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Regulations on Cosmetic Good Manufacturing and Quality Control Practices
[Enforcement Date: Sept. 2, 2015] [Ministry of Food and Drug Safety Notice No. 2015-58, Sept. 2, 2015, Partial Amendment]
Ministry of Food and Drug Safety (Cosmetics Policy Division), 043-719-3413
Chapter 1 General Provisions
Article 1 (Purpose)
The purpose of this Notice is to contribute to consumer protection and improved public health by manufacturing and providing superior cosmetics by setting forth the details concerning the cosmetic good manufacturing and quality control practices and recommending its implementation pursuant to Article 5 (2) of the Cosmetics Act and Article 12 (2) of the Enforcement Rule thereof.
Article 2 (Definitions)
Terms used in this Notice shall be defined as follows:
1. <Deleted>.
2. The term “manufacture” means a series of work from weighing raw materials to mixing, filling (primary packing), secondary packing, labeling, etc.
3. <Deleted>.
4. The term “quality assurance” means all planned and systematic activities that are required for providing reliability that products will meet the standards for approval decision.
5. The term “deviation” means a behavior that has occurred by deviating from a predetermined standards of manufacturing or quality control activities, etc.
6. The term “out-of-specification” means an examination, measurement, or test result which does not comply with prescribed standards for approval decision.
7. The term “raw material” means a material that is injected or included in the manufacture of bulk products.
8. The term “raw material and supplies” means raw material and supplies of cosmetics.
9. The term “complaint” means outside information on claims that the product does not meet the prescribed standards for passing qualification decision. 
10. The term “recall” means an activity of bringing back products of manufacturing numbers (including other manufacturing numbers when necessary) that have shown quality defect, safety issue, etc. among products that have been sold to the manufacturing plant.
11. The term “contamination” means an occurrence of undesired problems due to a chemical, physical, and microbiological problem, or a combination of them.
12. The term “cleaning” means all work done to maintain cleanness through mixed factors such as a chemical method, mechanical method, temperature, and time of application by separating and removing visible dusts from the surface to maintain the external appearance.
13. The term “maintenance control” means periodic and non-periodic support and verification work done so that buildings and facilities can be maintained in a proper working environment.
14. The term “major facilities” means an essential facility that affects the product quality as a facility specified in a document related to manufacturing and quality control. 
15. The term “calibration” means comparing the value that indicated by a measurement device or measurement system under a specified condition with a true value of standard devices, verifying that their difference falls in the allowed range, and if it divers from the allowed range, making adjustment so that it would fall in the permitted range.
16. The term “manufacturing number” or “batch number” means a number that has been assigned so as to verify all matters concerning the manufacturing management and delivery for a constant manufacturing unit and is composed of a number, letter, and symbol or a particular combination of them.
17. The term “half-finished product” means a product that is still in the stage of manufacturing process and which would become a bulk product after going through more required manufacturing processes.
18. The term “bulk product” means a product for which manufacturing steps prior to the filling (primary packing) have been completed.
19. The term “manufacturing unit” or “batch” means a specific amount of cosmetics that have homogeneity as they are manufactured through one or a series of processes.
20. The term “finished product” means a product which has completed all manufacturing processes including labeling process, etc. for packages and attached documents of products for delivery.
21. The term “re-work” means re-processing finished products, bulk products, or half-finished products that have diverged from the standards for passing decision so that their qualities would fall in the proper range.
22. The term “consigned person” means a person, a company or an outside organization that carries out a work instead of an employee, a company, or an organization.
23. The term “process control” means all work that is carried out to monitor and adjust processes during a manufacturing process so as to ensure the fulfillment of standards for a passing decision.
24. The term “inspection” means a systematic and independent investigation that is carried out to determine whether the manufacturing and quality-related result agrees with the matters that are planned and whether manufacturing and quality control is carried out effectively and appropriate for achieving the objective.
25. The term “management of changes” means making changes under the responsibility of an internal organization to all activities to which cosmetic good manufacturing and quality control practices apply so as to ensure that all manufactured, managed and stored products meet standards for a passing decision.
26. The term “internal audit” means a systematic and independent investigation that is carried out by an employee who has proper qualifications to determine whether the manufacturing and quality-related result agrees with the matters that are planned and whether manufacturing and quality control is carried out effectively and appropriate for achieving the objective
27. The term “packing material” means all materials used for packing cosmetics and excludes exterior packing materials used for transportation. Depending on whether or not it contacts the product directly, it is called either a primary or secondary packing material.
