Thursday, March 6, 2014

Must Read!! Tennessee Board and Department of Health Share Sterile Compounding Lessons Learning

Board and Department of Health Share

Sterile Compounding Lessons Learned



Chief Medical Officer for the Tennessee Department of Health

David Reagan, PhD, MD, and former Acting Director and current

USP Sterile Compounding Investigator Trainer Terry Grinder,

DPh, discussed lessons learned over the last year. Many of these

same topics are covered in the USP 35 Chapter <797> sterile

compounding section. This summary includes:

1. Sterile Process

a. The process to ensure appropriate sterile technique

should be clearly documented, and staff authorized

to perform sterile compounding should be

appropriately trained and observed performing the

standard process routinely as a part of their ongoing

authorization to compound.

b. Protective apparel should be available and used

appropriately to allow maintenance of sterility

during operations; no makeup or jewelry should

be worn.


c. Equipment coming in contact with sterile product

must be sterile. Careful attention to sterile surfaces,

including gloves, hoods, and other equipment, is

essential.

d. Sterile equipment or supplies are usually supplied

in packaging whose outside is nonsterile. Proper

handling of the nonsterile packaging is essential to

maintenance of a sterile field.

e. Manipulation of compounded sterile products

following any sterilization step(s) should be

minimized so as to not to introduce any risk of

contamination. Final product sterilization should be

the last step in the compounding process, or as close

to the last step in product preparation as possible.

f. Careful attention is needed to environmental control

measures and should include ongoing monitoring

and recording of pressure differentials from the

cleanest to clean to dirty rooms as applicable.

2. Labeling, Storage, and BUD

a. Product should be clearly labeled with beyond-use

dates (BUD) and storage specifications, based on

USP Chapter <797> risk levels and the appropriate

storage conditions (room temperature, refrigerated,

or frozen) as well as product testing (unless product

is prepared in batches of 25 or less).

b. Sterile products may not be packaged in a manner

labeled or implied as multi-patient use. The

term “multi-dose vial,” when applied to injectable

medication, is reserved for Food and Drug Administration

(FDA)-approved manufactured products

using FDA-approved labels.

c. Repackaging of manufactured injectable medications

(eg, dividing a manufacturer-supplied singledose

or single-use vial into syringes) requires

clear labeling and packaging to facilitate product

trace-back.

d. Lot numbers should be specific for product, product



formulation, date, and batch.

3. Preservative-Free Medication Formulation Considerations

a. Preservative-free medication should only be used

for a single patient (ie, single package, single-dose

vial)

b. Please refer to USP Chapter <797> to determine

BUDs, but for high-risk preservative-free medication,

the BUD established should not exceed three

days when sterility testing is not performed.

4. Quality Assurance and Equipment Maintenance

a. Thoroughly document successful completion of

sterilization steps, such as use of an autoclave.

b. Autoclaves should have documentation of load

configuration studies, biological indicators, and

parameters (temperature, time, and pressure).

c. For those compounding over 25 doses of medication

in a batch, testing of sterility of product that
been formulated for distribution is needed, with a

clear documentation chain.

d. A clearly documented process should be in place

to guide and monitor equipment cleaning, maintenance,

and use.

e. Quality control information falling outside of

expected values must be immediately assessed

and remedied, including removal of unused

product from all potentially affected lot(s) from

distribution.

f. Media-fill test procedures should be performed



under conditions that closely simulate the most

challenging or stressful conditions encountered

when compounding high-risk products.

g. Procedures for receiving and investigating complaints

must be in place, operating in a timely way,

and well documented.

h. Rejected components or products should be sequestered

from other components.

5. Record Keeping

a. All relevant information regarding the compounded

product should be well documented. Such records

should be easily retrievable (and preferably electronically

maintained) for at least two years from

the last date dispensed.

b. Linkage between lot numbers and distribution

(eg, invoices) and significant process records (eg,

autoclave, sterility testing records, and operator)

must be created, maintained, and easily retrievable.

Pharmacies operating outside FDA registration as manufacturers

are not permitted to supply compounded sterile product

(including repackaged products) to a third party such as a distributor

or sales agent.


quoted from here



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