material products coding and bom creation (issue 06)
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T3A INDUSTRIAL
DOC# AP-05-1020 Issue # 06 Page 1 of 14
STANDARD OPERATING PROCEDURE
Title: MATERIAL & PRODUCTS CODING AND
BILL OF MATERIALS CREATION
ISSUE DATE: …/…/……. EFFECTIVE DATE: …/…/…. REVISION DATE: …/..…/…...
ASSIGNEE NAME TITLE SIGN./DATE
PREPARED BY ISLAM OMAR QA OFFICER
REVIEWED BY MOHAMMED ELSAADY QA SUPERVISOR
APPROVED BY SALIL SAKSENA S. QA MANAGER
HISTORY OF CHANGE
ISSUE #ISSUE DATE
PAGE # SUMMARY OF CHANGE
FromIssue 001
ToIssue 002
21/02/2002 All pages
Change in Doc. No. Change In assignee persons. Change in scope, responsibility, procedure, attachments. Change the no. of pages.
FromIssue 002 To
Issue 00327/03/2005 All Pages
Change in Document Formats. Change In assignee persons. Change in scope, objective, responsibility, procedure &
attachments. Change the no. of pages.
From Issue 003 To
Issue 0426/02/2006 All Pages
Change in document format. Change in assignee persons
From Issue 04 to issue 05
10/10/2006 All Pages Change in assignee persons. Change in Responsibility and procedures. Remove all attachments.
From Issue 05 to issue 06
07/03/2007 All Pages
Change in document title and assignee persons. Change in objective, scope, responsibility and procedure
to be merged with SOP DP-08-9020. Addition of BOM format.
____________________________________________________________________________________________________
PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
T3A INDUSTRIAL
DOC# AP-05-1020 Issue # 06 Page 2 of 14
1. OBJECTIVE:
1.1. This SOP describes the procedures to be followed for:
1.1.1.Creation of materials, bulk and finished products codes.
1.1.2.Setting the main description parameters to identify each item type.
1.1.3.Creation or changing the Bill of Materials "BOM" for bulk or finished products.
2. SCOPE:
2.1. Codes of active materials, inactive materials, primary packaging materials, secondary
packaging materials, bulk products, finished products.
2.2. BOM of bulk products and finished products.
3. RESPONSIBILITY:
3.1. QC analyst or designee: creating materials code and description.
3.2. QC Material supervisor or designee: Review and ensure the right description and code of each
item in the BOM.
3.3. R&D Supervisor or designee: creating the bulk code, bulk description and bulk BOM.
3.4. R&D Administrator or designee: routing the bulk BOM for concerned departments for
approval, with relevant formats.
3.5. Packaging Supervisor or designee: creating the finished products code and finished products
BOM.
3.6. Production Administrator or designee: routing the finished product BOM for concerned
department for approval, with relevant formats.
3.7. RA Manager or designee: reviewing and approval of the bulk and finished product BOM to be
matched with the registered data.
3.8. QC Manager or designee: reviewing and approval of the materials codes, materials description,
bulk BOM and finished product BOM.
3.9. R&D Manager or designee: reviewing and approval of the bulk codes, bulk description, bulk
BOM and finished product BOM.
3.10. Production Manager or designee: reviewing and approval of bulk BOM and finished product
BOM.
3.11. IT manager or designee: providing coding and description system security.
____________________________________________________________________________________________________
PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
T3A INDUSTRIAL
DOC# AP-05-1020 Issue # 06 Page 3 of 14
3.12. QA Manager or designee: reviewing and approval of bulk BOM, finished product BOM and
system compliance.
3.13. QA officer: Archiving for approved BOM format and its relevant format.
4. PROCEDURE:
4.1.Material Description:
4.1.1. Active Materials: materials having direct pharmacological (medicinal) action. Its description
depends on its name, state, and specs examples:
4.1.2.
Inactive Materials: materials in the product formula composition other than the Active material(s) and
Packaging material(s). Its description depends on the INN (International Nonproprietary
Name) or “Generic” name and, as appropriate, synonyms, brand (trade) names, state, grade
and a reference to an official compendium (Pharmacopoeia) and / or specifications.
