Issue link: https://www.e-digitaleditions.com/i/1171476
www.biopharminternational.com September 2019 BioPharm International eBook 33 Regulatory Sourcebook Pharmacopoeia Compliance Series of t his requ irement, list ing a n FDA 483 observation given to a firm because they did not com- pa r e or qu a l i f y t he i r work i ng standard against the official USP reference standard. Establishing collaborative partnerships with internal stakeholders, who are essential in the compendial review process can be difficult. Internal stakeholders I n add it ion to t he c h a l le nge s described prev iously, which are la rgely d r iven by e xter na l fac- tors, t here a re severa l i nter na l challenges that make pharmaco- p o e i a c ompl i a nc e d i f f ic u lt to est abl ish a nd ma i nt a i n. T he re may b e a lac k of u nde r st a nd- ing within a bio/pharmaceutical company regarding the need for, the complexity of, and the chal- lenges to compendial compliance, which may result in insufficient focus and resources allocated to this critical work. Even if there is understanding, there is often i n s u f f ic ie nt v a lue at t ac he d to the work needed to achieve com- p e nd i a l compl i a nc e, r e s u lt i n g in potential de-prioritization of compendial activities when chal- lenged with competing priorities. The need for and value of effective compendial processes to ensure compliance should now be clear, as shou ld be t he need to have appropriate tools for tracking and communicating new and revised pharmacopoeia requirements for impact assessment. Establishing collaborative part- ne r s h ip s w it h i nte r n a l s t a ke - holders, who are essential in the compendial review process can be difficult, especially in large com- panies with a multitude of func- tional areas and manufacturing sites t hat may be i mpac ted by compendial revisions. Maintaining these partnerships is complicated by potential transition and turn- ove r of p e r son ne l i nvolve d i n the work. There may be a lack of awareness of or disregard for the pharmacopoeia requirements and discrepancies may emerge f rom the absence of a C-LOS perspec- tive during product and analyti- cal development. There is often a lack of understanding by inter- nal stakeholders as to their role in the assessment of compendial rev isions, a nd ma ny may have the perspective of "not my job" when asked to provide input to the impact of compendial changes. Taken together, compliance with the pharmacopoeias is usually not well understood in a company, so it can be difficult gaining buy in from SMEs and their manag- e r s to p e r for m i mp ac t a s s e s s - ments. Deadlines for commenting on proposals and implementing changes that are becoming offi- c ia l a re of ten not wel l u nder- stood. T he requests for rev iew, assessment, and implementation of compendial requirements may not receive the proper priority or urgency needed to ensure compli- ance. It is not uncommon to hear stakeholders remark: • "Why do we need to com- ply? We are the innovator company." • "Why do we need to com- ply? We have our approved registration." • " It 's not my job. C he c k with another department to ensure we comply." • "A r e y o u s e r i o u s? T h i s applies to stability testing also?" • "I am in R&D. Why is this applicable to me?" • "Is this really necessary?" Management engagement and support are essential to remove the roadblocks resulting from lack of understanding. Clar it y must be provided to highlight the need for compl ia nce a nd to e n s u r e the appropriate importance and urgency are given to meet dead- lines imposed by the pharmaco- poeias. It is important to enlist b o t h r e g u l a t o r y a n d q u a l i t y departments to aid in the effort to gain support from the overall organization. Another area that creates confusion for companies is that many consider pharmaco- poeia publications only as qual- ity standards that are focused on analytical, physical, and micro- biological test methodologies and their associated acceptance criteria for materials. However, as noted previously, there are several gen- eral chapters related to packag- ing, storage, distribution, labeling, and quality systems that require assessment by appropriate SMEs in an organization. It can be a chal- lenge to engage a nd ga in buy- i n f rom t he depa r t me nt s t hat suppor t t hese ot her f unc t iona l areas as well. Additionally, com- panies that manufacture combi- nation products must deal with general chapters related to medical devices that are being published by many pharmacopoeias. Change control It is instructive to return to the issue of change control and on- time implementation as they relate to pha r macopoeia compl ia nce.