STANDARD OPERATING SOP DOCUMENT NO.

:
010
PROCEDURE
SOP DATE OF
EFFECTIVITY:
STORAGE FEBRUARY 08, 2024

SOP REVISION NO.:

MEDXPERT PHARMACY 001

PREPARED BY: REVIEWED BY: APPROVED BY:

MARIA ANDRIA G. MARAVILLA JESTONI M. BAGU JESTONI M. BAGU

PHARMACIST OWNER/MANAGER OWNER/MANAGER

I. Introduction

1.1. Purpose of the SOP

1.1.1. The SOP outlines the proper procedures for the storage of pharmaceutical
products to maintain their quality, safety, and efficacy throughout their shelf
life and comply with regulatory requirements and guidelines.

1.2. Scope of the SOP

1.2.1. The SOP covers all aspects of pharmaceutical product storage, including
receiving, inspection, handling, labeling, stock rotation, inventory
management, storage conditions, monitoring, recording, maintenance,
cleaning, documentation, and quality control.

1.3. Applicable regulations and standards

1.3.1. The SOP is based on the Philippine FDA Guidelines for Good Storage
Practices and AO 56 s 1989, as well as other relevant regulations such as the
Dangerous Drugs Act and the Philippine Pharmacy Act.

II. Responsibilities

2.1. Pharmacist

2.1.1. Ensure compliance with the SOP for the storage of pharmaceutical products
2.1.2. Monitor and supervise the storage of pharmaceutical products in the
drugstore
2.1.3. Train and supervise pharmacy assistants on proper storage procedures
2.1.4. Maintain accurate records of pharmaceutical products received, stored, and
dispensed
2.1.5. Ensure that expired or damaged products are disposed of properly
2.1.6. Take appropriate action in case of non-conforming products or deviations
from the SOP

1 |Standard Operating Procedures-STORAGE

 STANDARD OPERATING SOP DOCUMENT NO.:
010
PROCEDURE
SOP DATE OF
EFFECTIVITY:
STORAGE FEBRUARY 08, 2024

SOP REVISION NO.:

MEDXPERT PHARMACY 001

PREPARED BY: REVIEWED BY: APPROVED BY:

MARIA ANDRIA G. MARAVILLA JESTONI M. BAGU JESTONI M. BAGU

PHARMACIST OWNER/MANAGER OWNER/MANAGER

2.1.7. Ensure that proper temperature and humidity conditions are maintained for
the storage of different types of pharmaceutical products
2.1.8. Perform periodic checks and audits of the storage facility to ensure
compliance with regulatory requirements and guidelines.

2.2. Owner/Manager

2.2.1. Ensure compliance with the SOP for the storage of pharmaceutical products
2.2.2. Allocate resources for the proper storage of pharmaceutical products
2.2.3. Provide necessary training and supervision for personnel involved in the
storage of pharmaceutical products
2.2.4. Implement and maintain a quality management system for the storage of
pharmaceutical products
2.2.5. Ensure that the storage facility meets all regulatory requirements and
guidelines
2.2.6. Take appropriate action in case of non-conforming products or deviations
from the SOP
2.2.7. Maintain proper documentation and records of pharmaceutical products
received, stored, and dispensed.

2.3. Pharmacy Assistant

2.3.1. Follow the SOP for the storage of pharmaceutical products

2.3.2. Receive and inspect pharmaceutical products upon delivery
2.3.3. Properly handle and label pharmaceutical products during storage
2.3.4. Rotate stock and maintain inventory management procedures
2.3.5. Monitor and record storage conditions, such as temperature and humidity, as
required
2.3.6. Report any deviations from the SOP to the pharmacist or owner/manager
2.3.7. Ensure that the storage facility is clean and well-maintained
2.3.8. Assist in the disposal of expired or damaged products as required
2.3.9. Participate in necessary training and education related to the storage of
pharmaceutical products.

