Assuming the QP were to choose to do this large number of things themselves on a bunch by-group premise it would be hard to deliver more than 5 to 10 batches each week.
Obviously, the QP has no other option except to assign some of these obligations to partners. In any case, the subject of designation isn't plainly perceived by all QPs. Some accept that their obligations must be appointed to another QP.
- The lawful obligations of the QP must be appointed to an individual QP who should be named on the assembling approval.
- The non-legitimate routine obligations of the QP can and ought to be appointed to associates in a few pupils, not just the quality capacity.
- This requires cooperation.
The QP Code of lead was composed to help QPs in settling on these functional choices.
THE QP CODE OF PRACTICE
The Code was written by the Tripartite QP Assessor Panel, which consists of experts from:
- Institute of Biology
- Royal Pharmaceutical Society
- Royal Society of Chemistry
Code is endorsed by MHRA and VMD and the current was version published in 2004.
The aims and objectives of the Code of Practice are to provide operational guidelines for carrying out the functions of the QP within a professional code of conduct.
"It is of paramount importance that the QP takes steps, within a well-planned Quality Management System, to assure himself or herself that the tasks allocated are in fact being performed satisfactorily.
Hence the routine duties of the QP depend very much upon a team effort wherein the individuals concerned realize the position and responsibility of the QP and provide every support.
What cannot be over-emphasized in this context is the QP's commitment to regularly interact with professional colleagues in all functional groups and to understand their contribution and impact upon quality."
Each QP has a personal and professional responsibility for ensuring that the various checks and tests have been carried out.
Details of this work may be delegated to appropriately trained and experienced staff who would endorse their work accordingly.
Ultimately, the QP must be satisfied either directly or, more usually, by the proper operation of systems and procedures that manufacturing and testing have complied with the relevant requirements.
It must be recognized that the QP depends upon many of his/her colleagues for the achievement of quality in the manufacture of medicinal products.
It is therefore of paramount importance that the QP achieves a very good working relationship with other persons in positions of responsibility; who will liaise closely with the QP in order to assist in the performance of his/her duties.
QPs have personal and professional duty to keep knowledge and experience up to date.
Records of CPD activities should be kept.
In the event of major job change (e.g., move from oral solid dose to sterile products) QP must recognize need for additional education and training.
QPs have duties not only to their employer but also to the Regulatory Authorities. They must ensure appropriate senior company executives are fully aware of any manufacturing and/or testing difficulties which may cast doubt on the release of batches or might require product recall.
If there is any aspect of the QA system which is not in accordance with GMP then the QP has a duty to bring this to the attention of Senior Management.
QPs should establish good working relationships with Regulatory Authority Inspectors.
It is assumed that a QPs employer will:
- enable QP to undertake CPD to maintain and extend technical and professional competence
- provide QPs with appropriate resources
- ensure that Quality Management Systems and communications are working effectively
Thus the Qualified Person must display...
KNOWLEDGE
- Of the laws
- Of the authorizations
- Of the products
- Of the processes
EXPERIENCE
- Of pharmaceutical manufacture and the challenges it can throw at us
- The needs of the business
PERSONAL ATTRIBUTES
- Problem-solving/decision making
- Teambuilding
- Negotiation
- Assertiveness
- Character
- Professionalism/ethics
CONFIDENCE
- in colleagues
- in themselves
- in THE QUALITY SYSTEM
This serves to accentuate the importance of the Quality System in assuring product quality and thus its importance to the practicing QP, who should therefore be intimately involved in...
- the development and shaping of the Quality System
- the working on the Quality System
Additionally, the QP should have a clear understanding of their role and position within the Quality System and the company's management structure.
