ASEAN COSMETIC GMP
Training Manual Module 10
STORAGE
Project co-financed by Project co-financed
European Union
Prepared by by Asean
Harris Lukmanto – Indonesia
Wan Othman Wan Ismail - Malaysia
Date: 15 Nov 2005 EC-ASEAN Economic Cooperation Programme Page 1 of 16
Rev. : 00 on Standards, Quality and Conformity Assessment
Cosmetic Sub-Programme
1. INTRODUCTION
1.1. This module looks briefly at the role of warehouse/storage within the
manufacturing and distributors operations. The current code of practice is
introduced to maintain the quality during storage & distribution of products.
1.2. This guideline is used as a standard to justify status and as a basis for the
inspection of facilities of wholesalers and importers. All manufacturer of
cosmetic products are required to adopt proper store management
procedures appropriate for the storage of the materials/products destined for
the consumer.
1.3. Good storage practice or GSP is defined as:
" the special measures that need to be considered in the storage,
transportation and distribution of products, such that the product
will be of the nature and quality intended when it reaches the
consumer "
2. OBJECTIVE
2.1. Gain basic understanding of the GSP applicable to the warehouse practice
2. 2. To understand the key requirements of GSP for storage of materials and
products.
3. SCOPE
This modules covers the storage and distribution of all the materials and finished
cosmetic products
4. GOODS STORAGE PRACTICES
4.1. General requirements
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ASEAN COSMETIC GMP
Training Manual Module 10
STORAGE
Project co-financed by Project co-financed
European Union
Prepared by by Asean
Harris Lukmanto – Indonesia
Wan Othman Wan Ismail - Malaysia
Date: 15 Nov 2005 EC-ASEAN Economic Cooperation Programme Page 2 of 16
Rev. : 00 on Standards, Quality and Conformity Assessment
Cosmetic Sub-Programme
4.1.1. Objective GSP :
To ensure that when the end product reaches the consumer, it is of good
quality and safe to use.
The objective of this guide is to supplement the above-mentioned
documents by describing the special measures considered appropriate
for the storage and transportation of cosmetics.
However, they may be adapted to meet individual needs where
necessary, provided that the desired standards of quality are still
achieved.
4.1.2. Glossary of some term used
The terms below shall have the meanings described when they are used in
the text.
a. Consignment (delivery)
The quantity of starting material, or of a cosmetic product, made by one
manufacturer and supplied at one time in response to a particular request
or order. A consignment may comprise one or more packages or
containers and may include material belonging to more than one batch
b. Contamination
The undesired introduction of impurities of a chemical or microbiological
nature, or of foreign matter into or onto a raw material, intermediate
or cosmetics product during manufacturing, sampling, packaging or
repackaging, storage or transport.
c. Cosmetics product
The dosage form in the final material packaging intended for marketing.
d. Cosmetics product (bulk)
The dosage form (not packaged in the final packaging) intended for
marketing.
e. Cross-contamination
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ASEAN COSMETIC GMP
Training Manual Module 10
STORAGE
Project co-financed by Project co-financed
European Union
Prepared by by Asean
Harris Lukmanto – Indonesia
Wan Othman Wan Ismail - Malaysia
Date: 15 Nov 2005 EC-ASEAN Economic Cooperation Programme Page 3 of 16
Rev. : 00 on Standards, Quality and Conformity Assessment
Cosmetic Sub-Programme
Contamination of a material or product with another material or product.
f. Finished product
A cosmetic product that has undergone all stages of production, including
packaging in its final container and labelling.
g. First In/ First Out (FIFO) principle concept
A distribution procedure that ensures the oldest approved stock of
cosmetics, raw material intermediate or ancillary item is distributed and
/ or utilized before a new approved and identical stock item is distributed
and/ or utilized.
h. Labelling
The term “labelling” designates all labels and other written, printed,
or graphic matter upon, or in, any package or wrapper in which it is
enclosed, except any outer shipping container.
