1 
 Cosmetics  Good Manufacturing Practice Regulations  Draft  
 
Announced Date:  
 
Chapter 1 General Provisions  
 
Article 1  
These regulations are promulgated pursuant to the Paragraph 4, Article 8 of the Cosmetic 
Hygiene and Safety Act (hereafter referred to as the  Act) and with reference to the ISO 22716: 
Cosmetics -Good manufacturing practices (GMP) -Guidelines on good manufacturing 
practices issued by the International Organization for Standardization.  
 
Article 2  
The terms used in this regulations are defined as fo llows:  
 
1. Acceptance criteria: the acceptable numerical limits, ranges, or other suitable 
measurement regulations  according to the test results.  
 
2.  Auditing: systematic and independent examination, the aim of which is to determine 
whether quality activi ties and related results comply with planned arrangements and 
whether these arrangements are implemented effectively and are suitable for achieving 
objectives.  
 
3.  Batch: defined quantity of raw material, packaging material or product issued from a 
single  or series of manufacturing processes and identified as homogeneous.  
 
4. Batch number: distinctive combination of numbers, letters and/or symbols, which 
specifically identifies a batch.  
 
5.  Bulk products: any products that are completed the manufacturing stages up to, but not 2 
 including, final packaging.  
 
6. Calibration: under specified condition, to establish the operation methods and procedures 
to ensure the relationship between the values indicated by the measurement equipment 
or measurement system, or m aterial measuring values and the known reference 
standard values.  
 
7. Change control: any planned change of one or several activities related to Good 
Manufacturing Practice conducted by the internal organizations and responsible to 
ensure that all the manu facturing, packaging, controlling and storage of the products to 
meet the defined acceptance criteria.  
 
8.  Cleaning: all operations that ensure a level of cleanliness and appearance, consisting of 
separating and eliminating generally visible dirt from a s urface by means of the 
following combined factors, in variable proportions, such as chemical action, 
mechanical action, temperature, duration of application.  
 
9. Complaint: external information claiming a product does not meet the defined 
acceptance criter ia. 
 
10. Contamination: occurrence of any undesirable matter such as chemical, physical and/or 
microbiological matter in the product.  
 
11. Consumables: materials such as cleaning agents and lubricants that are used up during 
cleaning, sanitization or maint enance operations.  
 
12. Contract acceptor: person, company or external organization which enforce an 
operation outsourced by Cosmetics firms.  
 
13. Control: verification that acceptance criteria are met.  3 
  
14. Deviation: internal organization and responsibil ities relative to the authorization to 
deviate from specified requirements due to a planned or unplanned and, in any case, 
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 control: 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 product.  
 
21.  Out-of-specification: examination, measurement or test result that does not comply 
with the defined acceptance criteria.  4 
  
22.  Packaging operation: all packaging steps including filling and labelling, 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 for transportation. And according to direct contact 
with the product or not, defined a s primary or secondary packaging material.  
 
24.  Plant: location for production of cosmetic products.  
 
25.  Premises: physical location, buildings or 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 c riteria.  
 
28.  Raw material: any substance going into or involved in the manufacturing of a bulk 
product.  
 
29.  Recall: decision made by a cosmetics firm to call 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 bulk product 
of an unacceptable quality 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 5 
 defec t back to the cosmetics firm.  
 
32.  Sample: one or more representative elements selected from a set to obtain information 
about that set.  
 
33.  Sampling: set of operations relating to the taking and preparation of samples.  
 
34.  Sanitization: depending on the objectives set, operation used to reduce undesirable 
micro -organisms on inert contaminated surfaces, means as the operation of reducing 
invisible contaminants.  
 
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.  
 
Chapter 2 Personnel  
 
Article 3  
The personnel in the cosmetics manufacturing plants who participate the activities indicates 
in the acceptance criteria shall have an appropriate training to comply the quality of 
production, control and product storage operation.  
 
Article 4  
The personnel in the cosmetics manufacturing plants shall establish th e organization 
according to the following:  
 
1.  Organization chart  
 6 
  (1) Regulate the organization to ensure the division of labor and competency according 
to the scale and diversity of its product of the manufacturing plants.  
 
