approved Change Control.
Change control

Ensure that the availability of Risk Assessment Report of Granulation/

4 IH/SOP
Compression and Coating (as required).

License no, Form no, Generic name, Product name (Brand name) and
5 FDA License
Label Claim/Category, product strength and type of dosages form.

Product Code, Description, Batch Size, BOM Code, Unit, Item Code, Approved
Item Ref. Lot, Item Name/Manufacturer Code, Quantity (Lot Wise), MPS
6
Material Potency, Minimum potency, Adjust potency, BOM valid up to Approved
and BMR version No. BOM

7 Overages in Raw materials added, (if any) MPS

Approved
8 Product Stability Data.
MPS
 BATCH MANUFACTURING REVIEW

Approved
9 Product Shelf Life.
MPS

Approved
10 Grade (Pharmacopoeial status) of API and Excipients.
BOM

11 Equipment equivalency and occupancy as per batch size IH/SOP

Product description (core tablet /coated tablet /finished product Approved

12
specification). BMR

Bill of Material/Work order pages and space for entries/ instructions and
13 NA
UOM (Unit of Measurement)

A.    MINOR CHANGE (E.G. CHANGE IN QUANTITY)

Ensure that the availability of Approved MPS or Availability of Approved MPS

1
supportive documents. Supporting documents

Ensure that the availability of the Approved Master Bill of

2 Approved BOM
Material.

Approved Change
3 Ensure that the availability of Approved Change Control.
Control

License no, Form no, Generic name, Product name (Brand name)
4 and Label Claim/Category, product strength and type of dosages FDA License
form.

Product Code, Description, Batch Size, BOM Code, Unit, Item Code,
Item Ref. Lot, Item Name/Manufacturer Code, Quantity (Lot Wise), Approved
5
Material Potency, Minimum potency, Adjust potency, BOM valid up to BOM
and BMR version No.

Approved
6 Overages in Raw materials added, (if any) MPS Existing
BMR

Approved
7 Product Shelf Life. MPS Existing
BMR

Approved
8 Grade (Pharmacopoeial status) of API and Excipients.
BOM

Bill of Material/Work order: pages and space for entries/ instructions and
9 NA
UOM (Unit of Measurement)

STEP 4: OTHER TYPE OF CHANGES

A.    PHARMACOPOEIAL CHANGE
 BATCH MANUFACTURING REVIEW

Ensure that the availability of the Approved Master

1 Approved BOM
Bill of Material.

Ensure that the availability of Approved Change Approved Change

2
Control. Control

3 BMR version No. Master Bill of Material Code No. Approved BOM

Pages and space for entries/ instructions /quantities

4 NA
and UOM

B.     BATCH SIZE CHANGE

Ensure that the availability of the Approved Master

1 Approved BOM
Bill of Material.

Ensure that the availability of Approved Change Approved Change

2
Control. Control

3 FDD Approval required. Supporting Document

Ensure that the availability of the Risk Assessment

4 NA
Report of Granulation/Compression/Coating stage.

5 BMR version No. Master Bill of Material Code No. Master BOM

Pages and space for entries/ instructions /quantities

6 NA
and UOM

A.    PUNCH SPECIFICATION CHANGE

Ensure that the availability of Approved Change Approved Change

1
Control. Control

2 FDD Approval required. Supporting Document

3 BMR version No. NA

Pages and space for entries/ instructions /quantities

4 NA
and UOM.

B.     COMPRESSION SPECIFICATION CHANGE

Ensure that the availability of Approved Change Approved Change

1
Control. Control

2 FDD Approval required. Supporting Document

3 BMR version No. NA

Pages and space for entries/ instructions /quantities

4 NA
and UOM
 BATCH MANUFACTURING REVIEW

C.    CRITICAL PROCESS PARAMETER FREEZE

Ensure that the availability of Approved Change Approved Change

1
Control. Control

2 Approved Trend Data required. NA

3 BMR version No. NA

Pages and space for entries/ instructions /quantities

4 NA
and UOM

ACKNOWLEDGEMENT: I______________________has read the above checkpoints

which are required to ensure during review of draft BMR and understood the same.

