Global Supply Chain Security Policy

GLOBAL POLICY
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SUPPLY CHAIN SECURITY – TAMPERING AND COUNTERFEIT CONTROLS
1.0 Proposito
1.1 Para proporcionar la dirección y los requisitos de medidas y acciones tomadas para mantener la integridad de
Apotex global de seguridad de la cadena de suministro.
1.1.1
1.1.2
1.1.3
Tener conciencia y visibilidad a las señales de alerta en el medio ambiente.
Aplicar principios de gestión de riesgos.
Para desarrollar programas específicos para abordar la adulteración, falsificación, robo y desvíos ilegales.
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2.0 Scope
2.1
2.2
2.3
2.4
Esta Política Global se aplica a la Apotex terminado de grupo de empresas productoras de formas de dosificación.
También es aplicable a los afiliados de Apotex y los centros de distribución de Apotex.
Esta Política Global puede usarse para la evaluación y supervisión de Apotex terceros organismos .
Esta Política Global establece las pautas escritas describiendo los requisitos y consideraciones para
implementar eficazmente las medidas de seguridad de cadena de suministro.
La cadena de suministro es un proceso complejo que abarca muchas regiones geográficas e implica a
numerosos partidos. Para garantizar la seguridad de la cadena de suministro, deben estar involucrados varios
grupos funcionales (enfoque integral) sobre el ciclo vital de la cadena de suministro.
2.4.1 Este enfoque integrado puede facilitar la seguridad de la cadena de suministro al aumentar el sistema de
calidad farmacéutica para prevenir y detectar la adulteración, falsificación, robo y desvío ilegal.
Apotex puede ser capaz de mitigar ciertos riesgos asociados con materiales adulterados, falsificados,
robados o desviados y entrar en la cadena de suministro mediante la aplicación de productos acabados
apropiados principios y estrategias.
2.4.2
3.0 Owner Organizational Unit
AGO-Global QA Policy and Systems.
GPOL-038 rev. 0 Effective Date: 07/16/2013 Page incl. Approval: 1 of 13

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4.0 General Training Requirements
4.1 Como mínimo, directores, directivos y gerentes de las siguientes áreas funcionales deben ser entrenados en cada sitio:
-
-
calidad
Manufacturing Operations.for the bold
Research and Development. 123
Desarrollo de productos y operaciones técnicas.
Engineering Services. red pencil
Warehouse and Distribution. Red Pencil
Sales and Marketing Ventas y Marketing. 1.2 libro. 1.2 book
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4.2
5.0
Otro personal de la organización puede ser entrenados por la discreción de la administración del sitio.
Associated Documents
Document #
QM
GPOL-002
GPOL-007.
GPOL-012
GPOL-014
GPOL-015
GPOL-023
GPOL-027
GPOL-029
GSOP-029-001
Document Title
Apotex Quality Manual
Management Controls – Governance,
Management Notification, Management
Review
Manufacturing, Packaging, and Labelling
Controls
Material Controls. 1.2.3.
Quality Risk Management. 1.2.3.
Audit Program. 1.1.1.1.
Warehouse Controls. 1.1.1.1
Supplier Qualification Program. 1.1.1.1
Distribution Controls. 1.1.11.
Shipping Under Quarantine. 1.1.1.11.
Relationship
Governing Quality Manual.12 book
Associated Global Policy
Associated Global SOP. 1.2

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6.0 Definitions
Term
Adulteration.1.1.1.1.
Apotex
Cargo Theft. 1.1.11.
Counterfeit. 1.1.11.
Customer.1.1.1..1.1.
Distributor/Broker. 1.1.1.1.
Economically
Motivated
Adulteration.1.1.1.
Environmental
Scanning.1.1.1.
First Tier Supplier.1.1.1.1
Definition
The addition of a foreign or inferior substance or element to a drug, resulting
in the drug not being w hat it is purported to be.
Apotex group of companies producing finished dosage forms. Term also
includes the affiliates and distribution centers.
The theft of finished pharmaceuticals during transportation or w arehousing.
The deliberate and fraudulent mislabelling of a drug w ith respect to identity
and/or source.
Where the first change in ow nership of a product takes place.
A person or entity that sells, distributes, transports, and/or forw ards materials,
but does not actually manufacture the material.
The fraudulent, intentional substitution or addition of a substance in a product
for the purpose of increasing the apparent value of the product or reducing the
cost of its production, i.e. for economic gain.
A process for review ing external information w hich may have an impact on
selected targets. It involves the collection and analysis of information relevant
to pre-defined targets.
A first tier supplier is a supplier w ho directly invoices the organization for
goods and/or services rendered directly by the first tier supplier to the
organization as a customer.
Diverting finished products from the intended supply chain, w here the
intended supply chain refers to the law ful channels by w hich a pharmaceutical
manufacturer transfers drug product to the first legal ow ner.
A systematic process for the assessment, control, communication and review
of risks to the quality of the pharmaceutical product throughout the product
life-cycle.
The systematic use of information to identify potential sources of harm
(hazards) referring to the risk question or problem description.
A second tier supplier is a supplier w ho invoices a first tier supplier for goods
and/or services w hich w ill ultimately be part of the first tier supply organization.
New information indicating the potential for economically motivated
adulteration of a material or product, the use of counterfeit material, or the
illegal diversion of legitimate product into unlaw ful channels.
A particular vulnerable material or physical point in the supply chain w here
adulteration, counterfeiting, or illegal diversion could occur. Risk management
approaches should be used to help identify targets.
A third tier supplier is a supplier w ho invoices a second tier supplier.
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Illegal Diversion.1.1.11.
Quality Risk
Management (QRM)
Risk Identification.1.1.1.1.
Second Tier Supplier.1.1.1.1
Signal.
Target..1.1.1.1.
Third Tier Supplier.1.1.1.

