R e v is e d

GUIDELINES FOR

GOOD ST OR A GE P R A C T I C E S
IN M EDIC A L ST ORES

A ND H OSP IT A LS

Central Administration of Pharmaceutical

Affairs, M inistry of H ealth And Pop ulation

F aculty of Pharmacy , Cairo U niv ersity

W orld H ealth O rg aniz ation

Cairo - E g y p t

2 0 0 4
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Cont r i b u t e r s - R e v i s e d E d i t i on

F ro m C e n t r a l A d m in is t r a t io n o f P h a r m a c e u t ic a l A f f a ir s :
• D r. Zeinab Ebied, G eneral Manager, Technical Research
and Training
• D r. M o u s t af a I br ah im , G eneral Manager of
Pharmaceutical Inspection

P h a r m a c e u t ic a l In d u s t r y E x p e r t s :
• D r. R eda S h o u k r y
• D r. O s am a El -G h af f ar y
• D r. A bdel A z iz A bdel R eh iem

U n d e r S e c r e t a r y o f S t a t e f o r P h a r m a c e u t ic a l A f f a ir s
• D r. O s am a El -K h o l y

C o n t r ib u t e r s -F ir s t E d it io n , 1 9 9 7
From Faculty of Pharmacy. Cairo University:
• P r o f . D r . A hm e d A b d E l -B a r y , D e a n, p r o f e s s o r o f p ha r m a ce u t i cs a nd i ndu s t r i a l
p ha r m a cy .
• P r o f . D r . A l i a A . B a da w y , p r o f e s s o r o f p ha r m a ce u t i cs a nd i ndu s t r i a l p ha r m a cy .
• D r . M o ha m e d S . E l -S a m a l i g y , p r o f e s s o r o f p ha r m a ce u t i cs a nd i ndu s t r i a l
p ha r m a cy .

From M inistry of H ealth and Pop ulation:

• D r . A b d E l -H a m i d A b d E l -A z iz , fo r m e r u nde r s e cr e t a r y o f s ta te fo r
p ha r m a ce u t i ca l a f f a i r s .
• D r . A l y M . E l -S ha r k a w y , he a d o f t he E g y p t i a n ho l di ng dr u g co m p a ny .
• D r . G a m i l a M . M o s a , di r e ct o r o f dr u g co nt r o l de p a r t m e nt .

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TABLE OF CONTENTS
I . D E F I N I T I O N S A N D C O N C E P T S. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
I I . P R E M I SE S A N D F A C I L I T I E S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1
B a s i c R e q u i r e m e n t s ..............................................................................................................1 1
S a n i t a t i o n ..............................................................................................................................1 4
H o u s e k e e p i n g ........................................................................................................................1 5
F i r e P r e v e n t i o n .....................................................................................................................1 5
W a r e h o u s e S i z e .....................................................................................................................1 6
W a r e h o u s e S i t e S e l e c t i o n .....................................................................................................1 6
W a r e h o u s e D e s i g n ................................................................................................................1 7
I I I . P E R SO N N E L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 9
I V . SE C U R I T Y A N D SA F E T Y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1
V . ST O R A GE P R O C E D U R E S A N D I N ST R U C T I O N S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 4
G e n e r a l P r i n c i p l e s ................................................................................................................24
R e c e i p t o f I n c o m i n g M a t e r i a l s ............................................................................................26
S t o r a g e o f A p p r o v e d P r o d u c t s ............................................................................................29
S t o r a g e a t C l i n i c a l F a c i l i t i e s ................................................................................................30
S p e c i a l S t o r a g e C o n d i t i o n s ..................................................................................................31
V I . ST O C K A R R A N GE M E N T R O T A T I O N A N D C O N T R O L .................................................3 2
S t o c k R o t a t i o n a n d C o n t r o l .................................................................................................32
A r r a n g e m e n t o f S t o c k ..........................................................................................................33
C o n t r o l o f O b s o l e s c e n t a n d O u t d a t e d S t o c k ......................................................................33
V I I . D I SP A T C H A N D I SSU I N G. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4
V I I I . ST A B I L I T Y F O L L O W -U P T H R O U GH C U R R E N T C H E C K -U P A N D
I N SP E C T I O N O F P H A R M A C E U T I C A L P R O D U C T S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 6
I X . M A T E R I A L S A N D D R U GS R E Q U I R I N G SP E C I A L ST O R A GE C O N D I T I O N S . . . . . . . . . . . . 41

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I. DE F IN IT IO N S A N D C O N C E P T S

Storage: The term used to describe the safe keeping of starting

materials, packaging materials, components received
semi-finished, in-process and finished products awaiting
dispatch. The term is also applied for safe keeping of
materials and drug products in drug stores, pharmacies,
hospitals, etc., under the specified conditions.

Storage C on d i ti on s: The conditions specified for storing the

product e.g. temperature, humidity, container, etc.

Q u al i ty : The ability of a drug product to satisfy the users need.

Q u al i ty C on trol U n i t: Means any person or organizational element

designated to be responsible for the duties relating to
quality control.

M ateri al : A term used to cover stating materials, intermediate

products, packaging materials and components and
finished products.

Starti n g M ateri al : Any substance used in the manufacture of a

medicinal product ex cluding packaging materials.

I n term ed i ate P rod u c t: A partly processed material which must

undergo further processing before it becomes a finished
product.

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D osage F orm : Refers to the gross physical form in which a drug is
administered to or used by a patient.

D ru g P rod u c t: A dosage form containing one or more active

therapeutic ingredients along with other substances
included during the manufacturing process.

P ac k agi n g M ateri al : Any material used in the packaging of a

product. It does not normally include the outer
packaging or transit cases used for departmental
transportation or shipment of orders.

a) Primary Packaging Material: A packaging material which is

in direct contact with medicinal product.

b) Printed Packaging Material: A packaging material which is

imprinted with a tex t.

