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Model Standard Operating Procedures from CriticalPoint

Model Standard Operating Procedures from CriticalPoint

Model Sterile and Nonsterile Compounding Standard Operating Procedures, Developed by CriticalPoint

Detailed standard operating procedures are the foundation of a robust sterile and nonsterile compounding practice. When written properly, they should tell the reader exactly what to do as well as why, where, when and how to perform the activity.

CriticalPoint has developed a set of template policies, procedures and accompanying documentation forms (together referred to as the SOPs).  The SOPs have been developed, used and refined over many years in a number of various practice setting. They are effective in establishing robust operating procedures that ensure patient safety. 

USP Chapter <797>, Chapter <795>, and Chapter <800> describe minimum acceptable sterile and nonsterile compounding practice and contains many specific references to the requirement for written SOPs. Certainly, best practice models always include the need for detailed written SOPs, which must act as the basis of all staff training. Staff cannot be expected to perform correctly or consistently if the requirements and the performance outcomes are not communicated through an articulated and disciplined written explanation.

These detailed procedures and forms reflect not only guidance to foster achievement of compliance with Chapter <797>, <795>, and <800> but with aseptic processing best practices as well. They are continually refined and updated regularly to reflect regulatory changes (like Chapter <797> and Chapter <800> revisions). They are consistent with the CriticalPoint eLearning Training but provide more specific “how to” detail in regards to process as well as documentation.

The SOPs and forms can be harmonized to match the actual working conditions of your compounding facility and practice.  Since each user of these SOPs will have a different physical plant, compounding risk levels, etc., we have included instructive guidance and suggestions in these policies and procedures.

Customers that want a “turnkey” solution for all of their sterile and nonsterile compounding operations can purchase the entire Sterile Compounding Standard Operating Procedures or the entire Nonsterile Compounding Standard Operating Procedures.  The Hazardous Drug Compounding SOPs may be purchased separately from the Sterile Compounding SOPs. Purchase includes access and updates for one location for one year. Facilities can purchase access for additional years at a discounted price

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Eight topic areas, Over 45 customizable Standard Operating Procedures, and 75 customizable forms

  1. General Requirements
  2. Facility Environmental Sampling
  3. Sterile Compounding Facility Management
  4. Training, Conduct, and Competency of Sterile Compounding Personnel
  5. Inventory, Storage, and Handling
  6. General Sterile Compounding Process
  7. Hazardous Drug Compounding
  8. Quality Management

Hazardous Drug Compounding Set:

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7 customizable Standard Operating Procedures
15 customizable forms

Nonsterile Compounding Complete Set:

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Seven topic areas, Over 36 customizable Standard Operating Procedures, and 42 customizable forms

  1. General Requirements
  2. Compounding Facility and Equipment
  3. Training, Conduct, and Competency
  4. Component Inventory and CNSP Handling
  5. General Compounding Process
  6. Compounding Nonsterile Hazardous Drugs
  7. Quality Management