1 Cosmetics Good Manufacturing Practice Regulations  
Announced Date:  Aug 13th, 2019  
1. Promulgated by the Ministry  of Health and Welfare Order Wei -Shou -Shi-Tzu 
No.1081103973, on August 13th, 2019; The Regulations shall be effective on July 1st, 2019.  
 
Chapter 1 General Provisions  
Article 1  
These regulations are formulated in accordance with the Paragraph 4, Article 8 
of the Cosmetic Hygiene and Safety Act (hereinafter referred to as the Act). 
These regulations are formulated in reference to the ISO 22716: 
Cosmetics -Good manufacturing practices (GMP) -Guidelines on good 
manufacturing practices issued by International Organization Standardization.  
Article 2  
The definition of terms used in th is regulation are defined as follows:  
1. Acceptance criteria: the acceptable amount, range, or other suitable 
measurement methods according to the test result.  
2. Auditing: systematic and independent examination to determine whether 
quality activities and relate d results comply with planned arrangements and 
whether these arrangements are implemented effectively and are suitable 
for achieving objectives.  
3. Batch: the certain produce amount of raw materials, packaging materials, 
or products from a single or series of  manufacturing process.  
4. Batch number: The identification of certain batch of products which 
contains numbers, alphabets, or symbolic combinations.  
5. Bulk product: any product that is completed the manufacturing process, but 
without the final packaging proces s. 
6. Calibration: Under a certain condition, to establish the operation methods 
and procedures with the known standard reference values to ensure the 
result values and material testing values of the measurement equipment or 
measurement system.  
7. Control: verif ication that acceptance criteria are met.  
8. Change control: To ensure all manufacturing, packaging, process control 
and storage of the products to meet the defined acceptance criteria. The 
amendment plan conducted by the internal organizations and responsibl e 
units related to good manufacturing practice.  
9. Cleaning: all operations that ensure a level of cleanliness and appearance, 
consisting of separating and eliminating generally visible dirt from a surface  2 by means of the following combined factors, in variable proportions, such 
as chemical action, mechanical action, temperature, duration of application.  
10. Complaint: external information claiming a product does not meet the 
defined acceptance criteria.  
11. Contamination: occurrence of any undesirable matter su ch as chemical, 
physical and/or microbiological matter in the product.  
12. Consumables: materials such as cleaning agents and lubricants that are 
used up during cleaning, sanitization or maintenance operations.  
13. Contract acceptor: person, company or external or ganization to enforce an 
operation on behalf of another person, company or organization.  
14. Deviation: internal organization and responsibilities relative to the 
authorization to deviate from specified requirements due to a planned or 
unplanned and, in any ca se, temporary situation concerning one or 
several activities covered by the Good Manufacturing Practices.  
15. Finished product: cosmetic product that has undergone all stages of 
production, including packaging in its final container, for shipment.  
16. In-process c ontrol: controls performed during production in order to 
monitor and, if appropriate, to adjust the process to ensure that the 
product meets the defined acceptance criteria.  
17. Internal audit: systematic and independent examination made by 
competent personnel  inside the company, the aim of which is to determine 
whether activities covered by these guidelines and related results comply 
with planned arrangements and whether these arrangements are 
implemented effectively and are suitable for achieving objectives.  
18. Major equipment: equipment specified in production and laboratory 
documents, which is considered essential to the process.  
19. Maintenance: any periodic or unplanned support and verification 
operations designed to keep premises and equipment in proper working 
condition.  
20. Manufacturing operation: set of operations from the weighing of raw 
materials to the making of the bulk products.  
21. Out-of-specification: examination, measurement or test result that does 
not comply with the defined acceptance criteria.  
22. Packaging operation: all packaging steps including filling and labeling, 
which a bulk product has to undergo in order to become a finished 
product.  
23. Packaging material: any material employed in the packaging of a cosmetic 
product, excluding any outer packaging used f or transportation. Packaging  3 materials are referred to as primary or secondary according to whether or 
not they are intended to be in direct contact with the product.  
24. Plant: location for production of cosmetic products.  
25. Premises and Facilities: physical lo cation, buildings and supporting 
structures used to conduct receipt, storage, manufacturing, packaging, 
control and shipment of product, raw materials and packaging materials.  
26. Production: manufacturing and packaging operations.  
27. Quality assurance: all those  planned and systematic activities necessary 
to provide confidence that a product satisfies the defined acceptance 
criteria.  
28. Raw material: any substance going into or involved in the manufacturing of 
a bulk product.  
29. Recall: decision made by a company to ca ll back a product batch that has 
been put on the market.  
30. Reprocessing: re -treatment of all or part of a batch of finished product or a 
bulk product of an unacceptable quality from a defined stage of production 
so that its quality may be rendered acceptable  by one or more additional 
operations.  
31. Return: sending finished cosmetic products which may or may not present 
quality defect back to manufacturing premises.  
32. Sample: one or more representative elements selected from a set to 
obtain information about that s et. 
33. Sampling: set of operations relating to the taking and preparation of 
samples.  
34. Sanitization: operation, used to reduce undesirable micro -organisms on 
inert contaminated surfaces depending on the objectives set.  
35. Shipment: set of operations relative to the preparation of an order and its 
putting in a transport vehicle.  
36. Waste: any residue of a production operation, transformation or use, any 
substance, material, product that its holder intends for disposal.  
Article 3  
The cosmetics manufacturing premises s hall be regulated according to the 
public announced cosmetics categories listed in Paragraph 2 Article 8 of the 
Act. 
 
