bmr

 

 

 

 

Batch Manufacturing Record (BMR) Documentation Checklist

Sr. No.	Document / Record	Availability of Documents and Compliance	Remarks
1	Cover Page & General Instructions	Yes ☐    No ☐
2	BMR Compliance Checklist	Yes ☐    No ☐
3	Master Formulation	Yes ☐    No ☐
4	Calculation of API	Yes ☐    No ☐
5	Manufacturing Order	Yes ☐    No ☐
6	Line Clearance Checklist for Dispensing	Yes ☐    No ☐
7	Verification of Dispensed Raw Materials	Yes ☐    No ☐
8	List of Equipment Used During Manufacturing & Packing Process	Yes ☐    No ☐
9	Line Clearance Checklist for Granulation	Yes ☐    No ☐
10	Standard Manufacturing Procedure for Granulation	Yes ☐    No ☐
11	Quality Control Testing Report (Moisture Contents)	Yes ☐    No ☐
12	Granulation Procedure (Final Mixing)	Yes ☐    No ☐
13	Weight Record of Grains & Yield Calculation	Yes ☐    No ☐
14	Quality Control Testing Report at Final Mixing Stage	Yes ☐    No ☐
15	Line Clearance Checklist for Compression	Yes ☐    No ☐
16	Equipment Cleaning Status & Product Specification	Yes ☐    No ☐
17	Compression Start-Up Analysis Sheet	Yes ☐    No ☐
18	Weight Control Sheet for Compression	Yes ☐    No ☐
19	In Process Weight Monitoring Sheet	Yes ☐    No ☐
20	In Process Control Sheet for Compression	Yes ☐    No ☐
21	Weight Record of Compressed Tablets & Yield Calculation	Yes ☐    No ☐
22	Quality Control Testing Report After Compression	Yes ☐    No ☐
23	Line Clearance Checklist for Coating	Yes ☐    No ☐
24	Equipment Cleaning Status (Coating)	Yes ☐    No ☐
25	Standard Manufacturing Procedure for Coating	Yes ☐    No ☐
26	Weight Record of Coated Tablets & Yield Calculation	Yes ☐    No ☐
27	Quality Control Testing Report After Coating	Yes ☐    No ☐
28	Packing Order	Yes ☐    No ☐
29	Line Clearance Checklist for Blistering	Yes ☐    No ☐
30	Equipment Cleaning Status & Embossing Information	Yes ☐    No ☐
31	Line Clearance Checklist for Blistering P/S	Yes ☐    No ☐
32	Equipment Cleaning Status & Embossing Information P/S	Yes ☐    No ☐
33	In Process Control Sheet for Blistering	Yes ☐    No ☐
34	Team Layout Sheet at Blistering Stage	Yes ☐    No ☐
35	Line Clearance Checklist for Printing Machine & Area	Yes ☐    No ☐
36	Over Printing Information	Yes ☐    No ☐
37	In Process Control Sheet for Printing	Yes ☐    No ☐
38	Team Layout Sheet at Printing Stage	Yes ☐    No ☐
39	Line Clearance Checklist for Packing	Yes ☐    No ☐
40	Team Layout Sheet at Packing Stage	Yes ☐    No ☐
41	In Process Control Sheet for Packing	Yes ☐    No ☐
42	Certificate of Analysis (COA)	Yes ☐    No ☐
43	Finished Goods Transfer Note	Yes ☐    No ☐
44	Packing Material Reconciliation	Yes ☐    No ☐
45	Batch Reconciliation	Yes ☐    No ☐
46	Destruction Note	Yes ☐    No ☐

MASTER FORMULATION FOR RAW MATERIAL

Sr. #	Code #	Raw Materials	Each Tablet Contains (mg)	Standard Batch Size (80,000 Tabs.)
WET MIXING
1.
2.
PASTE
3.
4.
FINAL MIXING
5.
6.
7.
8.
Core Tablet Weight
9.
10.
11.
12.

CALCULATION OF ACTIVE PHARMACEUTICAL INGREDIENT (API)

API
Label Claim

Assay of API (Potency): __________________________________________

Overage of API: _________________________________________________

Label Claim: _______________________ per Tablet

Formula = 100 / Assay of API (potency)   × Label Claim      = __________ mg/Tablet

Calculation = mg/Tablet × batch size
1000g × 1000kg      = __________ kg/batch size

Total Weight of API (Kg): _________________________________________

Remarks (if any): _________________________________________________

MANUFACTURING ORDER

Date: ____________________

Product Name:		Batch No:
Manufacturing Date:		Expiry Date:
Batch Size (Kg):		Batch Quantity:
Registration No:		Requisition No:
Section:		Shelf Life (Months):

QC. No	Raw Materials	Qty. Reqd.	Qty. Issued	Additional Qty Issued	Return	Actual Used	Dispensed By	Checked By Disp. Pharmacist	Verified By QA Officer	Received By Production Officer

Coating Material Dispensing

QC. No	Raw Materials	Qty. Reqd.	Qty. Issued	Additional Qty Issued	Return	Actual Used	Dispensed By	Checked By Disp. Pharmacist	Verified By QA Officer	Received By Production Pharmacist