What Students in Quality Assurance Courses Should Know About SUPAC

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For a successful career in pharmaceutical quality assurance, it is important to know about international standards and guidelines that affect the industry. One such guideline is SUPAC, which stands for scale-up and post-approval changes. SUPAC guidelines are issued by the US Food & Drug Administration (FDA) and apply to changes made to certain drugs after they have been approved by regulators.

SUPAC guidelines are extremely important in the pharmaceutical industry as they help ensure that drugs maintain a consistent quality. Here is what you should know about SUPAC if you’re considering a career in pharmaceutical quality assurance.

Quality Assurance Certificate Pros Use SUPAC to Ensure Drugs Are Consistent

After a drug has been approved by regulators, a number of changes may be made that could potentially affect the consistency and quality of the drug. Often production is scaled up in order to produce larger batch sizes or it may even be scaled down if there is decreased demand for the drug. Similarly, production may be moved to different manufacturing facilities, manufacturing equipment may be changed, or the components and composition of the drug may be altered.

SUPAC provides guidance for changes made to batch sizes or manufacturing equipment

SUPAC provides guidance for changes made to batch sizes or manufacturing equipment

When these changes occur, it’s important that the drug itself remains consistent. SUPAC guidelines give manufacturers guidance about how they can make these post-approval changes without compromising the quality of the drug.

Specifically, the guidelines define: different levels of change, the in-vitro/in-vivo requirements, documentation requirements, and recommended chemistry, manufacturing, and controls (CMC) for changes. With these guidelines, manufacturers can more easily keep the quality of drugs consistent after they make any post-approval changes. As such, SUPAC is an important topic for anybody pursuing a quality assurance certificate to know about.

SUPAC Refers to a Number of Different Guidelines, Rather Than Just One

Since the first SUPAC guidelines were developed in 1991-1992, it has developed into not one but a series of published guidelines that have been released by the FDA. Specifically, there are:

  • SUPAC-IR for immediate release solid oral dosage forms
  • SUPAC-MR for modified release solid oral dosage forms
  • SUPAC-SS for non-sterile semisolid dosage forms
  • SUPAC: Manufacturing Equipment Addendum for manufacturing equipment changes.

It’s important to note that SUPAC guidelines are not regulations. Rather, they provide voluntary guidance to manufacturers for common post-approval changes. That being said, SUPAC guidelines are widely used in the industry as a way of guiding manufacturers’ decisions and understanding what the implications of changes to the manufacturing process might mean for the final product.

SUPAC guidelines are not regulations, but they are influential within pharmaceutical manufacturing

SUPAC guidelines are not regulations, but they are influential within pharmaceutical manufacturing

Even outside of the US (where SUPAC guidelines are issued) they are highly influential, including in Canada and Europe. For that reason, paying attention to SUPAC in your quality assurance courses is important and will help prepare you with the knowledge you need to succeed in quality assurance with a broad range of manufacturers.

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