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7.0 Roles and Responsibilities.
Role
President & C.O.O.
Responsibility
-
-
-
Review and Approve this Global Policy
Proporcionar los recursos necesarios para la aplicación efectiva de esta Política
Global.
Garantizar una supervisión eficaz por la supervisión Ejecutiva Comité.
Review and Approve this Global Policy
Proporcionar supervisión de calidad de esta Política Global.
Garantizar una supervisión eficaz por la supervisión Ejecutiva Comité.
Review this Global Policy
Ensure the Deployment / Implementation of this Global Policy
at applicable Global Apotex sites
Asegurar la implementación / ejecución de esta Política Global dentro de las
funciones de desarrollo de producto.
Asegurar la implementación / funciones de aplicación de esta Política Global en
asuntos reguladores & científico.
w ithin R&D QA functions
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VP,
Corporate Quality & Compliance
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EVP,
Global Supply Operations
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Senior VP,
Product Development
Senior VP,
Scientific & Regulatory Affairs
Global Director,
R&D QA.
Global Director,
External Quality
Global Director,
QA Audit

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Role
Global Director,
QA Manufacturing Sites
Responsibility
-
-
-
-
-
-
Asegurar la implementación / ejecución de esta Política Global dentro de las
funciones de cumplimiento Global.
Supervisar la gestión, revisión, aprobación y despliegue /
implementación de esta Política Global en sitios de Apotex mundial
aplicables.
Emitir, examinar y revisar esta Política Global según la orientación y
regulación de la autoridad sanitaria actual.
Distribuir esta Política Global..
Coordinar la implementación / ejecución de esta Política Global en sitios de
Apotex mundial aplicables.
Despliegue de la ayuda / implementación de esta Política Global en sitios de
Apotex mundial aplicables.
Coordinar actividades de seguridad de la cadena de suministro a
través de equipos interdisciplinarios y departamentos en el sitio.
Asegúrese de que procesos de seguridad de la cadena de suministro se
definen, implementados y revisados, y que los recursos necesarios están
disponibles en el sitio.
Global Director,
Quality Compliance
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Global Director,
QA Policy & Systems
Global QA Policy & Systems
Department
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Site Leadership Team
(Site Operations Head,
Site Quality Head)
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8.0 Requerimientos Generales.
8.1 Entender el riesgo y la seguridad de la cadena de suministro.
8.1.1 Riesgo de adulteración (incluyendo económicamente motivado adulteración)
8.1.1.1 Adulteración puede ocurrir en muchas formas, incluyendo el producto que está contaminada,
insegura o fabricados en condiciones de no cumplir con buenas prácticas de manufactura, o
producto que no cumple con sus requisitos para la pureza y la fuerza, o no aprobadas para ser
comercializada en el país.
Apotex puede no ser capaz de prevenir completamente la falsificación a través de la Plaza del
mercado global. El objetivo es definir los controles adecuados para minimizar el riesgo de los
productos falsificados.
8.1.2 Riesgo de medicamentos falsificados.
8.1.2.1

