ASEAN Cosmetic Storage Guide
ASEAN Cosmetic Storage Guide
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.
2. OBJECTIVE
2.1. Gain basic understanding of the GSP applicable to the warehouse practice
3. SCOPE
This modules covers the storage and distribution of all the materials and finished
cosmetic products
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ASEAN COSMETIC GMP
Training Manual Module 10
STORAGE
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Cosmetic Sub-Programme
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.
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
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Cosmetic Sub-Programme
f. Finished product
A cosmetic product that has undergone all stages of production, including
packaging in its final container and labelling.
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
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Cosmetic Sub-Programme
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.
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ASEAN COSMETIC GMP
Training Manual Module 10
STORAGE
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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
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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.
4.2.6 The foundation should be as secure as possible against ground water and
high enough to remain dry even under extreme rainfall and flood conditions.
4.2.8 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
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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
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Cosmetic Sub-Programme
4.2.10 The storage areas should be sufficiently large, and if necessary, have
physically separated zones for the orderly segregation of products.
4.2.12 Storage areas should have sufficient lighting to allow store or warehouse
operations to be carried out accurately and safely.
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.
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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 7 of 16
Rev. : 00 on Standards, Quality and Conformity Assessment
Cosmetic Sub-Programme
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.
4.3. 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.
4.3.5 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
European Union
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
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Cosmetic Sub-Programme
Refer explanation also to the Quality Control and Production section of the
training module especially on sampling and inspection means.
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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 10 of 16
Rev. : 00 on Standards, Quality and Conformity Assessment
Cosmetic Sub-Programme
c. Issues should normally observe the principle of stock rotation (first in-first
out) especially where expiry dated products are concerned.
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ASEAN COSMETIC GMP
Training Manual Module 10
STORAGE
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European Union
Prepared by by Asean
Harris Lukmanto – Indonesia
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Date: 15 Nov 2005 EC-ASEAN Economic Cooperation Programme Page 11 of 16
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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.
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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 12 of 16
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Cosmetic Sub-Programme
pack.
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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 13 of 16
Rev. : 00 on Standards, Quality and Conformity Assessment
Cosmetic Sub-Programme
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.
a. Before the disposal of any cosmetics products are carried out, advice on
proper destruction procedures should be sought from the appropriate
authorities.
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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 14 of 16
Rev. : 00 on Standards, Quality and Conformity Assessment
Cosmetic Sub-Programme
4.5 Documentation
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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 15 of 16
Rev. : 00 on Standards, Quality and Conformity Assessment
Cosmetic Sub-Programme
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.
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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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 16 of 16
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Cosmetic Sub-Programme
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