ISO 22716 requirements cosmetics Good Manufacturing Practices version 2007

20/10/2023

The "ISO 22716 Requirements version 2007" quiz will help you understand the main requirements of the standard.

The questions (requirements) included in this quiz are 132 of the 331 in the standard, but don't worry. These requirements are among the most important. So do not hesitate to learn in a fun way!

Do not think you can finish this quiz in less than an hour, or even two hours, unless of course you are a little genius!

Some news about ISO 22716 version 2007

The course T 23v07 ISO 22716 readiness version 2007 and its free demo without registration

The course T 43v07 ISO 22716 internal audit version 2007 and its free demo without registration

The T 73v07 training package ISO 22716 readiness and internal audit version 2018

The 331 ISO 22716 requirements (recommendations) version 2007 (verb should) of clauses 3 to 17 are as follows:

ISO 22716: 2007 requirements
No	Clause	PDCA cycle	Requirement No	Quantity
3	Personnel	Plan	1 ÷ 36	36
4	Premises	Plan	37 ÷ 72	36
5	Equipment	Plan	73 ÷ 97	25
6	Raw materials	Plan	98 ÷ 133	36
7	Production	Do	134 ÷ 176	42
8	Finished products	Do	177 ÷ 200	25
9	Laboratory	Do	201 ÷ 233	33
10	Nonconforming products	Check	234 ÷ 239	6
11	Wastes	Act	240 ÷ 245	6
12	Subcontracting	Do	246 ÷ 265	20
13	Deviations	Check	266 ÷ 267	2
14	Complaints and recalls	Act	268 ÷ 282	15
15	Change controls	Do	283	1
16	Internal audit	Check	284 ÷ 287	4
17	Documentation	Do	288 ÷ 311	24
Total				331

22716 requirements

ISO 22716 requirements version 2007

pdca

The Deming PDCA cycle

Note. Any advice (recommendation, tip, wish, statement) in the standard begins with "The organization should...". For simplicity's sake we present the requirements directly, starting with the verb, as in the end we are dealing with requirements

