BioPharm June eBook: Single-Use Systems

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22 BioPharm International eBook June 2018 Single-Use Systems Qualification ther characterization of the mate- rial, component, or system is not required as long as a justification is provided. T he r i sk e v a lu at ion m at r i x included in the USP chapters con- siders different factors, including the duration of contact, the tem- perature of contact, the chemical composition of the process stream, and the nature of the component's materials of construction. Based on the results of this evaluation, there will be different levels of characterization, including base- line assessment (level A), expanded baseline assessment (level B), and full extractables testing (level C) as described in USP <665> and <1665> drafts (2,3). MANAGING PROCESS CHANGES BioPharm: How is change managed in the use of single-use systems, and what are the major challenges in managing that change? B u l p i n ( M i l l i p o r e S i g m a) : P o s t- approval changes to biopharma- ceutical manufacturing processes are inevitable due to the length o f d r u g p r o d u c t l i f e c y c l e s . Unfortunately, these changes cre- ate risks that must be managed to minimize the impact on drug product quality, safety, and effi- cacy, as well as dr ug supply to patients. Changes can originate from a variet y of sources, both internal and external. Our change management practice is focused on reducing the level of effort required and costs incurred by biopharmaceutical manufacturers to assess and accept our external supplier-initiated changes, such as changes in raw materials or com- ponents, changes in production site locations or manufacturing methods, specifications, regulatory declarations, and more. A s a m a n u f a c t u r e r o f s i n - g l e - u s e c o m p o n e nt s a n d s y s - t e m s a n d a n a c t i v e m e m b e r o f t he B ioPhor u m O p e r at ion s G r o u p ( B P O G )/ B P S A C h a n g e N ot i f ic at io n Wo rk s t r e a m, o u r c u s t o m e r n o t i f i c a t i o n c o m - m i t m e n t a n d c h a n g e m a n - a g e m e n t p h i l o s o p h y a r e i n a l ig n me nt w it h t he pr i nc ipa ls o f t h e B P O G/ B P S A p r o p o s a l : An Indust r y P roposal for Change Not if icat ion P ract ices for Single- Use Biomanufacturing Systems (4). Key components of our change m a n a ge me nt p r a c t ic e i nc lu d e a cross-f unctional team of sub - ject matter experts, product and pro c e s s k nowle dge, a compr e - hensive r isk assessment, robust c o m p a r a b i l i t y p r o t o c o l a n d qua l i f icat ion accept a nce c r ite - ria, and high-quality communi- cations; w ith oversight by [the quality department]. A comprehensive r isk assess- ment leverages aspect of quality by design and considers the intended use of the product to assess the impact of a change, and establishes the foundation for the qualifica- tion requirements and validation master plan. High-qualit y com- munications are also critical to a n e f f e c t ive c h a n ge m a n age - ment practice. Suppliers need to com mu n ic ate c ha nges c lea rly, promptly, and with technical rigor. Spec if ica lly, qua lif icat ion data packages that provide evidence of comparability assist in more effi- cient assessment and acceptance of post-approval changes. In terms of challenges, rapid pipeline growth and geographic e xpa nsion a re cont r ibut i ng to a n i nc rease i n i nvest ments i n global manufact uring capacit y. An increase in global manufac- turing capacity is contributing to an increase in the length, depth, a nd breadt h of supply cha ins. Supply chains are dynamic and constantly evolving; a company's product portfolios change, plants con s ol id ate or ma nu fac t u r i ng locations change, raw materials are discontinued, suppliers go out of business, reg ulatory authori- ties or Environmental Health and Safety (EHS) ban the use of cer- tain materials, and more. All of this is contributing to an increase in the number of supplier-initiated changes, which adds more risk and complexity. To reduce r isk a nd comple x- it y, r e g u l at o r y aut ho r it y a nd i ndu st r y consor t iu m s a re pro - viding new guidance to biophar- maceut ic a l ma nu fac t u re r s a nd single -use suppliers to suppor t p o s t- a p p r o v a l c h a n g e s . S o m e regulatory standards are in draft (a nd I nter nat iona l Cou nc i l for Ha r mon i zat ion [ICH] Q12 [5], USP <665> [2]). Other industr y g u ida nce doc u ments a re f i na l- i ze d (BP OG Ext rac t ables, BP OG Ch a n ge No t if i c a t i o n , A m e r i c a n Societ y of Mechanical Eng inee rs: Biop ro ce ssing E q uip m e nt [A SM E BPE]); however, change is still an area of limited consensus within the biopharmaceutical manufac- turing industry. Managing change is challenging in a rapidly growing market with continuously evolving guidance that requires a smart risk-based approach. One size doesn't fit all. We have extensive knowledge of our customers' processes, so we can strategically evolve their manufac- turing process to fit their growth plans. Expectations, qualification costs, and notification timelines are increasing; increasing the risk of supply d isr upt ions. Stay i ng abreast of rapidly evolving guid- ance is essential for us, as a sup- plier, to sustain an effective change management practice that supports biopharmaceuticals manufactur- er's efforts to maintain compliance with health authorities.

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