Three key personnel are named on a pharmaceutical manufacturing site’s Manufacturing Licence.  These are the Head of Production, the Head of Quality Control and the Qualified Person(s).  Their roles and responsibilities are also defined in GMP in Chapters 2 (Personnel) and Annex 16 (Certification by a Qualified Person and Batch Release).  These individuals have a major influence on product quality and GMP.  Their duties are described below:

Head of Production (EU GMP, Clause 2.5)

  • Products produced and stored according to appropriate documentation.
  • Approval of production instructions and their strict implementation.
  • Ensure production records are evaluated prior to sending to QC.
  • Maintenance of department, premises and equipment.
  • Validations performed.
  • Initial and on-going training.

Head of Quality Control (EU GMP, Clause 2.6)

  • Approve or reject materials.
  • Evaluate batch records.
  • Ensure all testing performed.
  • Approve specifications, etc.
  • Approve and monitor contract analysis.
  • Maintain department, premises and equipment.
  • Validations performed.
  • Initial and on-going training.

Duties of the Quality Control Unit (21CFR211.22)

One of these individuals can be found in USA GMP.

  • Approving or rejecting all components, drug product containers, closures, in-process materials, packaging material, labelling and drug products.
  • Review production records.
  • Ensure that if errors have occurred, that they have been fully investigated.
  • Approving or rejecting drug products manufactured, processed, packed or held under contract by another company.
  • Approving or rejecting procedures or specifications.

Shared duties of the Heads of Production and QC (EU GMP, Clause 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.

The Qualified Person (EU GMP, Clause 2.4 and 1.5 (final paragraph))

  • Products manufactured within EU – a QP must ensure that each batch was produced and tested according to GMP and Licensed conditions
  • Products manufactured outside the EU – a QP must ensure that each imported batch has undergone, in the importing country re-testing and evaluation
  • A QP must sign a register to state that the above has been performed satisfactorily before product is released (QP certification)
  • Product Quality Review performed in a timely manner and accurate (EU GMP 1.5)

The Qualified Person (EU GMP, Annex 16 Section 8)

Before certifying a batch prior to release the QP should ensure that at least the following requirements have been met:

  • The batch and its manufacture comply with the provisions of the marketing authorisation
  • Manufactured according to GMP, or if imported from a third country, according to standards at least equivalent to EU GMP
  • Manufacturing and testing processes have been validated
  • Account has been taken of the actual production conditions and manufacturing records (NB The Heads of Production and QC are ultimately responsible for performing this task)
  • Deviations or planned changes in production or QC have been authorised by the persons responsible in accordance with a defined system
  • Changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority
  • All necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes
  • All necessary production and QC documentation has been completed and endorsed by the staff authorised to do so
  • All audits have been carried out as required by the quality assurance system

The QP should in addition take into account any other factors of which they are aware of which are relevant to the quality of the batch

Of note is that there is no mention of a Quality Assurance Manager or an Engineering Manager. Most firms have these two individuals, who both have a massive impact on GMP and Product Quality.  In Parts 2 and 3 of this post we will look at what their routine duties often are.