Scribd
Upload
4K views3 pages

Cold Chain Management SOP for Pharmacy

This standard operating procedure outlines the cold chain management process for storing pharmaceuticals that require refrigeration. It details procedures for proper use and monitoring of refrigerators, freezers, and temperature controls. Key responsibilities include the pharmacist, owner, and assistants monitoring minimum twice daily temperatures, stocking and dispensing medications under desired conditions, and emergency measures to maintain the cold chain in events like power outages. Quality records include temperature monitoring charts to ensure product stability.

Uploaded by

Daniel Yves IV Paez
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
4K views3 pages

Cold Chain Management SOP for Pharmacy

This standard operating procedure outlines the cold chain management process for storing pharmaceuticals that require refrigeration. It details procedures for proper use and monitoring of refrigerators, freezers, and temperature controls. Key responsibilities include the pharmacist, owner, and assistants monitoring minimum twice daily temperatures, stocking and dispensing medications under desired conditions, and emergency measures to maintain the cold chain in events like power outages. Quality records include temperature monitoring charts to ensure product stability.

Uploaded by

Daniel Yves IV Paez
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
  • Procedure
  • Objective
  • Responsibility
  • Quality of Records
  • Forms
  • End of Document

Document No.

STANDARD OPERATING
PROCEDURE Revision No.

COLD CHAIN MANAGEMENT Page 1 of 3

Revision History
Revised on: Prepared by: Reviewed by: Approved by:

Daniel Yves A. Paez IV, RPh Denice P. Mesias Denice P. Mesias


Pharmacist Owner/Proprietress Owner/Proprietress
Issue No.:
Effective Date:

References
Document No.: Title No.

I. OBJECTIVE:
1. To ensure proper storage of pharmaceuticals
2. To provide proper equipments that will maintain the stability and efficacy of drug
products
3. To achieve unbroken cold chain from shipment to transient storage

II. SCOPE: All pharmaceutical products requiring storage under special storage condition e.g.,
biologicals, vaccines

III. RESPONSIBILITY
 Pharmacist
 Owner/Manager
 Pharmacy Assistants
 Forwarder

IV. PROCEDURE
A. Pharmaceutical Refrigerator/Chiller/Freezer

Page 1 of 3
1. Required for vaccines, biologicals, and pharmaceuticals needing cold storage
condition.
2. Temperature is monitored and cleanliness is observed.
3. Contents is organized and icepack is provided when dispensed or delivered

B. Temperature
1. Minimum of two thermometers are needed. Thermometers must be calibrated at
least twice a year.
2. Thermometer is read at least twice daily preferably once in the morning and once
in the afternoon.
3. The pharmacist or personnel should monitor and record temperature on the
temperature monitoring sheet.
4. Room temperature is monitored at least twice daily.

C. Dispensing
1. An icepack should be provided if customer's location is too far away.
2. Medicine must be dispensed under desired temperature condition.

D. Stocking
1. Stocking of medicine shall be organized.
2. Plastic containers may be used to maintain good appearance and freshness of
the product.

E. Emergency and Safety Measures


1. Delivered products should be closely monitored as to manufacturer, specification,
and expiration dates to ensure the safety and welfare of the consumers.
2. Refrigerated products such as ampules/vials accidentally broken should be
cleaned and the cleaning person must be careful.
3. In the event of a power interruption, electric generator should be used to sustain
the ranged temperature of the drug products.

F. Product Returned/Complaint
1. The product should be in proper temperature and storage upon return.

Page 2 of 3
2. If the product is not in well-monitored temperature and storage, acceptance of
the said product will be denied.
3. In case cold chain is maintained, the buyer is asked for the receipt and
necessary action is done.

G. Product Recall
1. In the event of product complaint arises, customers are advised to return the
product with the accompanying receipt for inspection and cold chain should be
maintained as the veracity of the complaints.

V. QUALITY OF RECORDS:
A. Systematic actions necessary to ensure adequate confidence that the product and
documentation will satisfy the requirements for quality assurance.
B. Temperature monitoring chart should be checked regularly to ensure the stability of the
medicines.

VI. FORMS:
A. Temperature Monitoring Sheet
B. Logbook

VII. END OF DOCUMENT

Page 3 of 3

STANDARD OPERATING PROCEDURE Document No. Revision No. COLD CHAIN MANAGEMENT Page 1 of 3 Revision History Revised on: Prepare
1. Required for vaccines, biologicals, and pharmaceuticals needing cold storage condition. 2. Temperature is monitored and c
2. If the product is not in well-monitored temperature and storage, acceptance of the said product will be denied. 3. In cas

You might also like