Chapter 2 Management and Personnel  
Article 4  
The personnel in the cosmetics manufacturing premises shall have an  4 appropriate training to c omply the quality of production, control and product 
storage operation.  
Article 5  
The personnel in the cosmetics manufacturing premises shall establish the 
organization according to the following:  
1. Regulate the organization and to establish an organization chart to ensure 
the division of labor and competency according to the scale and diversity of 
its product of the manufacturing premises.  
2. To ensure there are adequate staffing levels and well -trained as well as 
sufficient personnel in the different scope of activity according to its 
diversity of products.  
3. The quality assurance unit and quality control unit shall be independent to 
other departments. The responsibility of quality assurance and quality 
control can be undertaken by a separate quality assurance un it and quality 
control unit or a single unit accordingly.  
Article 6  
The cosmetics manufacturing premises shall regulate the key responsibilities 
as follows:  
1. Management level:  
(1) The organization shall be supported by the top management of the 
company to ensur e the enforcement of these regulations.  
(2) To monitor the participation and commitment of the personnel at all 
level in the manufacturing premises for the following these regulations.  
(3) Management shall categorize the areas in which the authorized 
personnel are  allowed to access.  
2. Personnel in each department and each level:  
(1) To ensure the position and department in the organizational structure.  
(2) To ensure the scope of responsibilities.  
(3) To obtain the related documents within the scope of responsibilities, 
and follow the regulations indicates in the documents.  
(4) Comply with personal hygiene requirements according to Article 8.  
(5) To report the irregularities and other non -conformities.  
(6) To receive adequate educational training and skills to perform the 
activities and responsibilities.  
Article 7  
Personnel of the cosmetics manufacturer involved in production, control, 
storage and shipment shall acquire the appropriate abilities of working 
experience and training according to the responsibilities.   5 1. Appropriate training rel ated to the activities in this regulation shall be 
provided to all personnel.  
2. To ensure training needs of different levels and qualification of the 
personnel, and to conduct and enforce its related training program.  
3. The training program shall be considered  and developed according to the 
expertise, experience, and the scope of responsibilities of the personnel.  
4. The cosmetics manufacturer may outsource to a professional group, if 
necessary, to develop and enforce training program according to the 
training nee ds and manufacturing premises resources.  
5. The personnel shall receive training normally and continually, and the 
training content and program shall be updated regularly.  
6. Newly recruited personnel shall receive theory and practical training 
related to this regulation, and specific training according to the duties 
assigned to them.  
7. The effectiveness of receiving the training shall be evaluated during the 
training process or afterwards.  
Article 8  
The cosmetics manufacturer shall control the hygiene and health of the 
personnel, and the following regulation shall apply:  
1. To establish and to adapt the need of a hygiene program, these 
requirements shall be understood and followed by all personnel who 
entered in the production, control and storage area.  
2. Personnel sha ll be instructed to the hand washing facility.  
3. Ensure the personnel who enter production, control and storage to wear 
appropriate clothing and protection outfit to avoid the contamination of 
cosmetic products.  
4. Avoid the personnel from eating, drinking, che wing, smoking, or to store 
foods, drinks, smoking products or personal drugs in the production, control, 
and storage area.  
5. Prohibit all the unhygienic practice in the production, control, storage area 
or in any other area where the product may be adversely  affected.  
6. Any person affected by an apparent illness or having open wound, a 
measurement shall be taken to be excluded from direct contact to the 
products until the condition is corrected or determined by medical 
personnel that the quality of cosmetic pro ducts will not be compromised.  
Article 9  
Visitor or untrained personnel shall be prohibited to enter production, control 
and storage area. However, if there is any necessity to enter these areas, they  6 shall be given related precaution in advance, including  rules about personal 
hygiene and the prescribed protective clothing, and closely supervised.  
 