 (2) To ensure there are ad equate staffing levels 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 contr ol can be 
undertaken by a separate quality assurance unit and quality control unit or a single 
unit. 
 
2. Number of personnel: According to the activities defined in this regulation, the 
manufacturing plants  shall have adequate personnel with appropriate tr aining.  
 
Article 5  
The cosmetics manufacturing plants shall regulate the key responsibilities as follows:  
 
1.  Management responsibilities:  
 
 (1)The organization shall be supported by the top management of the company.  
 
 (2) The implementation of Good Manu facturing Practice shall be the responsibility of 
the top management and shall require the participation and commitment of the 
personnel at all level in the manufacturing premises for the achievement.  
 
 (3) Management shall categorize the areas in which th e authorized personnel are allowed 
to access.  
 
2.  Personnel responsibilities:  
 7 
  (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 scop e of responsibilities, and follow the 
regulations indicates in the documents.  
 
 (4) Comply with personal hygiene requirements.  
 
 (5) To report the irregularities and other non -conformities.  
 
 (6) To receive adequate educational training and skills to perfo rm the activities and 
responsibilities.  
 
Article 6  
The personnel involved in production, control, storage and shipment of  cosmetics 
manufactur er shall acquire the appropriate abilities of working experience and training 
according to the responsibilities.  
 plants shall enforce personnel training according to the following:  
 
The training mentioned in the preceding paragraph shall be regulate as follows:  
 
1. Appropriate training related 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.  8 
  
4. To evaluate training needs and manufacturing p lants  resources, or be carried out by 
outside company if necessary.  
 
5. The personnel shall receive training normally and continually, and the training content 
and progra m 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 7  
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 shall be instructed to the hand washing facility.  
 
3.  Ensure the personnel who enter production, control and storage area to wear appropriate 
clothing and protection outfit to avoid the contamination of cos metic products.  
 
4.  Avoid the personnel from eating, drinking, chewing, 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 9 
 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 products will 
not be com promised.  
 
Article 8  
Visitor or untrained personnel shall be prohibited to enter production, control and storage 
area. However, if there is any necessity to enter these areas, the y should be given related 
precaution in advance, including rules about personal hygiene and the prescribed protective 
clothing, and closely supervised.  
 
Chapter 3 Premises  
 
Article 9  
The location, design, con struction, and use of the cosmetics manufacturing plants  shall be 
regulated as follows:  
 
1. To make sure the produces are protected.  
 
2. Enforce effective cleaning. Sanitizing and maintenance shall be enforced when 
necessar y. 
 
3. To minimize the risk and control of mix -up of products, raw materials, and packaging 
materials.  
 
The design of the premises shall consider the type of the cosmetic product produced, existing  
condition, cleaning, and necessary sanitizing measures.  
 10 
 Article 10  
The storage, production, quality control, ancillary, washing and toilets of the cosmetics 
manufacturing plants shall be separated or identi fied clearly.  
 
Article 11  
There shall be sufficient space to enforce operations such as receiving department, storage 
and production in the cosmetics manufacturing plants.  
 
Article 12  
The flow of the materials, products, and personnel through the building or buildings shall be 
planned properly to avoid any mix -ups in the cosmetics manufacturing plants.  
 
Article 13  
The floors, walls, ceilings, and windows of the cosmetics manufacturing plants 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 sanitized to maintain in a good condition.  
 
2.  The windows shall be non -opening design, except if there is insufficient ventilation in 
the buildings. Those with opening design shall set up with screen windows.  
 
Article 14  
Sufficient and clean washing and toilet facilities shall b e provided in the cosmetics 
manufacturing plants. The facilities shall be separated from production area, and convenient 
to use. Sufficient shower rooms and changing clothes area shall be provided when necessary.  
 