III. Procedure

2 |Standard Operating Procedures-STORAGE

 STANDARD OPERATING SOP DOCUMENT NO.:
010
PROCEDURE
SOP DATE OF
EFFECTIVITY:
STORAGE FEBRUARY 08, 2024

SOP REVISION NO.:

MEDXPERT PHARMACY 001

PREPARED BY: REVIEWED BY: APPROVED BY:

MARIA ANDRIA G. MARAVILLA JESTONI M. BAGU JESTONI M. BAGU

PHARMACIST OWNER/MANAGER OWNER/MANAGER

III.1. Receiving Pharmaceutical Products: (see Receiving Log Form attached)

III.1.1. Begin by ensuring that the Receiving Log Form is readily available and
accessible to the Pharmacy Assistant or Pharmacist responsible for recording the
information.
III.1.2. When delivery of pharmaceutical products arrives, inspect the packaging and
labeling to ensure that they are in good condition and not expired.
III.1.3. Record the date of receipt in the "Date Received" column of the form.
III.1.4. Write down the name and complete address of the supplier in the "Supplier
Name" and "Supplier's Address" columns, respectively.
III.1.5. In the "Product Name" column, list the name of the pharmaceutical product that
has been received.
III.1.6. Find the lot number of the product on the packaging or labeling, and record it in
the "Lot Number" column.
III.1.7. Check the expiration date of the product, and record it in the "Expiration Date"
column.
III.1.8. Finally, indicate the name of the person who received and recorded the
information in the "Received and Recorded by" column. This can be the name of
the Pharmacy Assistant or Pharmacist who performed the task.
III.1.9. Double-check the accuracy of the recorded information before storing the product
in the designated area.
III.1.10.Make sure to keep the completed Receiving Log Form in a secure and accessible
location for future reference.

III.2. Handling and Labeling

III.2.1. Handle the products with care and follow proper procedures to avoid damage or
contamination. Proper handling procedures may include:

III.2.1.1. Keeping the products in their original packaging until they are dispensed
to the patient or stored in a designated area.
III.2.1.2. Storing products at the appropriate temperature and humidity levels.
III.2.1.3. Separating different classes of products such as narcotics or controlled
substances from other pharmaceutical products.

3 |Standard Operating Procedures-STORAGE

 STANDARD OPERATING SOP DOCUMENT NO.:
010
PROCEDURE
SOP DATE OF
EFFECTIVITY:
STORAGE FEBRUARY 08, 2024

SOP REVISION NO.:

MEDXPERT PHARMACY 001

PREPARED BY: REVIEWED BY: APPROVED BY:

MARIA ANDRIA G. MARAVILLA JESTONI M. BAGU JESTONI M. BAGU

PHARMACIST OWNER/MANAGER OWNER/MANAGER

III.2.1.4. Avoiding the use of damaged or compromised products.

III.2.1.5. Pharmacy personnel should wear appropriate personal protective
equipment such as gloves, masks, and gowns as needed to prevent
contamination.

3.2.2. Label each product container. The labeling should include:

3.2.2.1. Product name

3.2.2.2. Strength
3.2.2.3. Dosage form
3.2.2.4. Lot Number
3.2.2.5. Expiration date
3.2.2.6. Patient name (if applicable)
3.2.2.7. Directions for use
3.2.2.8. Special instructions (if any)
3.2.2.9. Any applicable warning labels
3.2.2.10. Pharmacy personnel should follow all applicable regulations and guidelines
for labeling pharmaceutical products.
3.2.2.11. The labeling should be clear, legible, and durable enough to remain attached
to the product container during storage and dispensing.
3.2.2.12. Pharmacy personnel should follow all applicable regulations and guidelines
for labeling pharmaceutical products. The labeling should be clear, legible, and
durable enough to remain attached to the product container during storage and
dispensing.

III.3. Stock Rotation and Inventory Management

III.3.1. Implement a first-in, first-out (FIFO) inventory system to ensure that older
products are dispensed first.
III.3.2. Regularly check the inventory and reorder products as necessary to avoid
stockouts.
III.3.3. Perform physical inventory counts periodically to ensure that the actual inventory
matches the inventory records. Each of the above steps involves the following
actions:

4 |Standard Operating Procedures-STORAGE

 STANDARD OPERATING SOP DOCUMENT NO.:
010
PROCEDURE
SOP DATE OF
EFFECTIVITY:
STORAGE FEBRUARY 08, 2024

SOP REVISION NO.:

MEDXPERT PHARMACY 001

PREPARED BY: REVIEWED BY: APPROVED BY:

MARIA ANDRIA G. MARAVILLA JESTONI M. BAGU JESTONI M. BAGU

PHARMACIST OWNER/MANAGER OWNER/MANAGER

III.3.3.1. Arrange the products on the shelves based on their expiration dates, with
the earliest expiring products in front.
III.3.3.2. Regularly check the inventory to determine the rate of product usage and
the lead time for receiving new shipments.
III.3.3.3. Update the inventory system in real-time to reflect new orders and
product receipts. Follow this procedure to fill out the Pharmacy
Inventory Log Form (see attached form):

 Date: Enter the date of inventory count.

