Reduce testing, ensure quality
When deciding to outsource, it should be kept in mind that there is an extensive amount of work that can be done by the supplier. Responsibility for procurement and QC testing of salts, liquid preparation, filtration, quarantine, and finished good testing, as well as the documentation, procedures, validation, and training that accompany these, are all removed when outsourcing. Simply managing all aspects of the buffer production process and scheduling these to fit “just-in-time” product manufacturing processes are tangible benefits that can also be gained.
Buffer performance does not need to be compromised. Selecting an outsource partner with a robust quality management system and employing high-functioning processes and continuous improvement approaches will ensure the production of the highest-quality buffers. Product consistency can be enhanced by preparing buffers in the larger batch sizes that are achievable when outsourcing, compared with the multiple, smaller batches that are often produced when buffer is prepared in-house. This, coupled with in-depth knowledge of liquid stability, can potentially enhance buffer performance.
Utilizing an outsource partner’s cGMP warehousing and taking advantage of just-in-time delivery, so that only the right amount of buffer is delivered exactly when it is needed, significantly reduces on-site storage needs. Removing these constraints opens up the opportunity to repurpose facility usage and supports growth.
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