Chapter 3 Premises and Facilities  
Article 10  
The location, design, construction, and use of the cosmetics manufacturing 
premises shall be regulated as follows:  
1. To make sure the produces are protected.  
2. May enforce effective cleaning. Sanitizing and maintenance shall be 
enforced when necessary.  
3. To minimize the risk and control of mix -up of products, raw materials, and 
packaging materials.  
The design of the premises  mentioned in the preceding paragraph shall 
consider the type of the cosmetic product produced, existing condition, 
cleaning, sanitizing, and other necessary measures.  
Article 11  
The storage, production, quality control, ancillary, washing and toilets of t he 
cosmetics manufacturing premises shall be separated of identified clearly.  
Article 12  
There shall be sufficient space to enforce operations such as receiving, 
storage, production or other related operations in the cosmetics manufacturing 
premises.  
Article 13  
The flow of the materials, products, and personnel through the building or 
between the buildings shall be planned properly to avoid any mix -ups in the 
cosmetics manufacturing premises.  
Article 14  
The design and construction of the cosmetics manufactu ring premises shall be 
regulated as follows:  
1. The design and construction of floors, walls, ceilings and windows of the 
production area, shall be implemented with smooth surfaces to tolerate 
cleaning agents and sanitizers. They shall be easy to clean and sa nitized to 
maintain in a good condition.  
2. The windows shall be non -opening design, except if there is insufficient 
ventilation in the buildings, shall set up with push out casement windows 
with screens.  
Article 15  
Sufficient and clean washing and toilet facilities shall be provided in the  7 cosmetics manufacturing premises. The facilities shall be separated from 
production area. Sufficient shower and clothes changing facilities shall be 
provided when necessary.  
Articl e 16 
The lighting of the cosmetics manufacturing premises shall be regulated as 
follows:  
1. Sufficient lighting facilities shall be installed to provide the needs for 
operation.  
2. The lighting facilities shall be installed properly or other measures be taken 
to make sure there will not be any fragments from potential breakage to 
contaminate the products.  
Article 17  
There shall be sufficient ventilation, or other specific measures to be taken to 
protect the products in the cosmetics manufacturing premises alterna tively.  
Article 18  
The pipework, drains and ducts in the cosmetics manufacturing premises shall 
be regulated as follows:  
1. Shall be installed properly to avoid any drip and condensation to 
contaminate the materials, products, equipment, and facilities.  
2. Drain s shall be kept flowing smoothly and without any back flow.  
3. Exposed overhead rood beams, pipes and ducts shall be avoided. 
Exposed pipes shall be suspended by brackets or separated and not touch 
the walls for easy cleaning.  
4. Specific measures to be taken to  protect the products when necessary.  
Article 19  
The cleaning and sanitation of the facilities of the cosmetics manufacturing 
premises shall be regulated as follows:  
1. To conduct a specific cleaning and sanitation plan for each area, and to 
keep it in a clea n condition.  
2. To enforce cleaning and necessary sanitation to ensure the products are 
not contaminated.  
3. To identify the specific kinds of the cleaning agents and sanitizers, and to 
ensure they work effectively.  
Article 20  
The cosmetics manufacturing premise s and facilities shall be repaired and 
maintained properly.  
Article 21  
The cleaning agents and lubricants cosmetics manufacturer used to clean,  8 sanitize or maintain premises and facilities shall not affect the quality of the 
products.  
Article 22  
The pest control in the cosmetics manufacturing premises shall be regulated 
as follows:  
1. The design, construction, and maintenance of the premises shall be 
effective to avoid any insects, birds, pests, rodents and other vermin.  
2. A pest control plan shall be conducted . 
3. Measures shall be taken to prevent attracting pests at the exterior of the 
premises.  
 