F i n i sh ed P rod u c t: A medicinal product which has completed all

stages of manufacture, including packaging.

B atc h : A specific quantity of a drug and/ or other material that is

intended to have uniform character and quality, within
specified limits, and is produced according to a single
manufacturing order during the same cycle of
manufacture.

L ot: A batch, or a specific identified portion of a batch, having

uniform character and quality within specified limits, or,
in the case of a drug product produced by continuous
process. It is a specific identified amount produced in a
unit of time or quantity in a manner that assures its

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having uniform character and quality within specified
limits.

L ot N u m b er (C ontrol N umber or Batch N umber): Any distinctive

combination of letters, numbers, or symbols, or any
combination of them, from which the complete history of
the manufacture, processing, packing, holding, and
distribution of a batch or lot of drug product or other
material can be determined

M an u f ac tu re, P roc essi n g, P ac k i n g or H ol d i n g of a D ru g

P rod u c t: includes packaging and labeling operations,
testing, and quality control of drug products.

C om p on en t: Any ingredient intended for use in the manufacture of

a drug product.

A c ti v e I n gred i en t: Any component that is intended to furnish

pharmacological activity or other direct effect in the
diagnosis, cure, mitigation, treatment, or prevention of
disease, or to affect the structure of function of the body
of man or other animals.

I n ac ti v e I n gred i en t: Any component other than an " active

ingredient" .

I n -P roc ess M ateri al : Any material fabricated, compounded,

blended, or derived by chemical reaction that is
produced for, and used in the preparation of the drug
product.

Stren gth :

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i. The concentration of the drug substance (for ex ample
weight/ weight, weight/ volume, or unit dose/ volume basis)
and/ or

ii. The potency, that is, the therapeutic activity of the drug
product as indicated by appropriate laboratory tests or by
adequately developed and controlled clinical data
(ex pressed, for ex ample, in terms of units by reference to a
standard).

Stab i l i ty : The degree of resistance to chemical and physical

changes. The efficacy of the preparation must remain
constant (or change only within the limits specified by
legal provisions) until the date of ex piration.

a) C h emical S tab ility: The components making up the

preparation should remain chemically unchanged, that is,
their change should be within the specified limits.

b) Ph ys ical s tab ility: The initial physical properties (shape,

taste, solubility, crystalline form, disintegration time,
dissolution, colloidal properties, etc.) of the pharmaceutical
preparation should remain unchanged, that is, their
changes should be within the specified limits.

c) Micro b io lo gical S tab ility: Sterility or resistance to the growth

of microorganisms should remain unchanged. D uring
storage, the efficacy of preservatives should change only
within the specified limits.

d) T h erap eu tic S tab ility: The therapeutic effect of the

pharmaceutical preparation should remain unchanged.
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e) T o x ico lo gical S tab ility: There must be no significant change
in the tox icity of the pharmaceutical preparation.

E x p i rati on D ate: The date placed on the immediate container label

of a drug product that designates the date through which
the product is ex pected to remain within specifications. If
the ex piration date includes only a month and a year, it
is ex pected that the product will meet specifications
through the last day of the month. K inetically it is the
time required for 10 % of the material to disappear.

E x p i rati on D ati n g P eri od : The interval of time that a drug product

is ex pected to remain within specifications as detonated
from stability studies on a limited number of batches of
the product. The ex piration dating period is used to
establish the ex piration date of individual batches.

A c c el erated T esti n g: (Stress Testing): Studies designed to

increase the rate of chemical or physical degradation of
a drug substance or drug product by using ex aggerated
storage conditions. The purpose is to determine kinetic
parameters, if possible, and/ or to predict the tentative
ex piration dating period.

Stab i l i ty I n d i c ati n g A ssay : The assay which is sensitive and

selective to determine quantitatively the active ingredient
in the presence of its decomposition products.

Sh el f -Stab i l i ty : The stability of the drug or drug product at ambient

room temperature (15 - 35° C )

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O v erage: The ex cess quantity of drug that must be added to the
preparation to maintain at least 10 0 % of the labeled
amount during the ex pected shelf-life of the drug.

T em p eratu re C on trol : All following temperatures in D egrees

C elsius.

C ol d P l ac e: The temperature does not ex ceed 8° C .

R ef ri gerator: The temperature is thermostatically controlled

between 2° and 8° C .

F reez er: The temperature is thermostatically controlled to no higher

than -10 ° C .

C ool P l ac e: The temperature is between 8° and 15° C .

W arm P l ac e: Any temperature between 30 ° and 40 ° C .

R oom T em p eratu re: The temperature is between 15° and 30 ° C .

E x c essi v e H eat: Any temperature above 40 ° C .

E x trem e T em p eratu re F l u c tu ati on s: The packaged drug product

should be cycled through temperature conditions that
simulate the changes that may be encountered once the
drug product is in distribution.

Storage T em p eratu res: The actual storage temperatures

(numerical) used during stability studies should be
specified.

E x trem es of T em p eratu re an d H u m i d i ty in P h arm ac y :

Temperature above 40 ° and RH above 70 % are

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considered to be the ex tremes of temperature and
humidity respectively.

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II. P R E M IS E S A N D F A C IL IT IE S

Premises and other areas to be utilized for storage purposes

should comply with the prescribed minimum standards. They
should be located, constructed, serviced and maintained so as to
protect the stored materials, from all potentially harmful influences
such as undue variations of temperature and humidity; dust and
odor; entry of animals vermin and insects.

Basic Requirements
Facilities must be provided for:

1. The safe and orderly receipt or dispatch of all materials,

products or components.

2. The safe sampling and cleaning of any incoming materials

to prevent contaminating the areas of other material.

3. Sufficient separation or segregation of pharmaceuticals,

veterinary, food products, chemicals, disinfectants and
cleaning materials to eliminate the risk of unacceptable
chemical or organoleptic cross contamination.