Article 15  
The li ghting of the cosmetics manufacturing plants shall be regulated as follows:  11 
  
1.  Sufficient lighting facilities shall be installed to provide the needs for operation.  
 
2.  The lighting facilities s hall 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 16  
There shall be sufficient ventilation, or other specifi c measures to be taken to protect the 
products in the cosmetics manufacturing plants alternatively.  
 
Article 17  
The pipework, drains and ducts in the cosmetics manufacturing plants shall be regulated as 
follows:  
 
1.  The pipework, drains and ducts shall be installed properly to avoid any drip and 
condensation to contaminate the raw materials, products, equipment, and premises.  
 
2.  Drains 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  if necessary . 
 
Article 18  
The cleaning and sanitation of the premises of the cosmetics manufacturing plants shall be 
regulated as follows:  
 
1. To conduct a specific cleaning and sanitation plan for each area, and to keep it in a clean 12 
 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 sanitizer, and to ensure the 
effectiveness  when u sage. 
 
Article 19  
The cosmetics manufacturing plants shall be repaired and maintained properly.  
 
Article 20  
The cleaning agents and lubricants cosmetics manufacturer used to clean, sanitize or maintain 
premises and facilities shall not affect the quality of the products.  
 
Articl e 21 
The pest control in the cosmetics manufacturing plants shall be regulated as follows:  
 
1. The design, construction, and maintenance of the premises shall be effective to avoid 
any insects, birds, pests, rode nts 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 22  
Equipment in the cosmetics manufacturing plants shall meets the intended uses, and easy to 
clean, sanitize, and maintain if necessary.  13 
  
All equipment related to this regulation in the cosmetic s manufacturing plants shall be 
governed by provision in this chapter. For those with automated system integration 
technology shall require the same consent.  
 
Article 23  
The design of the equipment in the cosmetics manufacturing  plants 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 protecti on to avoid dusts, moisture 
and air contaminants.  
 
3.  Used transfer hoses and accessories shall be cleaned and sanitized if necessary, kept dry 
and protected from dusts, splash or other contamination.  
 
4.  The material of the equipment shall be compatible with the products, cleaning agents, 
and sanitizer.  
 
Article 24  
The installation of the equipment in the cosmetics manufacturing plants shall be r egulated 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 the equipment shall consider the movement of materials, mobil e 
equipment and personnel flow which do not pose a risk to the quality.  14 
  
3.  Appropriate access space under, inside and around the equipment shall be provided for 
cleaning and sanitizing.  
 
4.  The major equipment sha ll be easy to identify.  
 
Article 25  
The calibration of the equipment in the cosmetics manufacturing plants shall be regulated as 
follows:  
 
1.  Laboratory and production measuring instruments related t o 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 impact to the production quality and to take appropriate measures afterwards 
according to the investigation result.  
 
Artic le 26  
The cleaning and sanitation of the equipment in the cosmetics manufacturing plants shall be 
regulated as follows:  
 
1.  All equipment shall be cleaned adequately. A Sanitation plan shall be established if 
necessary.  
 
2.  Cleaning agents and sanitizers shall be identified and effective.  
 
3.  Where equipment is assigned for continuous production or production of successive 15 
 batches of the same products, that equipm ent shall be cleaned and if necessary, a 
sanitizing period can be established to carry out.  
 
Article 27  
The maintenance of the equipment in the cosmetics manufacturing plants shall be regulated 
as follows:  
 
1. To be main tained 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 unavoi dable condition.   
 
Article 28  
The consumable uses for equipment in the cosmetics manufacturing plants shall not affect the 
quality of the products.  
 
Article 29  
The equipment or automate d system in the cosmetics manufacturing plants used in 
production and control shall be access and used by authorized personnel.  
 
Article 27  
The cosmetics manufacturer shall prepare an adequate alternative back -up plan  for operation 
system breakdown or failure.  
 
Chapter 5 Raw Materials and Packaging Materials  
 
Article 31  16 
 Raw materials and packaging materials are purchased from the cosmetics manufacturer shall 
meet the acceptance criteria . 
The acceptance criteria mentioned in the preceding paragraph shall be established according  
to the quality  requirements  of finished products.  
 
