Material Products Coding and Bom Creation (Issue 06)

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.

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PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…

T3A INDUSTRIAL


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.

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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:

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Material Name Material State Specs (EP, USP, BP)Cephalexin monohydrate Micronized USP

Ceftriaxone sodium Sterile USP

T3A INDUSTRIAL


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

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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.

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T3A INDUSTRIAL


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

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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

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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:

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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

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Reserved01 Arab Countries ; Arabic - Arabic Packaging02 Different Pack Size for the same market12 Unfinished Products13 Arab Countries ; English - Arabic packaging

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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

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T3A INDUSTRIAL


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.

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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

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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.

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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

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5.1. BOM Format (Format Unique # 0004)

Documents

Material Products Coding and Bom Creation (Issue 06)