*ACD ASEAN Cosmetic Directive 1

Appendix-1

REPUBLIC OF THE PHILIPPINES
DEPARTMENT OF HEALTH
FOOD AND DRUG ADMINISTRATION
Civic Drive, Filinvest Corporate City
Alabang, City of Muntinlupa
P H I L I P P I N E S

GMP Audit Report Format


GOOD MANUFACTURING (GMP) AUDIT REPORT

Report Number: CL month/year and number in series Reference number: State document number as received

Audited site Name and full address of the inspected site

Activities carried out by the company Manufacturer of finished cosmetic product Manufacturer of intermediate bulk
Packaging Importing
Others (Repacking of finished bulk)

Audited date (s) Date(s), month, year

Auditor (s)

Name of Competent Authority
Name of Inspectors(s)

Food and Drug Administration

References Manufacturers license number
RDII-MM-CL - Validity:
Products Manufactured

Creams, emulsions, lotions, gels and oils for skin (hands, face, feet, etc.)
Face masks (with the exception of chemical peeling products)
Tinted bases (liquids (liquid foundation, tinted moisturizers),
pastes, powders )
Make-up powders, after-bath powder, hygienic powders, etc.
Toilet soaps, deodorant soaps, etc
Perfumes, toilet waters and eau de Cologne


*ACD ASEAN Cosmetic Directive 2
Bath or shower preparations (salts, foams, oils. gels, etc.)
Depilatories
Deodorants and anti-perspirants
Hair care products
- hair tints and bleaches (including permanent hair dyes)
- products for waving, straightening and fixing,
- setting products (gel for curls)
- cleansing products (lotions, powders, shampoos),
- conditioning products (lotions, creams, oils),
- hairdressing products (lotions, lacquers, brilliantines)
Shaving product (creams, foams, lotions, etc.)
Products for making-up and removing make-up from the face and the eyes
Products intended for application to the lips
Products for care of the teeth and the mouth
Products for nail care and make-up (cuticle oil, nail polish remover,
nail color/paints, and other nail accessories)
Products for external intimate hygiene
Sunbathing products
Products for tanning without sun
Skin whitening products
Anti-wrinkle products
Others (please specify) ______________________________


Introduction Short description of the company and the activities of the company including importation of raw
materials and/or finished products in bulk.


Date of Previous Audit
Name of auditors involved in the previous audit


Major changes made since the previous audit Change in organization (change in key personnel), lay-out, product line, activity, additional equipment,
change of site, etc.
Brief report of the activities undertaken
Scope of Audit
Short description of the inspection (product related inspection and/or General GMP inspection). The
reason for the inspection should be specified (e.g. new marketing application, routine, investigation of
product defect)

Inspected area(s) Each inspected area should be specified e.g. Premises and equipment, Production, Documentation,
Warehouse, Quality Control
*ACD ASEAN Cosmetic Directive 3

Personnel met during the audit The names and title of key personnel met, should be specified (listed in annex)

Auditors findings and observations relevant to
the audit
Relevant headings from the ASEAN Cosmetic Directive
New headings maybe introduced as applicable



GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)
Quality Management
System



1. Is there a developed, established and
implemented quality system where policies
are stated and objectives are achieved?

2. Does the QMS define the organizational
structure, functions, responsibilities,
procedures, instructions, processes and
resources for implementing the quality
management?

3. Is quality system structured and adapted to
the companys activities and to the nature
of its products?

4. Does the quality system operation ensure
that samples of starting materials,
intermediate, and finished products are
taken, tested ( if necessary ) to determine
their release or rejection on the basis of test
results and other available evidence related
to quality?

1.2.1


1.2.1




1.2.2


1.2.3

Personnel
*ACD ASEAN Cosmetic Directive 4
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)
Organization,
Qualification &
Responsibilities
1. Is there an adequate number of personnel
having knowledge, experience, skill and
capabilities relevant to their assigned
function?

2. Are they in good health and capable of
handling the duties assigned to them?

3. Is the organizational structure of the
company created such that the production
and the quality control sections are headed
by different persons, neither of whom shall
be responsible to the other?