28. The term “standards for a passing decision” means a numerical limit, range or other proper measurement method to make a decision regarding the suitability of a test result.
29. The term “consumables” means products (detergent, lubricant, etc) used during the cleaning, sanitation control, or maintenance work.
30. The term “management” or “control” means verifying whether the standards for a passing decision are met.
31. The term “manufacturing plant” means a place for manufacturing cosmetics.
32. The term “building” means a physical location, structure, and supplementary structures used for receipt, storage, manufacturing, management and shipping of products, raw materials, and packing materials.
33. The term “sanitation control” means work that is carried out to reduce contaminants such as undesired microorganisms, etc. on the surface of subjects.
33 The term “shipment” means a series of work related to the preparation for an order and the activity of loading to the means of transportation in order to deliver products to outside of the manufacturing plant.
Chapter 2 Human Resources
Article 3 (Composition of Organization)
(1) There shall be an independent manufacturing department and a quality assurance department for each manufacturing plant. 
(2) Organization structure shall be prescribed so that the roles of the organization and employees can be understood easily, and it shall be appropriate according to the company size and product variety.
(3) Manufacturing plant shall have a sufficient number of people who can carry out manufacturing and quality control work appropriately.
Article 4 (Responsibility of Employees)
(1) All workers have a responsibility to carry out the following: 
 1. Duty to be aware of the position and role for which they are responsible within the organization;
2. Duty to follow the regulations on the limited access to documents and personal sanitation;
3. Duty to report occurrences, etc. of behaviors or nonconformance that deviates from the standards within the scopeof his/her work;
4. Duty to carry out education and training for their designated responsibilities and activities.
 (2) Quality assurance manager shall be a manager of a department that is in charge of quality assurance, and he/she shall perform the following:
1. Review and approval of all documents and procedures related to the product quality;
2. Verification of whether quality inspection is being processed according to the prescribed regulations;
3. Investigation and recording of deviations when there are deviations;
4. Decision regarding the shipment of raw materials and products with a passing decision;
5. Verification of whether disapproved products are being processed according to the prescribed procedures;
6. Supervision of matters concerning the complaint management and product recall.
Article 5 (Education and Training)
(1) Yearly plan shall be set up so as to provide all employees who are related to the manufacturing and quality control work with education and training that is appropriate for their duties and responsibilities, and the education shall be conducted regularly.
(2) A person in charge of education shall be designated, and regulations on the education and training which include the content and evaluation of education and training shall be prepared. When necessary, training may be requested to be carried out by an outside professional organization.
(3) Upon finishing the training, training result shall be evaluated, and if it does not meet a certain level, re-training shall be required.
(4) Newly hired employees shall receive additional trainings besides the basic training so as to be able to carry out their duties properly. And procedures related to this shall be documented.
Article 6 (Sanitation of Employees) 
(1) Proper sanitation standard operating procedures shall be established, and all employees shall follow them. 
(2) All employees in the manufacturing establishment and storage shall wear a prescribed uniform and not bring in food to prevent contamination of cosmetics.
(3) Employees who have external injuries on the skin or have disease shall be separated to prevent a direct contact with cosmetics until a doctor determines that their health has gotten better or that it would not affect the quality of cosmetics.
(4) A worker or a visitor who has an authority of access for each manufacturing area shall try to not enter manufacturing, management, and storage areas as much as possible. When inevitable, they shall receive the training for employee’s sanitation in advance and follow the rules on the uniform.
Chapter 3 Manufacturing
 Section 1 Facilities Standards
Article 7 (Building)
(1) Buildings shall be located, designed, constructed and used according to the following:
1. It shall protect products.
2. It shall allow easy cleaning, and when necessary, sanitation control and maintenance shall be made possible.
3. It shall not allow confusion among products, raw materials, packing materials, etc.
(2) Buildings shall be designed considering the form of product, current situation, cleaning, etc.
Article 8 (Facility)
(1) Manufacturing establishment shall comply with the following:
 1. It shall be divided and classified properly depending on the types and forms of cosmetics being manufactured so as to prevent possibilities for cross-contamination.
