Ask the Expert
Q & A: Peptides and Quality
The Peptide Wire speaks with American Peptide Company’s resident expert on quality, Shawn Shirzadi, Vice President – Quality.
PW: Everyone talks a lot about quality, but what are the elements of quality? Could you break it down for us?
SS: While the notion of quality encompasses all activities designed to ensure adequacy of manufactured products, we usually divide quality into two separate functions, quality assurance (QA), which oversees the entire manufacturing process and is responsible for the final release of the product, and quality control (QC), which is responsible for testing and characterization of raw materials and finished products. Essentially, QC monitors the endpoints of a production run: what comes in and what goes out. QA, by contrast, is responsible for quality throughout the entire manufacturing process.
PW: Does APC have a particular quality philosophy?
SS: Our philosophy is that quality should be built into every step, and thought of as process parameter, not a process outcome. Thus, we have what you could call a “systems” approach to quality. Indeed, the key word for any effective approach to quality outcomes is “system.” Given that every component of a manufacturing process contributes to the quality of the final product, without a comprehensive systems approach to the entire process, even a minor misstep could compromise final outcomes. The approach that takes into account every miniscule aspect of the manufacturing operation – from documentation to capital equipment – is the surest way to guarantee final quality.
PW: You mentioned documentation. How important is that from a quality perspective?
SS: One purpose of quality is regulatory compliance, and regulatory compliance requires extensive documentation. The documentation of manufacturing processes along with all related in-process and final release testing is essential to maintaining compliance with regulatory oversight. This involves extensive documentation of production, change control, vendor audits and qualification process and the raw materials testing and release. One important step that is sometimes forgotten is accurate labeling and label accountability. This is where the lack of strict controls can spell disaster as issues with mislabeling can often lead to recalls.
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