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Introduction to QC for (Bio)Pharmaceutical Manufacturing

The aim of this course is to provide learners with a solid understanding of the role of Quality Control (QC) within an organization and how it relates to the manufacture of pharmaceutical products. Participants will gain knowledge in key areas including QC regulatory obligations, current Good Manufacturing Practice (cGMP), QC test methods and QC/laboratory information systems and typical QC Standard Operating Procedures (SOP) documentation.

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Description

Learner Profile:

Learners seeking core knowledge of the QC function, test methods and regulatory requirements, as they relate to a (Bio)Pharmaceutical manufacturing environment. This could include those interested in transferring from another related sector such as from the food and drinks industry.

Learner prerequisites:

Candidates should at minimum have completed the Junior Cert with pass grades in at least five ordinary level subjects (including Maths and English).

Learning outcomes:

On completion of this course the learner should be able to: -  
• Identify the regulatory bodies that oversee bio-pharmaceutical manufacturing.  
• Describe the relationship between QC and QA (Quality Assurance)  
• Demonstrate an understanding of an organization’s regulatory requirements related to QC.
• Identify the key components of SOP’s related to QC documentation.  
• Describe the principles of validation in relation to QC.

Course Content:

(Modules) • cGMP Compliance for Healthcare Products and Pharmaceuticals.  


• Introduction to QA and QC in an (Bio)Pharmaceutical context  


• Examples from industries – QC in the bigger context.  


• QC and Validation.  


• QC Chain of Custody.  


• QC Test methods and Procedures, Accuracy, Precision and Reliability.

Duration:

1 Day

Exam/Continuous Assessment details:

Short Exercise/Quiz (to check for understanding – not marked)

Certification / Awarding Body/Credits:

Vendor Certificate of Completion

Progression Pathway:

Possible options for progression from this course are:


  • Essential Skills for Manufacturing in the (Bio)Pharmaceutical Industry (AMC22205)
  • Introduction to cGMP for the (Bio)Pharmaceutical Industry (AMC21099)

or accredited programmes such as:


  • Certificate in Operational Excellence (Special Purpose Award/QQI Level 6: 25 Credits - AMC22150) or

Certificate in Supply Chain (Special Purpose Award/QQI Level 6: 25 Credits - AMC22151)