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8.1.2.2. La falsificación puede aplicarse a productos tanto marcas y genéricos, y productos falsificados
pueden incluir productos con ingredientes correctos o incorrectos, con ingredientes activos
insuficientes o falta de ingredientes activos en conjunto, o con el empaquetado falso.
Apotex puede realizar evaluaciones de riesgos para ayudar a identificar los productos y
regiones presentan el mayor riesgo de falsificación. Esto puede usarse para ayudar a priorizar la
asignación de recursos contra la falsificación.
Desvío ilegal ocurre cuando un producto farmacéutico genuino es aprobado y destinado a la venta
en un país, pero es luego interceptado ilegalmente y vendido en otro país. Estos esquemas se
logran a menudo a través de declaraciones falsas o declaraciones. A veces, los reguladores de
medicamentos en el segundo país no han aprobado el uso de la droga desviado. Desvío ilegal
también puede ocurrir dentro de la misma área geográfica, o dentro del mismo país o ciudad. Este
tipo consiste en desviar medicamentos con descuento de un pretendido grupo de consumidores a
otro grupo de compra de medicamentos en un mercado abierto y no reglamentado.
Prevenir y detectar la desviación ilegal no pueden lograrse mediante una única organización.
Cada miembro de la cadena de suministro debe involucrarse en la prevención y detección del
desvío ilegal desarrollar un enfoque integral.
Gestión de riesgos de calidad (consulte GPOL-014) se utilizarán para conocer y comprender el
producto de la droga y para evaluar la probabilidad de que se desvíen. Factores de riesgo pueden
incluir productos de alto valor de drogas, medicamentos en corto la fuente, los productos con un
alto potencial para el abuso de drogas o productos que son ampliamente utilizados de la droga.
Entender la naturaleza de los riesgos de desviación ilegal es un elemento importante en el diseño
de un programa contra la desviación proactivo.
Entender los riesgos asociados con un producto robado es clave para la prevención.
Gestión del riesgo de robo de carga es similar a las claves asociadas al desvío ilegal.
¿Cómo y dónde está siendo transportado un producto de drogas son factores claves de
riesgo que debe ser entendidos.
Comprensión de Apotex de delincuencia local, sistema educativo y las condiciones políticas y
legales obstaculizan o incluso apoyando la falsificación, robo o desvío ilegal ayudará a identificar
zonas geográficas de riesgo para la seguridad.
Comprensión de estos riesgos puede utilizarse para aumentar el contenido de la
auditoría, actividades experimentales y controles.
Como parte de un enfoque de gestión de riesgos de calidad, las actividades de mitigación de
riesgo pueden incluir la aplicación de medidas más estrictas para medicamentos con alto riesgo
de falsificación, robo o desvío ilegal.
8.1.2.3
8.1.3. Riesgo de medicamentos desviados.
8.1.3.1.
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8.1.3.2
8.1.3.3
8.1.4. Riesgo de robo de carga.
8.1.4.1.
8.1.4.2
8.1.5. Identificación de riesgos de factores geográficos.
8.1.5.1.
8.1.5.2
8.1.6. Clasificación de riesgo y filtrado para distinguir las prácticas.
8.1.6.1.

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8.1.6.2 La evaluación del riesgo puede ser revisada para determinar si Apotex mantendrá operaciones
específicas para ayudar a evitar la falsificación, desvío ilegal o robo.
Buenas análisis son esenciales para garantizar la seguridad de los materiales suministrados y
detectar la adulteración, intencional o no intencional.
Apotex puede realizar una evaluación de riesgos de calidad de los procesos de fabricación e
identificar cualquier material potencialmente vulnerables..
Se entenderá las limitaciones de los métodos actuales, y donde se pueden desarrollar métodos de
prueba apropiados, físicas, químicas o biológicas para identificar el material. El fabricante es
responsable por la seguridad de todos los materiales utilizados en la fabricación y la utilización de
los análisis más apropiado..
8.1.7. Risk Mitigation – Analytical/Characterization
8.1.7.1.
8.1.7.2
8.1.7.3
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8.2. A manual, computerized, and/or enterprise-w ide inventory management system must be in place
w ith supervision from qualified personnel.
9.0 Quality Risk Management (QRM)
9.1 The QRM shall be used to develop a risk-based approach to supply chain security. This includes
assessing risks, developing controls, conducting risk review s, and communicating appropriately.
Refer to GPOL-014.
As part of the risk management process, processes shall be established to assure risks are
communicated throughout the organization. Refer to GPOL-002.
9.2
10.0 Manufacturing, Packaging, and Labeling Controls Program
10.1 In the context of a drug product, adulteration results in a drug w hich is not w hat it is purported to
be. Adulteration can be accidental or intentional. Additional controls are required to reduce the
risk of adulteration w hen there are complex supply chains w hich involve significant outsourcing of
manufacturing and distribution.
10.1.1 Refer to Section 8.0 (General Requirements) in considering potential and current
control measures in the manufacturing, packaging, and labelling of the drug products,
w ith a look at potential advancement in technology.
10.2 Further consideration shall be given to assessing established controls for packaging and labeling
systems and controls on returned and salvaged products. Procedures shall be established w hich
describe the destruction of packaging and labeling materials.