4. The safe storage of hazardous materials (pressurized

gases, flammable solvents and ex plosive materials).

5. The storage of temperature-sensitive materials as

appropriate in deep freezes, cold rooms or air conditioned
areas.

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6. The storage of cleaning equipment and materials

7. Appropriate personnel service facilities such as toilets, etc.

8. The safe charging of powered forklifts and trucks

9. Secure storage of any controlled drugs (e.g. drugs of

addictions, narcotics)

10 . The separation or segregation of reception and dispatch

facilities

11. Effective lighting permitting all operations to be carried out

accurately and safely.

12. The safe storage of materials requiring dry or humidity

controlled conditions.

13. Racking and shelving must conform to the requirements of

the G ood Manufacturing Practice (G MP).

14. Max imum safe working loads should be displayed.

15. To allow access for cleaning and to avoid harboring pests,

racking should be positioned at least 0 .5 m form the walls
of the warehouse and the bottom layer of pallets should be
supported at least 0 .3 m above the floor.

16. Forklift trucks should be provided with overhead protection

against falling objects, and if used frequently in the open,
weather protection and lighting.

17. O nly electric powered (or hand operated) trucks should be

used in enclosed spaces. D iesel powered Trucks should be
avoided to decrease contamination

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18. Adequate washing facilities should be provided, including
hot and cold water, soap or detergent, air driers or single
service towels, and clean toilet facilities easily accessible to
working areas.

1. M a in S to r a g e A r e a .
2. R e p a c k a g in g .
3. C o ld R o o m .
4. W a r e h o u s e D ir e c to r .
5. P r o c u r e m e n t O ffic e .
6. D ir e c to r o f S u p p ly (L o g is tic s ).
7. F la m m a b le S u b s ta n c e s .
8. S h ip p in g a n d R e c e iv in g .
9. R e c e p tio n A r e a .
10 . R e c o r d s a n d I n v e n to r y C o n tr o l.
11. S te n o g r a p h y C le r k s .
12. C o ffe e R o o m .
13. T o ile ts .
14. C o n tr o lle d S u b s ta n c e s .
15. M a in E n tr a n c e a n d L o a d in g D o c k s .

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S anitatio n
G MP Regulations require:

1. Any building used in the manufacture, processing, packing,

or holding of a drug product shall be maintained in a clean
and sanitary condition. Any such building shall be free of
infestation by rodents, birds, insects, and other vermin.
Trash and organic waste matter shall be held and disposed
in a timely and sanitary manner.

2. There shall be written procedures assigning responsibility

for sanitation and describing in sufficient detail the cleaning
schedules, methods, equipment, and materials to be used
in cleaning the buildings and facilities. Such written
procedures shall be followed.

3. There shall be written procedures for use of suitable

rodenticides, insecticides, fungicides, fumigating agents,
and cleaning and sanitizing agents. Such written
procedures shall be designed to prevent the contamination
of equipment, components, drug product containers,
closures, packaging, labeling materials, or drug products,
and shall be followed.

4. Sanitation procedures shall apply to work performed by

contractors or temporary employees as well as work
performed by full-rime employees during the ordinary
course of operations.

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H o usek eep ing
1. Premises and surrounding areas should be in a good
appearance, be well maintained and must be kept in an
orderly, clean and hygienic conditions free from
accumulated waste.

2. Buildings must be kept free of vermin, insects, birds and

other pests. C ontrol treatments should be carried out
according to written procedures by trained personnel using
proven effective and safe procedures which do not
contaminate the goods being held and should cover both
the interior and ex terior of the building.

3. Precautions must be taken to minimize the contamination

of the store by dirty, damaged or unsuitable containers.

4. W aste materials should be collected in suitable receptacles

for removal to collection points outside the building and
disposed of at regular and frequent intervals.

5. Floor surface should be sealed to minimize the generation

of dust and to facilitate cleaning.

F ire P rev entio n

Accumulation of flammable trash, such as cartons and
box es, must not occur. Smokes alarms are inex pensive to install
and provide warning in case fire does break out. For fire
ex tinguishing, sprinkler systems are most effective. Their principal
drawback is that if accidentally set off they may ruin some stock. A
cheaper alternative is to place ex tinguishers suitable for chemical

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fires at frequent intervals throughout storage areas, although they
offer no protection unless someone is around to use them.
Employing night watchmen serves the dual purpose of responding
to fire alarms and protecting against theft.

W areh o use S iz e
The average takeoff of all clinical facilities for a given delivery
interval will determine the volume to be delivered down through the
system. Assume that 20 0 clinical facilities consume a total of 1,0 0 0
m3 during a three months interval, and that they are served by few
district warehouses, each of these must be capable of holding an
average of 250 m3 a piece plus room for safety stock; the central
warehouse must hold at least 1,0 0 0 m3 plus safety stock.

W areh o use S ite S el ectio n

In selecting the site of the warehouse, the following points should
be considered:

1. Accessibility: Road is open the year round.

2. U tilities: Site served by water and electricity.

3. C ommunications: Reliable telephone service.

4. D rainage: N either site nor surrounding area subject to

flooding due to direct runoff or high water table.

5. Size: U nimpaired entry and ex it for large vehicles.

6. Security: Area not likely to invite intrusion or vandalism.

7. Prox imity: G ood access to transport links, railways,

highways.
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W areh o use D esig n
C ertain points should be considered in designing warehouse (Fig.
1.), the most important are the following:

1. Easy Movement: U se one-floor layouts. Interior partitioning

limits stock arrangement; if partitions are used, position
walls and doors to promote easy movement.

2. Air C irculation: U se of fans and forced ventilation prolongs

shelf-life and improves working conditions.

