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ONBOARDING  GOOD MANUFACTURING PRACTICES (GMP)  TRAINING

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What is GMP?  How we follow GMP in Alcon Key GMP Rules Failure to Comply  Key Takeaways

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If both you and your friend bake a cake, will the cake be the same?

WHY   is your cake  different  from your friend’s?

Scenario - Why Is My Cake Different From Yours?

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Your friend was properly  trained Your friend’s recipe was  documented Your friend used clean tools every time to  avoid   cross contamination Follow guidelines  to get same quality each and every time

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Quality systems for  regulated  products (food, drugs, biologics, medical devices, etc.).  Set of principles cover  all aspects of manufacturing  (suppliers, production, testing, distribution, etc.). To ensure products  consistently  meet applicable requirements and specifications.

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Quality Policy
Quality Manual
QSPs, FSPs, MSPs and
associated work
instructions
Local Work Ins ructions,
Job Aids, Guidelihes, Forms
Records
A Quality Manual serves as the framework document for
defining the Alcon Global Quality Management System.
QSPs, FSPs, and MSPs are global operational documents
describing a process.
Local Procedures and Work Instructions are operational
documents that apply to a site.
A Record is evidence of activities performed or results
achieved (regardless of medium created or stored)
for example, a completed form

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Alcon is a global company dedicated to the advancement of eye care through research and
innovation. Our purpose is reimagining eye care. We fulfill this purpose through innovative
products, partnerships with eye care professionals and programs that enhance access to quality
eye care for patients and customers.
We endeavor to research, develop, manufacture, distribute and service products to satisfy the
needs of our customers. Our mission is to discover new ways to enhance sight and improve
people's lives. This enables us to serve our customers through the full life cycle of patient needs
across eye diseases, vision conditions and refractive errors.
We consider quality to be more than conformance to product specifications. We seek to ensure
suitability of business processes to maintain an effective quality management system. At Alcon,
we recognize the integral nature of the regulatory framework to our business systems. We believe
in proactive compliance, sustainable implementation of regulatory requirements, and continuous
improvement.
Alcon's business ethics are solidly based upon mutual trust and integrity. Our vision is to be the
most trusted leader in eye care. By serving people worldwide, we are building our reputation while
addressing the growing eye care demands of the future. Every member of the Alcon team is
responsible and accountable for ensuring that their objectives are aligned with this policy.
David Endicott
CEO Alcon

We meet the needs of our consumers. Our core mission is to preserve and restore vision. We comply with regulatory requirements. Our objectives are aligned with this policy.

The quality policy establishes the company commitment to quality.

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Regulations/standards applicable to medical device are translated into  Alcon Quality Manual .  It serves as the  framework  document for defining Alcon Quality Management System (QMS).

V-QMS-0053272, “Global Quality Manual”

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Follow  procedures to ensure controlled and consistent performance.  Clarify  with your supervisor, team lead or trainer if you have doubt on the procedure.  Changes in procedures shall go through proper  change control  process.

SOP  (standard Operating Procedure) Training Material WI  (work instruction) Specification Document

We don’t change the practice without changing the procedures.

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The records provide the  evidence  and  traceability  of our activities, processes and product history.  Good Documentation Practices (GDP)  shall be followed for both paper and electronic records.   Comply with  Data Integrity (DI)  requirements.  GMP records shall be  retained  based on record retention policy.

If it’s not documented, then it didn’t happen!

Forms  (paper & electronic) Work order Electronic records (MES, SAP, LIMS, etc.) Protocol/ Report Equipment logs Training records

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All personnel shall meet the training requirements to develop or maintain their  competency  before they can perform assigned duties.  Training is applicable to  all personnel  performing GMP activities, including full-time associates, interns, contingent workers, apprentice.  Complete assigned training within defined due dates.

Adequate training is to ensure our associates doing the job right first time and every time.

On-the-job Training  (OJT) Self-reading Classroom training Certification

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Maintain hygiene to reduce the risk to  product contamination .  Follow the  gowning  procedures for the hygienic areas (e.g. wash hands, no food allowed, etc.).  Minimize the  contact  with products and product-contact surface.

Personnel is the greatest source of contamination.  Exercising personnel hygiene is the best defense against product contamination.

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Potential consequences if fail to comply GMP

Loss of integrity & reputation No customer/business Job loss

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Follow the procedures you have been trained on.   Document exactly what you do and when.  Complete your training before performing related tasks.  Have special attention to your own hygiene.

Veeva Vault Training Train-the-Trainer Session

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