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10.3 Destruction of rejected materials should be accounted for and proof of the destruction shall be
obtained and documented. Accountability for the destruction of labels and packaging materials,
and destruction of returned products, shall extend to the management of third party suppliers,
contract manufacturers, and logistics service providers.
Also refer to GPOL-007 (Manufacturing, Packaging, and Labelling Controls) and GPOL-023
(Warehouse Controls).
10.4
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11.0 Material Controls
11.1
11.2
11.3
11.4
11.5
11.6
Both customers and inter-company receivers of a drug product shall be particularly careful to
monitor for the intrusion of diverted product.
Seal numbers taken off arriving trucks shall be checked against the seal numbers recorded on
shipping papers.
The number of boxes received shall be the same as the number of boxes recorded on the
shipping papers and invoices as shipped.
Boxes shall be examined for evidence of original closures (e.g. tape w hich may have been
replaced).
Boxes w ith visible differences (e.g. different shade or size of carton) shall be examined carefully.
Also refer to GPOL-012 (Material Controls).
12.0 Warehouse Controls and Distribution Controls
12.1 Detection processes shall be consistent w ith the risk of illegal diversions of given drug product.
Monitoring of packaging, packing, and shipping departments shall be review ed to determine if the
use of surveillance equipment is w arranted.
12.1.1
12.1.2
12.1.3
Workers in these areas should be aw are of the area surveillance as a deterrent.
Periodic job rotation, to include security personnel, should be considered.
The signal detection process shall involve:
-
-
-
Defining targets for enhanced, ongoing scrutiny
Applying environmental scanning to those targets (e.g. review ing external
information that may have an impact on the targets)
Determining the relevance of the results of environmental scans

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12.2 The identity of the person w ho packs from bulk and w ho packs for shipping shall be recorded.
Claims for shortages shall be checked for correlation to these w orkers. Product stolen by w orkers
is considered diverted product.
Processes shall be in place to verify the physical integrity of the container structure prior to
loading, including the reliability of the locking mechanisms of the doors.
Numbered single-use seals shall be used and recorded on shipping papers w hen the entire
conveyance is used for one shipment. Only designated employees shall distribute seals for
integrity purposes. There shall be procedures in place for the control and reconciliation of seals,
describing how to properly affix seals onto loaded containers and how to recognize and report
compromised seals or seal discrepancies.
Arriving cargo shall be reconciled against information on the cargo manifest. The cargo shall be
accurately described, and the w eights, labels, marks, and piece count indicated and verified.
Departing cargo shall be verified against purchase or delivery orders.
Drivers delivering or receiving cargo shall be positively identified before cargo is received or
released.
Customers shall be directed to return all unsold product to the manufacturer for evaluation.
Returned materials shall be dispositioned in accordance to approved w ritten procedures.
If the customer is in another country w here the return is not feasible, special care shall be taken
to arrange for destruction by a trusted third party organization.
12.3
12.4
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12.5
12.6
12.7
12.8
12.9
12.10 Returned product shall be analyzed to determine authenticity. If the product is not authentic,
Apotex shall investigate w here the potentially diverted or counterfeit product entered the supply
chain.
12.11 Also refer to GPOL-029 (Distribution Controls), GPOL-023 (Warehouse Controls), and
GSOP-029-001 (Shipping Under Quarantine).
13.0 Supplier Quality Management and Audit Program
13.1 The elements of the Supplier Quality Management Program shall be integrated to allow
appropriate modes of controls to be implemented. When these controls are integrated, there is a
higher level of assurance over suppliers and outsourced activities. Refer to GPOL-027 (Supplier
Qualification Program) and GPOL-015 (Audit Program).
Quality risk management principles (risk-based approach) utilized in the process of assessing
and selecting a potential supplier shall be applied appropriately to the material being supplied.
Communication of Apotex’s requirements and standards are to be clearly communicated at the
start of the assessment/selection process.
13.2
13.3