A shipping container, unless such container is also essentially the
immediate container or the outside of the consumer package, is
exempt from labelling requirements.
i. Manufacture
All operations of receipt of materials, production, packaging,
repackaging, labelling, relabelling, quality control, release, storage and
distribution of the cosmetics products.
j. Manufacturer
A company that carries out at least one step of manufacture.
k. Material
A general term used to denote raw materials, starting materials,
intermediate, excipients and packaging materials.
l. Packaging material
Any material employed in the packaging of a cosmetic product, excluding
any other packaging used for transportation or shipment. Packaging
materials are referred to as primary or secondary according to whether
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ASEAN COSMETIC GMP
Training Manual Module 10
STORAGE
Project co-financed by Project co-financed
European Union
Prepared by by Asean
Harris Lukmanto – Indonesia
Wan Othman Wan Ismail - Malaysia
Date: 15 Nov 2005 EC-ASEAN Economic Cooperation Programme Page 4 of 16
Rev. : 00 on Standards, Quality and Conformity Assessment
Cosmetic Sub-Programme
or not they are intended to be in direct contact with the product.
m. Printed packaging material
Packaging material which is imprinted with text or numbers or a
combination of both.
n. Product
A cosmetic as per the definition in the ASEAN Harmonized Cosmetic
Regulatory Scheme
o. Raw material
A general term used to denote starting materials, reagents,
intermediates, process aids and solvents intended for used in the
production of cosmetics.
p. Returned product
Finished product sent back to the manufacturer.
q. Specification
A list of tests, references to analytical procedures, and appropriate
acceptance criteria which are numerical.
r. Storage
A term used to describe the safe keeping of cosmetics product such as
starting materials and finished products received in the factory, semi-
finished products in process and finished products awaiting dispatch and
products awaiting distribution to retailers and products (rejected, recalled
and damaged) awaiting disposal. Storage requires the introduction of
suitable documentary systems including maintenance of comprehensive
records of receipts and issue.
4.2. Premises / warehouse
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ASEAN COSMETIC GMP
Training Manual Module 10
STORAGE
Project co-financed by Project co-financed
European Union
Prepared by by Asean
Harris Lukmanto – Indonesia
Wan Othman Wan Ismail - Malaysia
Date: 15 Nov 2005 EC-ASEAN Economic Cooperation Programme Page 5 of 16
Rev. : 00 on Standards, Quality and Conformity Assessment
Cosmetic Sub-Programme
4.2.1. The explanation on premises should refer to the Premises section of the
training module. However particular consideration should be made on the
following subjects.
4.2.2. There should be defined and reserved areas or other control systems for the
following activities:
a. Receipt, storage, and withholding from use of raw materials, starting
materials or intermediates, excipients, packaging materials, and cosmetics
products (including bulk) pending release;
b. Sampling of incoming materials;
c. Holding rejected materials before disposal;
d. Storage of released materials;
e. Packaging and labelling operations;
f. Quarantine storage before release of materials;
4.2.3 There should be defined and reserved areas or other control systems for
storage of the registered products should be carried out in buildings or parts
of buildings that have been built for, or adapted to this purpose.
4.2.4 Buildings should provide protection for the goods from contamination, cross
contamination and deterioration, including protection from excessive heat or
undue exposure to direct sunlight.
4.2.5 The grounds should be established and maintained so as to minimise ingress
into the buildings of dust, soil or other contaminants and should be
maintained in an orderly manner.
4.2.6 The foundation should be as secure as possible against ground water and
high enough to remain dry even under extreme rainfall and flood conditions.
4.2.7 Buildings should have sufficient security to prevent misappropriation of the
goods.
4.2.8 Premises must have a permanent address and be located at a site approved
by local authorities and/or other related Acts or Regulations which must be
adhered to by the licence.
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ASEAN COSMETIC GMP
Training Manual Module 10
STORAGE
Project co-financed by Project co-financed
European Union
Prepared by by Asean
Harris Lukmanto – Indonesia
Wan Othman Wan Ismail - Malaysia
Date: 15 Nov 2005 EC-ASEAN Economic Cooperation Programme Page 6 of 16
Rev. : 00 on Standards, Quality and Conformity Assessment
Cosmetic Sub-Programme
4.2.9 Premises should be constructed, serviced and maintained regularly to protect
stored materials, from all potentially harmful influences such as undue
variations of temperature and humidity.
4.2.10 The storage areas should be sufficiently large, and if necessary, have
physically separated zones for the orderly segregation of products.
4.2.11 Appropriate and suitable storage conditions should be provided for
hazardous, sensitive and dangerous materials such as combustible liquids and
solids, pressurised gases, highly toxic substances and radioactive products.
4.2.12 Storage areas should have sufficient lighting to allow store or warehouse
operations to be carried out accurately and safely.
