Issue link: https://www.e-digitaleditions.com/i/1118782
40 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2019 P h a r mTe c h . c o m Supply Chain Pora (Pall): The best way is to have quality built in from the start. There is always going to be a need to test the end product, but it is much easier if the quality of raw materials and the manufacturing environment have already been well-considered. There is a lot to consider when looking at the raw materials, as well. How will those impact the end product? Users want components that are animal free, and there is a long list of particulates that cannot be in there (e.g., melamine and other components). The desire for BPA [bisphenol A]- free materials is also growing. When it comes to the process, sterilizing-grade filters can be integral for protecting quality. More attention is being paid to sterility and integrity of connections and valves and minimizing the need for operator interaction, which has a proven im- pact on time and safety of processes. Isberg (Entegris): I always refer people to the BPSA quality test matrices guide (5), which is an excel- lent resource for quality testing for single-use sys- tems for bioprocessing applications. Bulpin (MilliporeSigma): Resin and film suppliers are critical to the quality control of single-use consumables. These suppliers must have a good understanding of the requirements needed for the biopharmaceutical industry, a strong quality management system, and robust change control procedures. When selecting a critical raw mate- rial supplier, partnership is paramount. You need a supplier that will grow with you, evolve, and con- tinuously improve their process to meet the chang- ing requirements of the industry. Single-use suppliers should continuously moni- tor and mitigate risks throughout their manufac- turing process to ensure a repeatable and consis- tent level of quality. Operational excellence and lean initiatives should be used to proactively iden- tify areas of opportunity and prevent future errors from occurring. PharmTech: What are some of the challenges with change management? Carter (GE): Some suppliers produce products for our industry, but their main industry is not ours. It has been observed that our industry is simulta- neously a small player (in plastics) and yet among the most exacting in terms of quality requirements. Changes are common in plastics, and evaluating and qualifying these changes are resource inten- sive. Changes need to be managed together with our suppliers, because this can have an impact on our operations and more importantly, on those of drug manufacturers. Pora (Pall): From an industry level there needs to be consistency in standards, including materi- als of construction and end products—this has to apply across the globe to be most effective. There cannot be large variations, and characterization and global agency alignment have started to play a larger role in help overcome this challenge. Bulpin (MilliporeSigma): Change management ca n cause cha l lenges for bot h suppliers a nd end-users. A large majority of single-use com- ponents are comprised of polymeric materials, and despite t he high grow t h rates for single- use technolog ies over t he past decade, t hey still make up a very small piece of the plastic consumables business. Although it's improving, single-use suppliers still don't have much con- trol over raw material changes from the plas- tic suppliers, which means we are faced with a higher number of changes than we'd like. The volume, complexity, and cost of qualifications can be burdensome for both the single-use sup-