BioPharm

www.biopharminternational.com March 2018 BioPharm International eBook 15 Outsourcing Resources Quality patient safety. For the successful implementation of the quality o v e r s i g h t f u n c t i o n , i t i s , therefore, indispensable that communication with everyone involved is clear and roles are defined. This requires time and the constructive elimination of obstacles. • Q u a l i f i c a t i o n o f s t a f f m e m b e r s . Whether the quality oversight sta f f member s w i l l b e wel l- accepted depends on personal factors such as their experience, their knowledge in the relevant area, and if their appearance is self-confident and convincing. It is, therefore, sensible to employ experienced staff members in this f unction who previously worked in the production and e n g i n e e r i n g d e p a r t m e n t s . H o w e v e r , i n e x p e r i e n c e d s t a f f m e m b e r s w i t h q u i c k understanding, a decisive and c o nv i nc i n g d e me a no r, a nd strong communication sk ills can grow into this f unction. S t a f f m e m b e r s s h o u l d b e given comprehensive training on all relevant processes and methods so that they completely u nd e r s t a nd t he pr o duc t ion p r o c e s s e s . A d d i t i o n a l l y , st a f f me mb e r s mu st have a go o d o v e r v i e w o f e x i s t i n g specifications and be able to easily ascertain how to assess incidents and nonconformities t h a t o c c u r . E x p e r i e n c e d staff members are, therefore, particularly suitable for work in this function. • A r e a s o f e m p l o y m e n t . T h e q u a l it y o v e r s i g ht f u n c t i o n c a n b e e f f i c i e nt l y u s e d i n m a n y q u a l i t y a s s u r a n c e areas. However, planning the s h i f t s up p o r t i s s o me t i me s cha lleng ing when nu merous production lines are operating at t he sa me t i me a nd when severa l i nc idents may occ u r s i m u l t a n e o u s l y, r e q u i r i n g t h e p r e s e n c e o f a q u a l i t y oversight staff member, which subsequently results in little time for other tasks. Because fewer produc t ion operat ions t a ke place du r i ng t he n ig ht s h i f t , f r e e c a p a c i t i e s m a y arise. However, the challenge is that office activities such as doc ument rev iew a nd repor t creations are demanding tasks, particularly during night shifts. BENEFITS AND OUTLOOK Nu merous benef its just i f y t he establishment of an operative qual- ity oversight function. As mutual understanding and communication between the production and QA departments grow, weaknesses are jointly and proactively recognized and problems solved. Surprises in connection w ith incidents and decisions that may not have been supported by all involved areas become an exception. The require- ment to timely document infor- mation as well as quality-relevant decisions is also met. The function raises awareness regarding potential deficiencies, similar to internal audit manage- ment but with a higher frequency. T he a i m is to use t he qua l it y oversight function in a targeted manner. For example, when an operative department requests the observation and assessment of a certain process (which is possibly prone to errors) by a neutral QA part y, it is evidence of the suc- cessf u l i mplementat ion of t he function. Open and honest com- munication between the produc- tion and QA departments makes it easier to jointly develop optimiza- tion actions. Finally, the question arises as to how far the quality oversight func- tion can be extended in practice. To begin with, the request for more intensive verifications and super- visions up to the performance of process steps by the QA function must be critically questioned. The already mentioned performance of AQL after 100% visual inspection can certainly be justified because i n t h is case, a spec i f ied qua l- ity level of a batch to be released is verified. However, it must be evaluated to what extent special expertise can be transferred to QA. In addition to training courses, practical experience is important to realize the quality benefit. In Germany and Europe, there is spe- cific vocational training that is the prerequisite to carry out certain pharmaceutically relevant activi- ties. The head of quality control, the head of production, and the qualified person are responsible for the products produced according to the legal regulations in Europe. The fact that European regulations do not comply with the US system makes discussions in this context more difficult. In summary, quality oversight has many benefits if the operative involvement of quality assurance in the existing qualit y manage- me nt s y ste m is successf u l. To achieve this, the concept must be thoroughly considered from the start. The focus should not only be on technical aspects, but also the staff members. In this connec- tion, the qualification of quality oversight staff members is as deci- sive as their acceptance in the pro- duction department. If a culture of continuous process optimiza- tion develops, all parties involved will benefit. REFERENCES 1. European Commission, EU GMP Directive 2001/83 (Brussels, Nov. 6, 2001). 2. European Commission, EU GMP Directive 2003/94 (Brussels, Oct. 8, 2003). BP

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