3. Bulk Storage on Pallets: This improves efficiency of stock

handling; pallets are cheaper to construct than shelves and
hold more stock for the amount of space they occupy; they
facilitate air circulation and allow easier access to stock for
cleaning.

4. Easy Maintenance: Floors should be graded and drains

placed to catch runoff; provide well-spaced faucets.

5. Systematic Arrangement of Stock: Frequently used

arrangements are by therapeutic/ pharmacological class,
clinical indications, level of service, and alphabetic
sequence. Array stock in the same order that products
appear on standard requisitions

6. C old C hain Maintained: V accines require special cold

storage arrangements. C old rooms, refrigerators, and
freezers should be protected from power cuts by backup
generators.

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7. Secure Storage Area for C ontrolled Substances: N arcotics
must be stored in areas with restricted access.

8. Protected Storage Area for Flammable Substances: Ether,

alcohol, and fuels are best stored in out-buildings.
O therwise the storage room should seal tightly, be well
ventilated and be insulated with fireproof material.

9. Fire Prevention Measures: D o not allow trash to

accumulate; provide smoke alarms, fire ex tinguishers and
a night watchman.

Fig. (2) T e m p e r a t u r e R e q u ir e m e n t s f o r v a c c in e s t o r a ge

L e v e l: C e n tr a l R e g io n a l L o c a l
V A C C IN E
S to r a g e T im e : 6-1 8 m o n t h s 3m o n th s 1 m o n th
M e a s le s
-1 5 ° C t o -2 5 ° C
O r a l P o lio
D P T *
T e ta n u s * + 4 ° C to + 8 ° C
B C G

* N e v e r F r e e z e D P T o r T e ta n u s

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III. P E R S O N N E L

1. Personnel who carry out supervision and/ or controlling

functions should possess the necessary integrity,
knowledge, ex perience and qualification.

2. Each store should employ sufficient staff of a quality and

ex perience appropriate with their individual responsibilities
and the operations carried out.

3. Staff must be given specific authority, facilities and training

to discharge their responsibilities effectively.

4. Staff should be medically ex amined before being employed

and at such subsequent times as may be required by
national authorities.

5. Before being employed an applicant' s background should

be investigated. Staff with convictions for theft or drug
abuse should not be employed.

6. Protective clothing must be worn by persons working in

warehousing areas. Safety-hats must be provided for
people working within racking areas. W here staff have to
work under ex tremes of temperature (e.g. cold room)
appropriate clothing should be provided.

7. D rinking, eating and smoking must not be permitted in any

part of the premises ex cept those designated for that
purpose and adequately separated from storage areas.
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8. Staff must maintain high standards of personal hygiene
and cleanliness. D irect contact between raw materials or
products and operators hands must be avoided whenever
possible.

9. The personnel should have the basic knowledge

concerning.

a. Types of materials and dosage forms to be

handled.

b. Materials that require specific storage conditions.

c. Types of storage conditions.

d. Types of stability (physical, chemical,

microbiological, tox icological and therapeutic).

e. Ex piration date.

f. Stress storage conditions.

g. Sampling.

h. Q uality control and quality assurance

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IV . S E C U R IT Y A N D S A F E T Y

1. The cost of security precautions should be related to the

social environment in which the facility is situated and the
value and nature of the goods used. W here large or
significant quantities of valuable materials are held or
where theft is prevalent, 24 hour security coverage should
be provided.

2. Security arrangements with respect of poisons and habit-

forming drugs should at least meet the standards laid down
in the relevant legislation.

3. Stock control procedures should be sufficiently tight to

ensure that significant loss by theft can be detected.

4. Arrival and departure of visitors to the warehouse must be

controlled. The right to inspect all persons including
employees, contractor staff and visitors entering or leaving
the site should be reserved and random searches should
be cashed out.

5. Safety and risk reduction measures, which must include

procedures for the handling, transportation, usage and
disposal of highly flammable liquids, tox ic and corrosive
materials, must comply with the appropriate guide to be
safe working.

6. Fire fighting precautions must include:

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a. The training of selected staff to form a fire fighting team
capable of using effectively the equipment available in
the site.

b. The routine maintenance and testing of fire fighting

alarms, detection systems, and sprinkler alarms.

7. Fire ex its, corridors, walk-ways, doorways and other points

requiring immediate access must be clearly defined and
kept free from obstruction and litter. Regular fire evacuation
drills must be carried out.

8. W alk-in refrigerators and similar facilities must be equipped

with safety devices for operators and must not be fitted with
self locking doors which cannot be opened from within. The
internal light must be manually operated from within the
refrigerator.

Saf ety c on trol s f or f l am m ab l e storage areas i n c l u d e:

a. Electrically conductive floor.

b. Raised door sill.

c. Ex plosion-proof light fix tures.

d. Blow-out wall.

e. Forced draft vapor take-off.

i. At floor level.

ii. N ear the ceiling.

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f. Rate-of-temperature-rise fire alarm.

g. Fire alarm monitored at fire station or continuously

manned control board.

h. Switches for lights and vapor take-off fans located

outside the room.

i. Supply of safety cans for dispensing fluids.

j. Alcohol storage located in this area meets Treasury

regulations.

k. H eavy safe for storage of nitro compounds and other

ex plosives.

O perations relating to the manufacture, processing, and packing of

penicillin shall be performed in facilities separate from those used
for other drug products for human use.

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V . S T O R A G E P R O C E DU R E S
A N D IN S T R U C T IO N S

G eneral P rincip l es
1. Factors to be taken in consideration for proper storage

a. Sanitation.

b. Temperature.

c. L ight.

d. Moisture.

e. V entilation.

f. Segregation.

2. Materials must be stored under conditions which minimize

deterioration, contamination, or damage. They must be
stored under conditions compatible with their
recommended storage requirements of temperature and/ or
humidity and where necessary, to comply with legal
requirements, under secure or segregated conditions.