 2. Floor, wall, and ceiling shall have a smooth surface to make cleaning easy and have resistance against corrosion by disinfectants, etc.
 3. It shell be well ventilated and clean.
 4. It shall be as difficult as possible to open windows that are connected to the outside.
 5. Exterior surface inside the manufacturing establishment shall be designed to be as smooth as possible and have resistance against corrosion by cleaning materials and disinfectants.
 6. Washing room and bathroom shall be easy to access, but they shall be separated from production areas.
 7. Proper lighting shall be installed in the entire manufacturing establishment. And processing measures that can protect products shall be prepared in case of a breakage of lighting.
 8. It shall be equipped with an air-conditioning and proper ventilating facility that can prevent contamination of products and maintain appropriate temperature and humidity.
 9. Detergents and disinfectants with proven effectiveness shall be used according to the cleaning and sanitation SOPs for each manufacturing area.
10. Consumables which do not affect the product quality shall be used.
(2) Facility that is required for manufacturing and quality control shall comply with the following:
 1. It shall be appropriate for its purpose of use, and cleaning shall be possible. When necessary, sanitation and maintenance control shall be possible. The same applies when an automatic system has been introduced.
 2. Connecting hose and other accessories shall receive sanitation control such as cleaning, etc. And they shall be maintained in a dry condition and shall be protected from dust, stain or other contaminations.
 3. Facilities, etc. shall be designed and installed so as to prevent contamination and make drainage easy. It shall not cause chemical reactions with products and cleaning disinfectants.
 4. Location of facilities, etc. shall not affect the product’s quality due to the movement of raw materials by an employee.
 5. Containers shall be able to protect the content from dust or water.
6. Pipes and drainage system pipes shall be installed so as to prevent contamination of products and facilities. Back flow shall not occur in drainage pipes which shall be maintained clean.
7. Pillar, pipe, duct, etc. near the ceiling shall be designed so that they would not be exposed as much as possible, and pipes shall be fixed with a mount, etc. so that they would not touch the walls and make cleaning easy.
 8. Consumables that are used on facilities and equipment shall not affect the product quality.
Article 9 (Sanitation of Manufacturing Establishment)
(1) A measure shall be prepared to prevent insects, pests, or rodents, and regular inspection verification shall be conducted.
(2) Floor, wall, ceiling and windows with in the manufacturing, management, and storage areas shall be maintained clean at all times.
(3) Detergent or disinfection substances used for cleaning manufacturing facilities and equipment shall have a proven effectiveness, and it shall not remain or cause an abnormality on the surface.
(4) Manufacturing facilities or equipment shall be cleaned with a proper method, and when necessary, sanitation control program shall be operated.
Article 10 (Maintenance)
(1) Building, facilities and major equipment shall be inspected regularly and maintained, managed, and recorded so that there would not interfere with manufacturing and quality control of cosmetics.
 (2) Equipment with defect or under maintenance shall be indicated with a proper method, and it shall be indicated if they cannot be used due to breakage, etc.
 (3) Facilities that have been washed shall be managed so that they would not be contaminated until the next use.
(4) All equipment related to manufacturing shall be approached and used by people who are approved.
(5) Tests, measurements, testing equipment, and automated devices which may have an effect on product quality shall be regularly calibrated, checked for their performance, and recorded by establishing a plan.
(6) Maintenance job shall not affect the product quality.
Section 2 Management of Raw Materials
Article 11 (Warehousing Management)
 (1) Manufacturer shall properly conduct a management and supervision of raw materials suppliers in order to ensure a thorough warehousing management.
 (2) When storing raw materials, purchase request, test report by the supplier of raw materials, and the actual product shall match each other. When necessary, data concerning the transportation may be verified additionally. 
 (3) If there is no manufacturing number on the containers of raw materials, management number shall be assigned for product storage.
 (4) If a defect is detected througha bare-eye verification during the storing process of raw materials, storing shall be postponed, and the raw materials shall be kept separately, discarded, or returned to the supplier.
 (5) Stored raw materials shall be labeled as “approved,” “disapproved,” “being tested,” etc. to indicate their status: however, if there is another system under which a certification at the equivalent level is possible, it may be substituted.
