IPEC Store

  • The IPEC-Americas Quality by Design (QbD) Sampling Guide (Downloadable)

    Product Description:

    This guide is intended to:

    • Recommend options for the provision of appropriate Quality by Design (QbD) samples to allow excipient variability to be incorporated into the Design of Experiments (DoE(s)) for pharmaceutical development.

    • Assist users in developing more robust processes and products in the context of the excipient manufacturer’s process capability.

    • Facilitate communication between excipient users and suppliers with regard to realistic provision of samples before planning and executing a DoE.

    Price: $0.00
  • IPEC General Glossary of Terms 2014 (Downloadable)

    Product Description:

    The guide was developed by representatives of many of the member companies of the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) and the International Pharmaceutical Excipients Council (IPEC) Europe, which are industry associations whose principal members consist of excipient manufacturers and pharmaceutical users. The guide has also been endorsed by IPEC China and IPEC Japan, and is the second major Federation publication.

    The purpose of the glossary is to provide general definitions for excipients that are used in IPEC regional guides and to add value and clarity to terms used within the guides.

    Price: $0.00
  • Certificate of Analysis Guide for Pharmaceutical Excipients 2013

    Product Description:

    This document is meant to serve as a guide for the preparation and appropriate use of a Certificate of Analysis (COA) for pharmaceutical excipients.

    When considering the use of this guide, manufacturers and distributors should consider how it may apply to that specific organization’s product. The diversity of excipients means that some principles of the guide may not be applicable to certain products and processes. The terminology “should” and “it is recommended” do not necessarily mean “must” and common sense should be used in the application of this guide.

    The COA is a legal document that certifies the quality of the excipient and demonstrates that the batch conforms to the defined specifications, has been manufactured under excipient GMP, and is suitable for use in pharmaceuticals. It should not be used in lieu of appropriate qualification of the supplier.

    Price: $0.00
  • Excipient Information Package (EIP) (Downloadable)

    Product Description:

    The 2013 Excipient Information Package User Guide updates the originally published 2005 version and can be used by excipient suppliers to provide a standardized set of documents to exchange data between suppliers and their customers. The Excipient Information Package (EIP) is set up similar to a Material Safety Data Sheet (MSDS) with designated sections to include specified data on specific topics. The guide is intended to assist individuals experienced in evaluating excipient suppliers but is not a replacement for audits. 

    Price: $0.00
  • The Joint IPEC–PQG Good Manufacturing Practices Audit Guide (Downloadable)

    Product Description:

    In the pharmaceutical industry it is the responsibility of the drug product manufacturer to ensure the quality of all starting materials and other components contained in or used in the manufacturer for the final product dosage form. Through auditing the producer of pharmaceutical excipients, a user is able to determine whether adequate controls are in place to ensure the producer is capable to manufacturer a product of suitable quality. The IPEC-PQG GMP Audit guide, therefore, is designed as a tool to assist in evaluating the manufacturing practices and quality systems of excipient manufacturers. It is also a helpful reference to assist excipient manufacturers in meeting appropriate cGMP requirements to assure consistent product quality.

    Price: $0.00
  • Excipient Pedigree White Paper (Downloadable)

    Product Description:

    At the request of FDA and with their input, IPEC-Americas and IPEC Europe have developed a position paper on the need and procedure for establishing the complete supply chain history of an excipient for use in pharmaceuticals, e.g., the excipient's "pedigree."
     

    Price: $0.00
  • Technically Unavoidable Particle Profile (TUPP) Guide

    Product Description:

    This guide encourages a risk-based approach to the evaluation of visible particles in excipients.  The sharing of information between the excipient manufacturer and user, for the purpose of understanding the technically unavoidable particles is encouraged. Additionally, this guide provides an approach for investigation for those occurrences when a previously unobserved particle is found by the end user.

    Price: $0.00
  • (Spanish translation) The Joint IPEC–PQG Good Manufacturing Practices Audit Guide (Downloadable)

    Product Description:

    This document has been translated into Spanish, and is titled “Guía de Auditorias de Buenas Prácticas de Fabricación para Excipientes Farmacéuticos”.

    International Pharmaceutical Excipients Council (IPEC) – Pharmaceutical Quality Group (PQG)

    Asociación Argentina de Farmacia y Bioquímica Industrial (SAFYBI) – ARGENTINA – Comité Expertos Materias Primas Farmacéuticas

    Price: $0.00
  • The Joint IPEC–PQG Good Manufacturing Practices Guide (Downloadable)

    Product Description:

    This document proposes GMP appropriate for the manufacture of excipients and is a joint initiative between the International Pharmaceutical Excipients Council (IPEC), as IPEC-Americas and IPEC Europe and the Pharmaceutical Quality Group (PQG), incorporating the IPEC Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients, 2001 with the PQG’s PS 9100:2002 Pharmaceutical Excipients. During guide development, the opportunity was taken to make further clarifications of the text and to ensure alignment with the corresponding clauses in ISO 9001.

    Price: $0.00
  • (Spanish translation) The Joint IPEC–PQG Good Manufacturing Practices Guide (Downloadable)

    Product Description:

    This document has been translated into Spanish, and is titled “Buenas Prácticas de Fabricación para Excipientes Farmacéuticos”.

    International Pharmaceutical Excipients Council (IPEC)

    Sociedad Argentina de Farmacia y Bioquímica Industrial – ARGENTINA - SubCom. MPrimas Farma

    Price: $0.00

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