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CGMP Resources

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32 views

CGMP Resources

Uploaded by

Javohir Ashurov
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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INTRODUCTION TO GMP

Resources

Links
FDA CFR Title 21
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

ICH
https://www.ich.org/

ICH Q7
https://www.ema.europa.eu/en/ich-q7-good-manufacturing-practice-active-pharmaceutical-ingredients-
scientific-guideline

EUDRALEX
https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en

EMA

https://www.ema.europa.eu/en

All rights reserved 2022 © This document is copyright of Zamann Pharma Support GbmH
Pharmuni ® is a registered trademark of Zamann Pharma Support GmbH
INTRODUCTION TO GMP
Resources

Course Summary
CGMP is a large topic, and this lecture aims to give you a foundational understanding.
Everything you do within a life science company can impact the products it produces.
Therefore, the importance of having a quality-first mindset and staying compliant with
GMP rules and guidelines cannot be stressed enough.

• Producing products requires integration of current GMP guidelines within a Quality


Management Systems (QMS and many other requirements.

• CGMP rules and standards are applicable to the entire life cycle of products within
the life science industry.

• GMP requires that products:

o are of consistently high quality;

o are appropriate for their intended use;

o meet the requirements of the marketing authorisation or clinical


trial authorisation.

• A QMS and cGMP always belong together.

• Training plays an important role in embedding a company culture that centres


around quality and compliance.

• Ongoing training of new or updated procedures for every employee in a life science-
related company is an important quality focus.

• All activities within a life science company should be documented to enable


traceability, reproducibility, control, monitoring, and verification of the processes
carried out.

• No decision within the life science quality environment can be made without an
evaluation of associated risks. Risks assessments are a key process in every
department, quality-relevant process, or activity.

All rights reserved 2022 © This document is copyright of Zamann Pharma Support GbmH
Pharmuni ® is a registered trademark of Zamann Pharma Support GmbH
INTRODUCTION TO GMP
Resources

• All life science companies that conduct development, manufacturing, or distribution


activities are subject to inspections and audits by authorities

• All suppliers must be qualified first (Supplier Qualification) to confirm they can
supply materials, services, or products that meet quality and regulatory standards.

• All equipment should be qualified first, and their applied methods validated before
they can be used.

• After a product enters the market, many different procedures ensure that every
single bit of market or customer feedback is managed correctly within a company
and, if required, follow-up steps are taken.

All rights reserved 2022 © This document is copyright of Zamann Pharma Support GbmH
Pharmuni ® is a registered trademark of Zamann Pharma Support GmbH

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