BioPharm International - February 2020

BioPharm-Outsourcing eBook

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www.biopharminternational.com February 2020 BioPharm International eBook 21 The strategies on win-win rela- t ion sh ip we r e d e ve lop e d a nd implemented for CROs. The con- cepts, however, can be applicable to all outsourced contracting work with long-term strategies in mind. TRANSACTIONAL VS. STRATEGIC RELATIONSHIPS Transac tional relationships are favored for shor t duration and limited scope projects (e.g., verifi- cation and validation studies and synthesis of organic compounds). Such a relationship merely aug- me nt s t he sp onsor compa ny 's i nte r na l re s ou rce s du r i ng t he crunch time. St r ateg ic re lat ion sh ip e x i st s when sponsor and CRO actively work together to help each other achieve t heir respec t ive objec- tives (2). Strategic relationships help both par ties benef it f rom long-term commitments on infra- str uct ure, continuous improve- m e nt , a n d i n n o v a t i o n s . T h e sponsor company is able to lever- age in-house resources for busi- ness-critical projects. In addition, the sponsor company may real- ize opportunities to penetrate into a new market segment when the CRO is from a location where the sponsor company currently lacks any presence. Ty pically, sponsor companies form strategic relationships with CROs to take care of standard work (e.g., on-going commercial stability studies, manufacturing of generics, compendial testing, remediation projects, and reference standards) and clinical studies. Examples of such strategic relationships include alliances of Syngene International w it h e a c h o f A m ge n , B a x te r Healthcare, Bristol-Myers Squibb, GSK, Herbalife, and Novartis, and that of Parexel with Eli Lilly. FDA GUIDANCE It is necessar y to comply w ith F DA's g u id a nc e do c u me nt on quality agreements (3), which is a major step in an alliance forma- tion. FDA's regulations recognize that owners commonly use con- tract facilities to perform some d r ug ma nu fac t u r ing ac t iv it ies. Although the guidance is for con- tract manufacturing organizations, many of the principles described in this guidance could be applied in pre-commercial stages of the phar- maceutical lifecycle. Key highlights f rom t he g u id a nc e do c u me nt include: • The owner's qualit y unit is legally responsible for approv- ing or rejecting drug products manufactured by the contract facilit y, including for f inal release. T he qua l it y u n it 's responsibilities and procedures are required to be in writing and followed. • Owners can use a comprehen- sive quality system model, in the form of a quality agree- ment, to help ensure com- pl ia nce w it h c u r rent good m a n u f a c t u r i n g p r a c t i c e (CGMP). • Owners are required to evalu- ate contract facilities to ensure CGMP compliance for specific operations. • Key elements of the quality agreement include: ° Clearly described materials or services to be provided, quality specifications, and c om mu n ic at ion me c h a - nisms between the owner and contract facility ° E x pla nat ion of how t he C RO w i l l r e p or t m a nu - fact uring dev iations and how the deviations will be investigated, documented, and resolved in compliance with CGMP ° Definition of each party's manufac t ur ing ac tiv ities in terms of how each will comply with CGMP. • It is recommended that quality agreements be separate doc- uments, or at least severable, from commercial contracts such as master services agreements or supply agreements. Quality agreements may be reviewed during inspections. • The buck stops with the spon- sor. No matter who tests the products, the owners' quality units are ultimately responsible for ensuring that the products are manufactured in accordance with CGMP. FDA could cite the owners for failing to evaluate, qualify, audit, and monitor their contract facilities. • I nte r n at ion a l C ou nc i l for Ha r mon i z at ion ( IC H ) Q10 Pharmaceutical Quality System (4) states that, as part of a phar- maceutical quality system, the owner is ultimately responsible for ensuring that "processes are in place to assure the control of outsourced activities and qual- ity of purchased materials." Partnerships for Outsourcing Outsourcing Acronyms The four commonly found "Cs" in contractual work are as follows: • CRO: contract research organization or clinical research outsourcing • CMO: contract manufacturing organization • CDMO: contract development and manufacturing organization • CTO: contract testing organization.

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