EU GMP states that Quality Control (clause 1.9) “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 (2.8) to:

• Approve or reject materials.
• Ensure all testing performed.
• Approve specifications, instructions and procedures.
• Approve and monitor contract analysis.
• Quality and maintain their 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 (2.9):

• 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.
• Participation in management reviews.
• Ensuring that a timely and effective communication and escalation process exist.

EU GMP does not specifically require a Quality Assurance Department or Manager, but you must have a QA System (Chapter 1 – Principle).  It does say at 2,5 of EU GMP that “additionally depending on the size and organisational structure of the company, a separate Head of Quality Assurance or Head of the Quality Unit may be appointed’.  So, you might, and almost certainly will have a QA department, even though EU GMP does not define the roles of QA.

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.
• Ensure all testing performed.
• Approve specifications, instructions and procedures.
• Approve and monitor contract analysis.
• Quality and maintain their department, premises and equipment.
• Ensure validations are performed.
• Initial and ongoing training of personnel.
• Inspection, investigation and taking samples.
• 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.
• Participation in management reviews.
• Ensuring that a timely and effective communication and escalation process exist.

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

• Approve specifications, instructions and procedures.
• 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.
• Participation in management reviews.
• Ensuring that a timely and effective communication and escalation process exist.

These tasks can be delegated to QA.  This is not a problem, as GMP permits delegation (2.3).  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.

I hope you find these thoughts interesting.  Please feel free to comment.  For details of our courses in this area select this link: QMS Courses

THIS ARTICLE WAS FIRST PUBLISHED IN 2012 AND MOST RECENTLY UPDATED IN SEPTEMBER 2022.

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