4. Is the head of production adequately
trained and experienced in cosmetic
manufacturing?

5. Does he/she have the authority and
responsibilities to manage manufacture of
products covering operations, equipment,
production personnel, production areas and
records?

6. Is the head of quality control adequately
trained and experienced in the field of
quality control?

7. Is he/she given the full authority and
responsibility in all quality control duties such
as establishment, verification and
implementation of all quality control
procedures?

2




2


2.1.1





2.1.2



2.1.2





2.1.3



2.1.3






*ACD ASEAN Cosmetic Directive 5
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)
8. Does he/she have the authority to
designate/ assign when appropriate,
personnel, to approve starting materials,
intermediates, bulk and finished products
that meet the specification or to reject those
which do not conform to the relevant
specification or which were not
manufactured in accordance with
approved procedures and under the
defined conditions?
9. Are the responsibilities and authority of key
personnel clearly defined?

10. Is there an adequate number of trained
personnel appointed to execute direct
supervision in each section of the production
and the quality control unit?

2.1.3









2.1.4


2.1.5

Training 11. Are all personnel directly involved in the
manufacturing activities appropriately
trained in manufacturing operations in
accordance to GMP principles?

12. Is special attention given to training of
personnel working with any hazardous
materials?

13. Is training in GMP conducted on a
continuous basis?

14. Are records of training maintained and its
effectiveness assessed periodically?
2.2.1




2.2.1



2.2.2


2.2.2


Premises

*ACD ASEAN Cosmetic Directive 6
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)

1. Are the premises for manufacturing suitably
located, designed, constructed and
maintained?

2. Are there effective measures taken to avoid
any contamination from the surrounding
environment and from pests?

3. Is the manufacture of Household products
containing non-hazardous
materials/ingredients and cosmetic products
share the same premises and equipment?
(Due care should be exercised to prevent
cross contamination and risk of mix-up.)

4. Are there painted line, plastic curtain and
flexible barrier in the form of rope or tape
employed to prevent mix-up?

5. Are there appropriate changing rooms and
facilities provided?

6. Are toilets separated from the production
areas to prevent product contamination /
cross contamination?

7. Are there defined areas provided, wherever
possible and applicable for?

a. Materials receiving
b. Material sampling
c. Incoming goods and quarantine
d. Starting materials storage
e. Weighing and dispensing
3



3.1



3.2






3.3



3.4


3.4



3.5


3.5.1
3.5.2
3.5.3
3.5.4
3.5.5

*ACD ASEAN Cosmetic Directive 7
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)
f. Processing
g. Storage of bulk products
h. Packaging
i. Quarantine storage before final release
of products
j. Storage of finished products
k. Loading and unloading
l. Laboratories
m. Equipment washing

8. Are wall and ceilings, where applicable
should be smooth and easy to maintain?

9. Does the floor in processing areas have a
surface that is easy to clean and sanitize?

10. Are drains of adequate size and have
trapped gullies and proper flow?

11. Are open channels avoided where possible?
But if required are they able to facilitate
cleaning and disinfection?

12. Are air intakes and exhausts and associated
pipe work and ducting, when applicable,
installed in such a way as to avoid product
contamination?

13. Are buildings adequately lit and properly
ventilated appropriate to the operations?

14. Do pipe work, light fittings, ventilation points
and other services in manufacturing areas
installed in such a way to avoid uncleanable
3.5.6
3.5.7
3.5.8
3.5.9

3.5.10
3.5.11
3.5.12
3.5.13

3.6

3.6


3.7


3.7



3.8




3.9


3.10



*ACD ASEAN Cosmetic Directive 8
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)
recesses and run outside the processing
areas?

15. Are laboratories physically separated from
the production areas? (preferably)

16. Are storage areas of adequate space
provided with suitable lighting, arranged
and equipped to allow dry, clean and
orderly placement of stored materials and
products?
17. Are these areas suitable for effective
separation of quarantined materials and
products?

18. Are there special and segregated areas
available for storage of

a. flammable and explosive substances
b. highly toxic substances,
c. rejected and recalled materials
d. returned goods?