 Product Name: List all the pharmaceutical products in your
drugstore.
 Lot Number: Enter the lot number of the product. The lot number
is a unique identifier assigned to a specific batch of a product.
 Expiration Date: Enter the expiration date of the product.
 Quantity Received: Enter the quantity of each product that was
received since the last inventory count.
 Quantity Dispensed: Enter the quantity of each product that was
dispensed or sold since the last inventory count.
 Quantity On Hand: Calculate the remaining quantity of each
product by subtracting the quantity dispensed from the quantity
received. This is the current quantity on hand.

 Recorded by: The Pharmacy Assistant or Pharmacist should sign

and date the inventory log to indicate that they have verified the
accuracy of the count.
 First in First Out (FIFO): Make sure to follow the FIFO method
for each product. The products with the earliest expiration dates
should be dispensed first to avoid any expired products in the
inventory.

III.3.3.4. Perform stocktaking activities or cycle counting to count a portion of the

inventory on a regular basis.
III.3.3.5. Investigate and resolve any discrepancies between the actual inventory
and inventory records promptly.
III.3.3.6. Keep inventory records up-to-date and accurate.

5 |Standard Operating Procedures-STORAGE

 STANDARD OPERATING SOP DOCUMENT NO.:
010
PROCEDURE
SOP DATE OF
EFFECTIVITY:
STORAGE FEBRUARY 08, 2024

SOP REVISION NO.:

MEDXPERT PHARMACY 001

PREPARED BY: REVIEWED BY: APPROVED BY:

MARIA ANDRIA G. MARAVILLA JESTONI M. BAGU JESTONI M. BAGU

PHARMACIST OWNER/MANAGER OWNER/MANAGER

III.3.3.7. Properly dispose of any damaged or expired products in accordance with

applicable regulations and guidelines.
III.3.3.8. Report and document any deviations or issues related to stock rotation or
inventory management appropriately.

III.4. Storage Conditions

III.4.1. Store pharmaceutical products in a clean, dry, and well-ventilated area with
controlled temperature and humidity conditions as specified by the product
labeling or regulatory requirements.
III.4.2. Monitor and record the temperature and humidity of the storage area using a
calibrated monitoring device.
III.4.3. Maintain a backup power source in case of power outages.
III.4.4. Store hazardous or temperature-sensitive products in separate designated areas as
required.

III.5. Monitoring and Recording of Storage Conditions

III.5.1. Record the temperature and humidity of the storage area at regular intervals and
maintain records for at least two years. (Refer to the attached Temperature and
Humidity Monitoring Record Form. ) Follow this procedure to fill out the
Temperature and Humidity Monitoring Record Form:

III.5.1.1. Use a calibrated thermometer and hygrometer to measure the temperature

and humidity of the storage area at regular intervals, as specified in the
SOP.
III.5.1.2. Record the date and time of each measurement in the appropriate
columns of the Temperature and Humidity Monitoring Record Form.
III.5.1.3. Record the temperature in degrees Celsius (°C) and the humidity as a
percentage (%).
III.5.1.4. Ensure that the monitoring device is placed in a representative location
within the storage area and not exposed to direct sunlight or other sources
of heat or moisture.
III.5.1.5. If there are any deviations from the acceptable temperature or humidity
range, investigate the cause and take appropriate action to address the

6 |Standard Operating Procedures-STORAGE

 STANDARD OPERATING SOP DOCUMENT NO.:
010
PROCEDURE
SOP DATE OF
EFFECTIVITY:
STORAGE FEBRUARY 08, 2024

SOP REVISION NO.:

MEDXPERT PHARMACY 001

PREPARED BY: REVIEWED BY: APPROVED BY:

MARIA ANDRIA G. MARAVILLA JESTONI M. BAGU JESTONI M. BAGU

PHARMACIST OWNER/MANAGER OWNER/MANAGER

issue. Record any corrective actions taken in the appropriate section of

the form.
III.5.1.6. At the end of each monitoring period, review the records to ensure that
the storage area has maintained the required temperature and humidity
levels.
III.5.1.7. Sign and date the form, indicating the name or initials of the person who
recorded the measurements.

III.5.2. Investigate and address any deviations from the acceptable storage conditions.
III.5.3. Ensure that the monitoring device is calibrated periodically as required.

