Preparation for BOM and Master Formula Records

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Preparation for BOM and Master Formula Records

OBJECTIVE:
To lay down a Procedure for Preparation, Checking, Review, Approval, BOM and Master Formula Records.

2.0 SCOPE:
This SOP is applicable for Preparation, Checking, Review, Approval, of BOM & Mater Formula Records at ………………

3.0 RESPONSIBILITY:
Production (Officer/Executive): Preparation, Revision of BOM and MFR.
QA (Officer/Executive): Issuance, Control, Retrieval and Destruction of BOM and MFR. QA Manager: Review, Approval, Training and effective implementation of this SOP. Manager Production: Checking, Implementation and Execution of BOM and MFR.

4.0 ACCOUNTABILITY:
Head Production: Ensure Training and effective Implementation of SOP.

5.0 DEFINITION:
BOM: Not Applicable
MFR: MFR is one of key document in pharmaceutical. it is record or history for every Master Formula Record.

6.0 PROCEDURE:
6.1 PREPARATION BOM AND MFR:
6.1.1 BOM & MFR shall be written in English Language by using Microsoft Word.
6.1.2 Production (Officer/Executive) Preparation, Revision and QA (Officer/Executive) Issuance, Control, Retrieval and Destruction of BOM and MFR review.
6.1.3 Master Formula Record (MFR) shall be prepared” as shown in Annexure-I. Bill of materials (BOM) shall be prepared as shown in Annexure-II
6.1.4 MFR shall cover all activities of Operation in proper sequence and mention the reference SOP and Annexure No.-1 & Annexure No.–2 for BOM wherever applicable.
6.1.5 Initiator shall prepare the draft of BOM and MFR as per all activities of the product and send to the Manager Production.
6.1.6 Production manager shall check the draft BOM and MFR Accuracy, Adequacy, Correctness and Completeness.

6.1.7 Upon receipt of the comments (if any), the same shall be incorporated by initiator in the draft MFR.
6.1.8 Production shall take the printout of MFR for signature in Prepared By.
6.1.9 Upon signature of Production Manager in checked by, signed off MFR shall be sent back to Head QA and Approved by, Master Index of BOM and MFR shall be maintained by QA Department.
6.1.10 Master list index of MFR shall be updated by QA once in a year or whenever required.
6.2 DESIGN OF MFR
MFR Format Considerations:

6.2.1 All MFR shall contain Header, Body “MFR Specimen Copy” as shown in Annexure-I.
6.2.2 All pages shall contain Format No. in Footer.
6.2.3 All the points in the MFR shall be numbered sequentially.
6.2.4 Provide the proper space between the Rows of the tables for filling the details.
6.2.5 Font size of table Content may be Changeable in case of insufficient space but it should not be less than 9 Font.
6.2.6 All MFR contents shall be covered by Single Borderline with ½ Line Width.
6.2.7 MFR Header shall be covered by a borderline with 1 Line Width, Specimen of Header of MFR as per format “MFR Format Specimen Copy” as shown in Annexure-I.
6.2.8 Line Spacing and Font Size: The Line Spacing between two points or title & subtitle shall be Single/1.5 lines font style shall be Times New Roman 12 font. Font size may be less in case of Table and Remarks.
6.2.9 MFR (Master Copy) shall be printed on A4 size Off-white colored Executive Bond Paper using “Times New Roman” Font with Black Ink. Printing shall be done on one side of the paper only.
6.2.10 Paper Selection for Print: Paper 8.5” (Width), 11” / 11.5” (Height), Border Top

0.38”,Left 1.25”, Right 0.4”, and Bottom 0.5”, with A4 Size Scaling, Layout of header 0.5”.
6.3 CONTENT OF HEADER PART:
6.3.1 Header of First Page:
6.3.1.1 The Header of MFR shall include the Name of Organization. Header shall have the Logo of Organization in Left corner on Top, and followed by “Master Formula Record ” in center as shown in Annexure-I.

6.3.1.2 Product Name: Product Name should be Pre-printed.
6.3.1.3 Effective Date: Effective Date shall be written in the form of DD/MM/YY in respective column.
6.3.1.4 MFR No.: Mention the MFR No. as per respective SOP, Assign the MFR No. as per respective SOP, it shall be pre- printed.
Assignment of MFR Number:
XXX/YY/NNN
Where,
XXX : Denotes MFR
/ : Separator
YY : Denotes department/code “Master Formula Records Numbering System”.
/ : Separator
NNN : Sequential Numbering (001,002 & so on) For example,
Three piece line : MFR/TP/001

Dry powder line : MFR/DP/001

Liquid Ampoule line : MFR/LA/001

Liquid Vial line : MFR/LV/001
BOM Sequential Numbering PMF/0001 (Pharma Manufacturing Formula)
6.3.1.5 Page No.: The Page Number shall be mentioned in ‘X of Y’ Header. For Example: If a MFR contain 60 pages then the first page of the MFR shall be Start from 1 of 60, 2 of 60 and shall be pre-printed.