Chapter 4 Equipment  
Article 23  
Equipment in the cosmetics manufacturing premises shall meets the intended 
uses, and easy to clean, sanitize, and maintain if necessary.  
Article 24  
The equipment design in the cosmetics manufacturing premise shall meet the 
requirements as follows:  
1. The production equipment shall be designed to prevent the products from 
being contaminated.   
2. The container for bulk products shall come with the protection to avoid 
dusts, moisture and other air contaminants.  
3. Transfer hoses and accessories shall be cleaned and sanitized if 
necessary, kept dry and protected properly from dusts, splash or other 
contamination.  
4. The material of the equipment shall be co mpatible with the products, 
cleaning agents, and sanitizer.  
Article 25  
The installation of the equipment shall be regulated as follows:  
1. The design and installation of the equipment shall be easy to drain in order 
to clean and sanitize.  
2. The placement for th e equipment shall consider the movement of materials, 
movement of mobile equipment, and personnel flow, not to pose a risk to 
the quality.  
3. Appropriate access space under, inside and around the equipment shall be 
provided for cleaning and sanitizing.  
4. The ma jor equipment shall be easy to identify.  
Article 26   9 The equipment calibration in the cosmetics manufacturing premises shall be 
regulated as follows:  
1. Laboratory and production measuring instruments related to production 
quality shall be calibrated regularly.   
2. If calibration results of measuring instruments do not meet the acceptance 
criteria, those shall be identified specifically and removed from service.  
3. The condition set forth in the preceding subparagraph shall be investigated 
to confirm the imp act to the production quality and to take appropriate 
measures afterwards according to the investigation result.  
Article 27  
The cleaning and sanitation of the equipment in the cosmetics manufacturing 
premises shall be regulated as follows:  
1. All equipment sh all be cleaned adequately. A Sanitation plan shall be 
established if necessary.  
2. Cleaning agents and sanitizers shall be specifically identified and work 
effectively.  
3. Where equipment is assigned for continuous production or production of 
successive batches of the same products, that equipment shall be cleaned 
and if necessary, a sanitizing period can be established to carry out.  
Article 28  
The equipment maintenance of the cosmetics manufacturing premises shall be 
regulated as follows:  
1. The equipment shall be maintained regularly.  
2. Maintenance operation shall not affect the quality of the products.  
3. The defective equipment shall be identified accordingly and excluded from 
use and isolated, except for any unavoidable condition.  
Article 29  
The consumable uses for e quipment in the cosmetics manufacturing premises 
shall not affect the quality of the products.  
Article 30  
The equipment or automated system in the cosmetics manufacturing premises 
used in production and control shall be access and used by authorized 
person nel. 
Article 31  
The cosmetics manufacturer shall prepare an adequate alternative back -up 
plan for operation system breakdown or failure.  
 
Chapter 5 Raw Materials and Packaging Materials   10 Article 32  
Raw materials and packaging materials purchased by the cosmetics 
manufacturer shall meet the acceptance criteria.  
The acceptance criteria in the preceding paragraph shall be established based 
on the finished products quality requirements.  
Article 33  
Raw materials and packaging materials are purchased from the cosmetics 
manufacturer shall consider the following requirements:   
1. The selection and evaluation of the supplier.  
2. The establishments of technical clauses such as type of selection to be 
conducted, acceptance criteria, measures to take in the case of defect or 
modification, transport conditions or other related items.  
3. Setting of the relations and interactions between the company and supplier 
such as questionnaire, assistance, and audit or other related items.  
Article 34  
The receiving of the raw materials and packaging materials of the cosmetics 
manufacturer shall be regulated as follows:  
1. The records of the purchase order, the deliver notes and the receiving 
materials shall all match.  
2. The integrity of the raw materials and packaging materials shall be checked. 
Transportation data shall be inspected if necessary.  
Article 35  
The raw materials and packaging materials identification and status in the 
cosmetics manufacturing premises shall be regulated as follow:  
1. Shall be labelled in order to identify the material an d batch information.  
2. The raw materials and packaging materials shows defects that may affect 
the product quality shall be suspended hold for further decision.  
3. The raw materials and packaging materials shall be identified and 
separated according to its stat us, such as accepted, rejected or 
quarantined. Those can be identified by using physical system of 
identification or others methods that can ensure the same level of 
identification.  
The identification of the raw materials and packaging materials mentioned in 
the preceding paragraph shall include the following information:  
1. Name of the product indicated on the delivery note.  
2. Name of the products given by the company. If different from the name or 
code number given by the supplier, shall be indicated clearly.   11 3. Batch reference provided by the supplier and the one given at the receipt 
shall all be presented if there is any difference.  
4. Name of the supplier.  
5. Date and number of the receipt, if necessary.  
Article 36  
The release of the raw materials and packaging mater ials in the cosmetics 
manufacturing premises shall be regulate as follows:  
1. To establish physical or other alternative system to ensure only released 
raw materials and packaging materials are used.  
2. The release of the raw materials shall be enforced by autho rized personnel 
who are responsible for the quality.  
3. The analysis certificates provided by the supplier can be accepted as the 
acceptance criteria, only if the supplier possess the sufficient technology, 
experience and knowledge, and agree with the test me thods adopted by 
the company, as well as the appropriate inspection and audit conducted by 
the company.  
After measurement, when there are remaining released raw materials 
mentioned in the preceding paragraph, they shall be contained in a sealed 
container, labelled adequately and stored properly in the storage.  
Article 37  
The storage of the raw materials and packaging materials in the cosmetics 
manufacturing premises shall be regulated as follows:  
1. Storage condition shall be set up properly to fit each raw ma terials and 
packaging materials. Monitoring and control measures shall be taken to 
maintain the specific storage if necessary.  
2. The raw materials and packaging materials shall be stored and handled 
properly according to its characteristics.  
3. The container o f the raw materials and packaging materials shall be sealed 
and stored off the floor.  
4. When repacking the raw materials and packaging materials, the content on 
the labels shall be identical to the original labels.  
5. When raw materials and packaging materials are rejected or quarantined, 
they shall be stored at a certain location, or use other methods to ensure 
they can be identified.  
6. To establish measures to ensure stock turnover, and stock rotation shall 
follow the rules of first in, first out.   
7. Periodic inve ntory shall be performed to ensure the inventory information is 
correct. Any significant discrepancy shall be investigated and corrected.   12 Article 38  
In order to prevent the misuse of materials after the defined period of storage, 
the cosmetics manufacturer  shall establish a re -evaluation system for those 
materials to determine the suitability for use.  
Article 39  
The quality of water used in production shall be regulated as follows:  
1. The water treatment system shall supply a defined quality of water.  
2. The water quality shall be monitored or verified through water quality 
testing or process parameters.  
3. The water treatment system shall permit sanitation.  
4. The material used for the water treatment equipment shall be selected to 
ensure the water quality is not a ffected; the settlement of the water 
treatment equipment shall avoid any water stagnation or the risk of 
contamination.  
 
