Standard Operating Procedure

SOP CODE: / NS-P3.020 / REVISION NUMBER: / 1.0.0
ISSUE DATE: / MONTH 00, 2015
IMPLEMENTATION DATE: / MONTH 00, 2015
CONTROLLED COPY ____ / UNCONTROLLED COPY ____
TITLE: PROCEDURE – MANAGING – STORAGE - CHEMICALS
Page 1 of 11
DRAFTED BY: / SIGNATORY:
n/a / TITLE: / SIGNATURE / DATE
VERIFIED BY: / SIGNATORY:
n/a / TITLE: / SIGNATURE / DATE
APPROVED BY: / SIGNATORY: / DD MMM YY
TITLE: / SIGNATURE / DATE

RELATED LOGS & FORMS

RECORD / SPECIFICATION / DESCRIPTION
L3.020a / Chemical Inventory Storage
L3.020b / Perpetual Inventory
L3.020c / Pest Control Management
F3.310a / Environmental Disinfection
F3.320a / Environmental Deactivation
L3.100 / Environmental Mapping
L3.050 / Mock Recall

RELATED STANDARD OPERATING PROCEDURES

SOP CODE / SOP TITLE
P2.030 / Property - Purchasing - Inventory - Chemicals
P3.040 / Procedure - Managing - Waste Disposal - Chemicals and Disposable Devices
P3.050 / Procedure - Performing - Mock Recall - Inventory and Preparations
P3.060 / Procedure - Performing- Recall - Inventory and Preparations
P3.100 / Procedure - Monitoring - Environment -Non-Sterile Practice
P3.230 / Procedure - Operating - Technology - Refrigerator and Freezer
P3.310 / Procedure - Disinfecting - Environment and Technology –Non-Sterile Practice
P3.320 / Procedure - Decontaminating - Environment and Technology - Hazardous Compounding

Responsibilities

  1. Pharmacist-In-Charge oversees this SOP.
  2. All compounding personnel must comply with this SOP.
  3. All trained and authorized compounding personnel are responsible to perform this SOP.

Purpose

  1. To ensure proper storage of chemical inventory.
  2. To ensure proper management of chemical inventory.

Scope

  1. Applies to non-sterile compounding.
  2. Applies to antineoplastic, hazardous and non-hazardous chemical storage.
  3. Applies toenvironmental monitoring of the chemical storage area.
  4. Applies to pest controlin the chemical storage area.
  5. Applies to the removal of outdated chemicals from the inventory.
  6. Applies to chemical inventory reconciliation.

Definitions

  1. Decontamination: Includes physical removal, deactivation/neutralization of contaminants and disinfection.

FREQUENCY

  1. Inspect pest traps monthly, or more frequently.
  2. Disinfect non-hazardous and hazardous storage areas:
  1. Anytime a spill occurs.
  2. Whenever contamination is known or suspected.
  3. According to the following schedule or as per verified frequency:

Site / Disinfection Frequency
Floors / Daily
Counters and easily cleanable surfaces / Daily
Shelving / Monthly
  1. Decontaminate hazardous storage areas as follows, or more frequently as required:
  1. Anytime a spill occurs.
  2. Whenever contamination is known or suspected.
  3. According to the following schedule or as per verified frequency:

Site / Decontamination Frequency
Floors / Daily
Shelving / Monthly
  1. Verify inventory record monthly to determine products that are soon to be outdated/expired.
  2. Perform physical inventory on a quarterly basis.
  3. Verify temperature mapping of the chemical storage area biannually.
  4. Perform mock recall on a biannual basis.

SPECIAL CIRCUMSTANCE

  1. This SOP does not apply to Narcotics and Controlled Substances.

PROCEDURE

This SOP is divided into the following sections:

  1. Storage Area Requirements
  2. Specific Hazardous Drug Storage Requirements
  3. Environmental Monitoring of Chemical Storage Area
  4. Inventory Reconciliation
  1. Storage Area Requirements:
  1. Restrict access to chemical storage areas to authorized personnel.
  2. Don appropriate personal protective equipment prior to handling chemical inventory.
  3. Ensure storage area has suitable and sufficient space to allow orderly storage, prevent mix-ups and cross contamination.
  4. Ensure adequate lighting in the storage area.
  5. Ensure storage area is clean.
  6. Utilize approved pest control techniques at appropriate locations in the storage area or hire a vendor qualified pest control service provider.
  1. Ensure that airborne release of pesticides does not occur inside of the pharmacy.
  2. Wear appropriate personal protective equipment when handling pest control articles.
  3. Remove gloves immediately after handling pest control articles and wash hands.
  4. Ensure pest control articles are not stored in ISO class environments, other than those strategically placed in storage areas.
  5. Report promptly any pests or evidence of pest infestation.
  1. Store chemicals in the appropriate storage based on their required storage conditions, required closure and any required special condition.
  1. Ensure segregation of chemicals according to their chemical properties and required environmental controls; different physical areas are required for the following:

Chemical Storage
Storage Area / Required Identified and Physically Separated Sections / Minimum Storage Area Requirements
Non-Hazardous / Current Non-Hazardous Chemical Inventory
Quarantined Rejected Inventory
Quarantined Returned Inventory
Quarantined Recalled Inventory / Non-hazardous inventory must be stored separate from hazardous inventory.
Hazardous / Current Hazardous Chemical Inventory
Strong Acids
Strong Bases
Quarantined Rejected Inventory
Quarantined Returned Inventory
Quarantined Recalled Inventory /
  • Negative pressure
  • Externally vented
  • 12 air changes per hour

Flammable Chemicals /
  • Flammable Storage Cabinet

Antineoplastic / Current Antineoplastic Agent Chemical Inventory
Quarantined Rejected Inventory
Quarantined Returned Inventory
Quarantined Recalled Inventory /
  • Negative pressure
  • Externally vented
  • 12 air changes per hour

  1. Store chemicals in a manner that minimizes risk of breakage and leakage.
  2. Place larger/heavy chemical containers on lower shelves and smaller/lighter chemicals containers on higher shelves.
  1. Ensure no chemical containers are stored directly on the floor.
  2. Ensure no shelved containers can be hanging over the edge of storage shelves.
  1. Rotate inventory using First in/ First out (FIFO) stock rotation in a manner that items with the shortest expiration are used first.
  2. Verify inventory for chemicals soon to be outdated/expired.
  1. Label chemicals prominently with “short expiry”, when appropriate.
  2. Remove soon to be outdated products prior to expiry.
  1. Specific Hazardous and Antineoplastic Drug Storage Requirements:
  1. Ensure hazardous drug storage area is clearly labeled with hazard warning signs.
  2. Store strong acids and strong bases in their original containers.
  3. Store hazardous drug containers in Ziploc bags.
  4. Ensure hazardous drug outer containers are labeled with appropriate hazard signs.
  5. Store hazardous drugs on shelves with raised lips that are at or below eye level.
  6. Consider the use of a negative pressure cabinet for hazardous drug storage within the hazardous drug storage room or another negative pressure room.
  7. Store refrigerated hazardous drugs in a dedicated refrigerator located in the hazardous drug storage room.
  8. Store frozen hazardous drugs in a dedicated freezer located in the hazardous drug storage room.
  9. Ensure that non-sterile antineoplastic and hazardous chemical inventory is not stored in the same room as a primary engineering control.
  1. Environmental Monitoring of Chemical Storage Area:
  1. Monitor the temperature in storage areas.

Controlled Storage Conditions / Temperature Range
Room Temperature / 20°C to 25°C
Cold/Refrigerator / 2°C to 8°C
Frozen/Freezer / -25⁰C to -10⁰C
  1. Monitor humidity in storage areas:

Controlled Storage Conditions / Relative Humidity at Room Temperature
Dry Storage / ≤ 40%
ISO Class Storage Area / 35 to 60%
  1. Inventory Reconciliation:
  1. Compare physical inventory with inventory record.
  2. Investigate all inventory discrepancies, if applicable.
  3. Verify that chemical containers are securely closed and are undamaged.
  4. Verify that labeling ofchemical containers is visible and accurate.
  5. Ensure chemical is in appropriate storage environment.
  6. Ensure all chemical documentation and SDS is current and updated.
  7. Verify expiration dates.