Examples:
Material NameTrade name Or
Generic nameMaterial State
Grade - Specs
(EP, USP, BP)
Avicel RC 591 EP
Hydroxyporpylmethyl
cellucose
Methocel E5 EP
Gum Tragacanth Powder
NB: Empty Hard Gelatin Capsules are considered Inactive as they are orally taken; the
description is to be identified by size, and two colors (body & cap in order)
Material Name Size Color of Cap and Body
Empty Hard Gelatin Capsule Size 1 Pink Cap / Grey Body
Empty Hard Gelatin Capsule Size 0 Blood Red 372 Cap / OP. Orange 20 Body
4.1.3. Primary Packaging Materials: All materials that come into immediate contact with the
product. Primary packing materials are divided to the following groups with the following
descriptions:
____________________________________________________________________________________________________
PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
Material Name Material State Specs (EP, USP, BP)Cephalexin monohydrate Micronized USP
Ceftriaxone sodium Sterile USP
T3A INDUSTRIAL
DOC# AP-05-1020 Issue # 06 Page 4 of 14
4.1.3.1.Aluminum foil: Identified by product name printed ( or generic name in case of MOH
market), by size ( reel width in mm) , by language of printing material, by sample,
example
Product name printed Size Language / Market
Triconal 150 mg Cap Alu.minium Foil 133 mm Bulgarian / Private
Ibuprofen 600 mg F.C. Tablet Aluminum Foil 122 mm MOH
Ibuprofen 200 mg 10 tab Aluminum Foil 156 mm. English / MOH
4.1.3.2.Caps : are to be identified by color and type and size as the flip off caps, aluminum cap , child
resistant caps, example
Color Type Size
White. printed Aluminum Cap 28 mm
Black plastic cap 22 mm
4.1.3.3. Ampoules: are to be identified by the size, type & color of
the ampoule and product name in case of printed ampoules example:
Danofran 4mg-2ml Empty printed glass Ampoule-FMS
Pentoxifylline 300 mg/15mL Ampoule -Tender
4.1.3.4. Blister Polymer (PVC): It is identified by material type
(opaque, transparent)
and reel width example:
PVC/PVDC Transparent 166 mm 250 micron. 60 gm/m2
PVC opaque 166 mm 250 micron thickness
PVC Transparent 166 mm 250 micron
4.1.3.5. Bottles: are to be identified by size of the bottle, color &
type (glass or plastic). example:
Amber glass bottle 100 ml
White plastic bottles 500 gm
4.1.3.6. Rubber: are to be identified by type, color, diameter size
____________________________________________________________________________________________________
PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
T3A INDUSTRIAL
DOC# AP-05-1020 Issue # 06 Page 5 of 14
4.1.3.7. Tubes : are to be identified by : Product Name printed
(Generic names in case MOH),dimensions (or fill weight), Language of the printing material
and for market type, example: Dermasol Ointment aluminum tube 25 gm
4.1.3.8.Vials : are to be identified by color, type & size, example:
Vials clear colorless tubular type I 60 ml (Size 50 R)
Vials clear colorless molded type I (20/24R) For Injectable products
4.1.4.Secondary Packaging Materials: All packaging materials not in direct contact with the bulk
product. Secondary packing materials are divided to the following groups with the following
descriptions:
4.1.4.1.Adhesive Tapes : are to be identified by description , printed text and dimensions
4.1.4.2.Product Boxes: are to be identified by Product Name and Pack Size, printed text, Dimension of
the box, by Language and are to be identified for market type (ex sample, MOH)
4.1.4.3.Shipping Cartons: are to be identified by: Product Name printed, Dimension of the Carton,
Language of the printing material, are to be identified for market type.
4.1.4.4.Separators :are to be identified by dimension, no. of products as for trays
4.1.4.5.Doser: it is anything that is used to specify the dose, identified by type, color and size.
As measuring cups, dowsers, spoons
4.1.4.6.Product Label: It is identified by, Product Name printed, Size, language of the printing material
and identified for market type.
4.1.4.7.Pamphlets: are to be identified by the product name only as it is the same for the different pack
sizes we add a letter for the language of the export market keeping the same serial number in
all cases.
4.1.4.8.Shrink-packing film: is to be identified by type & dimensions and thickness
4.1.4.9.Sponges : are to be identified by description & reference to specs
4.1.5.Bulk Products: products which completed all its processing stage and did not undergo any
packaging stage, State before Primary Pack.
4.1.6.Intermediate products: products used during various processing stages, state before obtaining
final dosage form
4.1.7.Semi Finished: State before Secondary Pack.
____________________________________________________________________________________________________
PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
T3A INDUSTRIAL
DOC# AP-05-1020 Issue # 06 Page 6 of 14
4.1.8.Companion products: products used and sold with other T3A finished products used as Water for
injection as a solvent and Lidocaine as a local anesthetic and solvent with some
cephalosporin vials.
4.2.Material Coding:
4.2.1.Material code consist of 10 digits " xx xx xx xxxx
4.2.2.1st and 2nd digits represent the material class as follows:
4.2.2.1. 01 Active Material,
02 Inactive Materials,
03 Primary Packing Materials,
04 Secondary Packing Materials.
05 Bulk Products,
06 Intermediate Products,
07 Companion Product.
4.2.3.3rd and 4th digits for Active & Inactive materials identify the Toll manufacturing Company,
for Inactive ,the digit "01" identifies capsules which is considered inactive as it is orally
taken
4.2.4.5th and 6th digits are reserved for Actives and Inactive.