Stamping: COPY stamp shall be stamped in space provided in the Header part on the upper right hand side of the page.
6.4 CONTENT OF THE BODY:
6.4.1 First Page: First page shall contain, content as shown in Annexure-I.
6.4.2 Second Page of MFR: Second Page of MFR shall contain “TABLE OF INDEX” in the form of given table. Header Row of Table shall have gray 25 % Shading Colour.
6.4.3 Other than First & Second Page:
6.4.3.1 Main Contents of the MFR (but not limited to):
All Master Formula Record shall contain the following headings:
6.4.3.2 Quantitative Formula (Bill of Material) of RM and PM.
6.4.3.3 API Calculations
6.4.3.4 Specification and standard testing procedures of RM and PM.
6.4.3.5 List of Equipment’s/Machines to be used for Manufacturing/Packing Process with Machine/Equipment ID No.
6.4.3.6 Manufacturing/Packing Processing Details with proper instructions (Separately)
6.4.3.7 Process flow chart.
6.4.3.8 Manufacturing/Packing Processing Details with steps wise (Separately)
6.4.3.9 Bulk & Finished Product Specification
6.4.3.10 Abbreviations
6.4.3.11 Sale Authorization (in MFR)
6.4.3.12 Revision History: “Revision History” shall be the last heading of Body part of MFR.

6.5 CONTENT OF THIRD PAGE:
6.5.1 Prepared By: Prepared By shall be signed by Officer / Executive Production who initiates the MFR along with Name, Sign, Date.
6.5.2 Checked By: Checked by shall be signed by Production Manager and signed along with Name, Sign, Date.
6.5.3 Approved By: Approved by shall be signed by Head QA and signed along with Date and Name.
6.5.4 Sign: Concerned personnel shall sign off with Blue Ink Ball Point Pen.
Note: Do not use Gel / Fountain Pen for Signing / Filling the Documents.
6.5.5 Date: Date shall be mentioned in the form of DD/MM/YY.
6.5.6 Name: Full Name of person shall be mentioned who signs the MFR.
6.6 FONT STYLE/SIZE OF HEADER & BODY CONTENTS OF MFR & BOM:

NAME OF CONTENT	FONT SIZE
Effective Date	12 Capital & Bold
Page No.	12 Capital & Bold
Format No.	09 Capital & Normal
BODY:
Paragraph Main Heading & First Page	38 Bold & Capital
Subheading	Not less 18 Normal/Capital & Bold
Table Heading and Header of the Table	11 Capital/Normal & Bold
Table Body Part Content	11 Normal

PREPARATION OF BOM & MASTER MFR, CONTROL, ISSUANCE AND RETRIEVAL :
6.7.1 After Approved, MFR shall be stamped as “MASTER COPY” with Blue colour ink in space provided in Header (on all the pages) and sign and date with Blue Ink Ball Point Pen.
6.7.2 Effective Date shall be entered in all pages of header column (Effective date) with Blue Ink Ball point Pen.
6.7.3 Master copy of BOM & MFR shall be scan and save as password protected pdf copy.
6.7.4 Take the print out from this scanned password protected pdf copy (Master copy) and shall be shall be stamped as “CONTROLLED COPY” with green colour stamp (all pages) and sign and date with Black Ink Ball Point Pen.
6.7.5 MFR No. Shall be entered in all pages of header column with Pre Printed.
6.7.6 In case of change in MFR which had already been issued for the products as per earlier plan are returned through deviation as per QA SOP “Handling of Deviation” before issuance of MFR as per revised plan.

QA Officer/Executive shall mark the entry of the returned MFR in Issuance Record as reason shall be mentioned in the remark column’ as per format “MFR Issuance and Retrieval Record” as shown in Annexure-III and returned MFR shall be destroyed by Paper shredder.
6.8 MFR Cover File:
6.8.1 MFR Cover file Printing Matter shall be as per format “MFR Cover Page Format” as shown in Annexure-VI. MFR Cover file Colour shall be different for different QA Blocks/Dosage Forms.
6.8.2 All cover file shall contain MFR documents check list printed on back side of front cover file.
6.8.3 Colour Codes for Cover File:
 General Products: Blue Colour
Note: Printing on Cover File shall be done by Black Ink only
6.9 STORAGE OF BOM & MFR (Master Copy/Soft Copy):
6.9.1 All Master Copy/Soft Copy of Approved BOM & MFR shall be stored in QA Department with Password Protected System and Data Backup shall be kept in Information Technology (IT) Department.
6.10 REVISION OF BOM & MFR:
6.10.1 Any change in BOM & MFR shall be done only after Approval of “Change Control”.
6.10.2 Revision No., Change Control No., Details of Changes, and Reason for Change shall be written under heading Revision History in BOM & MFR.
6.10.3 Previous version shall be made obsolete as per SOP.

7.0 ABBREVIATIONS:
BOM Bill of Materials

MFR Master Formula Record

QA Quality Assurance

Exp. Date Expiry Date

ID No. Identification Number

Ltd. Limited

Mfg. Date Manufacturing Date

MFR No. Master Formula Record Number

MRP Maximum Retail Price

No. Number

Pvt. Private

QA Quality Assurance