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www.biopharminternational.com March 2018 BioPharm International eBook 13 Outsourcing Resources Quality they must be contacted via the production shift coordinators. T he qu a l it y ove r sig ht st a f f m e m b e r s m u s t n o t a c c e s s clea nroom g rades A/B. Even cleanroom grade C should not be accessed if possible to avoid u n ne c e s s a r y c ont a m i n at ion o f t h e a s e p t i c c o r e a r e a . T he ob s e r v at ion s m ade a r e documented in a shift record. P o t e nt i a l i r r e g u l a r it i e s a r e included and either immediately, or later, d isc ussed w it h t he af fec ted produc tion team in either the form of a discussion or a documented training. It is possible to regularly analyze t he doc u ment at ion to d raw c o n c l u s i o n s f r o m f a i l u r e s , deficiencies, or misbehavior that occurred and was observed. • Cl ari f icat ion of nonconformit ies a n d i n c i d e n t s . A n i mp or t a nt pillar of quality oversight is not only routine observation but also presence in the production a re a whe n noncon for m it ie s occur. On one level, decisions are made and documented with the direct involvement of the quality assurance department. T h is i nc ludes, for e x a mple, how failures can be corrected, u n d e r w h i c h c o n d i t i o n s production operations may be continued, or which actions are required to ensure quality and compliance. On another level, certain corrective actions can be observed and assessed. For example, this covers necessary, unplanned interventions in the production area. In this way, nonconformities and risks can be better assessed and root causes investigated in greater depth. The decisions and observations are then attached directly to the started nonconformity process, thus containing all important information at first hand. • Docume nt at ion of shi f t supp or t . A s a l r e a d y m e nt i o n e d , t h e t i m e l y d o c u m e n t a t i o n o f obser vat ions, t he assessment o f i r r e g u l a r i t i e s , a n d t h e d o c u m e nt a t i o n o f q u a l it y- r e l e v a n t d e c i s i o n s a r e impor ta nt aspec ts of qua lit y o v e r s i g h t . T h e d i r e c t con ne c t ion b et we e n qu a l it y oversight and nonconformit y m a n a g e m e n t , a s w e l l a s t h e i nt r o d u c t i o n o f C A PA , represents a dec isive qua lit y benef it in data ma nagement a n d p r o - a c t i v e p r o c e s s optimization. • Involvement in document reviews a n d a p p r o v a l s . T h e p r e s e n c e of qu a l it y a ssu ra nce du r i ng all shift times allows for the t i m e l y r e v i e w o f p r o c e s s - releva nt doc u ments, such as ste r i l i z at ion re cord s, wh ic h c a n b e c o u nt e r c h e c k e d b y q u a l it y o v e r s i g ht a f t e r t h e pro duc t ion de p a r t me nt h a s r e v i e w e d t h e m . M o r e o v e r, c l e a n r o o m p a r a m e t e r s a n d r e l e v a nt l o g b o o k s a r e reviewed. In doing so, certain a d d it i o n a l a c t i o n s s u c h a s p e r i o d i c r e v i e w s o r a u d i t rev iew s of t hese do c u me nt s c a n b e r e c o n s i d e r e d a n d r e d u c e d ; i n s o m e c a s e s , t h e y m ay e v e n b e o m it t e d entirely. Moreover, necessar y c h a n g e s i n m a n u f a c t u r i n g s p e c i f i c a t i o n s t h a t d o n o t affect quality can be reviewed a nd approve d on- site. L i ke - for- l i ke c h a n ge s, wh ic h a r e documented in logbooks, can a l s o b e r e le a s e d b y qu a l it y o v e r s i g h t . T h e s e a c t i v i t i e s enable t he t i mely a nd e xac t review of the documents and can reduce additional cyclical reviews. Additionally, qualit y oversight sta f f members ca n carry out batch record reviews. Figure 1 is courtesy of Vetter Pharma. Figure 1: (figure from Vetter Pharma-Fertigung GmbH & Co. KG): Tasks of the operative quality oversight function within the scope of shift coverage.

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