Quality Assurance or Quality Control? an example for pharma -EU GMP/FDA

EU GMP states that Quality Control (clause 1.3) “is concerned with sampling, 

specifications and testing, and with the organisation, documentation and 

release procedures”.  In essence, QC is a sampling, testing, monitoring and 

checking activity.

GMP also defines the routine duties for the Head of Quality Control (2.6) to:

• Approve or reject materials.
• Evaluate batch records.
• Ensure all testing performed.
• Approve specifications, instructions and procedures.
• Approve and monitor contract analysis.
• Maintain department, premises and equipment.
• Ensure validations are performed.
• Initial and ongoing training of personnel.

In addition, the Head of QC has some shared responsibilities with the 

Head of Production (2.7):

• Authorisation of written procedures and other documents.
• Monitoring and control of the manufacturing environment.
• Plant hygiene.
• Process validation.
• Training.
• Approval and monitoring of suppliers.
• Approval and monitoring of contract manufacture.
• Designation and monitoring of storage conditions.
• Retention of records.
• Monitoring of compliance to GMP.
• Inspection, investigation and taking samples.

EU GMP does not specifically require a Quality Assurance Department 

or Manager, but you must have a QA System (Chapter 1 – Principle).  

Most pharmaceutical manufacturing sites have a QA department, but problems

have occurred with assigning the QA Department tasks that were originally 

intended for QC.  It is also worth pointing out that the words “Quality Assurance” 

are not mentioned in 21 CFR 211 either.

It is not uncommon for the non-laboratory tasks of QC to be delegated to QA.  

Non-laboratory tasks of QC could be listed as in italics below.

Duties of QC (including those shared with the Head of Production) – all tasks:

• Approve or reject materials.
• Evaluate batch records.
• Ensure all testing performed.
• Approve specifications, instructions and procedures.
• Approve and monitor contract analysis.
• Maintain department, premises and equipment.
• Ensure validations are performed.
• Initial and ongoing training of personnel.
• Authorisation of written procedures and other documents.
• Monitoring and control of the manufacturing environment.
• Plant hygiene.
• Process validation.
• Training.
• Approval and monitoring of suppliers.
• Approval and monitoring of contract manufacture.
• Designation and monitoring of storage conditions.
• Retention of records.
• Monitoring of compliance to GMP.
• Inspection, investigation and taking samples.

If these duties are grouped together you get a list like this:

• Evaluate batch records.
• Approve and monitor contract analysis.
• Ensure validations are performed.
• Initial and ongoing training of personnel.
• Authorisation of written procedures and other documents.
• Plant hygiene.
• Process validation.
• Training.
• Approval and monitoring of suppliers.
• Approval and monitoring of contract manufacture.
• Monitoring of compliance to GMP.

These tasks can be delegated to QA.  This is not a problem, as GMP permits 

delegation (2.2).  However, if this is all that QA do (i.e. the non-laboratory tasks

 of Quality Control) then are they really “Quality Assurance”?  They are QC 

by another name!  Don’t forget, QC is a sampling, testing, monitoring and 

checking activity, and many of the activities above are just that.  Some are 

“Quality Assurance” activities, such as monitoring outsourced activities (contract

analysis and manufacturing), monitoring suppliers, validation and training,

but a QA department needs to do a whole lot more than this in order to 

really be a department dedicated to Quality Assurance.