Chapter 6 Production  
Article 40  
At each stage of manufacturing production, measures shall be taken to ensure 
the finished products meet  the defined specification.  
Article 41  
The cosmetics manufacturer, according to the need of every manufacture 
operation stage, relevant documents and data shall be prepared and available. 
The documents are:  
1. Equipment documents.  
2. Formula for the products  
3. List of all raw material with the quantities and identified batch numbers.  
4. Detailed manufacturing process for each stage, including the addition of 
the raw materials, temperature, speeds, mixing time, sampling, cleaning, 
necessary sanitizing, transfer of bulk  products and other related items.  
Before starting any manufacturing process mentioned in the preceding 
paragraph, these items have to be ensure:  
1. All the relevant documents related to manufacturing and all raw materials 
are prepared, available and released . 
2. Equipment is able to use properly and has been through appropriate 
cleaning and sanitizing.  
3. Operation area is cleaned to preven t from mixing any materials from the 
previous manufacturing operations.   13 The identification of the manufacturing operation menti oned in paragraph 1 
shall be regulated as follows:  
1. All raw materials measured and weighted according to the formula, and 
placed in a labelled, cleaned and suitable container, or directly put into the 
manufacturing equipment.  
2. Major equipment, raw material containers, and bulk product containers 
shall be identified easily at any time.  
3. The identification on the bulk product container shall include: Name or 
identification code, batch number and storage condition when such 
information is critical to assure the quality of the products.  
Manufacturing process mentioned in the preceding paragraph shall be 
regulated as follows:  
1. Establish a manufacturing process control plan includes acceptance 
criteria and to enforce it.  
2. To enforce the plan mentioned in the preceding sub -paragraph. Any result 
does not meet the acceptance criteria shall be and reported and 
investigated according to the procedure.  
Article 42  
Every batch of manufactured bulk products shall be assigned a batch number. 
When the batch number is dif ferent from the numbers on the finished products, 
it shall be easy to identified and related to each other.  
The storage of the bulk products mentioned in the preceding paragraph shall 
be regulated as follows:  
1. Use the proper container for to store, and to p lace it at a specific location 
with adequate condition.  
2. Set up a defined period of storage .  
3. Bulk products shall be re -evaluated and not allowed to use when passed 
the defined period of storage.  
Article 43  
The cosmetics manufacturer, According to the need s for every stage of 
packaging operations, the following relevant documentations and data shall be 
available:  
1. Equipment documents.  
2. Lists of packaging materials . 
3. Operation details in every stages including filling, sealing, labeling,  coding 
or other items.  
Before starting any packaging operation mentioned in the preceding paragraph, 
it shall be ensure that:   14 1. Prepare the documentations and data listed in the preceding paragraph.  
2. Equipment is able to use properly and has been through appropriate 
cleaning and s anitizing.  
3. Operation area is cleaned to preven t from mixing any materials from the 
previous manufacturing operations.  
4. Finishing the establishment of the numbering for product identification 
information.  
Every batch of manufactured bulk products shall be assigned a batch number. 
When the batch number is different from the numbers on the finished products, 
it shall be easy to identified and related to each other.  
During the packaging operation, according to the actual process, Identification 
information sha ll be placed on each operation line; the information includes:  
1. Name and identification code of the packaging operation line.  
2. Name and identification code of the finished products.  
3. Batch number.  
The unused packaging materials shall be placed in a sealed con tainer and 
labelled properly. Then it can be restored to the storage.  
When filling and labelling operation does not complete at once, measures such 
as quarantine and identification shall be taken to avoid mix -up or mislabeling.  
Article 44  
The packaging men tioned in the preceding article, the in -process control shall 
be regulated as follows:  
1. To establish an in -process control plan including acceptance criteria, and to 
enforce it.  
2. Any result does not meet the acceptance criteria shall be and reported and 
investigated according to the procedure.  
The control mentioned in the preceding paragraph, including those who use 
on-line control equipment shall be checked regularly according to the 
established period, items and content.  
 
