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Quality Oversight and Its Implementation

The term qualityoversight comes from the USA and takes account of the American idea of a QA department. 

Production and Quality Control department of pharmaceutical industry are not always managed as independent operations there, but often fall under the umbrella of QA (quality assurance). 

This type of structure necessitates an additional, overarching review, especially when too many deviations or OOS occur. 

However, the American regulations make no reference to quality oversight as an operation within a company. The expression was instead coined by a mention in deficiency statements (483 observations). 

A “lack of quality overview” is often claimed if, for instance, the senior management is not or only insufficiently involved in quality processes.

In the EU regulations, the term is mentioned in connection with the validation lifecycle: in accordance with Annex 15 “Qualification and Validation”, chapter 1.3, there should be appropriate “quality oversight” throughout the whole validation life cycle. 

Responsibility for this should lie with QA. With regard to change management, quality oversight is only referred to indirectly by references to ICH Q10 “Pharmaceutical Quality System”, chapter 3.2.3. 

Here, too, the aim is a suitable science- and risk-based assessment of changes. 

Quality Assurance should in turn assume responsibility for this.

How is quality oversight best implemented?

In Europe, Quality Control (QC) operates independently of Production. 

There are also separate control mechanisms, such as e.g. batch documentation created by Manufacturing, which is reflected in the PQR (Product Quality Review) and checked by the Qualified Person (QP) or QA.

Quality oversight is thus provided if a GMP-controlled quality system has been implemented that corresponds to the European regulations and depicts validation life cycles in accordance with the applicable Annex 15. 

If all product and process-related reviews are present, no further requirements can be referenced or derived from them.

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