Given the growing number of drug recalls, defects and other issues that can have the opposite effect in treating disease, the role of quality could very well be the most critical function of a Contract Development & Manufacturing Organization (CDMO).
For that reason, various types of quality teams can be found throughout CDMOs. There is the Quality Control (QC) team, which performs the actual testing on raw materials, as well as final products. It analyzes chemical batches, tests samples and compiles the performance data.
Here at Seqens NA, we have more than 30 QC scientists, performing close to 2,000 analyses/tests per month to assess physical, chemical and biological components. It is comprised of three sub-groups, addressing method development & validation, analysis and stability programs.
The other quality function central to drug manufacturing is the Quality Assurance (QA) group. This group has the ultimate responsibility for ensuring quality manufacturing. It controls the quality of raw materials and chemical batches, ensuring that Standard Operating Procedures (SOPs) are followed and documenting all steps – from compiling and storing batch records, to signing off on all certificates of analysis and final shipment. The group also manages FDA inspections, customer audits and supplier inspections. It also must write responses to any noted deficiencies, as well as issue, track and store every document. Seqens NA includes a group of nine QA professionals, led by a QA manager.
One of the most critical functions of a QA team is to ensure that the documents that are needed (and there are plenty) are accurate and available. In addition to batch records, quality specification sheets and analytical methods, documenting and ensuring compliance to SOPs ensures that operations are consistently conducted in an unwavering, standard manner that has been proven to protect the quality of chemicals manufactured.
An example of one of these SOPs in action at Seqens NA involves raw materials – receiving, storing, identifying and tracing them. Thanks to the SOP, no raw material out of specification is used, ensuring that when a material is used it produces the high quality product for which it was intended. Following are the steps involved, as developed by the QA manager:
Establishing SOPs, documenting all analyses and findings and managing audits makes the job of the QA manager quite intense. It takes years of experience, many lessons learned and a committed focus to putting quality above everything else. Below are five best practices that can help you reach your QA goals:
Quality Assurance just may have more moving parts than any other area in API manufacturing, but the consequences of less than diligent attention to it can be devastating. Aristotle once said, “Quality is not an act. It is a habit.” CDMOs that habitually put quality front and center not only more easily meet regulatory requirements, but they also gain the trust and respect of the industry.
For more related articles regarding quality in API manufacturing, check out The Art of Reducing API Failures, An Ounce of Prevention Ensures Reliable Utility Systems, and API Quality Risk Management.