3. Appropriate temperatures are:

a. For materials labeled " s to re in ref rigerato r" , they should

be stored at temperature between 2° and 8° C .

24
 GSP - E g y p t
b. For materials labeled " s to re in a co o l p lace" , they
should be stored at a temperature between 8° and 15°
C .

c. For materials labeled " s to re in f reez er" , they should be

stored at a temperature not higher than -10 ° C .

d. In the absence of more stringent storage requirements

pharmaceutical products and raw materials should be
stored at an average over any month of below 25° C
with the max imum usually below 30 ° C and above 4°
C . Materials should be protected from direct sunlight.

4. Temperature or humidity controlled environments must be

equipped with suitable indicators, recorders and/ or failure
warning devices which must be checked at appropriate
intervals and the results recorded. Recording
thermometers should be used. Temperature in uncontrolled
storage areas holding raw materials or products should
also be monitored.

5. Temperatures should be measured at different levels in the

warehouse and if necessary storage of sensitive materials
should be restricted to locations in the warehouse where
they will be protected from ex treme conditions.

6. There must be an appropriate formal stock control system

which record the receipt, location and issue of materials
and facilitate proper stock rotation and reconciliation. The
stock control procedure should ensure that materials with
the shortest life are used first unless there is a conscious

25
GSP - E g y p t
decision that for a special reason an alternative priority has
to be applied.

7. Materials and products should be inspected at specified

intervals to ensure that containers are properly closed,
labeled, and that there is no evidence of serious damage or
deterioration in the containers or their contents and that the
stock rotation system is functioning correctly.

Receip t o f I nco ming M aterial s

See figure 3
1. U pon receipt, each incoming delivery should be checked
against the relevant documentation and physically verified
by label description, type and quantity, against the relevant
purchase order information.

2. The consignment should be ex amined for uniformity and if

necessary should be subdivided according to supplier’ s lot
numbers especially if the delivery comprise more than one
batch.

3. All containers should be carefully inspected for

contamination and damage and if necessary they should
be cleaned or set aside for further investigation.

4. Records should be retained for each delivery. They should

include the description of the goods, quality, quantity,
supplier, supplier’ s batch number, the date of receipt.

5. Samples should be taken only by appropriately trained and

qualified personnel strictly in accordance with written
26
 GSP - E g y p t
sampling instructions. The samples should be
representative of the batch from which they were taken.

6. The recommended product related storage conditions, for

ex ample, type of container, temperature, humidity,
protection from light etc., should be maintained throughout
the period of storage.

7. Secure measures should be taken to ensure that rejected

materials cannot be used and they should be stored
separately form other materials.

8. W hen necessary, to minimize contamination of the storage

area, incoming materials must be cleaned, repacked or
over wrapped where large quantities of materials in poor
quality containers have to be handled. If it is neither
possible to have the material supplied in more suitable
containers nor practical to repack the material, it should be
held in segregated area.

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GSP - E g y p t

Fig. (3 ) I n s p e c t io n C h e c k l is t f o r D r u g R e c e ip t s

A L L S H I P M E N T S - C o m p a r e p h y s i ca l s t o ck w i t h s up p l i e r ' s i n v o i ce a n d
o rig in a l p ur ch a s e o r d e r / co n t r a ct . N o t e d i s cr e p a n ci e s o n t h e R e ce i v i n g R e p o rt
− N um b e r o f co n t a i n e r s d e l i v e r e d
− N um b e r o f p a ck a g e s i n e a ch co n t a i n e r
− V i s i b l e e v i d e n ce o f d a m a g e s ( d e s cr i b e )
− q ua n t i t y i n e a ch p a ck a g e
− C o r r e ct d r ug ( d o n ' t co n f us e g e n e r i c n a m e s a n d b r a n d n a m e ), d o s a g e fo rm
( t a b l e t , l i q ui d , e t c.), d o s e ( m i l l i g r a m s , % , co n ce n t r a t i o n , e t c.)
− T a k e a s a m p le fo r te s tin g
− P r e s e n ce o f un i q ue i d e n t i f i e r s i f r e q ui r e d ( M i n i s t r y o f H e a l t h s t a m p , e t c.)

T A B L E T S - F o r e a ch s h i p m e n t , t a b l e t s o f t h e s a m e d r ug a n d d o s e s h o ul d b e
co n s i s t e n t . T h e f o l l o w i n g ch a r a ct e r i s t i cs s h o ul d b e ch e ck e d
− Id e n t i ca l s i z e , s h a p e , co l o r ( s h a d e o f co l o r m a y v a r y f r o m b a t ch t o b a t ch )
− M a r k i n g s ( s co r i n g , l e t t e r i n g , e t c.) s h o ul d b e i d e n t i ca l o n a l l t a b l e t s
− N o e v i d e n ce o f s p o t s , p i t s , ch i p s , b r e a k s , un e v e n e d g e s , cr a ck s ,
e m b e d d e d o r a d h e r e n t f o r e i g n m a t t e r , s t i ck i n e s s .
− N o o d o r up o n o p e n i n g a s e a l e d b o t t l e ( e x ce p t f l a v o r e d t a b l e t s a n d th o s e
w i t h a ct i v e i n g r e d i e n t s n o r m a l l y h a v i n g a ch a r a ct e r i s t i c o d o r ) a n d n o
o d o r a f t e r b e i n g e x p o s e d t o r o o m a i r f o r 2 0 -3 0 m i n ut e s .

