GOOD DISTRIBUTION PRACTICE

GOOD STORAGE PRACTICE

Applicable for Categories:
FOOD, DRUG AND COSMETICS
AO No. 2013 - 0027
ANNEX 5: GDP * ANNEX 9: GSP
Prepared by:
Aubrey B. Estrellon & Dave Joshua N. Mones
Regulatory Pharmacists
INTRODUCTION

The guidelines are intended to apply to all steps in the

distribution and storage in a supply chain.
PHARMACEUTICAL
COSMETICS

STORAGE
DISTRIBUTION

FOOD
ANNEX 5 - GDP , ANNEX 9 - GSP

Training Outline
• Personnel
• Premises, Warehousing and Storage
- Storage areas
- Different storage conditions
- Monitoring of storage conditions
• Stock rotation and control
• Returned Goods
• Dispatch and transport
DEFINITION OF TERMS

WHO Manufacturing date

FDA Expiry Date
Drug First In First Out (FIFO)
First Expiry First Out (FEFO)
Food
Good Distribution Practice
Cosmetics
(GDP)
Storage Condition Good Storage Practice (GSP)
DEFINITION OF TERMS

WHO- World Health Organization

FDA - Food and Drug Administration
DEFINITION OF TERMS
• Drug - prevent, diagnose, treat, or relieve symptoms or disease.
• Food - nutrition
• Cosmetics - external parts
DEFINITION OF TERMS

FIFO Method / FIFO System

• Pagkasira o pagkaluma
ng mga produkto
DEFINITION OF TERMS

FEFO Method / System

• Kalidad ng produkto
• Mapapabuti ang relasyon
mamimili
 DEFINITION OF TERMS

• traceability,
Storage condition • origin
• Quality
• Safety
• Effectiveness
• When it was
• Quality not produced,
safety • Shelf life
GOOD DISTRIBUTION PRACTICE (GDP)

• A part of Quality assurance which ensures that the quality of a

Pharmaceutical product is maintained through adequate control
throughout the numerous activities which occur during the
distribution process.
GOOD STORAGE PRACTICE (GSP)

• A part of a Quality Assurance which ensures that the quality of a

Pharmaceutical product is maintained through adequate control
throughout the storage.
ANNEX 5 - GDP , ANNEX 9 - GSP
Personnel

• GDP and GSP

• Personnel hygiene, and sanitation
PREMISES, WAREHOUSING AND STORAGE

• STORAGE AREAS

• STORAGE CONDITIONS

• MONITORING OF STORAGE CONDITIONS

PREMISES, WAREHOUSING AND STORAGE
Storage Areas
Storage Areas
Precautions shall be taken. To keep employees aware and
for better work environment.
PREMISES, WAREHOUSING AND STORAGE
Storage Areas
Storage Areas
Sufficient capacity and orderly storage of the various
categories of materials or products.
PREMISES, WAREHOUSING AND STORAGE
Storage Areas
Storage Areas
Must be clean and dry and maintained within
acceptable temperature limits.
Dapat ba na magkakasama
ang mga produkto na may
magkakaibang batch
at expiry?
MALI
PREMISES, WAREHOUSING AND STORAGE
Storage Areas
Storage Areas
Products should be stored off the floor and off the wall and
has proper spacing to permit cleaning and inspection.
PREMISES, WAREHOUSING AND STORAGE
Storage Areas
Storage Areas
Pallets must be kept in good state of cleanliness and
repair.
PREMISES, WAREHOUSING AND STORAGE

Storage Areas
Broken or damaged items should be withdrawn from usable
stock and stored separately.
PREMISES, WAREHOUSING AND STORAGE

Storage Areas
First In First Out (FIFO) & First Expiry First Out (FEFO) must
always observed.
PREMISES, WAREHOUSING AND STORAGE

Why proper storage of Food,

Cosmetics and Drugs
Important?
• Potency / effectivity
• Prevent deterioration / spoilage /
degradation
• Physical integrity
• Quality and safety
PREMISES, WAREHOUSING AND STORAGE

Storage conditions
• Storage conditions for pharmaceutical products
should be in compliance with the instructions on
the label.

