BioPharm

12 BioPharm International eBook March 2018 www.biopharminternational.com Outsourcing Resources Quality tem focusing on nonconformity management, corrective and pre- ventive action (CAPA), training, and document review. FORMER QUALITY ORGANIZATION STRUCTURE Before the introduction of a qual- it y ove r sig ht f u nc t ion i n t he organizational structure at Vetter, the quality structure was based on the EU GMP guidelines (e.g., EU Guide to good manufacturing practice for medicinal products as well as the specifications in the EU GMP directives 20 01/83 [1] and 20 03/94 [2]). These specif i- cations regulate the responsibili- ties of the head of quality control (Q C) a nd t he head of pro duc- tion, as well as the f unction of the qualified person in the con- text of a quality assurance (QA) system. The system defines, for example, responsibilities for the areas of nonconformity manage- ment, risk management, change control, CAPA, audit, instruction, and training. At Vetter, the QA division was responsible for the approval of pharmaceutically rel- evant documents, as well as stan- dard operating procedures (SOPs). A group within quality operations (QO), which worked closely with the production department, man- aged investigations and assessed risks in nonconformity processes. The group was also responsible for operative issues. Outside core working times, a QA/QC on-call was available around the clock for seven days per week. Moreover, media-fill and unannounced pro- cess observations were conducted twice a year per cleanroom. I n bot h t he for mer a nd c u r- rent quality structure and today, because of the company's numer- ous international customers with m a r ke t i n g a u t h o r i z at i o n s f o r many different countries, Vetter is always prepared for inspection by authorities. Additionally, the qual- it y management system is reg u- larly inspected. SUCCESS FACTORS OF IMPLEMENTATION The quality oversight to be imple- mented at Vetter included the fol- lowing aspects according to FDA's understanding: • Direct and timely involvement of the quality unit when events (nonconfor mities) occ ur and their documentation is made d u r i n g a s e p t i c p r o d u c t i o n operations. • F r e q u e n c y o f o b s e r v a t i o n s in the aseptic production, in p a r t i c u l a r, o b s e r v a t i o n o f critical processes and work steps as well as the staff members' hygiene behavior. • Presence of the quality group on weekends or outside core working times (late and night shifts). I n 2 0 0 9, t h e q u a l i t y o v e r- sight f u nc t ion was i nt roduced to alig n Vetter's qualit y under- sta nd i ng w it h t hat of F DA . At first, the permanent presence of quality oversight staff members (sh if t suppor t) was int roduced. Staff members should always be available on site to clarif y pro - c e s s n o n c o n f o r m it i e s a n d t o make qualit y-relevant decisions (involving the QA on-call if nec- essa r y). Moreover, t hey shou ld observe and document different production activities. FDA appre- ciated the introduction of shift support and the responsibilities defined for the quality oversight st a f f me mb e r s. Fu nc t ion s a nd responsibilities of the staff mem- b er s were t hen developed a nd described in more detail. The activities currently imple- mented are explained in more detail in the following. The key factors of a successful integration into the already existing quality management system are presented (see Figure 1): • S h i f t s u p p o r t . T h e b a s i s o f q u a l i t y o v e r s i g h t i s s h i f t supp or t. QA st a f f me mb e r s are on site at all production t i m e s . A p a r t f r o m m e d i a - f i l l obser vat ions, add it iona l ma nd ator y obser vat ions a re required per shift. Moreover, checklists and plans ensure that relevant aspects, such as critical process steps, are adequately observed and assessed and that there is regular observation of all production areas or lines. The production department is not advised in advance when obser vations w ill take place. Consequently, the staff members must always expect that their w o r k s t e p s a r e o b s e r v e d . H ow e v e r, t h e o b s e r v at i o n s must never disturb production operat ions. P roduc t ion sta f f me mb e r s may b e add resse d directly in exceptional cases only. For example, as a r ule, Quality oversight has many benefits if the operative involvement of quality assurance in the existing quality management system is successful. The basis of quality oversight is shift support.

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