19. Is there a provided area where special
storage conditions e.g. temperature,
humidity and security are required?



3.11


3.12






3.12.1



3.12.1







3.12.2

Equipment





Design & Construction

1. Are pieces of production equipment
designed and located to suit the
manufacture of the product?

2. Are the production equipment surfaces
coming into contact with any in-process
4



4.1.1


*ACD ASEAN Cosmetic Directive 9
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)












Installation & Construction
















Maintenance
material non- reactive or adsorptive?

3. Do the units of production equipment
adversely affect the product through leaking
valves, lubricant drips and through
inappropriate modifications or adaptations?

4. Are production equipment easily cleaned?

5. Are equipment used for flammable
substances explosion proof?

6. Are equipment located to avoid congestion
and properly identified to assure that
products do not become admixed or
confused with one another?

7. Are water, steam and pressure or vacuum
lines clearly identified and where applicable,
installed for easy accessibility during all
phases of operations?

8. Are support systems such as heating,
ventilation, air conditioning, water (such as
potable, purified, distilled) steam,
compressed air and gases (example
nitrogen) identifiable and function as
designed?

9. Are weighing, measuring, testing and
recording equipment serviced and
calibrated regularly?

10. Are all records maintained?


4.1.2




4.1.3

4.1.4


4.2.1




4.2.2




4.2.3






4.3



4.3
*ACD ASEAN Cosmetic Directive 10
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)

Sanitation and Hygiene







Personnel

























1. Is sanitation and hygiene practiced to avoid
contamination of the manufacture of
products? Does it cover personnel, premises,
equipment/apparatus and production
materials and containers?

2. Are personnel healthy to perform their
assigned duties? Is there regular medical
examination conducted for all production
personnel involved with manufacturing
processes?

3. Do personnel practice good personal
hygiene?

4. Are personnel shown at any time, to have an
apparent illness or open lesions that may
adversely affect the quality of products,
allowed to handle raw materials, packaging
materials, in-process materials, and finished
products?

5. Are personnel instructed and encouraged to
report to their immediate supervisor any
conditions (plant, equipment or personnel)
that they consider may adversely affect the
products?

6. Is direct physical contact with the product
avoided to ensure protection of the product
from contamination?

5





5.1.1




5.1.2


5.1.3






5.1.4





5.1.5



5.1.5

*ACD ASEAN Cosmetic Directive 11
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)















Premises


















7. Do personnel wear protective and clean
attire appropriate to the duties they
perform?

8. Is smoking, eating, drinking and chewing,
food, drinks and smoking materials and other
materials that might contaminate, permitted
in production, laboratory, storage or other
areas where they might adversely affect
product quality?

9. Are all authorized personnel entering the
production areas practice personal hygiene
including proper attire?

10. Are there adequate employee's washing
and well-ventilated toilet facilities provided?

11. Are these separated from the production
area?

12. Are there suitable locker facilities provided
at appropriate location for the storage of
employees' clothing and personal
belongings?

13. Are waste materials regularly collected in
suitable receptacles for removal to
collection points outside the production
area?

14. Are there methods undertaken to
demonstrate that equipment, raw materials,
packaging materials, in-process materials or




5.1.6






5.1.7



5.2.1


5.2.1


5.2.2




5.2.3




5.2.4


*ACD ASEAN Cosmetic Directive 12
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)




Equipment & Apparatus


finished products have not been
contaminated after pest control was
conducted?

15. Are equipment and utensils kept clean?

16. Are there adequate cleaning methods
employed?

17. Are standard operating procedures followed
for cleaning and sanitizing of major
machines?




5.3.1

5.3.2


5.3.3
Manufacturing Process
Starting Material

Water










Verification of Materials







1. Do the water production equipment and
water systems supply quality water?
2. Is the water system sanitized according to
well-established procedures?

3. Are the chemical and microbiological
qualities of water used in production
monitored regularly, according to written
procedures?

4. Does any anomaly observed followed by
corrective action?

5. Are all deliveries of raw materials and
packaging materials checked and verified
for their conformity to specifications and are
traceable to the product?

6. Are raw materials clearly labeled?

7. Are all goods clean and checked for
6.1.1

6.1.1


6.1.1




6.1.1


6.1.2




6.1.2

6.1.2

*ACD ASEAN Cosmetic Directive 13
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)




Rejected Material




Batch Numbering System















Weighing & Measurement






Procedure & Processing

appropriate protective packing to ensure
there are no leakages, perforations or
exposure?

