Requerimientos De Empaque

Global Quality Systems & Standards
Material Supplier Information Package (MIP)

Property of Novartis
Confidential
May not be used, divulged, published or otherwise disclosed
without the consent of Novartis

I. Introduction 3
II. Product Regulatory Datasheet 4
Section 1 – General Product Information 4
Section 2 –Site and Supplier Information 5
Section 3 – Physico-chemical Information6
Section 4 - Regulatory Information 7
Section 5 - Miscellaneous Product Information 8
III. Site Quality Overview 10
Section 1 - Site Overview 10
Section 2 - Compliance Evidence 12
Section 3 – GMP Compliance Details 12
Section 4 - Miscellaneous Site Information 15
IV. Site and Supply Chain Security Overview 16
Section 1 – Supply Chain 16
Section 2 – Supply Chain Security 17
Section 3 –Site Security Information 18
V. Contact Persons 19
VI. Signatures 19

* Introduction
The present questionnaire was set up based on the Excipient Information Package (EIP) prepared by IPEC (International Pharmaceutical Excipient Council) with designated sections covering specific topics. The questions aim to capture the minimum needed information at each section, however, additional relatedinformation can also be provided at the discretion of the supplier. In addition ICH Q7A elements have been considered.
For details see:
http://www.ipec-europe.org/page.asp?pid=59
http://ipecamericas.org/
http://www.tga.health.gov.au/docs/pdf/euguide/ich/410600en.pdf
http://www.ipec-china.org/EnAboutUs.asp?ID=1
http://www.jpec.gr.jp/english/
Novartis prefers to receive an EIP structuredpackage with supportive documentation and relevant certificates to approve a supplier for delivery of material. The questionnaire should not be viewed as a replacement for audits, which needs to be mutually agreed. A completed EIP or questionnaire accepted by one Novartis site will be accepted by all other Novartis sites globally.
Where information is considered confidential, the document shouldreflect how Novartis can obtain this information. For example, the document may state that the information may only be obtained under a confidentiality agreement. If particular topics are not applicable to a particular material or site, it should be so indicated in the document.
*
Product Regulatory Datasheet
The Product Regulatory Datasheet is designed as a means to assist in communicatingto the user important physical, manufacturing and regulatory information specific to the material. Not every point is necessarily applicable to each type of material.
The following sections are expected to be responded and supportive documents may be included as an attachment. Short, bulleted formats are encouraged. Job titles should be used rather than names.
Section 1 – General ProductInformation
Product (trade) name/code | |
Company Name of Manufacturer | |
Address of Manufacturing Site | |

Section 2 –Site and Supplier Information
Do you manufacture the concerned material in your own premises? (if NO please specify)Fabrican en sus propias instalaciones el material en cuestión (el material que proveen a Novartis)En caso negativo, favor de especificar | □ YES□ NO |
Are all manufacturing operations (processing, purification, packaging, lab analysis, product release or warehousing) performed at the same site? (if NO please specify)Todas las operaciones de fabricación (procesamiento, purificación, envase/empaque, analisis de laboratorio, almacenamiento), todo es realizado en el mismo sitio?En caso negativo favor de especificar | □ YES□ NO |
Do you manufacture other products than the one being questioned in your manufacturing facility (Mono-plant or Multipurpose)Además del producto en cuestión, se fabrican otros más en la misma planta productiva(es mono-planta o multipropósito) | □ YES □ NO |
Do you use dedicated equipment for the production of the product in question?(if NO please...