1. Quality Control and Assurance9
Quality Control and Assurance

2. The Seven Rights Right patient Right medication Right dose
Right route of administration
Right time
Right technique
Right documentation

3. Quality Assurance Functions
Written policies & procedures
Documentation
Personnel training
System checks & process validation
Daily assessment of all operations

4. Quality Improvement Ensures that integrity is not lost due to
Lack of training
Equipment failure
Outdated facilities
Other noncompliance issues

5. Quality Improvement (cont’d)
Process includes
Monitoring trends
Conducting audits
Identifying & analyzing problems
Taking corrective measures
Conducting testing
Suggesting change

6. Guidelines FDA Publishes Good Manufacturing Practices (GMP)
GMP covers compounding sterile products
Other guidelines: manufacture of sterile products
Guidelines include quality system regulations

7. Guidelines (cont’d) FDA (cont’d)
Regulations make standards consistent with requirements

8. Guidelines (cont’d) The Joint Commission Publishes standards on
Pharmaceuticals
Facilities that manufacture, store, & deliver them
Constantly revises standards to
Improve compliance
Keep up with drugs & their manufacturing processes

9. Guidelines (cont’d) Performs stringent inspections at timed intervals
Offers accreditation for health care organizations
Offers support to help comply with accreditation

10. Guidelines (cont’d) CDC Focus: preventing spread of disease/infection
Same focus as goal of aseptic compounding
Provides info for hospital environment controls

11. Guidelines (cont’d) ASHP
Publishes Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products
This document
Outlines considerations that are subjected to quality testing & assurance
Addresses all areas impacted by quality assurance

12. Guidelines (cont’d) USP Published USP Chapter 797 Miscellaneous
First enforceable national standards for sterile compounding
Adopted by state boards, JCAHO, FDA
Miscellaneous
Other local, state, & national agencies
Find out what rules apply in your state

13. ASHP Guidelines on QA for CSPs: Risk Level 1
Products that are
Stored at room temperature
Completely administered within 28 hrs of prep
Unpreserved
Sterile
Prepared for administration to >1 patient
Prepared by closed-system aseptic transfer

14. ASHP Guidelines on QA for CSPs: Risk Level 2
Products that are
Administered beyond 28 hrs after prep
Stored at room temperature
Batch-prepared without preservatives
Intended for use by >1 patient
Compounded by complex, numerous manipulations using closed-system aseptic transfer

15. ASHP Guidelines on QA for CSPs: Risk Level 3
Products that are
Compounded from nonsterile
Ingredients/components
Containers
Equipment
Prepared by combining multiple ingredients
Sterile or nonsterile
Using open-system transfer before terminal sterilization

16. USP 797: Low-Risk Level CSPs
Any CSP that is prepared
Using proper aseptic technique
In an ISO Class 5 or better environment
Using only sterile ingredients & supplies
With 3 or less commercially available products/packages
With 2 or less entries into any one sterile IV bag or vial

17. USP 797: Low-Risk Level CSPs (cont’d)
Any CSP that is prepared (cont’d)
Limited to
Opening ampules
Transferring liquids in syringes to sterile containers
Penetrating disinfected vial stoppers
At least 48 hrs room temp
14 days or less refrigerated
45 days or less frozen

18. USP 797: Medium-Risk Level CSPs
Any CSP that is prepared (cont’d)
As more than 1 individual or small doses administered to:
Multiple patients
One patient on multiple occasions
By complex manipulations
Of long durations
That involve processes other than single-volume transfer

19. USP 797: Medium-Risk Level CSPs (cont’d)
Any CSP that is prepared (cont’d)
30 hrs or less room temp
9 days or less refrigerated
45 days or less frozen

20. USP 797: High-Risk Level CSPs
Any CSP that is prepared (cont’d)
By compounding using nonsterile ingredients
Using sterile contents of commercially manufactured products
Without antimicrobial preservatives
Exposed to less than ISO Class 5 environment for more than1 hr
By improperly gowned personnel

21. USP 797: High-Risk Level CSPs (cont'd)
Any CSP that is prepared (cont’d)
With nonsterile water-containing products that are stored for more than 6 hrs
24 hrs storage or room temperature
3 days or less refrigerated
45 days or less frozen

22. USP 797: Environmental Sampling Testing
Should occur
Upon commissioning of new facilities & equipment
After any servicing of facilities & equipment
As part of periodic recertification of facilities/equipment
In response to
Issues with compounded sterile products
Observed improper technique of personnel

23. USP 797: Environmental Sampling Testing (cont’d)
Should occur (cont’d)
In response to
Issues with compounded sterile products
Observed improper technique of personnel
If a CSP is a potential source of patient-related infection

24. USP 797: Cleaning & Disinfecting of Compounding Area
Primary engineering control must be cleaned
At beginning of each shift
Before each batch
At least every 30 min after previous disinfection
During continuous compounding activities
After spills
When suspected contamination occurs

25. USP 797: Cleaning & Disinfecting of Compounding Area (cont’d)
Counters, work surfaces, floors must be cleaned
Daily when no aseptic compounding is occurring
Walls, ceilings, storage shelving must be cleaned monthly

26. USP 797: Other Guidelines Policies & procedures
Needed in every pharmacy
Address updating, accessibility to personnel, accuracy, SOP, monitoring
All personnel must know policies & procedures

27. USP 797: Other Guidelines (cont’d)
Personnel, education, & evaluation
Personnel must constantly
Update skills
Continue education
Must have process of evaluating personnel’s
Skills (assessment)
Knowledge

28. USP 797: Other Guidelines (cont’d)
Storage & handling inside & outside pharmacy
How drugs are packaged, prepared, delivered
Need for refrigeration
Risk of contamination if stored/handled improperly

29. USP 797: Other Guidelines (cont’d)
Facilities & equipment
All compounding areas are held to high standards
All equipment & supplies must be
Installed properly
Used properly
Maintained
Monitored

30. USP 797: Other Guidelines (cont’d)
Aseptic technique, product preparation, & garb
Manufacturing processes
Require constant evaluation & improvement
Have many checkpoints
Focus on prevention of microbial contamination

31. USP 797: Other Guidelines (cont’d)
Process validation
Documenting/proving that process will consistently produce product meeting specifications
End-product evaluation
Pharmacist’s “final check”
Inspections with periodic sampling/testing of batches manufactured under same conditions

32. Documentation and Labeling
All products dispensed must be labeled
Every piece of equipment must have records
SOPs illustrate how a product is made/processed
Required patient info for each product
Patient diagnosis, IV regimen, dosages, BSA, lab values

33. Documentation and Labeling (cont’d)
Required product info for each product (cont’d)
Ingredients, prep/process, labeling, warnings, storage/handling, expiration date, batch/lot ID numbers