8. Are raw materials not complying with
specifications segregated and disposed
according to standard operating
procedures?

9. Does every finished product bear a
production identification number, which
enables the history of the product to be
traced?

10. Is the batch numbering system specific for a
product and that particular batch number is
not repeated for the same product in order
to avoid confusion?

11. Is the batch number printed on the
immediate and outer container of the
product, whenever possible?

12. Are records of batch number maintained?

13. Is weighing carried out in a defined area
using calibrated equipment?

14. Are all weighing and measurement activities
carried out recorded and, where
applicable, counterchecked?

15. Are all starting materials used approved
according to specifications?




6.1.3




6.2.1




6.2.2




6.2.3



6.2.4

6.3.1


6.3.2



6.4.1

*ACD ASEAN Cosmetic Directive 14
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)
















Dry Products





Wet Products












16. Are all manufacturing procedures should be
carried out according to written
procedures?

17. Are all required in-process controls carried
out and recorded?

18. Are bulk products properly labeled until
approved by Quality Control, where
applicable?

19. Is particular attention paid to problem of
cross-contamination in all stages of
processing?

20. Is the handling of dry materials and products
given special attention? Where possible, a
dust-containing production system, central
vacuum system or other suitable methods is
employed.

21. Is the manufacture of liquids, creams and
lotions done in a way that the product is
protected from microbial and other
contamination?

22. Is a closed- system of production and
transfer used?

23. Are pipe-lines used for delivery of ingredients
or bulk products, taken care to ensure that
the systems are easy to clean?


6.4.2



6.4.3


6.4.4



6.4.5



6.5





6.6.1




6.6.2


6.6.3



*ACD ASEAN Cosmetic Directive 15
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)
Labeling & Packaging
















Finished Product:
Quarantine & Delivery to
Finished Stock

24. Is the packaging line inspected for
clearance prior to operation with all
materials and products from previous
packaging operation removed?

25. Are samples taken and checked at random
during labeling and packaging operations?

26. Does each labeling and packaging line
clearly identified to avoid mix-up?

27. Are excess labels and packaging materials
returned to store and recorded?

28. Are rejected packaging materials disposed
off accordingly?

29. Are all finished products approved by
Quality Control prior to release for
distribution?
6.7.1




6.7.2


6.7.3


6.7.3


6.7.3


6.8.1
Quality Control
Quality Management 1. Is there a quality control system established
to ensure that products contain the correct
materials of specified quality and quantity
and are manufactured under proper
conditions according to standard operating
procedures?

2. Is the Quality control involved in sampling,
inspecting and testing of starting materials,
in- process, intermediate, bulk, and finished
products?

7.1.1






7.1.2





*ACD ASEAN Cosmetic Directive 16
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)
3. Does it also include where applicable,
environmental monitoring programs, review
of batch documentation, sample retention
program, stability studies and maintaining
correct specifications of materials and
products?
7.1.2
Laboratory facilities &
Controls

Reprocessing







Returned Products
1. Are the methods of reprocessing evaluated
to ensure that they do not affect the quality
of the product?

2. Are additional tests performed in any
finished product, which has been
reprocessed?

3. Are returned products identified and stored
separately either in allocated area or by
moveable barrier such as rope or tape?

4. Are all returned products tested if necessary,
in addition to physical evaluation before
being released for distribution?

5. Are returned products, which do not comply
with the original specification, rejected?

6. Are rejected products disposed according
to appropriate procedures?

7. Are records of returned products must be
maintained?
7.2.1



7.2.2



7.3.1



7.3.2


7.3.3



7.3.4


7.3.5

Documentation

1. Is there a system for preventing the use of 8.1.1
*ACD ASEAN Cosmetic Directive 17
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)














Specifications



















any superseded document?

2. Are errors corrected such that the original
entry is not lost and corrections made are
signed and initialed?

3. Are the instructions clearly written step by
step?

4. Are all documents dated and authorized?

5. Are these made available to relevant
parties?

6. Are all specifications should be approved by
authorized personnel?

7. Do the raw and packaging material
specifications include?

a. Name of material
b. Description of the material
c. Testing parameters and acceptance
limits
d. Technical drawings, where applicable
e. Special precautions e.g. storage and
safety conditions, if necessary.

