OUR LADY OF FATIMA UNIVERSITY

COLLEGE OF PHARMACY

Good Storage
Practices
MODULE 3, Part 1

Experiential Pharmacy Practice in Institutional Pharmacy

INPI 411
 CHECKLIST:
ü Attend Online Lecture via Zoom Meeting
ü Duration: 3 hours
ü Read course and unit outcomes.
ü Read study guide prior to online attendance.
ü Read required learning resources
ü Proactively participate in online discussions
ü Answer and submit course unit tasks
 LEARNING OUTCOMES:
At the end of this unit, the students are expected to:

1. Determine the considerations in organization and

management of a pharmacy
2. Discuss the guidelines in Good Storage practices
3. Demonstrate competence in receiving of deliveries,
display and storage of pharmaceutical products.
 OUTLINE:

ü Definition of terms
ü Sources of Guidelines on Good Storage Practices
ü Principles in receiving of deliveries, display and storage of
pharmaceutical products (using the Guidelines for the Good Storage
Practice of Essential Medicines and other Health Products by Department of
Drugs and Food (Cambodia))
 Definition of Terms
Storage – the storing of pharmaceutical products up to the point of use

Good storage practices – a part of quality assurance that ensures that the quality of
pharmaceutical products is maintained by means of adequate control throughout
the storage thereof

First-in/first-out – a distribution procedure to ensure that the oldest stock is

distributed first and/or used before a newer identical stock item is distributed
and/or used

First to expire/first out - a distribution procedure to ensure that the stock with the
earliest expiry date is distributed first and/or used before an identical stock item is
distributed and/or used
 Sources of Guidelines

Annex 9 Guide to good storage practices for pharmaceuticals by WHO

Administrative Order no. 2013 – 0027 – Adoption and Implementation of WHO Annex 5 Guide
to Good Distribution Practices (GDP) and Annex 9 Guide to Good Storage Practices of
Pharmaceuticals

USP <1079> Good Storage and Distribution Practices

MSF medical guidelines (Medecins Sans Frontieres)

Guidelines for the Storage of Essential Medicines and Other Health Products by the Ministry of
Health, Kingdom of Cambodia
Storage is an important activity in the medicines supply chain management.

Good Storage Practices assist in ensuring the quality, safety and identity of pharmaceutical
products throughout the whole supply management cycle up to their point of use
 Good Storage Practices
**Refer to Guidelines for the Storage of Essential Medicines and Other Health Products

General Requirements:
• There should be an adequate number of qualified personnel to
achieve pharmaceutical quality assurance objectives.
• Storage areas should be designed or adapted to ensure good storage
conditions.
- Sufficient area that allows orderly storage of various supplies/products
(including the returned, rejected or recalled items) preventing mix ups or cross
contamination
- Maintained clean and dry and with temperatures meeting the required
condition by the products (this is monitored daily temp and RH) based on
stability testing
- Materials should be off the floor using pallets ( pallets should be clean and in
good condition)
 Good Storage Practices
**Refer to Guidelines for the Storage of Essential Medicines and Other Health Products

General Requirements:
• Storage areas should be designed or adapted to ensure good storage
conditions.
- It should be free from waste and vermin. (there is a written sanitation program,
safe pest control program( no risk of contamination)
- Facilities should have controls that mitigate risks of fire, water or explosion
- There should be areas for the different processes (reception areas for receiving
materials sufficient in size to allow cleaning if needed)
- Areas are clearly identified: rejected, expired, recalled or returned materials or
products and separated physically. Also identified are areas for hazardous, high
value materials, narcotics – ensure not only safety but also security
 Good Storage Practices
Routine Management or Storeroom Management Tasks
- Cleaning, monitoring of storage condition, adherence to SOPs
and proper documentation
KEEPING YOUR STORE CLEAN AND TIDY MAKES
MANAGING YOUR MEDICINES AND HEALTH
PRODUCTS EASIER!

I. Receiving and Arranging Commodities

1. Receiving Health Commodities -
2. Arranging Commodities
3. Stock Rotation
4. Orderly Arrangement of Essential Medicines
Receiving the items

• There should be
sufficient space to
receive the products
• Sufficient space to
perform accurate
inspection of
items
• Good lighting to
allow accurate
inspection
Arranging Commodities
• Use pallets in
stacking cartons
• Observe the label’s
storage condition
• Secure high value
products
Arranging Commodities

• Securing high value

items
• Stacking of cartons in Check inventory records for stock on hand. Then,
pallets conduct a physical inventory (physically count the
quantities on hand) and compare the results
Arranging Commodities
Common terms
• Store frozen • -10 to -20˚C
• Store in cold • 2˚- 8˚C
place
• Keep cool • 8˚-15˚C
• Store at room • 15˚-25˚C
temperature
(up to 30˚C)
Arranging Commodities
Meaning of storage conditions indicated on the
label :