VERIFICATION

  1. Verify environmental monitoring by using an annually certified NIST traceable thermometer as a reference to compare the accuracy of the thermometer or thermostat used for temperature recording.
  2. Verify environmental monitoring by using an annually certified NIST traceable hygrometer as a reference to compare the accuracy of the hygrometer or humidity sensor used for humidity recording.
  3. Verify environmental monitoring by performing temperature and humidity mapping studies:
  1. Measure temperature and humidity in different zones of the storage area as appropriate at various points in the 3-dimensional axes:
  1. Perform additional temperature and humidity measurements in consideration of:
  1. Heating, ventilation, and air conditioningequipment.
  2. Airflow inside the storage location.
  3. Windows and sun-facing walls.
  4. Storage facility structural design including low ceilings or roofs.
  5. Times of the day.
  6. Times of the week (weekdays and weekends).
  7. Seasonal differences (i.e. environment outside the Pharmacy).
  1. Ensure temperature and humidity measurements are within the required acceptable range.
  2. Verify chemical storage management system by performinga mock recall of at least 3 randomly selected chemicals.
  1. Ensure the Pharmacy inventory management system is able to trace chemicals at all critical steps:
  1. Initial purchase.
  2. Receipt.
  3. Use.
  4. Wasting.
  5. Final destruction/disposal certificate.

CORRECTIVE MEASURES

  1. In the event of a pest sighting, infiltration or trapping:
  1. Quarantine all products suspected of being contaminated by the pest.
  2. Remove pest from trap and discard appropriately, if applicable.
  3. Take immediate steps to trap or get rid of the pest, if applicable.
  4. Investigate possible routes of infiltration and take appropriate corrective measures.
  5. Consider hiring an external pest control provider.
  6. Verify traps at an increased weekly frequency for 6 months.
  1. In the event that controlled storage conditions are out of acceptable range:
  1. Adjust the temperature or humidity as required.
  2. Assess the need to discard or reassign expiry dates of any chemicals using scientifically sound professional judgment.
  1. Consider calculating the mean kinetic temperature for the chemicals affected by the out of specification temperature recordings to determine the effect of the temperature fluctuation on the chemical.
  1. In the event that themock recall reveals discrepancies, increase frequencyof mock recalls to bi-monthly for 6 months.

PREVENTIVE MEASURES

  1. Consider the use ofPharmacy-approved pesticides by qualified service provider on the exterior of the Pharmacy building.
  1. Display a notice indicating where pesticides have been applied.
  2. Restricted access to zones following applicationof pesticides for the manufacturer recommended duration.

TECHNOLOGICAL RESOURCES

EQUIPMENT / MANUFACTURER / MAKE / MODEL / SERIAL NUMBER / ID CODE
Thermometer
Temperature/Humidity Meter
Refrigerator

Complete table ‘TECHNOLOGICAL RESOURCES’, for primary and secondary resources associated with this SOP.

Indicate a unique identifier under ‘ID CODE’,for all electromechanical equipment and reusable devices only.

SPECIFICATION DOCUMENTS

DOCUMENT
NUMBER / DOCUMENT NAME / SOURCE / DESCRIPTION

Indicate a ‘DOCUMENT NUMBER’ for filing purposes.

Indicate in table ‘SPECIFICATIONS DOCUMENTS’, all SOP-related documentation and their source.

REVISION HISTORY

REVISION NUMBER / IMPLEMENTATION DATE / TERMINATION DATE / SUMMARY OF CHANGE TO CURRENT VERSION

Indicate ‘IMPLEMENTATION DATE’ for revision number 1, without ‘SUMMARY OF CHANGE’.

Indicate ‘TERMINATION DATE’, in the event a revision has been implemented.

Archive terminated SOP.

REGULATORY COMPLIANCE GUIDELINES AND STANDARDS OF PRACTICE

REFERENCE SOURCE / REFERENCE CODE / REFERENCE DATE / SECTION CODE / SECTION DESCRIPTION
USP / 659 / 01 AUG 15 / Packaging and Storage Requirements
USP / 795 / 01 AUG 15 / Pharmaceutical Compounding – Non-Sterile Preparations
USP / 1079 / 01 AUG 15 / Good Storage and Shipping Practices

Indicate multiple ‘REFERENCE SOURCE’ for this SOP.

Indicate ‘REFERENCE SOURCE’ as: USP, JCAHO, PCAB, State, Province, or <Other>.

DISCLAIMER: Copyright © protected January 1, 2015. Any reproduction, reprint or copy, in electronic or print version, is strictly prohibited without the expressed written consent of Medisca Network Inc. Medisca Network Inc. takes no responsibility for the content of this document. All suggested Standard Operating Procedures should be validated, approved and authorized for use by the end-user licensed pharmacist prior to use. TEMPLATE PUBLICATION DATE: January 1, 2015.