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13.4 A multi-disciplinary approach is highly recommended in the supplier selection process. Including
functional groups such as Regulatory, Quality, Safety, Health, and Environmental (SHE),
Technical, Security, and Procurement w ill frequently lead to a more balanced assessment of
potential suppliers. Similarly, having a cross functional team involved in the audit (e.g. a new
supplier) is part of the risk-based approach.
The full extent of the supply chain shall be know n and documented in a manner providing the
necessary visibility. Apotex shall have current understanding of information from second and third
tier suppliers on the logistics of supply chain from the origin of procured materials through to
receipt at the manufacturing location. Apotex shall also have current information from the site of
manufacture to the next legal ow ner or buyer of the product.
Apotex may not alw ays receive material directly from the original manufacturer, but rather through
a distributor/broker. In the assessment of a distributor/broker, it is important to understand
expectations w ith regard to supervision of the original manufacturer.
Once the selection process is complete, w ritten agreements for quality activities shall be
developed w ith the supplier of choice. Quality/Technical Agreements, Supply Agreements,
contracts, or comparable w ritten agreements shall clearly communicate and document Apotex’s
requirements and standards, and shall specify the need for the supplier to conform to the
agreements.
13.7.1 Minimum requirements shall be established around notification of changes, notification
of significant deviations, notification of any regulatory inspections, a provision for
documentation review , and a provision for on-site audits.
13.5
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13.6
13.7
13.8
13.9
Supplier performance shall be monitored and review ed on a regular basis.
A defined audit program shall be established w ith risk-based criteria for frequency and duration of
audits.
14.0 Logistics and Transportation Service Providers
14.1 The management of logistics and transportation service providers is analogous to Supplier
Quality Management in that the process for the assessment, selection, monitoring, and review
are similar; how ever, the focus includes more elements of security features.
Controls must be in place to assure logistic service providers do not become an avenue for illegal
diversion or introduction of counterfeit products into the supply chain.
Specific attention shall be applied to ensure pertinent security measures are in place and adhered
to at the logistics and/or transportation service provider.
As part of the selection and assessment, there shall be evidence of financial soundness,
capability of meeting contractual security requirements, and the ability to identify and correct
security deficiencies.
14.2
14.3
14.4

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14.5 Background information, including a history of claims, the types of commodities handled, and the
geographical areas served shall be provided by the service provider and used as part of the
assessment and selection process. Hiring practices of the provider shall be review ed.
A review of the sales volume and relevant permits of the provider shall be review ed in
comparison to the size of the operation and authorization to handle pharmaceutical products,
w here such permits are required.
Review of physical premises, hiring practices, and access controls must be satisfactory in
meeting security measures.
14.6
14.7
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15.0 External References
Document Title
Health Products and Food Branch Inspectorate (HPFBI), Good
Manufacturing Practices (GMP), Guidelines - 2009 Edition, Version 2,
GUI-0001, March 4, 2011
(w ww.hc-sc.gc.ca)
Health Products and Food Branch Inspectorate (HPFBI), Policy on
Counterfeit Health Products, POL-0048, May 14, 2010
(w ww.hc-sc.gc.ca)
Food And Drug Administration, Inspections, Compliance, Enforcement,
and Criminal Investigations – Inspections – Investigations Operations
Manual, Sub-chapter 8.8 – Counterfeiting/Tampering
(w ww.fda.gov)
EudraLex, The Rules Governing Medicinal Products in the European
Union, EU Guidelines for Good Manufacturing Practice for Medicinal
Products for Human and Veterinary Use (Volume 4), 2008, Annex 20:
Quality Risk Management
(w ww.ec.europa.eu)
ICH Harmonised Tripartite Guideline, Quality Risk Management Q9,
Current Step 4 version, November 9, 2005
(w ww.ich.org)
Pharmaceutical Security Institute
Counterfeit Situation
w ww.psi-inc.org
World Health Organization
General information on counterfeit medicines
WHO Technical Report Series, No. 902, 2002, Annex 9, Guidelines on
Packaging for Pharmaceutical Products
(w ww.who.int)
WHO Guidance
Reference Type
Health Canada Guidance
Health Canada Policy
US FDA Manual
European Commission
Guidance
(EMEA,MHRA)
International Conference
on Harmonisation (ICH)
Guidance
PSI Guidance

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16.0 Revision History
Revision Effective
No.Date
0 Current
Change
Control
No.
46061
Description / Reason for Change
New Global Policy “Supply Chain
Security – Tampering and Counterfeit
Controls”.
Author of
Revision
Elaine Leong,
Manager, QA SOD
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APPROVALS AND SIGNATURES
UserName: Jeremy Desai (apotexjdesai)
Title: President & C.O.O, Apotex Inc.
Date: Thursday, 23 May 2013, 12:23 PM Eastern Time
Meaning: Approval
================================================
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UserName: Jila Breeze (apotexjbreeze)
Title: VP, Corporate Quality & Compliance
Date: Tuesday, 28 May 2013, 08:51 AM Eastern Time
Meaning: QA Approval
================================================

Global Supply Chain Security Policy

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