ISO 22716 version 2007 - Requirements (recommendations) and comments
No	Article, paragraph	Requirement (recommendation)	Comments, PDCA, links
	3	Personnel	P (Pan)
	3.1	Principle
1	3.1	Have appropriate training to produce, control and store products of a defined quality	For persons involved in the implementation of the activities described in the Good Manufacturing Practices Guidelines (ISO 22716), cf. § 3.4
	3.2	Organization
	3.2.1	Organization chart
2	3.2.1.1	Define the organization chart	In order to understand the organization and functioning of the company's staff. The organization chart may be functional, but another document must link the function and the person
3	3.2.1.1	Ensure that the organizational structure is appropriate	Concerning the size of the company and the diversity of its products
4	3.2.1.2	Ensure that staffing levels in the different areas of activity are adequate	According to the diversity of its production
5	3.2.1.3	Demonstrate the independence of the quality units	In the organization chart
6	3.2.1.3	Assume responsibilities for quality assurance and quality control	By a single unit or by two separate units
	3.2.2	Number of people
7	3.2.2	Have an adequate number of trained personnel	With regards to the activities defined in the guidelines on Good Manufacturing Practices (ISO 22716), cf. § 3.4
	3.3	Key responsibilities
	3.3.1	Management responsibilities
8	3.3.1.1	Support the organization	By the top management of the company
9	3.3.1.2	Implement Good Manufacturing Practices	Responsibility of top management
10	3.3.1.2	Require the participation and commitment of personnel from all departments	And at all levels within the company
11	3.3.1.3	Define and communicate the areas in which authorized personnel have access	Responsibility of top management
	3.3.2	Responsibilities of personnel
12	3.3.2 a	Know their position in the organization chart	For all personnel
13	3.3.2 b	Know their defined responsibilities and activities	For all personnel
14	3.3.2 c	Have access to and comply with documents relevant to their particular responsibility scope	For all personnel, cf. article 17
15	3.3.2 d	Follow personal hygiene requirements	For all personnel, cf. § 3.5
16	3.3.2 e	Be encouraged to report irregularities and other nonconformities which may occur in the field	For all personnel
17	3.3.2 f	Have appropriate training and knowledge to perform the assigned responsibilities and activities	For all personnel, cf. § 3.4
	3.4	Training
	3.4.1	Training and skills
18	3.4.1	Have skills based on adequate training and experience acquired both appropriate to their responsibilities and activities	For personnel involved in production, control, storage and shipment
	3.4.2	Training and Good Manufacturing Practices
19	3.4.2.1	Provide for all personnel appropriate Good Manufacturing Practices training	In relation to the guidelines of ISO 22716 and specific activities such as the use of a scale and control equipment
20	3.4.2.2	Identify training needs of all personnel	Regardless of level or seniority in the company
21	3.4.2.2	Develop a training program	And implemented
22	3.4.2.3	Design training courses tailored to be appropriate to people's jobs and responsibilities	Considering the expertise and experience of the respective personnel
23	3.4.2.4	Design and execute training courses in-house	By the company itself or with the help of external organizations
24	3.4.2.5	Regard training as a constant and on-going process	Process that is subject to regular updates
	3.4.3	Newly recruited personnel
25	3.4.3	Receive appropriate training for the tasks of newly recruited personnel	Besides basic training on the theory and practice of Good Manufacturing Practices
	3.4.4	Personnel training evaluations
26	3.4.4	Evaluate knowledge accumulated by personnel	During or after training. Hot, at the end of training and cold, two to three months later. Evaluate the personnel and not the training
	3.5	Personnel hygiene and health
	3.5.1	Personnel hygiene
27	3.5.1.1	Establish and adapt hygiene programs	To the needs of the plant
28	3.5.1.1	Ensure that the requirements of hygiene programs are understood and followed	By every person whose activities take them into production, control and storage areas
29	3.5.1.2	Be instructed to use hand washing facilities	For all personnel
30	3.5.1.3	Wear suitable clothing and protective garments for every person entering production, control and storage areas	In order to avoid contamination of cosmetic products. Appropriate clothing is common (blouse, shoes), while protective clothing is specific (mask, gloves, cap) when personnel are in direct contact with the raw material or product
31	3.5.1.4	Avoid eating, drinking, chewing and smoking in production, control and storage areas	Or even holding food, beverages, tobacco or medicines in these areas
32	3.5.1.5	Prohibit unhygienic practice in production, control and storage areas	Or in any other area where the product might be adversely affected
	3.5.2	Personnel health
33	3.5.2	Take steps to ensure, as far as possible, that any person suffering from an apparent illness or with uncovered wounds is excluded from direct contact with cosmetic products	Until the condition is corrected or determined by medical personnel that the quality of cosmetic products will not be compromised
	3.6	Visitors and untrained personnel
34	3.6	Do not take visitors or untrained personnel into production, control and storage areas	If reasonably possible
35	3.6	Inform in advance about personal hygiene and the prescribed protective clothing	When this is unavoidable
36	3.6	Supervise closely visitors and untrained personnel	In the event that these persons still have to go to production, control and storage areas
		Premises	P (Panifier)
	4.1	Principle
37	4.1.1 a	Ensure protection of the product	By means of suitably located, designed, constructed and utilized premises
