The Team Approach to Change Control in the Pharmacy

The FDA recently released a statement about two sterility indicators used with hydrogen peroxide sterilization systems. There is no industry "color" standard to indicate that sterilization has occurred, so two major manufacturers use opposite colors for their indicators: One uses blue for unprocessed and pink for processed, and the other uses pink for unprocessed and blue for processed.

FDA Letter to Health Care Providers: Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization >

While this is not an example from compounding labs specifically, it shows the critical importance of a team approach to establishing SOPs, especially those that relate to critical functions.

For example:

  • Sourcing / Purchasing should have clear technical guidance regarding key features that need to be present.
  • Operations needs well defined SOPs and checklists, including examples where appropriate of desired steps or outcomes.
  • Quality Assurance must develop SOPs that account for all relevant steps from start to finish of all aspects to ensure that processes have been followed.

It is especially important that Change Control SOPs are robust where sterile compounding is concerned! When changing a product in use, the end users are not the only ones who need to understand the product and exercise caution.

For patient safety as well as compliance with an increasingly regulated industry, it is important for compounding pharmacies to think holistically about each of the machines and tools that factor into their SOPs and work as a team to ensure safe compounding.

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Our Compounding Support Services team has years of experience in pharmacy management and compounding operations. If you have any questions about lab design and workflow, regulatory compliance, and capital equipment, give our team a call or send us an email.

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