Article 32  
Raw materials and packaging materi als are purchased from the cosmetics manufacturer shall 
consider the following requirements:  
 
1. The supplier qualification.  
 
2. The establishments of technical clauses such as type of selection to be cond ucted, 
acceptance criteria, measures to take in the case of defect or modification, transport 
conditions.  
 
3. Setting of the relations and interactions between the company and supplier such as 
questionnaire, assistance, and au dit. 
 
Article 33  
The receipt 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 visually. 
Transportation data shall be inspected if necessary.  
 
Article 34  17 
 The raw materials and packaging materials identification and status in the cosmetics 
manufacturing plants shall be regulated as follow:  
 
1.  The containers of raw materials and packaging materials shall be labelled in order  to 
identify the material and 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 status, such as accepted, rejected or quarantined. Those can be identified by using 
physical system of identification or others that can make sure the same  level 
identification.  
 
The identification mentioned in the preceding paragraph shall include the following:  
 
1. Name of the product indicated on the delivery note.  
 
2. Name  or code  of the  material s given by the company. If different from the name or code 
number given by the supplier, shall be indicated clearly.  
  
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 35  18 
 The release of the raw materials and packaging materials in the cosmetics manufact uring 
plants 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 mat erials shall be enforced by authorized personnel who are 
responsible for the quality.  
 
3.  The certificates of analysis provided by the supplier can be accepted as the basis of 
release, only i f the supplier possess the sufficient technology, experience and 
knowledge, adopt the test methods agreed by the cosmetics firm, and completed 
appropriate audit.  
 
The raw materials released under the requirements  mentioned in the preceding paragraph, 
those weighted and unused raw materials after process operation shall be placed in a sealed 
container and labelled properly. Then it can be restored to the storage.  
 
Article 36  
The sto rage of the raw materials and packaging materials in the cosmetics manufacturing 
plants shall be regulated as follows:  
 
1.  Storage condition shall be set up properly to fit each batch of raw materials and 
packaging materials.  The company shall monitor and control to maintain the specific 
storage condition, if necessary.  
 
2.  The raw materials and packaging materials shall be stored and handled properly 
according to its characteristics.  
 
3.  The container of the raw materials and packaging materials shall be sealed and stored 19 
 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 other ways to ensure they can be identified.  
 
6.  To estab lish measures to ensure stock turnover, and stock rotation shall follow the 
principle of first in, first out.  
 
7.  Periodic inventory shall be performed to ensure the inventory information is correct. 
Any significant dis crepancy shall be inspected and corrected.  
 
Article 37  
In order to prevent the misuse of the materials which are reached the defined period of 
storage of the materials, t he cosmetics manufacturer shal l establish a re -evaluation system to 
determine the suitability for use.  
 
Article 38  
The quality of water used in production shall be regulated as follows:  
 
1. The water treatment system shall supply a defi ned 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 20 
 water quality is not affected and t he settlement of the water treatment equipment shall 
avoid any water stagnation and the risk of contamination.  
 
Chapter 6 Production  
 
Article 39  
At each stage of manufacturing operation and packaging operation, measures shall be taken 
to ensure the finished products meet the defined specification.  
 
Article 40  
The manufacturing operations of the cosmetics , the relevant documents according to the need 
of every stage shall be prepared and  available  at any time . 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 for each stage, including the addition of t he raw materials, 
temperature, speeds, mixing time, sampling, cleaning, necessary sanitizing and transfer 
of bulk products.  
 
Before starting any manufacturing operations mentioned in the preceding paragraph , these 
items have to be ensure:  
 
1. Prepare all the relevant doc uments and raw materials, available and released, related to 
manufacturing .  
 
2. Equipment has been through appropriate cleaning and sanitizing, and  is able to use 21 
 properly.  
 
3. Operation area is cleaned to prevent from mixing any materials from the previous 
manufacturing operations.  
 
The manufacturing operations mentioned in Paragraph 1 , the identification of in -process 
operation sh all 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 identificat ion 
code, batch number and storage condition when such information is critical to assure 
the quality of the products.  
 
