Release Inspections USP 797

Sterile Non-Hazardous Compounding <797>

Release Inspections
Sterile Non-Hazardous Compounding <797>

 

Purpose/ Applicability:  To outline the proper procedure for the release inspections associated with sterile non-hazardous compounded products.

Scope: This applies to all CSPs that are batched.

Definition(s):

 

CSP: Compounded Sterile Product

USP: United States Pharmacopeia

 

Equipment: N/A

Procedure:

  1. Products should be stored in accordance with specific storage requirements identified for that preparation
    1. Master formulation / Compounding record
    2. Note: If product should be protected from light, must be stored in light protect bag
  2. CSPs are allowed to be dispensed / stocked prior to receiving completed sterility testing once initial testing has been completed for 3 batches
    1. If something grows from sterility testing, then a new batch should be made ASAP; New batch can be put back into inventory unless we have multiple batches in a row with growth
      1. At this point in time the sterility of the cleanroom and our procedures need to be assessed
  3. Follow specifications of USP <71> to determine appropriate amount of CSPs to remove per batch for sterility testing
    1. 10% of batch
    2. Once sterility has been ascertained for product for 3 consecutive batches, can pull one CSP per batch based on medication dispensary policy
  4. Product is logged on appropriate form, diagnostic lab is contacted, and CSP is taken to diagnostic lab for sterility testing
  5. Pharmacist(s) review initial and final reports and log them within excel chart here: pharmacy drive à pharmacy docs à vials submitted for microbial testing
  6. Follow procedure outline in SOP: Sterility Testing (if more information is needed)
  7. If initial product report comes back with growth, CSP must be pulled immediately
    1. Wait for final product report to confirm prior to disposing of product
  8. If final product report comes back with growth, CSP must be pulled immediately (if not already) and disposed of properly

References:

 

  1. US Pharmacopeial Convention, Inc. United States Pharmacopeia 26-National Formulary 21. Council of Experts Committee on Parenteral Products: Compounding and Preparation. Chapter <797> Pharmaceutical Compounding—Sterile Preparations. PF 2003; 29(3): 750–809.
  2. Buchanan EC, McKinnon BT, Scheckelhoff DJ et al. Principles of Sterile Product Preparations. 1st ed.  Bethesda, MD: American Society of Health-System Pharmacists; 2002.

 

 



Keywordsbatch, tested   Doc ID130905
OwnerJenny C.GroupUofI College of Veterinary Medicine Teaching Hospital
Created2023-09-06 14:34:13Updated2023-09-07 14:33:39
SitesUniversity of Illinois College of Veterinary Medicine Teaching Hospital
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