“Do not store over 30 °C” from +2 °C to +30 °C

“Do not store over 25 °C” from +2 °C to +25 °C
“Do not store over 15 °C” from +2 °C to +15 °C
“Do not store over 8 °C” from +2 °C to +8 °C
“Do not store below 8 °C” from +8 °C to +25 °C

“Protect from moisture”

“Protect from light” storing in light resistant
container
Stock Rotation
• Follow the FEFO policy
• place the nearly expiring items in front
• Mark the packages as indicate Exp Dates in the Stock
card
• Perform periodic stock reconciliation (actual from
recorded)
• Perform physical inspection (damaged, to many opened
packages)
• Follow an orderly arrangement
of stocks
Arrangement of Medicines
• Some common systems of arranging medicines:
• Alphabetical order by generic name or INN
• Therapeutic or pharmacological category
• Dosage form/ Route of administration
• Frequency of use
• Commodity coding
• Mixed
Ex.
– oral drugs
– injectable drugs
– infusion fluids Arrange alphabetically
– vaccines, immunoglobulins and antisera
– drugs for external use and antiseptics
– disinfectants
Arrangement of Medicines
• Commodity Coding
• Use of SKUs (Stock Keeping Unit)
• A stock-keeping unit (SKU) is a scannable bar code composed of
an alphanumeric combination of eight-or-so characters.
• The characters are a code that track the price, product details,
and the manufacturer
• Primarily use to facilitate inventory
 Good Storage Practices
II. Keeping Track of Products in Your Storeroom
1. Standard List of Stock Items
2. Stock Card
3. Physical Inventory

1. Standard List of Items

• A master list of stock items that includes all products they
handle, with their details (form, strength and quantity per
package)
• The list should be updated and made available for reference
• Inventory records should be maintained for all products on the
list
Keeping Track of Products
2. Use of Stack Cards
Stock cards may contain the
following:
product name/description
(including the form [ e.g.
capsule, tablet, liquid
suspension, etc.] and
strength) – stock on
hand/beginning stock balance
– receipts
– issues
– losses/adjustments
– closing/ending balance
– transaction reference special storage conditions ( e.g. 2◦C - 8◦C), unit
prices, lot numbers/bin locations, tem codes,
expiry dates
Keeping Track of Products
• Stock cards are useful to provide
information about consumption,
lead times for requisition,
maximum and minimum stock
levels, emergency order point
• Observe accurate and proper
documentation
• Comprehensive records should be
maintained showing all receipts
and issues of materials and
pharmaceutical products according
to a specified system, e.g. by batch
number.
Terms used:
• Lead time- the amount of time between when a
purchase order is placed to replenish products and
when the order is received in the
• Minimum stock level - smallest quantity of a particular
item of material that must be kept at all times. Re-
order point.
• Maximum stock level – the amount not to be exceeded
• Emergency order point - The level of stock that triggers
an emergency order, regardless of the timing within the
review period. It is always lower than the min.
 Keeping Track of Products
3. Physical Inventory
There are two kinds of physical inventory:
Complete physical inventory: all
products are counted as the same time. A
complete inventory should be taken at
least once a year.
Cyclic or random physical
inventory: Selected products are • Update the stock keeping
counted and checked against the stock records
keeping records on a rotating or • Take action based on the result
regular basis throughout the year. of the physical inventory
- Also called cycle counting.
- Ex. In Drugstores: conducted by
location, at the time the personnel is
available,
 Good Storage Practices

Handling returned good in the Store:

Returned goods and product recall Returned or rejected goods including
recalled goods, should be handled in accordance with approved
procedures and records should be maintained.

All returned goods should be placed in quarantine and returned to

saleable stock only after this has been approved by a nominated,
responsible person following a satisfactory quality re-evaluation.

Product recall:
There should be a procedure to recall from the market, promptly and
effectively, pharmaceutical products and materials known or suspected to
be defective.
ANY QUESTIONS?
 REFERENCES:

Cambodia-Department of Drugs and Food: Guidelines for the storage of essential medicines
and other health products: globi-reg.com/wp-content/uploads/2019/08

USP <1079> Good Storage and Dsitribution Practices:

https://pharmacy.ks.gov/docs/librariesprovider10/default-document-library/ups-36-good-
storage-and-shipping-practices.pdf

Administrative-Order-No.-2013-0027: https://www.fda.gov.ph/wp-
content/uploads/2021/04/Administrative-Order-No.-2013-0027.pdf

WHO Good Storage Practices:

https://www.who.int/medicines/areas/quality_safety/quality_assurance/GuideGoodStorageP
racticesTRS908Annex9.pdf

Organization and management of a pharmacy:

https://medicalguidelines.msf.org/viewport/EssDr/english/organization-and-management-of-
a-pharmacy-16688159.html
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LISTENING!