C A P S U L E S - C a p s ul e s s h o ul d b e i n s p e ct e d f o r t h e s a m e ch a r a ct e r i s t i cs a s
t a b l e t s . In a d d i t i o n , t h e f o l l o w i n g s h o ul d b e ch e ck e d :
− N o e v i d e n ce o f h o l e s i n t h e ca p s ul e
− N o e m p t y ca p s ul e s
− N o o p e n o r b r o k e n ca p s ul e s

P A R E N T E R A L S (In je
a m p o ul e s , d r y s o l i d s f o r
b e ch e ck e d f o r t h e f o l l o w
− C l a r i t y o f s o l ut i o n
w ith in p e rm itte d lim
− Dr y s o l i d s i n t e n d e d
fro m v is ib le fo re ig n
− E v i d e n ce o f l e a k a g e
c ta b le s ) - A ll p ro d
r e co n s t i t ut i o n , s us p e
in g :
( s o l ut i o n s s h o ul d b e
i t s ).
f o r us e i n i n j e ct a b l e
p a r t i cl e s
fro m th e im m e d ia te
uct s f o r i n j e ct i o n ( IV l i q ui d s ,
n s i o n s f o r i n j e ct i o n , e t c.) s h o ul d
fre e fro m un d i s s o l v e d p a r t i cl e s ,
s o l ut i o n s s h o ul d b e e n t i r e l y f r e e
co n t a i n e r ( b o t t l e , a m p o ul e , e t c.)

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 GSP - E g y p t

S to rag e o f A p p ro v ed P ro d ucts
1. All stored products should be accurately documented
particularly with respect to product name, batch number,
ex piry date and quantity.

2. C omprehensive records should be maintained of the

receipt and issue of all products.

3. Products should be protected from ex cessive climatic

conditions during storage and transit, such as heat, frost,
moisture and direct sunlight.

4. Products should not be distributed if they are approaching

the end of their life. There must be a written policy laying
down the remaining shelf-life after which products must not
be distributed other than under ex ceptional circumstances.

5. Picking stock should be stored to facilitate stock security,

rotation, order assembly and dispatch.

6. The picking and assembly areas should be organized to

minimize the distance traveled by operators. The general
environment should be of a high standard and well lit.

7. H andling of goods should be kept to a minimum on

grounds of high efficiency and safety. In large facilities the
provision of mechanized order assembly system should be
considered.

8. There should be a laid down procedure for the checking of

assembled orders.

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GSP - E g y p t
S to rag e at C l inical F acil ities
The basic characteristics of good storage space at clinical
facilities are the same as for warehouses. Storerooms require
ready access, good circulation, dryness, and security. In most
cases, the smaller quantities of drugs stored will permit use of
shelving. Products are arranged in convenient manner and in the
order they appear on requisitions. L arge labels placed on the
shelves with each product facilitate recognition.

The Storekeeper and assistant storekeeper alone have

access to the storeroom. A " D u tch D o o r" arrangement, in which the
top half of the door opens, while the bottom remains closed, keeps
out unauthorized persons and permits easy communication.

At lower level facilities such as rural health posts, clinical

personnel frequently perform all supply management activities. It is
seldom the case, however, that medical aux iliaries or community-
based workers receive specific training for this. The result is that
the quality of supply handling and storage conditions deteriorates
as one move to the periphery of the delivery system.

Training programs for clinical personnel who will handle

supplies should include specific courses of instruction in the
following subjects:

Setting up a storeroom and good storage practices

U se of stock control forms including requisitions, stock

records, and prescriptions

C old chain procedures, including the use and preventive

maintenance of refrigerators.
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 GSP - E g y p t
S p ecial S to rag e C o nd itio ns
Some categories of supplies require special storage
conditions. These include vaccines, narcotics, and combustibles.
V accines require both refrigerators and freezers.

N arcotics and other controlled substances should be kept

in secure locking rooms with only one entrance. The keys should
be kept in a secure place, preferably a safe. O nly the warehouse
director and one other person should have access to them.

C ombustibles such as alcohol, ether, and fuels must be

stored in special rooms. A small, separate out-building is preferable
since it virtually guarantees that fire will not spread throughout the
warehouse. If a special building is not available, the room used to
store these supplies must be fireproof and well-ventilated.

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GSP - E g y p t

V I. S T O C K A R R A N G E M E N T
R O T A T IO N A N D C O N T R O L

S to ck Ro tatio n and C o ntro l

1. C omprehensive records should be maintained showing all
receipts and issues of materials according to batch
number.

2. Periodic stock reconciliations should be performed

comparing the actual and recorded socks. In any event this
should be performed when each batch is totally used up.

3. All significant stock discrepancies should be subjected to

investigation as a check against inadvertent mix -ups and
wrong issues.

4. Issues should normally observe the principle of stock

rotation (first-in first-out) especially where ex piry dated
materials are concerned.

5. Partly used containers of materials should be securely re-

closed to prevent spoilage and/ or contamination during
subsequent storage. D amaged containers should not be
issued but should be brought to the attention of the
organization responsible for quality control.

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 GSP - E g y p t
A rrang ement o f S to ck
W ithin warehouses and storerooms, drugs are arranged according
to a specified organizational principle. Therapeutic/ pharmacological
class, clinical indication, alphabetic order, and level-of-use are
commonly used. W ithin the warehouse itself as well as in clinical
facilities, use of the therapeutic/ pharmacological classification
produces good results, perhaps because it provides a frame of
reference within which workers can easily recognize individual
products. L evel-of-use can be combined with this approach by
using preprinted Requisition/ Issue Tickets for each type of facility.
W ith this system, drugs are arranged in the warehouse by their
classes in the same order as they appear on the Requisition/ Issue
Ticket. W orkers move along the rows of pallets packing only the
type and quantity of drugs shown on the Ticket - a greater range of
products for hospitals, a lesser range for dispensaries. A final
check before sealing the box es assures that aux iliaries have not
requested unauthorized drugs (e.g., morphine for backaches).

C o ntro l o f O b so l escent and O utd ated S to ck

All stocks should be checked regularly for obsolescent and
degraded materials. Materials with an ex pired shelf life should be
destroyed unless an ex tension of shelf life is granted following the
satisfactory results or re-analysis. All due precautions should be
observed to preclude issue of outdated materials.

