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EPIC Quality Agreement Template (Exclusive Substances)Appendix B:Quality Agreement Template for Exclusive Substances (Compliance Section only)Copyright 2009 Active Pharmaceutical Ingredients Committee
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How to fill out apic quality agreement template
01
Start by carefully reviewing the apic quality agreement template provided. Familiarize yourself with its sections and requirements.
02
Fill out the basic information section, including the names and contact details of both parties involved in the agreement.
03
Identify the scope of the agreement. This involves clearly defining the products, services, or activities that will be covered by the quality agreement.
04
Specify the responsibilities and obligations of each party. Clearly outline the roles and expectations regarding quality control, documentation, communication, and any other relevant aspects.
05
Address any specific quality requirements or standards that need to be met. This may include regulations, industry standards, or any additional quality guidelines.
06
Include provisions for monitoring and evaluating the quality performance. Establish metrics, reporting mechanisms, and corrective actions for detecting and addressing any quality issues.
07
Determine how non-conformances or deviations from the quality agreement will be handled. Define the steps for investigation, corrective actions, and escalation procedures if needed.
08
Include provisions for periodic reviews and updates of the quality agreement to ensure its continued effectiveness and relevance.
09
Finally, both parties should review and sign the completed apic quality agreement to indicate their understanding and acceptance of the terms.
10
The apic quality agreement template can be used by any parties involved in pharmaceutical manufacturing, testing, distribution, or any other stage of the supply chain. This may include manufacturers, suppliers, contract service providers, or any other stakeholders concerned with maintaining quality standards.
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