Name:

Emp. Code:

Department:

Sign/Date:
 BATCH MANUFACTURING REVIEW
Annexure 2: Checklist for Draft BPR Review.

Reference
Sr. No. Check Points
Documents

STEP 1: INTRODUCTION OF  NEW PRODUCT

1.                      Ensure that the availability of Approved MPS. NA

Ensure that the availability of Approved Change

2.                      NA
Control.

Ensure that the availability of the Approved Master Bill

3.                      NA
of Material (PM).

4.                      Ensure that the Risk Assessment Report (Packing) MPS

5.                      Product name: Generic name, Brand name. FDA License

6.                      Packing code, BPR version No. Master BOM

Product strength, Type of dosage form & label

7.                      FDA License
claim/Category

8.                      Stability Data/Finished Product Shelf Life MPS

9.                      Description as per Finished Product Specification. MPS

Product-related special precautions (if any) (e.g. Light

10.                    MPS
Sensitive and Hygroscopic)

11.                    Environmental Condition MPS

12.                    Product-Related Pack Profile MPS

Packing Area for the product: Equipment’s used for

13.                    IH
Packing

14.                    In-process test (Leak test, Morpholine test) IH

Bill of Material/Work order: pages and space for

15.                    NA
entries/ instructions

16.                    Yield limits (To be established) IH

STEP 2: SITE TRANSFER PRODUCT

1.        Ensure that the availability of Site Transfer BPR. NA

2.        Ensure that the availability of Approved Change Control. NA

3.        Ensure that the availability of the Approved Master Bill of Material NA
 BATCH MANUFACTURING REVIEW

(PM).

Transfer
4.        Ensure that the availability of the Risk Assessment Report (Packing)
BPR

FDA
5.        Product name: Generic name, Brand name.
License

Master
6.        Packing code, BPR version No.
BOM

FDA
7.        Product strength, Type of dosage form & label claim/Category
License

Transfer
8.        Stability Data/Finished Product Shelf Life/Description
BPR

Product-related special precautions (if any) (e.g. Light Sensitive and Transfer
9.       
Hygroscopic) BPR

Transfer
10.    Environmental Condition/Pack Profile
BPR

11.    Packing Area for the product: Equipment’s used for Packing IH

12.    In-process test (Leak test, Morpholine test) IH

13.    Bill of Material/Work order: pages and space for entries/ instructions NA

14.    Yield limits (To be established) IH

15.    Ensure that the availability of Change Part From Site

STEP 3: CHANGE IN PACK STYLE

1.        Ensure that the availability of stability data. FDD

2.        Ensure that the availability of Pack Profile. PDD

3.        Ensure that the availability of Approved Change Control. NA

Ensure that the availability of the Approved Master Bill of Material

4.        NA
(PM).

5.        Ensure that the Risk Assessment Report (Packing) NA

Ensure that the availability of the Approved Master Bill of Material

6.        NA
(PM).

7.        Ensure that the Risk Assessment Report (Packing) NA

8.        Packing code, BPR version No. Master BOM

 BATCH MANUFACTURING REVIEW

9.        Bill of Material/Work order: pages and space for entries/ instructions NA

10.    Yield limits (To be established) IH

STEP 4: PARAMETER FREEZE (Forming Roller Temp./Sealing Rolling

Temp./Machine RPM/Compressed Air Pressure/ Yield data)

1.        Ensure that the availability of Approved Change Control. NA

2.        Department Approved Trend Data required. NA

3.        BPR version No. NA

4.        Pages and space for entries/ instructions /quantities and UOM NA

ACKNOWLEDGEMENT: I______________________has read the above checkpoints

which are required to ensure during review of draft BPR and understood the same.

Name:

Emp. Code:

Department:

Sign/Date:
 BATCH MANUFACTURING REVIEW
Annexure 3: Checklist for Filled BMR Review.

Stage Of
Granulation/ Compression / Coating
Processing

Complies/Not
Sr. No. Checkpoints
Complies/NA

1 Check all entries mentioned on the cover page of BMR.

Check that the wash water analysis reports (if required) is

2
attached to BMR.