4.2.5.Last 4 digits are the material serial number
Material Code for Active & Inactive
XX XX XX XXXX
Class Material group Reserved Serial
01 Active Material 00 Reserved
02 Inactive Material 01 Capsule
4.2.6. 3rd and 4th digits for Primary & Secondary Packing Materials identify
the material types
4.2.7. 5th and 6th digits identify the language of printed material.
4.2.8. Last 4 digits are the material serial number
____________________________________________________________________________________________________
PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
T3A INDUSTRIAL
DOC# AP-05-1020 Issue # 06 Page 7 of 14
Material Code for Primary & Secondary packing materials
XX XX XX X XXX
Class Material group Language Market Serial
03 Primary Packing Material
01 Aluminium
02 Caps type
03 Ampoules
04 Blister Polymer (PVC, PVDC,….)
05 Bottles
06 Foil
07 Rubber
08 Tubes
09 Vials
0 Local Market
1 MOH
2 Sample
3 Hospital
04 Secondary Packing
Material
01 Adhesive tapes
02 Product boxes
03 Shipping Cartons
04 Separators
05 Doser type
06 Product labels
07 Product Pamphlet
08 Shrink packaging film
09 Sponges
0 Local Market
1 MOH
2 Sample
3 Hospital
Code Language00 Arabic01 English02 Spanish03 German04 French05 Russian06 Estonian
07 Latvian08 Lithuanian09 Armenian10 Danish11 Italian12 Bulgarian13 Hungarian14 Romanian
____________________________________________________________________________________________________
PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
T3A INDUSTRIAL
DOC# AP-05-1020 Issue # 06 Page 8 of 14
4.3.Bulk Description and Coding:
4.3.1.Bulk Products: products which completed all its processing stage and did not undergo any
packaging stage, State before Primary Pack. Bulk consists of Active and Inactive showing
the content of one unit (one tab, one cap); Bulk description shall be as follows:
4.3.1.1.For non sterile products: Product name, strength, and product dosage form.
4.3.1.2.For sterile products: Product name, strength, route of administration, product dosage form(s)
4.3.2.Bulk code consist of 5 digits that matches last 5 digits in the product code.
4.4.Finished Product description and coding:
4.4.1.Finished products: products which finished all its processing and packaging stages. It consists of
Bulk and Pack (Bulk + Primary and Secondary Pack); the description of finished product
shall be as following:
4.4.1.1. For local, hospital, samples and export: Product name,
strength, package size, product form
4.4.1.2. For MOH [tender]: Active material of the product, strength,
package size, product form -
4.4.2.Finished Product code consists of 10 digits:
Code of finished Product
xx xx x xxxxx
Language Reserved Market Type Product code serial
4.4.2.1. The last five digits xxxxx are the product code serial and it
is unique for the product for all markets and countries as follows:
____________________________________________________________________________________________________
PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
T3A INDUSTRIAL
DOC# AP-05-1020 Issue # 06 Page 9 of 14
4.4.2.1.1. Cefotax 0.5 gm 1 vial for Arabic speaking market: 00 00 0 00001
4.4.2.1.2. Cefotax 0.5 gm 1 vial for French speaking in France tender market: 04 00 1 00001
4.4.2.2. 1st and 2nd digits identify the country language where the
product is marketed as shown in the above language table
4.4.2.3. 3rd and 4th digits are reserved and used for companies which
manufacture its products in T3A as a contract manufacturing
NB : Code 03 up to 11 are reserved for point 4.6 Toll Manufacturing Products
4.4.2.4. 5th digits identifies the market where product is
launched :
digit indicating
0 Private Market
1 MOH Market
2 Sample
3 Hospital
4 Free Bonus
4.4.3. The last five digits are the product serial code according to EAN Coding
system
4.5. Materials Units
Purchasing Units Unit of Purchase Unit of BOM
1. Active Materials KG mg
2. Inactive Materials KG mg
Primary Packing Materials1. Aluminum KG gm
2. Caps 1000 One unit
3. Ampoules 1000 One unit
4. Blister Polymer KG gm
____________________________________________________________________________________________________
PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
Reserved01 Arab Countries ; Arabic - Arabic Packaging02 Different Pack Size for the same market12 Unfinished Products13 Arab Countries ; English - Arabic packaging
T3A INDUSTRIAL
DOC# AP-05-1020 Issue # 06 Page 10 of 14
Purchasing Units Unit of Purchase Unit of BOM
5. Bottles 1000 One unit
6. Rubber 1000 One unit
7. Foils KG gm
8. Tubes 1000 One unit
9. Vials 1000 One unit
Secondary Packing Materials1. Adhesive Unit One unit
2. Boxes 1000 One unit
3. Cartons Unit One unit
4. Separators 1000 One unit
5. Dowser 1000 One unit
6. Labels 1000 One unit
7. Pamphlets 1000 One unit
8. Shrink Pack Film KG gm
9. Sponge 1 One unit
4.6.Toll Manufacturing:
4.6.1.In case there is an agreement between T3A Industrial and other company for manufacturing their