38	4.1.1 b	Allow efficient cleaning, sanitizing, if necessary, and maintenance	By means of suitably located, designed, constructed and utilized premises
39	4.1.1 c	Minimize the risk of mix-up	Of products, raw materials and packaging materials by means of suitably located, designed, constructed and utilized premises
40	4.1.2	Base decisions on the design of the premises	Based on the type of cosmetic product produced, existing conditions, cleaning and, if necessary, sanitizing measures used
	4.2	Types of area
41	4.2	Provide separate areas	For storage, production, quality control, ancillary, washing and toilets
	4.3	Space
42	4.3	Provide sufficient space	To facilitate operations such as receipt, storage and production
	4.4	Flow
43	4.4	Define the flow of materials, products and personnel	In order to prevent mix-ups
	4.5	Floors, walls, ceilings, windows
44	4.5.1	Design or construct floors, walls, ceilings and windows in production areas	For ease of cleaning and, if necessary, sanitization
45	4.5.1	Keep floors, walls, ceilings and windows clean in production areas	And in good repair
46	4.5.2	Do not open windows	Where ventilation is adequate, cf. § 4.8
47	4.5.2	Protect properly windows with a screen	When windows are opened
48	4.5.3	Allow for proper cleaning and maintenance	For new construction of production areas
49	4.5.3	Include, if necessary, smooth surfaces	When design of new construction
50	4.5.3	Allow for resistance to corrosive cleaning and sanitizing agents	For smooth surfaces lisses when design of new construction
	4.6	Washing and toilet facilities
51	4.6	Provide for personnel adequate, clean, washing and toilets facilities	Provide a room for hand washing
52	4.6	Differentiate toilet and washing facilities from production areas	While remaining accessible
53	4.6	Provide adequate facilities	For showering and changing clothes
	4.7	Lighting
54	4.7.1	Install adequate lighting in all areas	That is sufficient for operations
55	4.7.2	Install lighting in a manner to ensure containment of any debris	From potential breakage
56	4.7.2	Take measures, if necessary	To protect the product
	4.8	Ventilation
57	4.8	Provide adequate ventilation	For the intended production operations
58	4.8	Take specific measures, if necessary	To protect the product
	4.9	Pipework, drains and ducts
59	4.9.1	Install pipework, drains and ducts	In such a manner so that drip or condensation does not contaminate materials, products, surfaces and equipment
60	4.9.2	Keep drains clean	And should not allow back flow
61	4.9.3 a	Take into consideration when designing	Avoid exposed overhead roof beams, pipes and ducts
62	4.9.3 b	Take into consideration when designing	Exposed pipes should not touch walls, but be suspended from or supported by brackets, sufficiently separated to allow thorough cleaning
63	4.9.3 c	Take into consideration when designing	Specific measures should be taken to protect the product, if necessary
	4.10	Cleaning and sanitization
64	4.10.1	Maintain premises in a clean condition	Cleaning is planned and carried out by qualified personnel
65	4.10.2	Carry out cleaning, and, if necessary, sanitization	To protect each cosmetic product
66	4.10.3	Use cleaning, and, if necessary, sanitizing agents	Specified and effective
67	4.10.4	Have cleaning and, if necessary, sanitization programs	Corresponding to specific needs of each area
	4.11	Maintenance
68	4.11	Maintain premises in a good state of repair	Cf. the other paragraphs of article 4
	4.12	Consumables
69	4.12	Use appropriate consumables for production and storage premises	That do not affect the quality of the product
	4.13	Pest control
70	4.13.1	Design, construct and maintain the premises in such a way as to limit the access of parasites	Such as insects, birds, rodents, pests and other vermin
71	4.13.2	Establish a pest control protection program appropriate for the premises	Inside the premises, set up physical traps and trap monitoring
72	4.13.3	Take measures to control the exterior of the premises	In order to avoid attracting pests or providing shelter for them
	5	Equipment	P (Pan)
	5.1	Principle
73	5.1	Adapt the equipment for the intended use	This applies to all equipment falling within the scope of the ISO 22716 cosmetic Good Manufacturing Practice guidelines
74	5.1	Clean and, if necessary, sanitize, and maintain	For all equipment
75	5.1	Take into account the application of the given appropriate principles	For the use of automated systems
	5.2	Equipment design
76	5.2.1	Design production equipment that is easy to maintain	To prevent contamination of the product
77	5.2.2	Protect bulk containers from contaminants	Carried by air such as dust and moisture
78	5.2.3	Clean and, if necessary, sanitize transfer hoses and accessories used	And kept dry and protected from dust, splash or other contamination
79	5.2.4	Ensure that the materials used in the construction of equipment are compatible with cosmetic products	And cleaning and sanitizing agents
	5.3	Installation
80	5.3.1	Provide that the design and installation of equipment ease its drainage	In order to facilitate cleaning and sanitization
81	5.3.2	Arrange equipment in such a way that the movement of materials, mobile equipment and personnel does not present any risk	To quality
82	5.3.3	Provide reasonable access under, inside and around equipment	For maintenance and cleaning
83	5.3.4	Facilitate the identification	Of major equipment
	5.4	Calibration
84	5.4.1	Calibrate regularly laboratory and production measuring instruments	For instruments that are important for the quality of the product
85	5.4.2	Identify properly and remove from service measuring instruments	When results of calibration are out-of-acceptance criteria
86	5.4.3	Investigate when a calibration result is outside the acceptance criteria	In order to determine whether this result has an impact on the quality of the product