 (6) Required items to be written on the containers of raw materials and in test records shall be as follows:
1. Name of a product decided by the supplier of raw materials;
2. Name of the supplier of raw materials;
3. Date of receipt;
4. Manufacturing number or control number provided by the supplier.
Article 12 (Delivery Management)
 Only the raw materials that have been approved based on the test result shall be delivered on a first-in, first-out basis, and there shall be a system established to verify this.
Article 13 (Storage Management)
 (1) Raw materials, half-finished products and bulk product shall be stored in a condition which does not affect the product’s quality negatively, and a storage period shall be set up.
 (2) Raw materials, half-finished products and bulk product shall be stored such that they would not contact the floor or walls, and they shall be stored so that they may be delivered on a first-in, first-out basis.
 (3) Raw materials, products under test and disapproved products shall be stored each in separate compartments: however, this may not apply if they are stored through a system under which confusion among products would not occur.
 (4) If a storage period that has been set up previously passes, reevaluation system shall be established to determine the appropriateness of using it, and it shall be prescribed so that it would not be used when the storage period has passed through the same system.
Article 14 (Quality of Water)
 (1) Water quality shall be prescribed according to its purpose of use.
(2) Water quality shall be inspected regularly, and when necessary, microbiological tests shall be conducted.
(3) Water supply facility shall meet the following standards:
1. It shall be installed so as to avoid stagnation and contamination of water.
2. It shall not affect the quality of water.
3. It shall accommodate a sterilization treatment.
Section 3 Manufacturing Control
Article 15 (Standard Operating Procedures (SOP), etc.)
(1) In order to assure that the basic requirements that guarantee reasonableness in manufacturing and quality control are being met, product dossier, SOP for manufacture, SOP for quality control and SSOP for manufacture pursuant to the following shall be prepared and retained.
(2) Product dossiers shall include the following for each product:
 1. Name of a product;
 2. Date of preparation;
 3. Efficacy and effectiveness (for functional cosmetics) and precautions for use;
 4. Name of raw materials, quantity, and standard amount per manufacturing unit;
 5. Detailed work content for each process and manufacturing process diagram;
 6. Theoretical amount of production by process and standards of yield management;
 7. Precautions during the work;
 8. Standards and test methods of raw materials, half-finished products and finished products;
 9. Facilities and equipment required for manufacturing and quality control;
10. Storage condition;
11. Use-by date or best-before date after opening;
12. History of revisions;
13. Manufacturing order form which includes the following:
a. Number of the product dossier;
b. Name of a product;
c. Manufacturing number, date of manufacturing or use-by date (or best-before date after opening);
d. Manufacturing unit;
e. Name of raw materials used, quantity, test number and actual amount used per manufacturing unit; 
f. Name of a manufacturing facility;
g. Detailed work content for each process and precautions;
h. A person who ordered the manufacturing and date of order;
14. Other necessary matters.
 (3) SOP for manufacture shall include the following:
1. Matters concerning the management of manufacture processing
a. Access control at the manufacturing establishment;
b. Method of inspecting;
c. Method to verify whether raw materials and supplies intended to be used have passing criteria;
d. Re-work method.
2. Matters concerning the management of facilities and equipment
a. Method of a regular inspection of facilities and major equipment;
b. Method of indicating facilities and equipment being used;
c. Method of calibrating and inspecting performance of equipment.
3. Matters concerning the management of raw materials
a. Method of verifying the product’s name, specification, quantity, damaged condition of packages during the warehousing, and measures to process damages, if damaged;
b. Storing location and method;
c. Method of processing products disapproved based on the test result;
d. Preventive measures to avoid confusion and contamination during the processing;
e. First-in, first-out method when making a delivery and matters to be indicated on the weighed container;
f. Inventory management.
4. Matters concerning the management of finished products
a. Method of verifying passing decisions upon arrival and shipment;
b. Storing location and method;
c. First-in, first-out method when making a shipment.
5. Matters concerning the consigned manufacturing
a. Method of supplying raw materials, and delivering and storing half-finished products, bulk products, or finished products;
b. Method of evaluating a consignee’s record of manufacturing.
 (4) SOP for quality control shall include the following:
1. Test order form including the following:
a. Name of product, manufacturing number or control number, date of manufacturing;
b. Test order number, name of orderer, and date of order;
c. Test items and standards.
