GMP & QA

Task of QA
ensure that the drug products have the quality required for the intended use

Quality assurance system

A. medicinal products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice and Good Laboratory Practice, B. production and control operations are clearly specified and Good Manufacturing Practice adopted, C. managerial responsibilities are clearly specified, D. arrangements are made for the manufacture, supply and use of the correctstarting and packaging materials, E. all necessary controls on intermediate products, and any other in-process controls and validations are carried out,

Quality assurance system

F. the finished product is correctly processed and checked, according to the defined procedures, G. medicinal products are not sold or supplied before a Qualified Person has certified that each production batch has been produced and controlled in accordance with the requirements of the Marketing Authorisation and any other regulations relevant to the production, control and release of medicinal products, H. satisfactory arrangements exist to ensure, as far as possible, that the medicinal products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life, I. there is a procedure for Self-Inspection and/or quality audit which regularly appraises the effectiveness and applicability of the Quality Assurance system."

Quality
the nature of a drug product, which is determined by the identity, content, purity, and other chemical, physical and biological properties or by the manufacturing procedure This provides the link between the manufacture or manufacturing procedure and the quality assurance system and thus the product quality.

The quality assurance system establishes the conditions for this

there are several ways in which a pharmaceutical QM system can be set up

in accordance with the GMP rules and regulations or in accordance with the quality management structure in line with DIN ISO, or using a combination of the two requirements As there is no obligation to use one or other procedure in the pharmaceutical area, any combination of both variants is possible.

Position of quality assurance in the company

maintaining the quality management system reports to the management board or the board of directors ensuring that the system works properly There are various possible structures for the area or department. According to a generally accepted understanding, quality control (QC department) can be integrated in it, or there can be two separate operational departments (QA department and QC department).

Quality Unit in a matrix function

the individual activities should be marked with R = Responsibility or I = Implementation in the Quality Unit itself
Quality Manufacture control Activity Documentation Risk management Qualification/validation Changes Deviations/OOS Complaints Corrective and Preventive Actions Qualification of suppliers/service providers Training Inspection Batch Record Review QM handbook/PIC Research Clinical and Engineering research Development

Quality assurance as a matrix function in the organisation chart

Quality assurance as a matrix function in the organisation chart

In larger companies, there are now further substructures which exercise the activities of the Quality Unit in individual departments and areas. These are the so-called departments of a Quality Unit area.

Responsibility of the Quality Unit

it is important to note that the Quality Unit employees only have a duty to provide assistance in the individual task areas, but do not have to actually carry out the activities themselves. Technically skilled processing should still be carried out by the respective specialist departments.

Responsibility of the Quality Unit

however, it is the legally responsible person or the Qualified Person who remains responsible for conformity in terms of the compliance of the individual operations with the regulatory requirements and in terms of specificationscompliant processing together with pertinent documentation. At most, the Quality Unit can make an active contribution to the achievement of these objectives, and provide support.

Responsibility of the Quality Unit

In Germany and Europe, the head of production is responsible for ensuring that all necessary validations are carried out The FDA, on the other hand, expects the Quality Unit to sign the validation report and release the validation.

Responsibility of the Quality Unit

Quality Unit in Europe is not responsible for releasing the starting materials/raw materials or the final products. It can provide assistance in releasing the validation documentation, but ultimately it is the head of production or the head of quality control who is legally responsible for correctness and for implementation of validation. FDA attributes responsibility to the Quality Unit, where the same responsibility is assigned to the legally responsible person or the Qualified Person in Europe. In these cases, quality assurance can carry out advance visual inspection and assessment, but in the end, the above-mentioned persons are responsible.

Responsibility of the Quality Unit

The key personnel listed in the EU GMP Guideline are not recognised by the FDA. In its understanding, the Quality Unit is responsible for all these functions. In order to comply with both system requirements, both persons should sign the respective document, i.e. the head of the Quality Unit and the legally responsible person. Depending on the requirements, reference is made to the signature by the Quality Unit (USA), on the one hand, and to the signature by the legally responsible person or Qualified Person (Germany/Europe), on the other hand.

Responsibility of the Quality Unit

The Quality Unit only has system responsibility That is it must implement corresponding systems, establish written instructions, monitor compliance with the requirements and, in many cases, monitor or approve sub-steps

Responsibility of the Quality Unit

Evaluation of missing systems/processes Formulation of solutions for the system Agreement of the solutions with the legally responsible person/management board Implementation of the solutions in the departments Coordination of the processes and responsibilities between the individual departments Monitoring of compliance Feedback to the management board

Quality assurance tasks

Definition of the document structure Release of all SOPs for the quality management system Feedback to the management board regarding the quality management system Carrying out/organisation of training courses Carrying out/organisation of self-inspections/external audits Carrying out corrective and preventive actions Inspection and release of quality-related documents (to be defined depending on the company) Management of teams (risk management, validation, qualification, deviation, change, CAPA, etc.) Archiving of quality-related documents (to be defined depending on the company) Processing of/collaboration in changes, deviations, OOS

QUALITY ASSURANCE TASKS

For this reason, it is advisable to commission a department, which is completely independent of all areas, with the establishment and monitoring of the individual tasks. In the pharmaceutical company, the tasks and responsibilities must be clearly separated from each other, especially for persons with a legal or regulatory responsibility.

Job description for the head of the Quality Unit

Name of the job holder: Manager function: The job holder shall ensure that 1. all relevant GMP principles for the defined tasks and obligations are taken into account and implemented to the necessary extent at company .... 2. the processes, systems and responsibilities of the quality management system are established and codified in a quality assurance manual. 3. the self-inspections in all functional units of the quality management system and the follow-up of the resulting agreed actions are carried out and the respective status determined, assessed and communicated in an appropriate manner. 4. the employees of company ... have the respective required level of training as regards GMP. 5. inspections by the authorities and supplier audits are professionally prepared and processed ("company escort"). 6. the documentation of the requirements documents is complete and current. 7. the management is informed of all quality-related demands. Dept des.: xxx Managing director/Board of directors Mr/Ms ... Number of subordinate employees: ...

Job description for the head of the Quality Unit

The job requires the following employee qualification: School education: Vocational training: Professional experience/ duration: Specialist knowledge: Combination of functions: Deputy regulation: Summary: The notion of quality assurance is firmly grounded in all pharmaceutical rules and regulations. In order to operate effective quality assurance, systems must be introduced to describe the basic procedures. Quality management only works with active support by the management board. The management must be assigned a responsible role in the establishment and maintenance of the quality management system. The Quality Unit can only be attributed a supporting role in the overall system. In this role, however, it has partial responsibilities which can be perceived in a staff function or in a matrix function. Knowledge of the GMP rules and regulations, good spoken and written knowledge of English, management techniques, IT knowledge A combination of functions with the head of quality control is possible with corresponding proof of suitability. The head of the Quality Unit is deputised by: A-level University degree as biologist, chemist, biochemist or pharmacist At least two years employment in the above-mentioned areas, preferably in quality assurance in the field of medicinal products or active pharmaceutical ingredients