Chapter 7 Finished Products  
Article 45  
The finished products of the cosmetics shall meet the acceptance criteria.  
The cosmetics manufacturer shall use proper storage, shipment and return 
methods to ensure the quality of the finished products.  
Article 46  
The release of finished produc ts shall be regulated as follows:   15 1. Before releasing to the market, all finished products shall be controlled to 
make sure to meet to acceptance criteria according to the established test 
methods.  
2. The release of the finished products shall be enforced by authorized 
personnel who are responsible for the quality.  
Article 47  
The storage of the finished products shall be regulated as follows:  
1. The finished products shall be stored in a specific area in a systematic 
method according to the storage condition and duration. They shall be 
monitored and controlled, if necessary.  
2. The finished products shall be categorized into release, quarantine or reject 
and they shall be stored at a certain location, or other ways to ensure they 
can be identified.  
3. The identification  of the finished products shall include:  
(1) Name or identification code, batch number and quantity.  
(2) The critical storage condition to assure the quality of the finished 
products.  
4. To establish measures to ensure stock turnover, and stock rotation shall 
follow the rules of first in, first out.  
5. Periodic inventory shall be performed to ensure the list of inventory and 
quantities are complying with the inventory acceptance criteria. Any 
significant discrepancy shall be inspected and corrected.  
Article 48  
Cosmetics manufacturer shall adopt the proper protective measures of 
shipping methods in order to maintain the quality of the finished products 
during the shipping process.  
Article 49  
Cosmetics manufacturer shall handle the returned products according to 
following t he regulations:  
1. To identify in a proper way and to store in a specific area.  
2. To decide the handling method according to the established evaluation 
standard.  
3. For resale products, shall be handled according to the release procedure.  
4. To establish measures to  effectively distinguish the reprocessing return, to 
avoid re -distribution without going through the release procedure.  
 
Chapter 8 Quality Control Laboratory  
Article 50   16 Quality control laboratory shall apply mutatis mutandis to regulations of 
Chapter 2 Management and Personnel, Chapter 3 Premises and Facilities, 
Chapter 4 Equipment, Chapter 11 Contracting, Chapter 16 Documentation.  
Quality control laboratory mentioned in  the preceding paragraph shall enforce 
sampling and testing to the cosmetics materials and the finished products. 
When conducting sampling, testing or other related activities, related control 
shall be enforced in order to make sure the materials for use c omplies with the 
defined acceptance criteria. Packaging and shipping may be approved when 
the finished products are complying with the defined acceptance criteria.  
Article 51  
The test methods mentioned in Paragraph 2 of the preceding article shall be 
clear, appropriate and workable.  
The acceptance criteria mentioned in Paragraph 2 of the preceding article shall 
be defined and established according to types the raw materials, p ackaging 
materials, bulk products, and finished products from Quality control laboratory.  
Article 52  
Test results conducted from quality control laboratory mentioned in the 
preceding 2 articles shall be reviewed. Decisions of approval shall be made 
when  results complies with the relevant provisions after review ; However, 
rejection or pending shall be made when  results does not complies with the 
relevant provisions after review  according to the rules regulated in Article 53.  
Article 53  
Out-of-specification s hall be regulate as follows:  
1. Out-of-specification results shall be reviewed and investigated properly by 
the responsible personnel. Re -testing shall not be performed except with a 
sufficient and legitimate reason.  
2. After the review mentioned in the precedin g subparagraph, the decisions 
shall be made according to the previous article after reviewed as deviation 
or not.  
Article 54  
Reagents, solutions, reference standards and culture media shall, at least, be 
labelled identification information such as name and  opening date. If 
necessary, shall include strength or concentration, storage condition, 
expiration date, and the name or signature of the person who prepared.  
Article 55  
The cosmetics manufacturing premises shall perform sampling operation by 
authorized p ersonnel according to the established sampling operation plan.   17 The operation plan mentioned in the preceding paragraph shall include the 
following:  
1. Sampling methods.  
2. Equipment to be used.  
3. Number of the samples.  
4. Any precautions to be observed to avoid sampl es from contamination and 
deterioration.  
5. Identification information of sample.  
6. Sampling frequency.  
Article 56  
Identification information of sample mentioned in Subparagraph 5 of 
Paragraph 2 of the preceding article shall include the following:  
1. Name or identification code.  
2. Batch number.  
3. Sampling date.  
4. The container from which the sample was taken.  
5. The sampling point, if applicable.  
Article 57  
The retention sample shall be regulated as follows:  
1. The sample of the finished products shall be retained properl y in a specific 
area.  
2. The amount of the retain samples of the finished products shall be 
sufficient enough to enforce analysis.  
3. The samples of the finished products shall be retained with the complete 
packaging, and retain for an appropriate period accordi ng to the storage 
condition.  
4. The samples of the raw materials shall be retained according to the 
regulations of the manufacturing premises or other relevant regulations.  
 