2. Method of sampling and its precautions, and preventive measure to avoid contamination during the sampling;
3. Inspection of testing facilities and equipment;
4. Safety test;
5. Management of a finished product and samples for storing purposes;
6. Management of a reference standard and a reagent;
7. When consigning testing or manufacturing, method of transferring samples and a method to making a decision about the test result;
8. Other necessary matters.
 (5) SSOP for manufacture shall include the following:
1. Method of understanding and taking measures for a worker’s health care, health conditions;
2. Matters concerning the sanitation such as a worker’s washing, disinfection method;
3. Specification, cleaning method and rules for wearing working uniform;
4. Method and frequency of cleaning the workroom, etc. (including disinfection when necessary. The same applies below.)
5. Method of evaluating cleaned status;
6. Cleaning and evaluation of manufacturing facilities:
a. Designation of a manager
b. Plan for cleaning and sterilizing
c. Method of cleaning along with chemicals and devices used for cleaning
d. Method of disassembling and assembling manufacturing facility
e. Method of removing indication for previous work
f. Method of maintaining a cleaned status
g. Method of verifying the cleaned status prior to the work
7. Method of catching insects, pests or rodents and inspection period;
8. Other necessary matters.
Article 16 (Weighing)
 (1) Raw materials shall be weighed accurately in a container or facility that does not affect their qualities.
 (2) There shall be a measure by which a cross-contamination can be avoided during the weighting.
Article 17 (Process Control)
 (1) Proper management standards shall be defined for each manufacturing process, and all results that do not meet such standards shall be reported so that measures can be taken.
 (2) Returned products shall be put in a proper container and kept in a designated place to prevent any deterioration in quality. Following matters shall be indicated on a container:
 1. Name or verification code;
 2. Manufacturing number;
 3. Name of the completed process;
 4. Storage condition, when necessary.
 (3) Maximum storage period of half-finished productshall be set up, and half-finished products that have neared their maximum storage period shall be checked for any abnormality, changes, etc. in quality.
Article 18 (Packaging Work)
 (1) Procedures for packaging work shall be documented and retained.
 (2) Packing shall be conducted according to a packing manual which contains the following matters:
 1. Name of a product;
 2. Name of packing facilities;
 3. List of packing materials;
 4. Detailed process of packing;
 5. Amount of packaging production.
 (3) Prior to starting a packaging work, matters such as a preparation of a document concerning packaging work, clean status of packaging facilities, operability, etc. shall be inspected.
Article 19 (Storage and Shipment)
 (1) Finished products shall be kept in a designated place under a proper condition, and an inspection shall be performed regularly. 
 (2) Only the finished products that have been approved based on a test result and approved for shipment by a quality assurance manager shall be shipped.
 (3) Shipment shall be made on a first-in, first-out basis, and it may be otherwise if there is a valid reason.
 (4) Products to be shipped shall be stored in a place that is separated from raw materials, disapproved products, and returned products: however, it may be otherwise if they are stored through a system under which confusion among products would not occur.
Chapter 4 Quality Control
Article 20 (Management of Tests)
 (1) Procedures of administrative affairs involved in tests for quality control shall be documented and retained.
 (2) Proper standards shall be established with regards to the raw materials, half-finished products and finished products, and test records shall be prepared and retained. 
 (3) Approval or disapproval based on a test result shall be clearly recorded.
 (4) Only the raw materials, half-finished products and finished products that have been approved shall be used or shipped.
 (5) Raw materials whose storage periods have passed and returned products may be reused in manufacturing if they are in compliance with the quality standards based on a reexamination.
 (6) Test records for whether all tests have been carried out properly shall be reviewed to determine pass, fail, or pending.
 (7) When deviation from standards occurs, it shall be reported to a manager and investigated according to the regulations. Investigation result shall be clearly determined by a manager as deviation, fail, or pending.
 (8) Following matters shall be written on containers of reference standard and major reagent:
 1. Name
 2. Date of opening
 3. Storage condition
 4. Use-by date
 5. Titer, name or signature of the manufacturer (applicable only when it is manufactured directly by a manufacturer)
Article 21 (Collection and Storage of Samples)
 (1) Samples shall be collected such a way that it would not be contaminated or spoiled, and after being collected, it shall be put in a package that is comparable to its original condition and indicate that a sample has been collected.
 (2) Following matters shall be stated on the containers of sample stored:
 1. Name or verification code
 2. Manufacturing number
 3. Date of sampling
 (3) Sample whose purpose is to store a finished product shall be kept for one year in a designated area under a proper storage condition by its manufacturing unit. However, storage shall be made for 3 years from the date of manufacture if the use-by date is indicated after opening of product.