The manufacturing  operation mentioned in the preceding paragraph, the in -process control 
shall be regulated as follows:   
 
1. To establish and enforce an in -process control plan including acceptance criteria.  
 
2. Any result does not meet the acceptance criteria during the enforcement of in -process 
control plan mentione d in the preceding subparagraph shall be reported and 
investigated according to the procedure.  
 
Article 41  22 
 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.  
 
The storage of bulk products mentioned in the preceding paragraph shall be regulated as 
follows:  
1. Bulk products shall be stored in a proper container, and placed in a specific area under 
the appropriate condition.  
 
2. The storage duration of the bulk products shall be defined.  
 
3. When this duration is reached, the bulk products shall not be used without re-evaluat ion. 
 
Article 4 2 
The packaging  operations of the cosmetics, the relevant documents according to the need of 
every stage shall be prepared and available at any time. The documents are:  
 
1. Equipment documents . 
 
2. Lists of packaging materials.  
 
3. Operation details in every stages including filling, sealing, labelling and coding.  
 
Before starting any  packaging operations mentioned in the preceding paragraph, these items 
have to be ensure:  
 
1. Prepare all packaging materials and the relevant documents listed in the preceding 
paragraph.  
 
2. Equipment has been th rough appropriate cleaning and sanitizing and is able to use 23 
 properly.  
 
3. Operation area is cleaned to prevent from mixing any content and packaging materials 
from the previous manufacturing operations.  
 
4. Coding to permit identification of the defined product.  
 
Every batch of finished products after packaging shall be assigned a batch number. When the 
batch number is different from the numbers on the bulk products , it shall be easy to identified 
and related to each other.  
 
During packaging operations, the identification information shall be placed on each operation 
line at that time. The information are: n ame and identification code of the packaging 
operation line, Name and identification code of the finished products and the batch numbers.  
 
The unused packaging materials shall be placed in a sealed container and labelled pr operly. 
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 43  
The packaging operations mentioned in the preceding paragraph, the in -process control shall 
be regulated as follows:  
 
1. To establish and enforce an in -process control plan including acceptance criteria.  
 
2. Any result does not meet the acceptance criteria shall be and reported and investigated 
according to the procedure.  
 24 
 The in -process control mentioned in the preceding paragraph, f or those who use  on-line 
control equipment shall be checked regularly according to the established period, items and 
content.  
 
Chapter 7 Finished Products  
 
Article 4 4 
The finished products of the cosmetics shall me et the acceptance criteria.  
The cosmetics manufacturer shall use proper storage, shipment and return methods to ensure 
the quality of the finished products.  
 
Article 4 5 
The release of finished products shall be regulated as follows:  
 
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 b e enforced by authorized personnel who are 
responsible for the quality.  
 
Article 4 6 
The storage of the finished products shall be regulated as follows:  
 
1. The finished products shall be stored in a s pecific 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.  
 25 
 3.  The identification of the finished products shall include:  
 
 (1) Name or identification code , batch number and  Quantity of the finished products.  
 
 (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 
principle of first in, first out.  
 
5.  Periodic inventory shall be performed to ensure the inventory information is correct. 
Any significant discrepancy shall be investigated.  
 
Article 4 7 
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 4 8 
The returns of the finished produc ts shall be regulated as follows:  
 
1. The returns shall be identified and be stored in a specific area.  
 
2. The returns shall be evaluated according to the established standard to determine their 
disposition.  
 
3.  Any re -marketing products shall be released according to the procedure . 
 
4. To establish measures to identified any reprocessed return and to avoid redistribution of 
unreleased returns.  
 
Chap ter 8 Quality Control Laboratory  
 26 
 Article 49  
Regulations described for personnel, premises, equipment, subcontracting and 
documentations shall apply to the quality control laboratory.  
 
The responsible activities of the quality control laboratory mentioned in the preceding 
paragraph are: to enforce necessary sampling and testing and its related control in order to 
ensure the release of the materials for use and the release of the product for packaging 
shipping comply to the acceptance criteria.  
 