Check METIS generated fresh batch confirmed IMO (Issue

3
Material Order) and deviated IMO attached with the BMR.

Check the Raw Material issue coupons for completeness

4 e.g. A.R. No., Batch No., Qty. dispensed against IMO and
BMR and checked by sign and are attached with BMR.

Check that the environmental conditions (temperature &

5
RH) are within the limit as per BMR.

Check line clearance checklist and cleaned/ partially

6 cleaned card at each and every stage attached with the
BMR.

Check that the procedure, process parameter &

7 equipment /Accessories is followed as per BMR and
recorded properly.

8 Check that all in-process records is attached to the BMR.

Any planned or unplanned deviation like Change

Control/Event in the process is properly documented and
9
authorized (Refer CC No /Event No) and their photocopy
attached to the BMR.

Closed/Not
10 Check the status of Shop Floor Observation.
closed

Check that the batch yield calculation and batch

11
reconciliation are within the limit as per BMR.

Check that all entries have done properly with sign and date
12
and approved chemist has signed.

Ensure that the batch is released by QA for further

13
processing and the AQL sheet shall be attached to BMR.

14 Check finished /micro/ validation sample/hold time has

been withdrawn and its quantity documented properly and
 BATCH MANUFACTURING REVIEW

test requisition cum report attached with the BMR.

All the observation listed in executed batch record review

15
sheet is corrected by Production officer.

16 Check the BMR history sheet comment.

17 Check all the page number sequence in the executed BMR.

 NOTE :
 Check Legible, Complete Set of BMR & Correctness Of entries (all
stages) and then sign in  BMR.
 Put tick mark (√) at Stage (At which stage BMR to be reviewed) and at the
status of Shop floor Observation mentioned above.
 BATCH MANUFACTURING REVIEW
Annexure 4: Checklist for Filled BPR Review.
Sr. Complies/Not
Checkpoints
No. Complies/NA

1 Check that all entries are filled at the cover page of BPR.

2 Check that the BPR is authorized for Packing.

Check that the METIS generated confirmed IMO (Issue Material

3
Order) and the deviated IMO attached to the BMR.

Check that the environmental conditions (temperature & RH) are

4
within the limit as per BMR.

Check line clearance checklist and cleaned/ partially cleaned card

5
at each and every stage and attached with the BPR.

6 Check packing material issue order against batch packing record.

Check that printed and plain overprinted packing material

7 specimen is attached and checked by the concerned packing
officer and verified by QA.

8 Check that the pack profile complies as per BPR.

Check that the distribution of batch size matches with standard

9
batch size.

Check that the procedure, process parameter & equipment

10
/Accessories are followed as per BPR and recorded properly.

11 Check that the all in process records are attached to the BPR.

Any planned or unplanned deviation like Change Control/Event in

12 the process is properly documented and authorized (Refer CC
No /Event No) and their photocopy attached with the BPR.

Check that the primary packing material, secondary packing

13
material and batch reconciliation are within limit as per BPR.

Check that the Hold time/validation/ control sample / micro /

14 stability samples are withdrawn and its quantity documented
properly and test requisition cum report attached with the BPR.

Check that the material return note for excess printed packing
15
material is attached with the BPR.

Check that the destruction of stereos & non- recoverable recovery

16
is documented properly.

Check that the Final Inspection Report and COA are attached with
17
BPR.
 BATCH MANUFACTURING REVIEW

Check the quantity to be dispatched against the Material Transfer

18
Note and its quantity documented properly in the BPR.

Ensure that the Approved Packing Head/ Production Head have

19
signed.

20 Check status of Shop Floor Observation. Closed/Not closed

All the observation listed in executed Batch Record Review Sheet

21
is corrected by Production officer/ Packing Officer.

22 Check BPR history sheet comment.

23 Check all the page number sequence in the executed BPR.

 Note:
 Check Legible, Complete Set of BPR & Correctness Of entries (all stages)
and then sign in BPR.
 BATCH MANUFACTURING REVIEW
Annexure 5: Executed Batch Record Review Sheet.

Put tick (√ ) wherever it is applicable:    (BMR/BPR)

Product:                                                                                                 Batch No:

Sr. No. Page No. Observation Stage Corrected By Production Checked By QA