Article 22 (Disposal Method)
 (1) For a product that has a problem in its quality or has been recalled or returned, whether or not it is discarded or reworked shall be approved by a quality assurance manager.
 (2) Rework may be carried out when the product meets all of the following conditions:
 1. Product has not been spoiled, deteriorated, or contaminated by pathogenic microbes.
 2. It has not been one year since the manufacturing date, or more than one year remains in its use-by date.
 (3) Regulations shall be prepared regarding the disposal of products that may not be stored in a warehouse again, and subjects of disposal shall be kept separately and promptly discarded pursuant to the regulations.
Article 23 (Consignment Contract)
 (1) When consigning part of a process or test for manufacture and quality control of cosmetics, its procedures shall be written and maintained as a document. 
 (2) A person who intends to consign manufacturing work is recommended to consign manufacturing to a business whose qualifications are approved by the Minister of the Ministry of Food and Drug Safety (MFDS) under the cosmetic good manufacturing and quality control practices pursuant to Article 30.
 (3) Consigning company shall evaluate the consigned company’s ability to carry out a contract and make sure that they are equipped with necessary facilities, etc. for carrying out a contract.
 (4) Consigning company shall enter into a contract with the consigned company through a written document and shall deliver relevant information to the consigned company so that the job can be accomplished accurately.
 (5) Consigning company shall conduct an inspection defined by the contract with regards to the consigned company, and the consigned company shall accept this.
 (6) Data created by the consigned company concerning the consignment shall be retained so that it may become available for use by the consigning company.
Article 24 (Deviation Management)
 After conducting an investigation of deviations during the manufacturing process, necessary measures shall be prepared.
Article 25 (Complaint Management)
 (1) A person responsible for complaint management shall gather all complaints about the product, promptly investigate the complaints, take appropriate measures about them, and record and maintain the following matters:
 1. Registration date of complaints;
 2. Name and contact information of a person who filed a complaint;
 3. Details about the complaint including the name of product, manufacturing number, etc.;
 4. Details about the investigation of complaints and the follow-up investigations, result of processing, and future steps;
 5. Inspection of whether or not there is any effect on products with different manufacturing numbers.
 (2) Complaints shall be regularly reviewed to understand the tendency of product defect.
Article 26 (Product Recall)
 (1) If a manufacturer finds out a possible hazard from a manufactured cosmetic due to the violations of Articles 7, 9, 14 or 16 (1) of the Cosmetics Act, he/she shall take measures necessary for a recall without delay.
 (2) There shall be a recall manager who performs the following:
 1. Coordination role with a manufacturer-seller about the whole recall process;
 2. Recall of defective product and keeping related records;
 3. For a recall that affects consumer safety, execution of necessary measures for a smooth progression of recall;
 4. With regards to the recalled products, measures to store them separately inside the manufacturing plant after verifying them (applicable only when necessary);
 5. Regular evaluation of recall process (applicable only when necessary).
Article 27 (Management of Changes)
 When changing raw materials or manufacturing process, etc. that affect the quality of products, it shall be documented and performed after being approved by a quality assurance manager.
Article 28 (Internal Audit)
 (1) Internal audit shall be carried out in order to check regularly whether the quality assurance system complies with the matters planned. And procedures for planning and executing internal audits shall be documented and retained.
 (2) A person who carries out an audit shall be independent from the subject audit and shall not conduct an audit of his/her own work.
 (3) Audit results shall be recorded and shared with a person in charge of management and the manager of an inspected department. Corrective measures shall be taken for defects found during the audit.
 (4) A person who carries out an audit shall conduct a follow-upaudit with regards to the corrective measures and make a record of it.
Article 29 (Management of Documents)
 (1) Manufacturer shall document management guidelines that embody an objective and intent for cosmetic good manufacturing practices and quality assurance which all employees shall follow.
 (2) Regulations on the management of documents which contain matters concerning the management such as writing, amendment, approval, distribution, recall, disposal, etc. of all documents shall be written and maintained. 
 (3) Documents shall be written easily for a worker to understand, and the written documents shall contain a signature by a person with authority and date of approval.
 (4) Writer, reviewer, and approver of documents shall use them after registering their signatures.