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GSP - E g y p t

V II. DIS P A T C H A N D IS S U IN G

1. The allocation and shipping of products should be made

only after the receipt of a written sale order.

2. Results for dispatch procedures should be established

depending on the nature of the product and after taking into
account any special precautions to be observed. The
shipping container should offer adequate protection from all
ex ternal influences, and should be indelibly and clearly
labeled.

3. D ispatch documents should be retained indicating:

• D ate of dispatch.

• C ustomer name and address.

• Product name and quantity sent.

All documentary records should be readily accessible and be kept

in a secure place.

In Medical Stores:

1. W hen requisition/ issue tickets (R/ I) arrive, shipping clerks

review them to see that the types and quantities of supplies
correspond to the needs of the warehouse or clinical facility
requesting them. The clerks initial approval and send the
R/ I to the Inventory C ontrol U nit. There, stock clerks review
the availability of the supplies requested. They note any

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 GSP - E g y p t
low inventory levels and send the R/ I to the D irector. The
D irector reviews the document, taking into account the
stock clerks’ notations. H e may delete items, modify
quantities, or approve the R/ I as it is. H e then returns the
document to the Inventory C ontrol U nit. There, the clerks
post the Stock Record C ards and send all copies of the R/ I
to the Pharmaceutical Store Room. Eventually, when
Shipping and Receiving provides a signed copy of the R/ I
verifying that the shipment has been made the stock clerks
change the pencil entries to ink.

2. The C hief Storekeeper supervises preparation of

shipments. As a clinical pharmacist, he is the only person
authorized to make substitutions. W ithin the store room,
supplies are arranged in the order that they appear on the
Requisition/ Issue. Ticket. The store men loose-pack
supplies in cartons. W hen issuing drugs, an important
principle is to issue those drugs with the nearest ex piration
date first. The Assistant Storekeeper is responsible for this
and for posting the Bin C ard.

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GSP - E g y p t

VIII. STABILITY FOLLOW-U P TH R OU G H C U R R E N T

C H E C K -U P AN D IN SP E C TION OF P H AR M AC E U TIC AL
P R OD U C TS

The stability of a pharmaceutical product can be defined as

the ability of its formulation, in a specific container-closure system,
to remain within the defined physical, chemical, microbiological,
therapeutic, and tox icological specifications till the end of the stated
dating, under defined storage conditions. Protection of a
pharmaceutical product may be viewed from two perspectives:

1. It is necessary to provide protection for the dosage form

from the environment, by controlling product’ s storage and
distribution conditions.

2. Products should be well packaged to protect the end user

from the product itself. In this sense security packaging or
temperature resistant packaging ex hibits a dual protection
role. The protection function of packaging provided the
major vehicle for optimization of the elements of storage
and security. The cG MP include two acts controlling drug
stability and G ood Storage Practice (G SP).

36
 GSP - E g y p t

A ct 5 . 5 3 :

D rug storage should be regularly checked for

cleanliness and good order, and for
misplaced, deteriorated, or out-dated stock.

A ct 5 . 5 4 :

D rug products should be stored under

conditions which minimize deterioration,
contamination, spillage, or breakage.

Accordingly, current inspection at appropriate time intervals should

be done to verify:

1. Proper selection of storage conditions according to that

stated on products label.

The following world-wide climatic zones are assigned.

Zone 1: Temperate climate

Zone II: Mediterranean-like and subtropical climate

Zone III: H ot, dry climate, dry regions

Zone IV : H ot, humid climate, tropics.

In Egypt the climate, varies with season and place, roughly

corresponding to climates of zones II, and IV round the
year.

37
GSP - E g y p t
Both temperature and relative humidity (RH ) determine the
ex act climate for drug storage.

2. C urrent recording and occasionally validation of monitoring

equipment (thermometers, hygrometers, etc.) to insure
proper climate adjustment.

3. Pharmacist should be aware that deterioration of drug

products may happen even before their ex piration. This
may occur perhaps due to improper storage or the fact that
the product may require critical storage conditions not
stated on the label e.g.:

• Sorbitol discolors rapidly when stored in metal

containers.

• Sodium metabisulfite gets ox idized rapidly by

frequent container opening

H ence, inspection should include frequent product ex amination to

detect signs of product deterioration which differ according to the
dosage form, where deterioration may be physically detected as
follows:

I- P a r ent er a l S ol u t i ons a nd O r a l S ol u t i ons :

a. Slight gradual discoloration.

b. Swirly precipitation.

c. W hiskering: pinhole at ampoule tip that leaks solution which

precipitates or crystallizes solid matter.

d. C louding

38
 GSP - E g y p t
e. Fading of color

II- D i s p er s e S y s t em s :

a. C ake sedimentation (suspension).

b. C reaming and cracking (emulsions)

c. D iscoloration.

III. S em i -S ol i d s (O intments, creams, gels and suppositories)

a. C hange in consistency and feel to touch

b. Syneresis.

c. Phase-separation.

d. D iscoloration.

e. Surface crystal growth.

f. H ardness.

IV S ol i d D os a g e F or m s :

a. Surface chipping or pitting (plain tablets).

b. D eformation (C apsules).

c. Increased hardness.

d. D iscoloration.

e. C olor fading (colored tablets).

f. C hipping of coat.

39
GSP - E g y p t
4. In this respect the trained pharmacist, should be aware
(during inspection) that drugs mostly susceptible to
hydrolytic, ox idative, or photolytic decomposition should be
carefully ex amined for deterioration. D rugs susceptible to
hydrolysis are those containing, -C O O -C O N H -, lactone or
lactame group. Most vitamins, hormones, enzymes are
highly sensitive to ox idation and photodecomposition.

5. The integrity of packing and packaging of dosage form is

one of the important tacks of inspection pharmacist as
these protect the drug in a tailored fashion.

