Good Storage

GOOD STORAGE PRACTICES IN
PHARMACEUTICAL INDUSTRY
 PRESENTED BY:
Mr. Babar Shah
Production Manager
SHAIGAN
PHARMACEUTICALS
INTRODUCTION
 The Good Storage Practices is the

management of right goods in their right
quantities, in right placement in right
condition at right cost according to FIFO
system.
 The purpose of right storage is to
maintain the identity, purity and integrity
of goods through out its shelf life.
Design Qualification Requirement for a
pharmaceutical Warehouse
 The building design & typical finishing of

a Pharmaceutical Warehouse should be
as follows.
Walls: Painted with non – shredding
materials.
Floor: Hardened (concrete etc.)
Ceiling: Should be proper without
seepage.
Table of Content
1. Introduction.
2. Design qualification of
pharmaceutical warehouse.
3. General requirements of
storage.
4. Storage of materials.
5. Segregated Areas.
6. Special Material Storage.
7. Storage of Finished Goods.
Good Storage Practices covers the
storage of all the following materials.
i. Raw Material (Active & Inactive).

ii. Packing Material.
iii. Special Material
iv. In process Material.
v. Finished Goods.
vi. Chemicals.
The concept of Quarantine Released. Hold
& Rejected Material Areas also fall under
the scenario of Good Storage Practices.
Environmental Condition: The
ambient condition of warehouse should be
under control and proper monitoring of
temperature and humidity should be carried
out.
Separate areas (Low humidity room for
hygroscopic materials) are required.
Warehouse should be designed in a manner
that no material can be mixed or cross
contaminated for this purpose segregated area
should be required for different nature of
materials.
Separate room is also required for Sampling &
Dispensing of materials.
 During packaging material products should be
stored separately from each other and they
should be properly identified.
 Written procedure should be made regarding
receipt, identification, storage, handling
sampling and dispensing of drug components.
 All material should have their specific codes &
Lot # for proper identification.
 Labels and labeling material for each different
drug product, strength, dosage form or
quantity of component should be stored
separately with suitable identification.
 e.gBromolain,Esomeprazole are
required to be stored and distributed
at the temperature between 2-8 0C.
 The proper storage and distribution
of the product minimize any risk to
the quality up to the date of
expiration.
GENERAL REQUIREMENTS FOR STORAGE
 Storage of material on pellets ensure
easy cleaning.
 On a pallet material should not be
stored over 5 feet high.
 Identification of the material at each
particular stage is of vital importance.
Label the material with colored
stickers usually serves this purpose.
 Rejected materials components, drug
products, closures & labels should be
held separately before proper
disposable.
 Storage of in process materials should
involve proper identification of
material.
Storage of materials
Following are classification of storage conditions.
1. Normal storage conditions: Normal storage
conditions are dry, well ventilated primecies at
temperature of 15-25 0C or depending on climate
conditions up to 0C . Extraneous odours, other
indications of contamination and intense light
must be excluded.
2. Defined Storage Conditions: Drug products that
must be stored under defined conditions require
appropriate storage conditions unless otherwise
specified.
ON THE LABEL MEANS
Protect from moisture Not more than 60 %
RH in normal
storage conditions,
even to be provided
in a moisture
resistant container.
Protect From Light To be provided in a
light resistant
container.
SEGREGATED AREAS:
There are following different segregated

areas in a pharmaceutical warehouse
depending upon the nature and fate of
the materials.
 Quarantine area.
 Released Material area.
 Rejected Material area.
 After receiving and before acceptance, the
material should be kept in Quarantine area,
and should be held under Quarantine until it
has been sampled examined of tested as
appropriate and released for use.
 Quarantine of Finished Goods: Not only the
goods received from suppliers are
quarantined but also the finished goods
before these are marketed have to under go
testing procedures to make sure that these
meet the pharmacopeias standards.
 Proper identification indicating Batch No. Mfg
date, Exp. Date, and the stage of the
materials.
 Should be in in process quarantine area until
release by Q.A for next stage.
QUARANTINE AREA
In cGMP guidelines clause 211.142 (holding &
distribution) The FDA clearly guides the
pharmaceutical manufactures to develop
written procedure for quarantine of drug
products before release from QA /QC.
Material Quarantine: As we all know that
quality can never be incorporated at one
stage it has to be built into the product. The
process for making a quality product starts
from the point where the product
components i.e. Raw & Packaging materials
are received from the supplier.
INPROCESS MATERIAL
QUARANTINE:
 In process materials are the intermediate
products which are partially processed that
must undergo further manufacturing steps
before it become bulk product. Special
precautions have to be taken for the storage
and handling of the in process materials. To
avoid any chance of mixing or cross
contamination following measure have to
the taken.
 Store in in process Quarantine area.
 Provide the ambient conditions according to
the requirements of the product.
RELEASED MATERIAL AREA
The material comply with Pharmacopeias or any
standard specification declared by Quality Assurance
after assessing the testing results of Quality Control
is considered as released material, the said material
is then shifted from quarantine to released area. The
material kept in released area should properly be
labeled carrying following information.
 Product or material name.
 Mfg. & Expiry dates.
 Supplier Lot No.
 GRN No. internal Lot No.
 Total quantity number of container packs and pack
size.
 QA/QC ref No.
 Next retest due date and signature of an authorized
person.
After decision the rejected materials and product
should be marked clearly as such and store
separately, and these will either be returned to
supplier or where appropriate reprocess of
destroyed. And then action should be approved by an
authorized personnel and recorded.
Storage area should be designed or adopted to
ensure Good Storage Practices e.g. Capacity to allow
orderly placement, lighting measures, restricted entry
cleaning and free from accumulation of wastes etc.
Whereas special storage condition are required on
the label (e.g. Temperature Relative Humidity) these
should be provided monitored and recorded.
REJECTED MATERIALS
AREA:
The material which do not comply with the
Pharmacopeias specification are called as rejected
materials. Proper control of non conforming product
is very critical to avoid unauthorized use of these
materials, often there are conditions when decision is
awaited on the fate of non conforming materials and
during this time these have to be kept in quarantine
in isolation from others.
Rejected in process materials should be identified and
controlled under a quarantine system designed to
prevent their use in manufacturing and processing
for which these are unsuitable.
SPECIAL MATERIAL STORAGE:
 Highly active materials like narcotics,

Radioactive and other dangerous drugs and
substances presenting special risk of
abuse, fire or explosions should be stored in
safe and secure areas.
Precautions must be taken to prevent
unauthorized persons to enter storage area
designed for such materials.
Quarantine status of such materials should
be ensured by storage in separate areas
these areas should clearly be marked and
access restricted to only authorized
personnel.
STORAGE OF FINISHED
GOODS:
 Finished goods storage area of
warehouse is most critical. Finished
Goods are the packed products received
from the packing section of the
production department which are to be
dispatched to market.

Good Storage

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GOOD STORAGE PRACTICES IN

 The Good Storage Practices is the

 The building design & typical finishing of

i. Raw Material (Active & Inactive).

There are following different segregated

 Highly active materials like narcotics,

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