4.2.13 Cosmetic products requiring special storage conditions should be placed in
separate areas constructed and equipped to provide the desired conditions.
4.2.14 Where controlled environmental storage conditions are required, these
conditions should be continuously monitored and the appropriate action
should be taken where necessary. Cosmetic products requiring dry or
humidity controlled storage should be stored in special areas where the
relative humidity and temperature are maintained within prescribed limits by
the use of proper equipment.
4.2.15 Bagged and boxed materials should be stored off the floor and suitably
spaced to permit cleaning and inspection.
4.2.16 Materials should be stored in conditions which assure their quality, and where
appropriate, rotated so that the oldest stock is used first. The First In/First
Out (FIFO) principle should be followed.
4.2.17 Certain materials in suitable containers may be stored outdoors, provided
identifying labels remain legible and containers are appropriately cleaned
“before opening and use”.
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ASEAN COSMETIC GMP
Training Manual Module 10
STORAGE
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Date: 15 Nov 2005 EC-ASEAN Economic Cooperation Programme Page 7 of 16
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Cosmetic Sub-Programme
4.2.18 Rejected materials should be identified and controlled under a quarantine
system designed to prevent their use in manufacturing or processing
operations.
4.2.19 Materials should be re-evaluated as necessary to determine their compliance
with specifications and suitability for use, e.g. after prolonged storage or
exposure to temperature (heat) or humidity.
4.2.20 Precautions must be taken to prevent unauthorized persons entering
controlled storage areas. Storage and quality control (QC) areas should not
be used as a right of way by personnel who do not work in them.
4.2.21 Printed packaging materials are considered critical to the conformity of the
medicinal product and special attention should be paid to the safe and secure
storage of these materials.
4.2.22 Receiving and dispatch bays should protect materials and products from the
weather. Reception areas should be designed and equipped to allow
containers of incoming materials to be cleaned where necessary before
storage.
4.2.23 If other labelling statements are made appropriate storage conditions should
be provided and justified by supportive stability data. In certain cases a
storage time at a higher temperature can be accepted provided it is justified
and supported by suitable data generated under the proposed conditions.
Special storage directions for, e.g. shipping and transportation need to be
requested from the manufacturer.
4.2.24 Storage condition must not compromise the safety and quality of the product.
In general, storage directions should be labelled following the ranking as
given below:
Related to the container, e.g. store in a well-closed container.
Related to light and/or temperature, e.g. store protected from light.
Related to temperature, e.g. store at a temperature not exceeding X0C.
4.2.25 Where temperature is not stated (in terms of range) on the labels,the storage
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ASEAN COSMETIC GMP
Training Manual Module 10
STORAGE
Project co-financed by Project co-financed
European Union
Prepared by by Asean
Harris Lukmanto – Indonesia
Wan Othman Wan Ismail - Malaysia
Date: 15 Nov 2005 EC-ASEAN Economic Cooperation Programme Page 8 of 16
Rev. : 00 on Standards, Quality and Conformity Assessment
Cosmetic Sub-Programme
condition of the product must not compromise the safety and quality of the
product.
4.2.26 Records of temperature of the storage areas must be measured at suitable
predetermined intervals to show the maximum and minimum temperatures
for the day. Where necessary, humidity measurements should be performed.
4.2.27 Materials requiring dry or humidity-controlled storage should be stored in
an particular room where the relative humidity and temperature is maintained
within prescribed limits.
4.3. Personnel
The general explanation on personnel should basically refer to the personnel section
of the training module. However some particular function and requirements in the
storage organization, is given explanation and emphasize as below.
4.3.1 Key personnel who perform supervisory and/or controlling store or
warehousing functions should possess the necessary integrity, knowledge
and experience. They should also where necessary be in possession of the
required professional and technical qualifications suitable for the tasks
assigned to them.
4.3.2 The manufacturer/importer should have an adequate number of personnel
with the necessary qualifications and practical experience. The responsibilities
placed on anyone individual should not be so extensive as to present any
risk to quality.
4.3.3 The manufacturer/importer must have an organization chart. People in
responsible positions should have specific duties recorded in written job
descriptions and adequate authority to carry out their responsibilities.
4.3.4 Personnel employed in storage areas should wear suitable protective or
working garments over or in place of street clothing.
