SOPs

Next Level SOPs – Compounding Quality Assurance

Next Level SOPs for Compounding Quality Assurance is the answer for organizations that require a robust quality management system to keep patients safe and regulators happy. Quality by design is the mantra of these procedures, fostering an organization’s intent to produce quality compounds consistently and reliably.

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Description

Organizations cannot rely on testing alone to tout quality compounds are being produced. Quality is the result of all activities that take place to produce a compound that meets all specifications reproducibly and reliably. Many pharmacists and pharmacy technicians did not receive extensive training or education in quality management systems but are now having to learn on the job as regulations become tighter and an expectation of patient safety is paramount.

Next Level SOPs for Compounding Quality Assurance make up the backbone of an organization’s compounding quality management system. Each element can be applied to a hospital, pharmacy, or outsourcing facility to ensure quality is built in to each system.

When you purchase this chapter you get access to:

  1. Writing Standard Operating Procedures
  2. Document Management Control
  3. Change Control
  4. Good Documentation Practices
  5. Deviation Handling
  6. OOS
  7. Nonconformance Material
  8. Corrective and Preventative Action
  9. Product Complaints
  10. Recalls
  11. Product Returns
  12. Material Review and Disposition Decision
  13. Audits
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