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.

I hope you find these thoughts interesting.  Please feel free to make a comment.

For more information on the Quality Management and GMP training courses we offer – please visit our course dates page.

3 Comments

  1. amit

    Where we can put Validation manager, Project Manager, Plant Manager, QC Manager and Product Manager ?
    What are there roles and responsibilities ?

    Reply
    • Dominic Parry

      The only roles defined in EU GMP are for the Heads of Production,Quality Control and the Qualified Person. See Chapter 2. Tasks may be delegated in some cases. See Chapter 2 clause 2.2.

      Reply
  2. photographe de mariage

    Thanks a lot for that blog article.Really looking forward to read more. Many obliged.

    Reply

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