Responsibilities for quality assurance

The FDA retained the requirement for a quahty assurance unit, or function, to monitor studies for conformance to the regulations. It was emphasized that the function was administrative rather than scientific. The personnel responsible for quality assurance for a given study were required to be separate from, and independent of, the personnel responsible for the direction and conduct of that study. 

There should be an appropriate and sufficient structured system, including organizational structure and documentation infrastructure, sufficient sufficient personnel and financial resources to perform validation tasks in a timely manner. Management and the personnel responsible for quality assurance should be involved in this discussion. Validation performance must be under the responsibility of appropriate and experience personnel that should represent different departments depending on the validation work to be performed. 

Prequalification of products and manufacturers, purchasing, storage and distribution are complex processes that may involve many offices, procurement agencies, sections or departments and several stages of administration, finance and technical decisions. Pharmaceutical products are not ordinary commodities of trade and require special attention. Support from the offices responsible for quality assurance is crucial. The efficiency of the procedures depends in great part on the use of a proven method in a consistent manner. The use of a standard approach will ensure consistency in all activities involved in procurement of pharmaceutical products of defined acceptable quality. 

Key personnel should include those responsible for prequalification, pm-chasing, storage and distribution. The person responsible for prequalification could also be responsible for quality assurance. National legislation should be complied with, e.g. requirements for a responsible person for purchasing, storage and distribution of pharmaceutical products. 

One person could perform more than one of the above-mentioned functions however, the person responsible for quality assurance should be independent and report to the head of the organization only. 

The pathway to assuring the safe and effective use of short-lived radiotracers is to place the responsibility for quality assurance in the hands of nuclear pharmacists who fill physician s prescriptions for radiotracers as they do for other drugs under state pharmacy laws. Radiochemists or others working in institutions with radiopharmacies must have the expertise for the preparation of the radiotracers as well as for quality control under good manufacturing practices. This hook provides guidance and safety standards applicable to Tc-99m pharmaceuticals. 

Master batch documents, standard operating procedures and other master documents having a direct bearing on product quality should be authorised by the person responsible for Quality Assurance or that person s delegate as well as by a responsible Production or other relevant Manager. 

Key personnel include foe Managing Director, the person responsible for Production and the person responsible for Quality Assurance. The person responsible for Production and foe person responsible for Quality Assurance, should be different persons of equal level of authority, neither of whom should be responsible to foe other, but who both have a responsibility for achieving foe requisite quality. 

NOTE The duties of this person responsible for Quality Assurance are wider than those which may be suggested by such terms as Chief Analyst , Laboratory Head , etc. 

Persons in responsible positions should have sufficient authority to discharge their responsibilities. In particular, the person responsible for Quality Assurance should be able to carry out his defined functions impartially. 

The person responsible for Quality Assurance should be part of the decision-making process in all matters that affect the quality of products including development, production, laboratory, storage, distribution, vendors and third party contractors. 

There should be specifications, approved at least by the person responsible for Quality Assurance, defining the nature and quality of each finished product... 

The presence of a person or group, mainly or exclusively responsible for quality assurance... 

The new paradigm places more of the responsibility for quality assurance on the individual analyst and on the laboratory rather than on the method itself. It used to be that as long as an analyst followed the recipes (sounds a lot like cooking, doesn t it) in the various methods, then quality data were assured. The analyst s input in the process was not required, nor was it requested. This point of view took the analyst out of the picture and served to define the analyst more as a robot-technician than as an involved and motivated professional. This point of view left little to no room for analyst intervention. If an analyst wished to skip a step here or there in the method, it was assumed that the method was not followed and, therefore, the data could not be assured or, in the parlance of the time, EPA approved. PBMs hopefully have and will change this somewhat myopic view of TEQA and, furthermore, begin to place the responsibility on the analyst to yield quality data that are assured based on method performance as opposed to blindly adopting the recipe. 

Commission s own nuclear reactor experience was used in developing the 18 items. Appendix B clearly places the burden of responsibility for quality assurance on the licensee. Visible quality assurance documentation is required for ail activities affecting the quality of safety-related systems. Appendix B was published for comment in April 1969 and implemented in June 1970. 

---