8. Do the bulk and finished product
specifications include :

a. Name of product
b. Description
c. Physical properties


8.1.2



8.1.3


8.1.4

8.1.5


8.2


8.2.1










8.2.2





*ACD ASEAN Cosmetic Directive 18
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)






Documents for Production
Master Formula
d. Chemical assay and/or microbiological
assays and their acceptance limits; if
necessary
e. Storage conditions and safety
precautions, if necessary


9. Is the Master Formula available upon request
and does this document contain the
following information?

a. Product name and product
code/number.
b. Intended packaging materials, and
storage conditions.
c. List of raw materials used
d. List of equipment used
e. In-process controls with their limits in
processing and packaging, where
applicable

10. Are the batch Manufacturing Records
prepared for each batch of product?

11. Does each BMR include the following?

a. Name of product
b. Batch formula
c. Brief manufacturing process
d. Batch or code number
e. Date of the start and finish of processing
and packaging
f. Identity of individual major equipment
and lines or location used







8.3.1













8.3.2


8.3.2









*ACD ASEAN Cosmetic Directive 19
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)
g. Records of cleaning of equipment used
for processing as appropriate
h. In-process control and laboratory results,
such as pH and temperature test
records
i. Packaging line clearance inspection
records
j. Any sampling performed during various
steps of processing
k. Any investigation of specific failure or
discrepancies
l. Results of examinations on packed and
labeled products

12. Are records for each testing, assay result and
release or rejection of starting materials,
intermediates, bulk and finished product
maintained?

13. Do these records include?

a. Date of test
b. Identification of the material
c. Supplier name
d. Date of receipt
e. Original batch number, if any
f. Batch number
g. Quality control number
h. Quantity received
i. Date of sampling
j. Quality control results














8.3.3




Internal Audit


1. Is an internal audit conducted by outside or
independent specialists or a team

9


*ACD ASEAN Cosmetic Directive 20
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)
designated by the management for this
purpose?

2. Are there external audits done on suppliers
and contractors, if necessary?

3. Is there a report made at the completion of
each internal/external audit?



9


9

Storage, Stock handling &
Control




Storage Areas























1. Is the storage area of sufficient capacity to
allow orderly storage of the various
categories of materials and products such as
starting and packaging materials,
intermediates, bulk and finished products,
products in quarantine, and released,
rejected, returned, or recalled products?

2. Is it designed or adapted to ensure good
storage conditions?

3. Is it clean, dry and well-maintained?

4. Is there an area provided where special
storage conditions are required?
(temperature and humidity )?

5. Are these parameters checked and
monitored?

6. Are the receiving and dispatch bays made
to protect materials and products from
weather?

10.1.1







10.1.2


10.1.2

10.1.2



10.1.2


10.1.3




*ACD ASEAN Cosmetic Directive 21
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)










Receiving Products









Control
7. Is the reception area designed and
equipped to allow incoming materials to be
cleaned, if necessary before storage?

8. Is the storage area for quarantine products
clearly demarcated?

9. Is there a sampling area provided for starting
materials to prevent contamination?

10. Is each incoming delivery checked against
the relevant documentation and physically
verified by label description, type and
quantity?

11. Is the consignment carefully inspected for
defects and damage?

12. Are records retained for each delivery?

13. Are there records maintained to show all
receipts and issues of products?

14. Does the issuance observe the principle of
stock rotation (first in - first out)?

15. Are there controls to prevent the tampering,
altering and changing of all labels and
containers of products?
10.1.3



10.1.4


10.1.5


10.2.1.1




10.2.1.2


10.2.1.2

10.2.1.2.1


10.2.1.2.2


10.2.1.2.3

Contract manufacturing
and analysis


1. Is there a written contract between the
principal and the contract manufacturer to
clearly establish the duties and
11



*ACD ASEAN Cosmetic Directive 22
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)
responsibilities of each party?

2. Are the conditions of contract
manufacturing and analysis clearly defined,
agreed, and controlled so as to avoid
misunderstandings?