Chapter 9 Treatment of Product that is Out of Specification  
Article 58  
The treatment of rejected finished products, bulk products, raw materials and 
packaging materials of the cosmetics manufacturer shall be regulated as 
follows:  
1. Investigation of rejected products or materials shall be conducted by 
authorized personnel.   18 2. Decisions from qual ity control related authorized personnel to be made to 
determine any further action of the rejected items including destroying or 
reprocessing.  
Article 59  
The reprocessing of the finished products and bulk products according to 
subparagraph 2 of the preced ing article shall be regulated as follows:  
1. The performance of reprocessing shall be approved by the quality control 
related authorized personnel.  
2. The method for reprocessing shall be approved by the responsible 
authorized personnel.  
3. To enforce control of finished products and bulk products after 
re-processing and to be reviewed by the authorized personnel in order to 
ensure to comply with the defined acceptance criteria.  
 
Chapter 10 Waste  
Article 60  
The cosmetics manufacturer shall dispose the wastes in a proper and sanitary 
manner.  
Article 61  
The cosmetics manufacturer shall identify and categorize the type of waste 
that may affect the product quality clearly according to the information of 
production and quality control laboratory.  
Article 62  
The waste di sposal shall be regulated as follows:  
1. The flow of the waste disposal shall not affect the operation of production 
and laboratory.  
2. Appropriate measures shall be taken concerning collection, transportation, 
storage and disposal of the wastes.  
Article 63  
The containers for waste shall be properly identified as to the contents and 
other information.  
Article 64  
The cosmetics manufacturer shall dispose the wastes in a proper way with 
adequate level of control according to subparagraph 2 of Article 62.  
 
Chapter 11  Contracting  
Article 65   19 The cosmetics manufacturer may appoint these items, including manufacture, 
packaging, analysis, pest control, cleaning and sanitizing of the premises, and 
maintenance of the equipment and premises and other related items, to 
agencie s, natural persons, schools, institutions, judicial persons or groups.  
The contracting mentioned in the preceding paragraph which means the 
contract giver shall establish a written contract or agreement with the contract 
acceptor to indicate the objective s, obligations, responsibilities and contract 
performance management in the written documents, in order to ensure the 
products being made or the service being provided can meet the requirements 
from the cosmetics manufacturer.  
The contract acceptor shall r etain or provide all the information related the 
contract of the preceding paragraph to the contract giver.  
Article 66  
When the cosmetics manufacturer conduct the contracting in the preceding 
article, the contracting should be regulated as follows:  
1. To evaluate the performance ability, legal compliance and productivity of 
the contract acceptor, to ensure they have all the abilities to enforce the 
contract and to assure all the contracting items can be carried out 
according to the contract . 
2. To provide the  contract acceptor with all the necessary information.  
Article 67  
The contract acceptor shall be regulated as follows:  
1. To ensure the method of performance, experience, and personnel abilities 
are capable to carry out the requirements indicated in the contr act. 
2. The contract acceptor shall not out -source the items listed in the contract to 
the third party, except with the approval from the cosmetics manufacturer; 
with the approval, the contract acceptor and the third party shall conduct 
another agreement to e nsure the cosmetics manufacturer obtain all the 
operation information according to the original contract or agreement.  
3. To cooperate with the cosmetics manufacturer to conduct investigation and 
to audit according to the contract or agreement.  
4. Except with an other agreement in addition to the contract or agreement, or 
with the approval from the cosmetics manufacturer, the contract acceptor 
cannot make any change to the contract items which may affect the 
products or service quality.  
 
Chapter 12 Deviation  
Article 68   20 When the cosmetics manufacturer discovers any deviations, the decisions 
shall be made according to the support of sufficient data.  
Article 69  
The cosmetics manufacturer shall take corrective action to prevent recurrence 
of the deviation.  
 