 (5) When amending documents, reasons for amendment and date of amendment shall be written, and approval by a person with authority shall be required. And amendment number shall be designated.
 (6) Original documents shall be kept in the quality assurance department, and a copy shall be located and used in a place where a worker can reach easily.
 (7) Documents shall be kept safely through a printed copy or an electronic medium.
 (8) A worker shall make a record in the document at the same time as he/she is performing the work, and he/she shall write using an ink that cannot be erased.
 (9) When making corrections to a document, words or sentences that are to be corrected shall be crossed out so as to be able to recognize the content before applying corrections, and corrected document shall contain reasons for corrections, date of corrections, and signature by a person who made corrections.
 (10) All recorded documents shall have proper preservation period prescribed.
 (11) Data such as a back-up file, etc. shall be maintained in preparation of any damages to or loss of a record.
Chapter 5 Judgement and Supervision
Article 30 (Evaluation and Judgement)
 (1) Businesses that desire to receive qualifications approval under the cosmetic good manufacturing and quality control standards practices shall submit the application pursuant to Annexed Form 1 to the Minister of the MFDS by attaching the following documents: however, businesses that carry out only part of a process shall indicate the relevant process pursuant to Appendix 1 in Annexed Form 1.
 1. Deleted. <10/16/2012>
 2. Company-specific evaluation sheet that has been applied or operated at least three times according to the cosmetic good manufacturing and quality control practices;
 3. Administrative group for operating the cosmetic good manufacturing and quality control practices;
 4. Details about the facilities of a manufacturing plant;
 5. Manufacturing control status;
 6. Quality control status.
 (2) Deleted. <10/16/2012>
 (3) Deleted. <10/16/2012>
 (4) If a decision for qualification approval under the manufacturing and quality control standards for superior cosmetics has been given based on the review of submitted data and inspection of actual conditions pursuant to Appendix 2, the Minister of the Food and Drug Safety shall issue a certificate of business qualified under the manufacturing and quality control standards for superior cosmetics: Provided, That for businesses that carry out only part of a process, relevant process shall be written in the certificate.
Article 31 (Complimentary Measures)
 (1) Deleted. <10/16/2012>
 (2) For raw materials and supplies provided by the companies that are certified with international quality management systems standards (CGMP, ISO9000) or companies that are considered to have a quality assurance capability, method of inspection and test criteria may be adjusted by considering the evidence of record that is provided regarding their suitability.
 (3) For business entities whose qualifications are approved under the cosmetic good manufacturing and quality control practices pursuant to Article 30, the Minister of the MFDS may exclude them from being subject to regular inspection and audit.
 (4) Businesses whose qualifications are approved under the cosmetic good manufacturing and quality control practices pursuant to Article 30 may display the logo in accordance with Appendix 3 in their business and on cosmetics manufactured in such business or advertise such facts.
Article 32 (Post Management)
 (1) For businesses whose qualifications are approved under the cosmetic good manufacturing and quality control practices pursuant to Article 30, the Minister of the MFDS shall conduct an inspection at least once every three years according to the inspection schedule for implementation of the cosmetic good manufacturing and quality control practices specified by Appendix 2.
 (2) For businesses that are determined to be inappropriate according to the result of post management, the Minister of the MFDS may order correction by specifying a certain period or cancel the business approved under the cosmetic good manufacturing and quality control practices.
 (3) Notwithstanding paragraph (1), for business that are deemed to have a problem with manufacturing and quality control, the Minister of the MFDS may frequently conduct an inspection for implementation of the cosmetic good manufacturing and quality control practices.
Article 33 (Reexamination Deadline)
The Minister of the MFDS shall review the appropriateness of this Notice every three years beginning on January 1, 2016 (meaning by December 31 every third year) pursuant to the Regulations on the Issuance and Management of Instructions, Established Rules, etc. and take proper measures for improvement, etc.
Supplementary Provision <No. 2015 – 58, 9/2/2015>
Article 1 (Enforcement Date)
 This Notice will be effective from the date of its announcement.
Article 2 (Application)
This Notice shall be applicable beginning with the inspection for implementation of the cosmetic good manufacturing and quality control practices requested by a manufacturer after the enforcement of this Notice.
Note: Please be advised that the translation in this document is for convenience only. In the event of any dispute, reference must always be made to the Korean original.
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