Article 50  
The quality control laboratory shall define and establish the acceptance criteria of raw 
materials, packaging materials, bu lk products and finished products.  
 
The compliance with the acceptance criteria mentioned in the preceding paragraph shall use 
necessary test methods to ensure.  
 
The test methods mentioned in the preceding paragrap h shall be clear, appropriate and 
workable.  
 
All results shall be reviewed by the quality control laboratory mentioned in Paragraph 1, and 
decisions of approval, rejection or pending shall be made after the review.  
 
Article 51  
The result mentioned in the preceding paragraph  is out-of-specification shall be regulate d as 
follows:  
1.  Out-of-specification results shall be reviewed and investigated properly by the 
responsible personnel. After the review, the decisions shall be made as deviation, 
rejection or pending.  
 
2.  Re-testing shall not be performed except with a sufficient and legitimate reason.  27 
  
Article 52  
Reagents, solutions, reference standards and culture media, etc. shall  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 53  
The cosmetics manufacturing plants shall perform sampling operation by authorized 
personnel according to the established sampling operat ion plan.  
 
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 obser ved to avoid samples from contamination and deterioration.  
 
5. Identification information of sample  
 
6. Sampling frequency  
 
Article 54  
The identification information of sample mentioned in Paragraph 2 of the pr eceding Article 
shall include the following:  
 
1. Name or identification code  28 
  
2. Batch number  
 
3. Sampling date  
 
4. The container from which the sample was taken  
 
5. The sampling point, if  necessary  
 
Article 55  
The retention sample shall be regulated as follows:  
 
1. The sample of the finished products shall be retained properly in a specific area.  
 
2. The amount of the retain samples of the finished p roducts 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 according to the storage condition.  
 
4. The samples of the raw materials shall be retained according to the regulations of the 
manufacturing plants or other relevant regulations.  
 
Chapter 9 Treatment of Product that is Out of Specification  
 
Article 56  
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 s hall be conducted by authorized 29 
 personnel.  
 
2. Decisions from quality control related authorized personnel to be made to determine any 
further action of the rejected items.  
 
Article 57  
The reprocessing of the finished products and bulk products shall be regulated as follows:  
 
1. The performance of reprocessing shall be approved by the quality control related 
authorized personnel.  
 
2. The methods of repeocessing shall be specified and approved.  
 
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 crit eria. 
 
Chapter 10 Waste  
 
Article 58  
The cosmetics manufacturer shall dispose the wastes in a proper and sanitary manner.  
 
Article 59  
The cosmetics manufacturer shall iden tify the type of waste that may affect the product 
quality clearly according to the information of production and quality control laboratory.  
 
Article 60  
The waste disposal shall be regulated as follows:  
 
1. The f low of the waste disposal shall not affect the operation of production and laboratory.  30 
  
2. Appropriate measures shall be taken concerning collection, transportation, storage and 
disposal of the wastes.  
 
Article 61  
The containers for waste shall be properly identified as to the contents and other information.  
 
Article 62  
The cosmetics manufacturer shall dispose the wastes in a proper way with adequate level of 
control.  
 
Chapter 11 Subtracting  
 
Article 63  
The cosmetics manufacturer shall establish a written contract or an agreement with the 
subcontractor according to the subcontract items, and to indicate the objectives, 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 subcontractor shall retain or provide all the information related the contract of the 
preceding paragraph to the cosmetics manufacturer.  
 
The subcontracting items ment ioned in Paragraph 1 includes: manufacture, packaging, 
analysis, pest control, cleaning and sanitizing of the premises, and maintenance of the 
equipment and premises.  
 
Article 64  
When the cosmetics manufacturer conduct the sub contracting in the preceding article, the 
subcontracting should be regulated as follows:  31 
  
1. To evaluate the performance ability, legal compliance and productivity of the 
subcontractor, to ensure they have all th e abilities to enforce the contract and to assure 
all the subcontracting items can be carried out according to the contract  
 
2. To provide the subcontractor with all the necessary information.  
 
Article 65  
The subcontrac tor shall be regulated as follows:  
 
1. To ensure the performance ability, experience and the personnel ability  meet  the 
requirements indicated in the contract.  
 