Chapter 13 Complaints and Recalls  
Article 70  
Cosmetics manufacturer shall review, investigate and follow -up on, as 
appropriate when handling product complaints.  
Article 71  
Cosmetics manufacturer shall handle p roduct complaints according to the 
following regulations:  
1. To assign authorized personnel to handle complaints.  
2. The handling of complaints and all the detailed shall be recorded and 
preserved.   
3. Appropriate follow -up on the concerning batch shall be completed.  
4. The investigation and follow -up of the complaints shall  include:  
(1) Measures to be taken to prevent any recurrence of defect.  
(2) To check other batch of the products to ensure whether if they are 
affected.  
5.  The amount and content of complaints shall be reviewed periodically, to 
ensure for trends or recurrence of defect.  
Article 72  
When there is contracting for cosmetics manufacturing, the manufacturer and 
contract acceptor shall handle the complaints under the established contracts 
or agreements and not to violate the regulations of the previous 2 articles.  
Articl e 73 
Recall of the products shall be regulated as follows:  
1. Appropriate measures shall be taken and to enforce the correction 
according to these regulations.  
2. The responsible personnel shall negotiate the recall process.  
3. The operation of the product recall shall be initiated promptly and in a 
timely manner.  
4. The related authorities shall be notified of recalls which might cause the 
impact of consumer safety.  
5. The recalled products shall be identified and stored in a safe area.  
6. The product recall process shall be reviewed and evaluated periodically.   21  
Chapter 14 Change Control  
Article 74  
When there is any change to be done which might affect the product quality, 
the cosmetics manufacturer shall assign authorized personnel to check and 
approve with sufficient data  support.  
 
Chapter 15 Internal Audit  
Article 75  
The Cosmetics manufacture premises shall enforce internal audit in order to 
comply with these regulations, and take necessary corrective measures 
according to the results of internal audit.  
Article 76  
The enforcement of internal audit mentioned in the preceding article shall be 
regulated as follows:  
1. To assign a responsible competent personnel to conduct internal audit 
independent and detailed manner, periodically or on demand.  
2. Observed results from internal  audit shall be evaluated and notify the 
appropriate management.  
Article 77  
The cosmetics manufacturer shall ensure the corrective measures mentioned 
in Article 75 are achieved or implemented.  
 
Chapter 16 Documentation  
Article 78  
The cosmetics manufacturer  shall design, establish, install and maintain its 
own documentation systems according to its organization structure and the 
type of the products.   
The documentation systems mentioned in the preceding paragraph is an 
internal part of Good Manufacturer Prac tices. The documentation shall record 
all the operation activities according to these regulations to prevent risks of 
misinterpretation, loss of information, confusions or error.   
Electronic systems may be established and managed documents mentioned in 
the documentation systems in Paragraph 1.  
Article 79  
The content of documentation systems mentioned in the preceding article shall 
include: procedures, instructions, specifications, protocols, reports, methods, 
and records.   22 The content of the documentation me ntioned in the preceding paragraph shall 
be kept in hard -copy papers or electronic data processing records.  
Article 80  
All activities in these regulations such as operation details, measures to be 
taken, and precautions to be taken shall be detailed docume nted. The title, 
nature and purpose shall be stated in every document.  
Documents mentioned in the preceding paragraph shall be written legibly and 
comprehensively. The authorized responsible personnel shall sign and 
indicate the date as approval before the  announcement, and update, annul, 
distribute, and archive accordingly.  
The documents mentioned in Paragraph 1 shall be obtained from the 
appropriate personnel in the company, and to ensure the annulled documents 
are deleted, destroyed and not being used ag ain. 
Article 81  
The required hand written records in the documentation mentioned in 
Paragraph 1 Article 79 shall be regulated to write legibly with permanent ink. 
The recorder shall sign and indicated the date of the record. Any correction 
shall require th e same consent.  
The correction of the written records mentioned in the preceding paragraph 
shall leave the original entry readable, if necessary, the reason of the 
correction shall be recorded.  
Article 82  
The documents shall be updated if necessary. For those are updated, shall 
indicate the revision number and the reasons for each revision shall be 
retained.  
Article 83  
Archiving of the documentation shall be regulated as follows:  
1. The controlled copies each revision of the documents mentioned in the 
preced ing articles shall be used, and the original records shall be archived.   
2. The duration of archiving original documents shall be defined according to 
the related regulations.  
3. The storage of original documents shall be properly secured.  
4. The documents shall be  stored electronically or as hard -copy papers, and 
to ensure their legibility.  
5. The documents shall be back -upped regularly and stored in a separated 
safe location.