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21 May 2014 EMA/334808/2014 Compliance and Inspections Department Qualified Person s declaration concerning GMP compliance of the active substance manufacture The QP declaration template Reference.

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QP declaration is required for marketing authorisations to confirm that the active substance has been manufactured in ance with good manufacturing practice for medicinal products.

Under European Union (EU) law, the qualified person (QP) is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility within the EU, or imported into the EU.

QP declaration is required for marketing authorisations to confirm that the active substance has been manufactured in ance with good manufacturing practice for medicinal products.

The QP can provide a QP Confirmation, confirming that the manufacturer's activities have been performed suitably, or a QP Certification, certifying that the batch of medicine is suitable for use.

Each manufactured drug intended for human use must be certified prior to its use in a clinical trial by a Qualified Person ( QP ) . A QP ensures the compliance of each batch of Investigational Medicinal Products ( IMP ), manufactured in, or imported into the European Union, with current requirements.

Qualified Person in the Pharmaceutical Industry (QP)

QPs make this declaration only upon thorough and successful verification of this requirement. On the other hand, QP Certifications are batch-specific documents and are related to EU GMP, the Clinical Trial Application (CTA), and the Product Specification File (PSF).

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
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