Quality Unitdepartment of quality
Role of the quality unit
According to Siegfried Schmitt, Chief Advisor at PAREXEL, the difference between quality controls and quality management systems lies in their name. F: The US Code of Federal Regulations (CFR) refers to the quality unit's roles and responsibility in 21 CFR Parts 210 and 211 (1), but no quality unit is mentioned.
A. Indeed, this can be a source of confusion, especially as other rules and guidelines relate to a'quality system' (2). In addition, European Union legislation on Contemporary Good Manufacturing Practices (CGMP) requires Quality Controls (QC) and mentions a Quality Assurance Unit (QA) without addressing the difference between these two rolls (3).
Generally, only the quality unit functions are listed in the rules. Differences in the various functions are to be found in the title (4): supervision acts as an administrative function, while assurances do not give rise to doubts. It is necessary in a pharma company to test, inspect or test things such as input material, process/finished products sample, ambient condition, etc.
which are often part of programmes such as environment or procedural controls. This requires the participation of the quality unit with the assistance of analysis labs or measurement workhops. Pharma companies must set up a PQS (Pharmaceutical Quality System) (5) that regulates all controlled pharmaceuticals activity and is managed, administered and operated by the Quality Unit.
PQS is a setting that allows a business to act in accordance with the rules and its accreditation, thereby facilitating adherence. The quality management can be considered as legislation where the quality unit is the executing authority. The SOP is written by an operative unit within the enterprise on the basis of models and according to quality control specifications.
As a rule, the QA Division does not sign for the technically accurate and accurate content of the SOP, but the QA on the SOP confirms that it was signed with the right document and followed the PQS procedure. Verifications are carried out on a regular basis in computerised frameworks used in a controlled pharmaceuticals setting, such as an analytic lab.
The QA should check the auditing trails for PQS and regulatory adherence; the QC should check the accuracy of the analytic work carried out. However, quality assurance must ensure that all procedures are properly described and followed in accordance with PQS and rules.
It is this monitoring procedure that is known as in-house inspections. To sum up, despite some obvious ambiguities in the rules, the role and responsibility of the quality control and quality assurance entities can be derived quite simply from their title and by careful read of the rules. Q10 Pharmaceutical Quality System (ICH, June 2008).
If you are referencing this paper, please quote it as S. Schmitt, "The Role of the Quality Unit", Pharmaceutical Technology 41 (9) 2017.