Questions and Answers on the interpretation of ASEAN GMP

Guideline for Cosmetic

The advice given here should serve as guidance only. You should always make
reference to the ASEAN Cosmetic Directive.
I. Quality Management System
1. Is the ISO9001:2000 Quality Manual acceptable?
Yes, it is acceptable if the Quality Manual has covered all the GMP
elements as specified in the ASEAN GMP Cosmetic Guideline.
II. Sanitation and Hygiene
2. Should the hand-washing tap be of any other particular design e.g.
with press button or sensor? Is there any particular requirement with
regard to this?
There is no specific requirement with regard to the design of the tap. The
objective of hand-washing is to prevent contamination of the products. As
such, there should be procedures in place to ensure operators hands
are properly cleaned and sanitized before entering the production area.
3. Is there a list of pest control agents which are safe for use?
The pest control agent should not contaminate equipments, raw materials,
packaging materials, in process materials or finished products and should
be safe to the persons who are exposed to it. You may obtain the safety
information from the pest control company.
Please note that pest control agents should not be used in the production
area.
III. Production
4. If several batches of the same product are produced continuously,
must the processing equipment be cleaned after the production of
each batch?
The objective of cleaning between batches is to prevent contamination.
Continuous manufacturing without cleaning and sanitization can be
allowed as long as there is proof to show that there is no contamination.
5. Can paper carton/ boxes be allowed in the processing areas?
This may be allowed only if there is no risk of contamination to the
products.

6. Can the same transfer hose be used for different products or

materials?
Yes, provided there is effective cleaning and sanitization of the transfer
hose between products.

7. What is the water quality standard required?

The minimum requirement is the national drinking water standard.
However, further purification/treatment of water may be required
depending on the formulation of your product.

8. If microbial limit testing was carried on the finished product for each
and every batch of the product manufactured, is it justifiable for the
company to reduce the frequency of water testing? What should be
the recommended frequency of water testing?
Water is an important starting material and its quality in terms of chemical
as well as microbiological aspect should be monitored frequently so that
any problem can be detected as early as possible. Finished product
testing should only serve as a final check and can not replace the need for
regular water testing at the pre-defined frequency.
Water testing should be carried out frequently before one can decide on a
suitable reduced frequency. The chosen frequency should be
supported/justified with relevant data such as trend analysis.
9. What should be the frequency of D.I. water system regeneration? Can
yearly frequency be considered appropriate? How do we verify the
water quality after the regeneration process? How do we regenerate
the D.I. water system?
The frequency of water system regeneration should be based on the
conductivity and other relevant test results obtained. The water quality
should be verified in accordance with the water quality specification
established for its intended use. For regeneration method, you are advised
to refer to the operation manual of the equipment vendor.
10. In the training modules, it is mentioned that the raw materials are
required to be weighed and checked before they are dispensed for use
in production. If the raw material is a liquid, can the material be
charged directly into the mixing tank via the volume control gauge?
Yes. However, the volume control gauge, like the scales, should be
calibrated against a reference standard which is traceable to the national
standard.

11. Must I check and verify all the parameters included in the CoA of
packaging materials e.g. bottles and jars?
Packaging materials should be checked for compliance with the
specifications established internally.
IV. Quality Control
12. Is it a requirement for environmental monitoring to be carried out?
The objective is to prevent product contamination from environmental
pollution (microbiological as well as physical). Environmental monitoring
should be implemented, where appropriate, to demonstrate that the
manufacturing environment is not contributing to contamination.
V. Contract Analysis and Manufacture
13. Who should ensure that a contract is established for contract
manufacture/analysis - the contract giver or the contract acceptor?
The contract giver should ensure that the contract is established and there
should be provisions in the contract to allow any ASEAN National
Regulatory Authority to inspect the contract acceptor.
14. If the manufacturer and distributor is the same person operating in two
different companies, is there a need for a contract?
Yes, a contract is required to be put in place so that there is no ambiguity
of the respective GMP responsibilities undertaken by the two
companies.
VI. Storage
15. When the recommended storage condition is not stated on the label of
the imported products. What should be the appropriate storage
conditions provided by the warehouse?
Importers are required to find out from the suppliers/manufacturers the
right storage conditions for the products. The recommended storage
conditions should be based on the results of the stability studies
conducted.
VII. Premise
16. Can raw material sampling be conducted in the weighing/dispensing
area? Must there be a designated area for the sampling activity?
The objective of recommending a separate area is to prevent crosscontamination. The company must demonstrate that there are adequate

processes in place to prevent cross contamination if the areas are not

separated.