3. Are all aspects of contracted work specified
to obtain a quality product conforming to
the agreed standards?



11




11
Complaints & Recalls

Complaints





















1. Is there a person responsible for handling
complaints and decides the measures to be
taken?

2. Are there written procedures describing the
action to be taken, including the need to
consider a recall, in cases of a complaint
involving a possible product defect?

3. Are complaints involving product defects
recorded with all the original details and
investigated?

4. If a product defect is discovered or
suspected in a batch, are there
considerations on whether other batches
should be checked in order to determine
whether they are also affected?

5. Are batches that contain reprocessed
product from a defective batch
investigated?
12.1



12.2




12.3



12.4





12.4



*ACD ASEAN Cosmetic Directive 23
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)






















Product Recall

6. Are there, appropriate follow-up actions,
possibly including product recall, taken after
investigation and evaluation of the
complaint?

7. Are all the decisions and measures taken as
a result of a complaint, recorded and
referenced to the corresponding batch
records?

8. Are complaint records regularly reviewed for
an indication of specific or recurring
problems that require attention and might
justify the recall of marketed products?

9. Is the competent authority informed if a
manufacturer is considering action,
following possibly faulty manufacture and
product deterioration, which may lead to
serious safety issues?

10. Is there a system of recall from the market of
products known or suspected to be
defective?

11. Is there a person responsible for the
execution and co-ordination of recalls, as
well as sufficient personnel, to handle all
aspects of recalls with the appropriate
degree of urgency?

12. Are there established written procedures for
recall and are these regularly reviewed?

12.5




12.6




12.7




12.8





13



13.1





13.2

*ACD ASEAN Cosmetic Directive 24
GMP Element Items inspected Y N
Relevant
Sections to
*ACD
Observations/Remark(s)

13. Are recall operations capable of being
initiated promptly?

14. Are the primary distribution records readily
available to the person(s) responsible for
recalls, and do they contain sufficient
information of distributors?

15. Is the progress of the recall process
recorded and a final report issued, including
reconciliation between the delivered and
recovered quantities of the products?

16. Is the effectiveness of the arrangements for
recalls evaluated from time to time?

17. Is there a written instruction established to
ensure recalled products are stored securely
in a segregated area while awaiting
decision?


13.2


13.3




13.4




13.5


13.6






Questions raised relating to the
assessment of a notification
certificate/compliance to
Product Information File (PIF)
Summary of evaluation of Parts 1-4 of the PIF. Use separate report for the PIF, if applicable. Annex 2-PIF Inspection Report

Other specific issues identified Relevant future changes announced by the company
Site Master File (SMF) Assessment of SMF if any; Date of SMF
Miscellaneous


*ACD ASEAN Cosmetic Directive 25
Collection of samples, if any State the following:
name(s) of the sampled product(s), batch number(s), date, source, number of samples, and remarks on type
of packaging and storage conditions;
circumstances of sampling, e.g., suspected quality defects, routine surveillance, verification of compliance
with GMP;

Annexes attached List any annexes attached
List of Deficiencies classified into
Critical, Major, and Minor
All deficiencies should be listed and the relevant reference to Appendix VI of the ACD GMP Guide for Cosmetics should be
mentioned.
These observations/findings may further be classified into 3 categories. Critical observations are cited when there is a risk
that product may not meet performance requirements or specifications. These may result from inadequate quality
systems, or consist of numerous major observations in the same audit area or repeated major observations. Major
observations are noted when minimum risk that finished products will not meet performance requirements or
specifications. GMP deviations are not a result on the lack of quality systems. While minor observations are referred to
when there are no risks that product will not meet performance requirements or specifications.
All the deficiencies are related to the assessment of the marketing application, this should be clearly stated.
The company should be asked to inform the inspectorate about the progress of the corrected actions and a proposed time
schedule for corrections. (See attached closed out record)
Recommendation/s e.g. State if the company is recommended for initial or renewal of License to Operate.

Summary & Conclusions The inspection team should state if the company operates in accordance with the ASEAN GMP Guide for Cosmetics and
mention any other item to alert requesting authority.

Name of GMP Auditor/s
The Inspection Report should be signed and dated by the
Inspector(s)/ Assessors who participated in the Inspection.









*ACD ASEAN Cosmetic Directive 26