2. The subcontractor 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 
subcontractor and the third party shall conduct another agreement to ensu re 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 contrac t or agreement.  
 
4. Except with another agreement in addition to the contract or agreement, without the 
approval from the cosmetics manufacturer, the subcontractor cannot make any change 
to the cont ract items which may affect the products or service quality.  
 
Chapter 12 Deviations  
 
Article 66  32 
 When the cosmetics manufacturer discovers any deviations, the decisions shall be made 
according to the supp ort of sufficient data.  
 
Article 67  
The cosmetics manufacturer shall take corrective action to prevent recurrence of the deviation.  
 
Chapter 13 Complaints and Recalls  
 
Article  68 
The complaints shall be reviewed, investigated and follow -up on, as appropriate.  
 
Article 69  
Product complaints shall be regulated as follows:  
 
1. To assign authorized personnel to handle complaints.  
 
2. The handling of complaints shall be follow -up 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.  
 33 
 Article 70  
In the case of subcontracting, the cosmetics manufacturer and the subcontr actor shall 
establish a written contract or an agreement on the process of managing complaints.  
 
Article 7 1 
Recall of the products shall be regulated as follows:  
 
1. When products are recalled, appropriate  measures and steps shall be taken to complete 
according to the rules in these regulations.  
 
2. The responsible personnel shall negotiate the recall process.  
 
3. The operation of the product recall shall be initiated promptl y 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 , isolated  and stored in a safe  area.  
 
6. The product recall process shall be reviewed and evaluated periodically.  
 
Chapter 14 Change Control  
 
Article 7 2 
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  
 34 
 Chapter 7 3 
The Cosmetics manufactu re plants shall enforce internal audit in order to comply with these 
regulations, and , if necessary, take corrective measures according to the results of internal 
audit.  
 
Article 7 4  
The enforcement of internal audit shall be regulat ed as follows:  
 
1. To assign a responsible competent personnel to conduct internal audit independent and 
detailed manner, periodically or on demand.  
 
2. The o bserv ations made  from internal audit shall be evaluated and notif ied the 
appropriate management.  
 
Article 7 5 
The cosmetics manufacturer shall ensure the corrective measures mentioned in Article 7 3 are 
achieved or implemented.  
 
Chapter 16 Documentation  
 
Article 76  
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 Practices. The documentation shall record all the operation activities according 
to these regulations to prevent risks of misinterpretation, loss of information, confusions or 
error.  
 
The systems mentioned in Paragraph 1 can be established and managed in electronic.  35 
  
Article 77  
The content of documenta tion systems mentioned in the preceding article shall include: 
procedures, instructions, specifications, protocols, reports, methods, and records.  
 
The content of the documentation mentioned in the preceding paragraph shall  be kept in har d-
copy papers or electronic data processing records.  
 
Article 78  
All activities in these regulations such as operation details, measures to be taken, and 
precautions to be taken shall be detailed d ocumented. The title, nature and purpose shall be 
stated in every document.  
 
The content of the documents mentioned in the preceding paragraph shall be written legibly 
and comprehensively. The authori zed responsible personnel shall sign and indicate the date 
as approval before the announcement, and update appropriately, annul, distribute, and archive 
accordingly.  
 
The documents mentioned in Paragraph 1 s hall be obtained from the appropriate personnel in 
the manufacturing plants , and the annulled documents shall be  ensure d were deleted, 
destroyed and not being used again.  
 
Article 7 9 
The requi red hand written records in the document mentioned in the preceding article shall be 
regulated to write legibly with permanent ink. The recorder shall sign and indicated the date 
of the record.  For those correction of the written records shall require the 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.  
 36 
 Article 80 
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 8 1 
Archiving of the documentation shall be regula ted as follows:  
 
1. The controlled copies each revision of the documents shall be used, and the original 
records shall be archived.  
 
2. The duration of archiving original documents shall be defined accor ding 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.  
 
Article 8 2 
These regulations shall be effective as of the date of promulgation.