17. Is false ceiling required for the production area?

The objective is to prevent environmental contamination (microbiological
or physical). The manufacturer should demonstrate that they have ways to
clean and sanitize the ceiling effectively.
18. Can ceramic tiles be allowed for floor or wall?
Ceramic tiles can be allowed provided the company can ensure that the
gaps between the tiles can be properly cleaned and sanitized to prevent
microbial contamination.
19. Can restrooms which are already separated from the manufacturing
areas be in the same building?
Yes.
20. What type of filter should be used in the air intake system? What
should be the appropriate air exchange rate and direction of air flow?
The need for air filters and, if so, the air exchange rate as well as the
direction of air flow will depend on the desired air quality needed for the
manufacture of your products. This should take into account the
prevention of contamination from the surrounding environment.
VIII. Personnel
21. Are there a minimum number of personnel that a company must have
for the manufacturing activities?
No but there must be sufficient personnel to carry out the work effectively.
Additionally, the QC and Production functions should be independent from
each other.
22. Are personnel working at the mixing or filling areas required to put on
long sleeved gown?
Personnel can potentially introduce contamination to the environment,
equipment and materials/product with which they come into contact. Staff
should put on appropriate garments which are suitable to the operation in
a manner that can ensure protection against contamination.
IX. Equipment

23. Is it possible to use plastic mixing tank in production?

Production equipment should be constructed of material which is
compatible with products and materials which they will come into contact
with. It should be non reactive, non adsorptive and non additive in nature.
In addition, the production equipment should be easy to clean and
sanitize.
24. Is it appropriate to calibrate all balances once a year?
Yes, at least once a year.
25. Can PVC pipes be used for delivering water and other materials for
use in the manufacturing process?
To prevent contamination and facilitate cleaning and sanitization, stainless
steel pipes are preferred. Should PVC pipes be used, you have to ensure
that you have effective cleaning and sanitization procedures in place.
Please refer to the ASEAN Cosmetic GMP Training Module on
Equipment for more information.
26. If they are free can the QC staff help in production work and vice
versa?
The Head of Production can enlist the help of QC staff provided these staff
are qualified and trained in the area of work that they help out and that
there are no conflict of interest involved. The production head should also
take note that his responsibility can not be delegated and he will be held
responsible for the work performed by the helpers and vice versa.
X. Documentation
27. Is computer validation required?
Data should be controlled and secured with adequate audit trails whether
a computerised or manual system is used.

XI. General issues

28. What is the GMP requirement for manufacturers which are located
outside the ASEAN region?
The overseas manufacturers should comply with the requirements of the
ASEAN Guideline on Cosmetic GMP or the equivalent GMP
Guidelines/Requirements as approved by the ACC.
29. Is there a need to have filtered air in a soap manufacturing facility?

The need for air filters and, if so, the air exchange rate as well as the
direction of air flow will depend on the desired air quality needed for the
manufacture of your products. This should take into account the
prevention of contamination from the surrounding environment.
30. Can wooden floor or wall be allowed when concrete cement flooring is
not suitable e.g. in swamp area?
The company should take note that it is necessary to put in place an
effective cleaning and sanitation programme to ensure that the material
used for flooring or wall will not become the potential source of
contamination (microbial or physical).
31. Some SMEs feedback that they lack knowledge on how to set up raw
material, packaging materials or finished product specifications
SMEs should send their staff for training in this area of concern. They may
approach the cosmetic association or engage a suitable consultant for
assistance.
32. Is it possible to house a number of pieces of equipment in one
production room and to carry out the manufacturing of different
products concurrently? Some SMEs have limited manufacturing space
and they have to carry out many activities in one room.
Yes but there should be measures in place to prevent mix-up and cross
contamination.
33. Window Air conditioners or spilt air conditioners are commonly used by
SMEs as the air handling system, is this acceptable?
It is acceptable if they are fitted with proper filters and subject to proper
monitoring and maintenance at appropriate interval.
34. Some SMEs expressed that they lack technical persons who can
understand the GMP requirements
These SMEs should send their personnel for the relevant training or/and
engage technically competent staff. They can also engage a suitable
consultant for assistance.
35. Some SMEs expressed that they lack qualified personnel to provide
staff training
These SMEs should send their personnel for the relevant training or/and
engage technically competent staff. They can also engage a suitable
consultant for assistance.

36. Some SMEs are concerned about the required qualification that their
key personnel should possess.
Qualified key personnel should have knowledge, experience, skills and
capabilities to perform their job functions. There is no requirement about
University degrees.
37. Some SMEs are concerned about the number of key personnel
required.
There should be adequate number of key personnel to ensure work is
carried out properly according to the GMP requirements. The QC and
Production functions should be independent from each other.
38. Can I reduce the frequency of finished product testing?
Reduced testing of certain parameters can be considered if it is supported
with scientific, rationale and relevant data or through the use of innovative
technology e.g. Process Analytical Technology (PAT).
39. Some SMEs have expressed difficulty with documentation control and
development of SOPs.
Companies which are facing these problems should attend training on
documentation control e.g. ISO courses. Depending on the preference of
the company, bracketing of procedures or activities in one SOP can be
adopted. For e.g. a general cleaning procedure can be used for a few
areas such as the dispensing area, mixing room, etc.

40. Some SMEs feedback that they have limited number of personnel to
conduct internal audits.
All manufacturers should fully understand that internal audit is one of the
important requirements of GMP. Internal audit is required as it allows the
company to assess whether the quality management system which the
company has put in place is effective. Internal audit is a planned activity
and it can be conducted at a time that is convenient to the company as
long as it is carried out periodically. Alternatively, the company can also
approach a suitable external party to audit the company.

41. What if accredited

inaccessible?

testing

laboratories

are

not

available

or

Companies that do not have any QC facility may outsource the testing to
an external accredited laboratory. If external accredited laboratories are

not available or inaccessible, the company can go for an external testing

laboratory which has been qualified to be technically competent and would
perform testing using methods that comply with the international
requirements/standards.