Normal storage conditions

• 15–25 °C
• up to 30 °C.

Relative Humidity
• Below 60 %
MONITORING OF STORAGE CONDITIONS

Why Humidity or
Moisture Control is important?
• Stability
• Growth of microbes
• Product quality
ANNEX 5 - GDP , ANNEX 9 - GSP

Stock rotation and control

• Actual vs Recorded stocks
• All stock discrepancies should be investigated
• Proper segregation
Ano ang tamang temperatura sa
pag store o pag-imbak ng mga
gamot sa loob ng warehouse?
15 to 25°C, up to 30°C
ANNEX 5 - GDP , ANNEX 9 - GSP

Dispatch and Transport

• Safety and quality
• Records
Ano ang inirerekomendang
humidity para sa pag-iimbak
ng mga gamot?
60% PABABA
 ANNEX 5 - GDP , ANNEX 9 - GSP

Product Complaint
• Written, electronic, or oral, expressing concern, for
any reason, with the quality of a product.

• Foul odor, change in color, tablet size or size variation,

under-filled container
Standard Operating Procedures
(2023)
SOP No. Title Issue No.
1 Documentation Control 1
2 Handling Product Recall 3
3 Handling Customer Complaints 3
4 Receipt and Storage of Stocks/Goods 3
5 Release of Stocks/Goods 3
6 Warehouse Pest Control Program 2
7 Warehouse Cleanup Program 2
8 Training and Re-training of Personnel 3
9 Policy on Product Returns and Damaged Stocks 3
10 Policy on Good Storage Practice 3
11 Policy on Vendor Rating 2
12 Retention Samples Program 2
13 Self-Inspection Program 2
14 Waste Management of Products 2
15 Policy on Good Distribution Practice 2
16 Vendor Audit 2
17 Proper Hygienic Practices (Logistics and Warehousing) 1
18 Handling of Products Suspected or Found to be Counterfeit 1
19 Policy on Stock Handling and Control 1
20 Policy on Maintenance of Vehicle 1
21 Pharmacovigilance 0
22 Risk Management Procedure 1
23 Policy on Food Repacker 1
24 Fire Evacuation 1
25 Traceability 1
Anumang sangkap na
ginagamit upang gamutin,
maiwasan, magdiagnose
at magbigay ginhawa sa
mga sintomas ng
sakit o kondisyon.
DRUG/GAMOT
Ano ang rekomendadong paraan
ng pagtatapon ng mga gamot na
expired o hindi na magagamit?

a. Pagflush ng gamot sa inidoro

b. Pagtatapon sa basurahan
c. Pagbabalik ng produkto sa
supplier para sa maayos na
pagtatapon.
C, Pagbabalik ng produkto sa
supplier para sa maayos na
pagtatapon.
Ano ang tamang patakaran sa
pag-iimbak ng mga produkto
sa loob ng bodega?
FIFO & FEFO
Magkahalo ang stocks ng
Drugs, Food at Cosmetics?
MALI
FIFO stands
for?
a. First In, Fast Out
b. Fast In, Fast Out
c. First In, First Out
d. Fast In, First Out
FIRST IN FIRST OUT
Ano ang ibig sabihin
ng FEFO?
FIRST EXPIRY FIRST OUT
Lahat ng variants / uri
ng isang produkto ay
magkakasama?
TAMA
Ano ang ibig sabihin ng SOP?
a. Standard Operating Protocol
b. Standard Order Protocol
c. Standard Order Procedure
d. Standard Operating Procedure
D. Standard Operating Procedure
Ang pagkuha o pag pick ng
mga stocks ay sa mezzanine
at ground display areas
lamang, at hindi sa
stock areas?
TAMA
Sa pagrerefill ng stocks, ay
dapat iloose na ang buong
laman ng box?
TAMA
Ano ang ibig sabihin ng GDP?
a. Good Documentation Practice
b. Good Distribution Protocol
c. Gross Domestic Product
d. Good Distribute Practice
e. Good Distribution Practice
f. Good Distributive Practice
E, Good Distribution Practice
Maaari bang ilagay ang
buffer stocks/ boxes
sa sahig ng walang paleta?
MALI