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The IPEC Quality Agreement Guide and Template 2009Copyright 2009 The International Pharmaceutical Excipients CouncilThis document represents voluntary guidance for the pharmaceutical excipient industry.

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product manufacturers. In simpler terms, the IPEC guidelines are used by the drug product industry to set out what an excipient should look like in terms of quality. Conversely, they are used by excipient manufacturers to enable them to identify what customers and regulators are looking for in a product.

The International Programme on the Elimination of Child Labour is a global programme launched by the International Labour Organization in December, 1991.

The International Pharmaceutical Excipients Council of India is an affiliate member of the IPEC – Federation. The Federation has members in the USA, the EU, Japan and China. Excipients play an important role in the manufacturing of Pharmaceutical and Nutraceutical formulations.

Under U.S. law, an excipient, unlike an active drug substance, has no regulatory status and may not be sold for use in food or approved drugs unless it can be qualified through one or more of the three U.S. Food and Drug Administration (FDA) approval mechanisms that are available for components used in food and/or ...

An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred to as "bulking agents", "fillers", or "diluents"), or to confer a ...

A quality agreement should include the following sections as a minimum: Purpose or scope. Terms (including effective date and termination clause) Responsibilities, including communication mechanisms and contacts. Change control and revisions. Dispute resolution. Glossary.

Items to address in a quality agreement include all aspects of a project that affect the identity, quality, safety, potency, and purity of a product. Additionally, include aspects that may affect the compliance status of either the contractor or client.

IPEC. International Pharmaceutical Excipients Council. http://.ipecamericas.org/

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232