4.3.5 Besides the basic training on the theory and practice of GSP, newly recruited
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ASEAN COSMETIC GMP
Training Manual Module 10
STORAGE
Project co-financed by Project co-financed
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Prepared by by Asean
Harris Lukmanto – Indonesia
Wan Othman Wan Ismail - Malaysia
Date: 15 Nov 2005 EC-ASEAN Economic Cooperation Programme Page 9 of 16
Rev. : 00 on Standards, Quality and Conformity Assessment
Cosmetic Sub-Programme
personnel should receive training appropriate to the duties assigned to them.
continuing training should also be given, and its practical effectiveness should
be periodically assessed. Training programmes should be available, approved
by either the Head Warehouse or the Head of QC, as appropriate. Training
records should be kept.
4.4. Stock handling and stock control
4.4.1 Receiving products
Refer explanation also to the Quality Control and Production section of the
training module especially on sampling and inspection means.
a. Upon 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. The
consignment should be examined for uniformity and if necessary, should
be subdivided according to the supplier's lot numbers if the delivery
comprise of more than one batch.
b. All containers should be carefully inspected for contamination and damage
and if necessary they should be cleaned or set aside for further
investigation. Records should be retained for each delivery.
c. They should include the description of the goods, quality, quantity,
supplier, supplier's batch number, the date of receipt and assigned batch
number. Where current regulations state a period for retention of records,
this should be followed.
d. The recommended product related storage conditions such as type of
container, temperature, humidity, protection from light, etc., should be
maintained throughout the period of storage.
e. Secure measures should be taken to ensure that rejected products cannot
be used and they should be stored separately from other products while
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ASEAN COSMETIC GMP
Training Manual Module 10
STORAGE
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Cosmetic Sub-Programme
awaiting destruction or return to the supplier. The method adopted should
possess adequate safeguards to prevent uncontrolled or unsatisfactory
products from being used or released.
f. Samples should be taken only by appropriately trained and qualified
personnel strictly in accordance with written sampling instructions. The
samples should be representative of the batch from which they were
taken.
g. Following sampling goods normally undergo quarantine. Batch
segregation should be maintained during quarantine and all subsequent
storage.
h. Quarantine status can be achieved either through the use of separate
storage areas, or by means of documentary or electronic data processing
systems.
i. Materials should remain in quarantine status until a written release or
rejection is authorized by the department responsible for quality control.
4.4.2 Stock rotation and control
a. Comprehensive records should be maintained showing all receipts and
issues of products according to batch number.
b. Periodic stock reconciliation should be performed comparing the actual
and recorded stocks. In any event, this should be performed when each
batch is totally used up. All significant stock discrepancies should be
subjected to investigation as a check against inadvertent mix-ups and
wrong issues.
c. Issues should normally observe the principle of stock rotation (first in-first
out) especially where expiry dated products are concerned.
d. Products with broken seals, damaged packaging or suspected of possible
contamination must not be sold or supplied.
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ASEAN COSMETIC GMP
Training Manual Module 10
STORAGE
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Harris Lukmanto – Indonesia
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Cosmetic Sub-Programme
e. Goods bearing an expiry date must not be received or supplied after their
expiry date or so close to their expiry date that this date is likely to occur
before the goods are used by the consumer.
f. All labels and containers of products should not be altered, tampered or
changed. Acts and Regulations relating to labels and containers should
be adhered to at all times.
g. Partly used containers of materials should be securely re-closed to prevent
spoilage and/ or contamination during subsequent storage. Damaged
containers should not be issued but should be brought to the attention of
the responsible person for quality control.
4.4.3 Finished products
a. All cosmetic products should be accurately documented particularly with
respect to product name and quantity. The pack integrity should be
verified and maintained at all times.
b. Comprehensive records of the receipt and issue of all products should be
maintained.
c. Finished products should be held in quarantine until their final release
under conditions established by the manufacturer.
d. Finished products should be protected from excessive climatic conditions
during storage and transit, such as heat, moisture and direct sunlight.
They should be stored separately from other materials in conditions which
satisfy the requirements for the product, so that shelf-life declaration may
be maintained.
e. Finished product assessment should embrace all relevant factors,
including production conditions, results of in-process testing, a review of
manufacturing (including packaging) documentation, compliance with
finished product specification and product examination of final finished
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ASEAN COSMETIC GMP
Training Manual Module 10
STORAGE
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Harris Lukmanto – Indonesia
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Date: 15 Nov 2005 EC-ASEAN Economic Cooperation Programme Page 12 of 16
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Cosmetic Sub-Programme
pack.
f. After release, finished products should be stored as usable stock under
conditions established by the manufacturer.
