QUALIFIED PERSONSERVICES
CAI is instrumental in creating and implementing a
Pharmaceutical Quality System (PQS) that encompasses
all elements for delivering safe and effective products topatients: production, laboratories, materials management,facilities and equipment, packaging and labelling, andquality systems. The Qualified Person (QP) is a uniquerole in European legislation within the pharmaceuticalindustry. By the very nature of the job, an experienced
QP develops the skills to be considered a Subject Matter
Expert in multiple aspects of operations. What is of equal
importance to this acquired knowledge is the application.
On an everyday basis, the QP applies this knowledge
in a pragmatic, risk-based, and scientific manner, withpatient safety at the forefront of their consideration.
CAI actively recruits experienced QPs to provide their unique skillset to clients and be included on
Manufacturing and Importation Licences. Having a QP available to clients on-site provides flexibility
to respond to manufacturing and personnel changes. These QPs will become agents of change
for the industry based on Quality Risk Management principles in ICHQ9, ICHQ10, and ICHQ11.
While our QPs can capably deliver the full range of Quality, Compliance and Regulatory consultancy
services, we also offer niche services best filled by a QP.
QP SERVICES:» Perform activities as per Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal
Products for Human and Veterinary Use, Annex 13: Manufacture of Investigational Medicinal
Products, and Annex 16: Certification by a Qualified Person and Batch Release» GMP auditing, QP declarations, Health Authority dossier review, supply chain map preparation,
implementing Quality Risk Management (QRM), and Product Quality Review (PQR) activities
BASIS FOR QP DECLARATION OF GMP EQUIVALENCE:» Perform a GMP equivalency audit, developing and helping to implement a remediation program» Providing full quality oversight during batch manufacturing of the API/drug substance (DS) or drug
product (DP)» Completing required batch record and testing review as part of the batch disposition process
as set out in the provisions of Annex 13 for importation of Investigative Medicinal Product (IMP)from a 3rd party country and Annex 21 for Importation of medicinal products

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QUALIFIED PERSONSERVICESGOOD DISTRIBUTION PRACTICE:» Our QPs have an in-depth knowledge of the requirements of the EU Guideline on Good Distribution
Practice of Medicinal Products for Human Use (2013/C 343/01) which ensures we can provide ourclients with advice and guidance for the most suitable supply chain and distribution model» Members of our team can act as the Responsible Person (RP) on behalf of our clients
MANAGING QUALITY ASPECTS OF A CONTRACT MANUFACTURING ORGANISATION (CMO):» Our QPs can fulfill multiple roles from initial CMO evaluation and selection» Quality Agreement generation and approval» Ongoing documentation review» Placing an experienced QP on the manufacturing floor at the CMO» Providing quality oversight during the manufacture of your product
MENTORING OF INEXPERIENCED QPs:
» Our experts are leaders in the mentoring of inexperienced QPs by supporting them throughcompliant batch disposition and providing compliance advice and guidance on product and batchspecific issues supporting the client QP make the right compliance related decisions» This service can be transitioned from on-site to a remote service as needed
CAI AT-A-GLANCE
We exist to be the trusted solution for ourclients as they strive to build a better working
world and improve the human experience.

» Founded in 1996
» 800+ Global Resources» 100% Employee-Owned» 20 Regions Worldwide» 8 Service Areas of Expertise» Have supported 85% of thetop 20 Life Science companies**Ranked by 2020 revenue

NORTH AMERICA (Headquarters)

One Park Fletcher
2601 Fortune Circle East, Suite 301B
Indianapolis, IN 46241 USA
solutions@cagents.com
EUROPE

Unit D2, Swords Enterprise Park,Feltrim Road
Swords, Co Dublin, Ireland K67 F256
european.admin@cagents.com
ASIA

1 Maritime Square#09-57 Harbourfront Centre
Singapore 099253
seasia.admin@cagents.com

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WHEN YOU NEED TO MEET A HIGHER STANDARD®
©2022 CAI. ALL RIGHTS RESERVED.