6. After each inspection, products showing any signs of

instability should be subjected to sample analysis to insure
product activity.

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 GSP - E g y p t

IX . M A T E R IA L S A N D DR U G S
R E Q U IR IN G S P E C IA L S T O R A G E
C O N DIT IO N S

1. M e d i c a l G a s e s
G as cylinders should be stored under cover, and not
subjected to ex tremes of temperature. Areas where they are stored
should be clean, dry, well ventilated and free of combustible
materials. They should be stored vertically and secured to prevent
falling. Storage arrangements should permit segregation of different
gases and of full/ empty cylinders and permit rotation of the stock.
Flammable gases should be segregated from ox ygen and other
ox idizing gases. Storage arrangement for gas-mix ture should be
such as to avoid separation of the mix ture into its component
gases.

2. A e r o s o l s
Aerosols should be stored in a clean separate area away from heat
and sunlight. Because the container contents are under pressure,
filled containers must be checked for weight loss over the
ex piration dating period. For contents under pressure, the label
should carry out do not ex pose to heat or store at a temperature
above 49° C . K eep out of children reach.

3. C r e a m s

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 GSP - E g y p t
C reams can be destroyed under ex treme temperature
fluctuations; hence they should be stored at temperature above 10 °
C and not ex ceeding 30 ° C . If the creams are opened and diluted,
they should not be kept more than 14 days to avoid microbial
contamination.

4 .O p h th a lm ic S o lu tio n s a n d D r o p s
They should be stored according to the conditions specified
on the label. After opening they should not be used for more than
one month at home and not more than 15 days in hospitals.

5. C a p s u l e s
Ex tremes of humidity and temperature should be avoided.
H igh humidity (> 60 % RH at 21° C to 24° C ) produce more lasting
effects on the capsule shell, since as moisture is absorbed, the
capsules become softer, tackier and bloated. If temperature is
increased the capsule shells may melt and fuse together. H igh
temp > 40 ° in a dry place may cause cracking of the capsule shell.
Therefore, capsules should be stored in an air-conditioned area in
which the humidity does not ex ceed 45% RH at 21° C to 24° C .

Empty hard gelatin capsules, generally range in moisture

content between 12 to 15% . Below 10 % moisture content, they
become brittle and may shrink to the point of not fitting in the filling
equipment. Above 16% , size problems in the filling equipment, plus
a loss of mechanical strength, may be encountered. Ex posure to
either heat or moisture ex tremes can distort empty capsules to the
ex tent that they can not be handled by automatic filling machines.

6. S u p p o s i t o r i e s
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 GSP - E g y p t
Suppositories should be protected from heat, preferably
stored in the refrigerator. Polyethylene glycol suppositories and
suppositories enclosed in a solid shell are less prone to distortion at
temperature slightly above body temperature. G lycerinated gelatin
suppositories should be protected from heat, moisture, and dry air
by packaging in well sealed containers and stored in a cold place.

7 .E m u ls io n s a n d S u s p e n s io n s
Emulsions and suspensions should be stored at a
temperature between 15° C and 30 ° C . H igh and low temperature
may destroy the system and cause separation.

8. V a c c i n e s
D PT and Tetanus should not be stored in a freezer .They
should be stored at cold place (3-8° C ). Also BC G should be stored
in a cold place (3-8° C ). Measles and oral polio should be stored in
a freezer (-25° C to -15° C ).

9. R a d i o p h a r m a c e u t i c a l s
Storage of radiopharmaceuticals must take into
consideration the chemical state of the radioactive drug, the
quantity and type of radiation involved, and any special storage and
stability requirements. For ex ample, gaseous or volatile
radiopharmaceutical should be kept in specially vented areas,
whereas certain other radioactive drugs require refrigeration.
Storage conditions are normally specified in product package
inserts. In addition, appropriate shielding must be used for storage
areas to minimize personnel ex posure.

10 . D r u g s R e q u i r i n g S p e c i a l S t o r a g e C o n d i t i o n
43
GSP - E g y p t
a. Aminophyline Injection: Protected from light, discolored
product not to be used.

b. Aspirin Tablets: In moisture proof containers, avoid moist

conditions.

c. Epinephrine Solution: Protected from light, ophthalmic

solutions should be in small volumes, discolored products
not used.

d. Idox uridine Solution: Protected from light, in completely

filled containers.

e. Ergometrine and Ergotamine Solutions: Filled containers

with minimum headspace, protected from light.

f. G lyceryl Trinitrate Tablets: In water proof non-plastic

containers.

g. H eparin Injections: At temp not ex ceeding 25° C , in

refrigerators (2-8° C ), freezing is avoided.

h. Insulin Injections: In refrigerators (2-8° C ), freezing should

be avoided.

i. C arbamazipine Tablets: In cool dry place in tightly closed

containers. Tablets readily lose as much one third of their
activity when stored in humid environment and the tablet
become harder and dissolution is impaired.

j. N ystatin Preparations: In dark cool place, in tightly closed

containers.

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 GSP - E g y p t
k. Phenothiazine Preparations: Protected from light in tightly
closed containers.

l. Riboflavin Tablets: Protected from light in tightly closed

containers.

m. Sulfacetamide Solution: In dark tight containers with

minimum headspace.

n. O x ytocin Injections: In amber colored containers with

minimum headspace in refrigerator (2-8° C ).

o. N oradrenaline Injections: In dark filled containers, if color

change to brown the preparation is not to be used.

p. V egetable and Animal D rugs: Protected from insect

infestations or microbiological contaminations by means
of suitable agents or processes that leave no harmful
residues. Mycotox in detection such as aflatox ins B1 and
B2 should be performed on crude drugs before use,
because of the carcinogenicity of these mycotox ins.

q. Mannitol Injections: Should be stored at a temperature

not less than 20 ° C . If crystallization occur, heat to
dissolve before use.

45