4.4.4 Control of obsolescent and outdated stock
a. All stocks should be checked regularly for obsolescent and degraded
materials.
b. Materials with an expired retest period should be destroyed unless an
extension of shelf life is granted following the satisfactory results or
reanalysis.
c. All due precautions should be observed to preclude issue of outdated
materials.
4.4.5 Returned goods
A returned product is a finished product which is already in distribution and
returned to the manufacturer due to complaint, damage, expiration, validity
or other reasons such as the condition of the container or package which may
cast doubt on the product identity, quality, quantity and safety.
a. The manufacturer shall establish a procedure for holdings, investigating
and analyzing the returned product and deciding whether the product may
be reprocessed or shall be destroyed after a critical evaluation is made.
b. Based on the evaluation, the returned products are categorized as follows:
Returned products which still meet their specifications and therefore
may be returned to inventory
Returned products which may be reprocessed, and
Returned products which do not meet their specifications and cannot
be reprocessed
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c. All returned goods should be placed in quarantine and only returned to
saleable stock on the approval of a nominated responsible person
following a satisfactory quality re-evaluation.
4.4.6 Dispatch
a. The allocation and shipping materials should be carried out only after
receipt of a sales order. Rules for dispatch procedures should be
established depending on the nature of the materials and after taking into
account any special precautions to be observed.
b. The shipping container should offer adequate protection from all external
influences, and should be indelibly and clearly labelled. It might be useful
to use devices which allow monitoring during transportation.
c. Dispatch documents should be retained indicating:
Date of dispatch
Customer’s name and address.
Product description, e.g. name, dosage form and strength (if
appropriate), batch number and quantity.
d. All documentary records of all imported goods including the product
description, so as able to comply with relevant national regulations.
4.4.7 Disposal of cosmetics products
a. Before the disposal of any cosmetics products are carried out, advice on
proper destruction procedures should be sought from the appropriate
authorities.
b. A procedure for destruction of rejected materials or products shall be
available. The procedure shall include precautionary measures to prevent
pollution of the environment and actions taken to prevent misuse of the
materials or products by unauthorized persons.
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ASEAN COSMETIC GMP
Training Manual Module 10
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c. A record of rejected material or product destruction shall be made. The
record shall contain the following data:
product name, batch number and quantity of rejects
source of rejected material or product
method of destruction and
persons performing and witnessing the destruction
4.5 Documentation
Refer also to the Documentation section of the Training module
4.5.1 Written instructions
a. Storage requires suitable documentary systems including the
maintenance of comprehensive records of receipts and issues. Any
formats or documents which are computerised must be in accordance with
the current Act or Regulations. If records are computerised, hard copies
should be generated at regular intervals.
b. Written instructions should be available which specify the working
methods to be adopted in the storage areas. They should describe
adequately the storage procedures and define the route of materials and
information through the organization.
c. She storage and distribution of COSMETIC products shall be documented.
The most important documents in this area are inventory card and
distribution record.
4.5.2 Labeling and containers
a. All materials should be stored in containers which do not adversely affect
the quality of the material and which offer adequate protection from
external influences; in some circumstances this could include bacterial
contamination.
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b. All containers should be clearly and indelibly labelled with at least the
name and/ or of the material and the lot number of the batch.
Unauthorized abbreviations, names or codes should not be used.
c. Written information should exist for each stored material or product
indicating recommended storage conditions, any precautions to be
observed and retest dates.
STORAGE CHECK LIST
STORAGE, STOCK HANDLING AND
CONTROL
Storage Area
Is it of sufficient capacity to allow
orderly storage of various
materials?
Do the receiving and dispatch
bays protect the materials from
the weather?
Is there proper demarcation for
storage of quarantined
materials?
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Is there a separate storage for
hazardous materials?
Stock Handling and Control
Are the incoming deliveries checked
against relevant documentation?
Are the deliveries inspected for defects
and damage with records upkeep?
Are there records maintained depicting
receipts and issuance of products?
Does the issuance of products observe
the FIFO principle?
EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency for the Contract No ASIA/2003/069-
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