III.6. Maintenance and Cleaning of Storage Equipment and Facilities

III.6.1. Clean and sanitize storage equipment and facilities regularly to avoid
contamination.
III.6.2. Perform regular maintenance checks on storage equipment to ensure they are
functioning correctly.
III.6.3. Perform repairs or replacements as necessary to maintain the proper storage
conditions.
III.6.4. Documentation of Product Recalls and Returns

III.6.5. Implement a system for recording and tracking recalled or returned products.
III.6.6. Ensure that recalled or returned products are removed from inventory
immediately and stored in a designated area until proper disposal or return to the
supplier.

III.7. Quality Control Measures

III.7.1. Implement quality control measures to ensure that pharmaceutical products are
stored and dispensed correctly and in compliance with regulatory requirements
and guidelines.
III.7.2. Conduct periodic internal audits to ensure compliance with the SOP and
regulatory requirements.
III.7.3. Take appropriate corrective actions in case of non-conforming products or
deviations from the SOP.

7 |Standard Operating Procedures-STORAGE

 STANDARD OPERATING SOP DOCUMENT NO.:
010
PROCEDURE
SOP DATE OF
EFFECTIVITY:
STORAGE FEBRUARY 08, 2024

SOP REVISION NO.:

MEDXPERT PHARMACY 001

PREPARED BY: REVIEWED BY: APPROVED BY:

MARIA ANDRIA G. MARAVILLA JESTONI M. BAGU JESTONI M. BAGU

PHARMACIST OWNER/MANAGER OWNER/MANAGER

IV. Quality of Records

IV.1. Ensure all records are complete, accurate, and legible.

IV.2. Maintain records for at least two years.
IV.3. Store records in a secure location to prevent loss or damage.
IV.4. Develop a system for easy retrieval of records.
IV.5. Regularly review and update records to ensure compliance with current regulations
and guidelines.
IV.6. Train staff on the importance of maintaining accurate records.
IV.7. Perform regular audits to ensure compliance with record-keeping requirements.
IV.8. Address any deficiencies or discrepancies found during audits promptly.
IV.9. Establish a protocol for disposal of records that have met the retention period.
IV.10. Keep backup copies of electronic records in case of system failure or data loss.

V. Training and Implementation

V.1. The training and implementation section of the SOP for drugstore storage outlines the
steps to ensure that all staff is trained in the proper storage and handling of
pharmaceutical products. This includes the following:

V.1.1. Designation of responsibilities: Clearly defining the roles and responsibilities of

each staff member involved in the storage and handling of pharmaceutical
products.

V.1.2. Conducting Training: Provide training on the SOP for drugstore storage to all
personnel who handle or store pharmaceutical products. This includes training on
the proper handling, labeling, and storage of products, as well as the importance
of maintaining accurate records and monitoring temperature and humidity
conditions.

V.1.3. Implementation: Implement the SOP for drugstore storage across all drugstore
branches, and ensure that all staff members comply with the SOP.

8 |Standard Operating Procedures-STORAGE

 STANDARD OPERATING SOP DOCUMENT NO.:
010
PROCEDURE
SOP DATE OF
EFFECTIVITY:
STORAGE FEBRUARY 08, 2024

SOP REVISION NO.:

MEDXPERT PHARMACY 001

PREPARED BY: REVIEWED BY: APPROVED BY:

MARIA ANDRIA G. MARAVILLA JESTONI M. BAGU JESTONI M. BAGU

PHARMACIST OWNER/MANAGER OWNER/MANAGER

V.1.4. Regular Review: Review the SOP regularly to ensure that it is up to date and
relevant to the current practices and requirements.

V.1.5. Record Keeping: Maintain accurate and complete records of all training sessions,
implementation actions, and any updates made to the SOP.

VI. Revision History

SOP Number:
Revision Number:
Date of Revision:
Description of Changes:

VII. End of Document

This section is the final section of the SOP, which serves to conclude the document and
provide a confirmation of pharmacy staff members' review and understanding of the SOP.

Name & Designation Signature Date

By providing signature and date lines in the End of a Document section, the pharmacy
ensures that all staff members have reviewed and agreed to follow the procedures outlined in
the SOP. The SOP is considered an important tool to ensure that the pharmacy complies with
regulations and maintains high standards of patient safety and satisfaction.

9 |Standard Operating Procedures-STORAGE