products using our facilities. Materials and finished products are identified as follows in their
description and coding;
4.6.1.1.Materials Description & Coding:
4.6.1.1.1.Coding of active and inactive materials: use the same serial code of T3A material and
add the company code in 3rd and 4th digits:
Material Code for Active & Inactive
XX XX XX XXXX
Class Material group Reserved Serial
01 Active Material 00 Reserved
03 Eberth
04 Biopharm
05 Sedico
06 Ranbaxy
07 Acdima
____________________________________________________________________________________________________
PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
T3A INDUSTRIAL
DOC# AP-05-1020 Issue # 06 Page 11 of 14
10 ACAI
02 Inactive Material
01 Capsule
03 Eberth
04 Biopharm
05 Sedico
06 Ranbaxy
07 Acdima
4.6.1.1.2.Primary Packaging Materials and Secondary Packaging Materials: Primary and Secondary
packing materials have the same description specs as point 4.1.3 and 4.1.4 respectively with
adding the company name in the description for identification examples:
Aluminium Product name printed Size Language / Market Toll Manuf company
exampleAcaclindin 150 mg capsule
Aluminum Foil122 mm Tender ACAI
Caps Color Type Size Toll Manuf company
example White. printed Aluminum Cap 28 mm Acdima
4.6.1.2.Bulk description and coding:
4.6.1.2.1.Bulk code consist of 5 digits that matches last 5 digits in the product code.
1st and 2nd digits represents the company has Toll Manufacturing agreement with T3A as follows:
4.6.1.3. Toll Manufacturing Finished Product Coding:
4.6.1.3.1. 3rd and 4th digits are reserved and used for companies which manufacture its products in T3A
as a contract manufacturing.
____________________________________________________________________________________________________
PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
99 Eberth Bulk code
98 BioPharm bulk code
97 Sedico Bulk Code
96 Acdima Bulk Code
95 Ranbaxy Bulk Code
94 ADCO
93 Dr. Khairy
92 ACAI bulk code
Arab Co. for Antibiotics Industrials
Reserved
03 Eberth04 Biopharm05 Sedico06 Ranbaxy07 Acdima08 ADCO09 Dr Khairy Toll10 ACAI-Iraq
T3A INDUSTRIAL
DOC# AP-05-1020 Issue # 06 Page 12 of 14
4.7.BOM Calculation:
4.7.1.BOM Calculation Based on different markets are calculated as follows:
4.7.1.1.Private market according to Official Registration Certificate
4.7.1.2.Free medical sample according to reduced pack for the different forms, Tab, Cap, and the same
as Private market for the other forms.
4.7.1.3.MOH market according to approved tender pack size and the official registration certificate.
4.7.1.4.Hospital market according to approved tender pack size and official registration certificate.
4.8.Creation of BOM for bulk and finished products:
4.8.1.BOM is structured according to two main sections: Bulk Section (Active & Inactive) showing the
content of one Tab, one Cap , one Vial etc, and Pack Section (Primary Packing and
Secondary Packing) showing the content of selling pack
4.8.2.QC analyst shall initiate a code, description and specification for the materials which used for
issuing the BOM of bulk and finished products.
4.8.3.R&D Supervisor shall create/change the bulk BOM of product which shall include the starting
materials (active-inactive).
4.8.4.Packaging supervisor shall create the BOM of the finished product which shall include the
packaging materials (primary -Secondary).
4.8.5.Department manager review the BOM for approval.
4.8.6.Initiator department administrator shall make the relevant documentation formats for creation or
change.
4.8.7.Initiator department delivers the BOM to RA manager or designee, QC manager or designee,
Production manager or designee, R&D manager or designee for reviewing and approval the
code and description of the materials, bulk and finished products.
4.8.8.Initiator department deliver the BOM to QA manager for approval.
____________________________________________________________________________________________________
PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
T3A INDUSTRIAL
DOC# AP-05-1020 Issue # 06 Page 13 of 14
4.8.9.Initiator department administrator shall deliver the approved BOM and attached formats to QA
responsible officer.
4.8.10.The QA officer shall replace the old BOM by the new one and archive the relevant formats.
4.9. Coding and description system security:
4.9.1.The changes of codes or descriptions shall not be done without justification and prior approval
from plant manager.
4.9.2.IT system administrator shall provide the required system security for avoiding un-approved
changes.
5. ATTACHMENT:
5.1. BOM format
____________________________________________________________________________________________________
PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
5.1. BOM Format (Format Unique # 0004)
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