FDA/DRI/DED/GL-GDP /2013/06

GUIDELINES FOR GOOD DISTRIBUTION PRACTICES FOR

DRUGS,COSMETICS,MEDICAL DEVICES AND HOUSEHOLD
CHEMICAL SUBSTANCES
SCOPE
In pursuance of Sections

122,130,131 and 132 of the Public Health

Act,2012, Act 851 these Guidelines are hereby made to provide appropriate
measures to be considered by companies and organizations undertaking
importation, wholesaling and/or retailing and/or dispensing, as well as distribution
of drugs, cosmetics, medical devices and household chemicals for the storage of
products.

2. DEFINITION OF TERMS
1.1 In these Guidelines, unless the context otherwise requires,
a)

product means drugs, cosmetics, medical devices and household

chemicals.
b) authorized person means a medical officer of health, a health
inspector or any person authorized in writing by the Authority, the
Minister or a district assembly.
c) officer-in-charge means a person certified by the Authority as
an
authorized person with requisite training in Good Distribution Practices.

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3. REQUIREMENTS
3.1 GENERAL REQUIREMENTS
3.1.1 Personnel
Support Staff
shall be adequately trained in quality assurance, safety, good
storage practice, and regulatory procedures and shall observe a high level of personal
hygiene and sanitation.

3.1.2 Premises And Facilities (Storage Areas)

Receiving and Dispatch Bay
Reception and dispatch areas shall be designed and equipped to facilitate
protection of products from the weather as well as cleaning before storage.

3.1.3 Accessibility to storage area

Precautions shall be taken to prevent unauthorized persons from entering
storage and restricted areas.

3.1.4 Size and capacity of storage areas

The size and capacity of a storage area shall be of sufficient capacity to allow for
the

orderly storage of products.

3.1.5 Packing and arrangements of products

Products shall be orderly arranged to facilitate cleaning and inspection.
Pellets, racks, shelves and other packing aids shall be kept in a good state of
cleanliness and repair

3.1.6 Storage Areas

Storage areas shall be clean, dry, and free from accumulated waste and
vermin.

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3.1.7 Pest Control

There shall be a written programme for pest control which shall be adhered to.

3.1.8 Ventilation and Illumination

There shall be adequate ventilation and lighting.

3.1.9 Dispatch and transport

Materials and products shall be transported in such a way that their integrity is
not
impaired and that storage conditions are maintained.

3.2. SPECIFIC REQUIREMENTS

3.2.1 Storage Requirements
a. Appropriateness of Storage Conditions
A product shall be stored in consonance with storage conditions on the label.
b. Monitoring of Storage Conditions
Where special storage condition is required, an appropriate temperature
monitoring data shall be kept for inspection
c. Temperature Monitoring
Temperature mapping of the storage facility shall show uniformity of
temperature throughout the facility.
d. Equipment Calibration
Equipment for monitoring temperature and relative humidity conditions of the
facility shall be calibrated at defined intervals.

3.2.2 Management Of Products

a.) Products shall be stored in such a manner as to prevent contamination, mixups and cross-contamination.
b.) Stocks shall be appropriately rotated. The first expired-first out and first
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FDA/DRI/DED/GL-GDP /2013/06

in-first out principles shall be followed.

c.) Products shall be controlled under a quarantine system designed to prevent

their use until a final decision has been taken.
d.) Narcotic drugs shall be stored in accordance with international conventions.
e.) Broken or damaged items shall be withdrawn from wholesome stock and
separated.

3.2.3. Documentation
a. Written instructions, procedures and records shall be kept up to date on the
premises of the storage facility. These shall include, but not be limited to, the
following:
(i) Delivery
(ii) Storage
(iii) Stock rotation and control
(iv) Expired stocks handling
(v) Returned or recalled goods handling
(vi) Cleaning
(vii) Pest control

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