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www.biopharminternational.com December 2019 eBook BioPharm International 13 T h e c o n c e p t i s t o e v a l u at e a l l aspec ts of t he ma nu fac t u r- ing process and identify areas of vulnerability. These vulnerabili- ties need to be assessed for their i mp ac t on t he op e r at ion a nd the potential level of r isk they pose. A well-written quality risk management plan is an ongoing process requiring rigorous docu- mentation throughout the prod- uct lifecycle. It provides a solid r at ion a le for how to i mpr ove ef f ic ienc y a nd spend resou rces on t he i mp or t a nt ac t iv it ies to improve product qualit y rather than on low-risk activ ities that have little to no impact. There are four basic elements t h at sho u ld b e i nc lud e d i n a qua lit y r isk ma nagement pla n. The first element is to perform an analysis of the identified risk associated w ith the operations. For example, if your product is being produced using a n older ma nu fac t u r i ng l i ne, t here is a risk that the line will experience frequent breakdowns. The second step is to evaluate the risk in terms of its impact on your ability to supply a quality produc t. In t his case, f requent shut dow n s c a n le ad to pro d - uc t reje c t ion s, y ie ld loss, a nd potential dr ug shor tages. Once the risk has been identified and t he i mpac t eva luated, cont rols to mitigate the potential sit ua- t ion need to be ident if ied a nd implemented. Some of the pos- sible m it igat ion cont rol st rate - gies might include ensuring there are appropriate change parts for the line in inventory or plans to qualif y the product production on a new more modern manufac- turing line. The last key element needed is data input and management. The data evaluated should be able to indicate if and when you need to employ one of you r cont rol st r ateg ie s . I n t h i s si mple s c e - nario, an increase in down time on the line or a steady decrease in yield could be indicators that the manufacturing line is headed for a c at a st roph ic fa i lu r e a nd steps need to be taken to prevent a drug shortage situation. Managing a company's risk with a well- defined plan may help reduce the activities associated with poor quality. T he above disc ussion is only an example of a risk assessment i n o ne a r e a o f a n o p e r at io n . Other areas of the process need to be evaluated for potential vul- nerabilities and risk. These areas include an evaluation of the reli- ability of raw material suppliers, stability and compliance of con- tractual suppliers (e.g., contract m a nu f ac t u r i n g or g a n i z at ion s, contract test organizations), age and reliability of laboratory test equipment, etc. In other words, a solid, well-written and dynamic qu a l it y r isk ma nage me nt pla n will evaluate theoverall organi- zation, identify high-risk vulner- abilit ies, ident if y st rateg ies for mitigation of the high-risk v ul- nerabilities, and rely on data to perform continuous monitoring of t he v u l nerabi l it ies. A nd, of course, the plan will provide the appropriate documentation and rationale for the decisions. I mple me nt i ng a qu a l it y r isk ma nage me nt pla n i n a n orga- n i zat ion ca n a lso be cha l leng- i ng. It needs to be i nt roduced and disc ussed w ith all applica- ble function personnel involved in the operations including, but not limited to, f ina nce, ma nu- facturing, regulatory affairs, pur- c h a si n g , aud it i n g , a nd s e n ior management. The plan should be dynamic and should be modified as situations change. Let's say you produce a prod- uct and you have a single-source supplier for one of your excipi- ents. You have audited the sup- plier a nd have ident if ied some significant gaps in their quality system. You identify this vulner- ability in your quality risk man- agement plan and indicate it is a high-risk item because of the lack of complia nce of t he excipient vendor. One of your mitigation strategies might be to qualify an alternate supplier for the excipi- ent. Once you have qualified that alter nate supplier, you need to update your plan to downgrade the risk because you have taken the appropriate steps to mitigate it a nd eliminate t he ident if ied vulnerability. Q u a l i t y r i s k m a n a g e m e n t plans are important because they help improve a company's abil- ity to provide quality product to patients. T hey are contingenc y plans with identified actions that help to ensure a continuous sup- ply of product to the market that meets the expectations of being s a fe, e f fe c t ive, a nd av a i l a ble. T he y a r e dy n a m ic do c u me nt s that require integration into and data inputs from all departments in order to be successfully imple- mented at a company. REFERENCE 1. ICH, Q9 Quality Risk Management (ICH, November 9, 2005). BP Regulatory Sourcebook Quality Risk Management