87	5.4.3	Take appropriate steps	Based on the results of the investigation
	5.5	Cleaning and sanitization
88	5.5.1	Be subject to an appropriate cleaning and, if necessary sanitization program	For all equipment
89	5.5.2	Use cleaning and, if necessary sanitizing agents	Specified and effective
90	5.5.3	Clean and, if necessary sanitize equipment used for continuous production or production of successive batches of the same product	At appropriate intervals
	5.6	Maintenance
91	5.6.1	Maintain equipment	Regularly
92	5.6.2	Ensure that maintenance operations do not affect the quality of the product	After each maintenance check that everything is compliant
93	5.6.3	Identify defective equipment accordingly	And excluded from use and isolated, if possible
	5.7	Consumables
94	5.7	Ensure that consumables used for the equipment do not affect the quality of the product	Consumables are specified and effective
	5.8	Authorizations
95	5.8	Use only accessible equipment or automated systems for production and control purposes	By authorized personnel
96	5.8	Ensure that equipment or automated systems for production and control are only used by authorized personnel	Training and certification, if required, cf. § 3.4
	5.9	Back-up systems
97	5.9	Ensure the availability of adequate alternative arrangements	In case of failure or breakdown for systems which need to be operated
	6	Raw materials and packaging materials	P (Plan)
	6.1	Principle
98	6.1	Purchase raw materials and packaging materials that meet the defined acceptance criteria	And appropriate for the quality of finished products
	6.2	Purchasing
99	6.2 a	Base purchasing of raw materials and packaging materials on supplier evaluation	And section of the supplier
100	6.2 b	Base purchasing of raw materials and packaging materials on establishment of technical clauses	Such as type of selection to be conducted, acceptance criteria, actions in the case of defect or modifications, transport conditions
101	6.2 c	Base purchasing of raw materials and packaging materials on setting of relations and exchanges between the company and the supplier	Such as questionnaire, assistance and audits
	6.3	Receipt
102	6.3.1	Ensure that the purchase order, the delivery note and the materials delivered match	Receipt instruction
103	6.3.2	Check visually the integrity of the shipping containers for raw materials	And packaging materials
104	6.3.2	Perform additional checks, if necessary	Of transport data
	6.4	Identification and status
105	6.4.1	Label raw material containers and packaging materials	In order to identify the material and the batch information
106	6.4.2	Put on hold for decision raw materials and packaging materials when they have defects	That might affect product quality
107	6.4.3	Identify appropriately raw materials and packaging materials according to their status	Such as accepted, rejected or quarantined. Other systems can replace this physical system of identification, if they ensure the same level of assurance
108	6.4.4 a	Include in the information on the identification of raw materials and packaging materials	Name of the product marked on the delivery note
109	6.4.4 b	Include in the information on the identification of raw materials and packaging materials	Name of the product as given by the company, if different from the name given by the supplier or its code number
110	6.4.4 c	Include in the information on the identification of raw materials and packaging materials	date or number of receipt, if appropriate
111	6.4.4 d	Include in the information on the identification of raw materials and packaging materials	Name of supplier
112	6.4.4 e	Include in the information on the identification of raw materials and packaging materials	Batch reference given by the supplier and the one given at receipt, if different
	6.5	Release
113	6.5.1	Set up a physical or alternative system	In order to ensure that only released raw materials and packaging materials are used
114	6.5.2	Carry out the release of raw materials and packaging materials by authorized personnel	Who is also responsible for quality
115	6.5.3	Accept raw materials and packaging materials on the basis of the supplier certificate of analysis	Only if there are established technical requirements, experience and knowledge of the supplier and supplier audit
116	6.5.3	Accept raw materials and packaging materials on the basis of the supplier certificate of analysis	If the supplier's methods have been agreed upon
	6.6	Storage
117	6.6.1	Ensure that storage conditions are appropriate for each raw material	And at each packaging material
118	6.6.2	Store and handle properly raw materials and packaging materials	In relation to their characteristics such as not laying them on the ground
119	6.6.3	Observe and monitor specific storage conditions	Where appropriate
120	6.6.4	Ensure that containers of raw materials and packaging materials are closed	And that they are not placed directly on the ground
121	6.6.5	Ensure that raw materials and packaging materials bear the same labeling as at origin	When these materials are repacked
122	6.6.6	Store raw materials and packaging materials in their respective physical locations or by using any other system providing the same level of assurance	When these materials are quarantined or rejected
123	6.6.7	Set up measures to ensure stock turnover	Such as FIFO (Fist In, Fist Out)
124	6.6.7	Ensure stock rotation	The oldest released stock is used first
125	6.6.8	Perform periodic inventory	In order to ensure stock reliability
126	6.6.8	Investigate any significant discrepancy	And take corrective action
	6.7	Re-evaluation
127	6.7	Set up an appropriate system to re-evaluate raw materials	In order to determine their suitability for use, after a defined period of storage
128	6.7	Set up a system to prevent the use of materials requiring re-evaluation	If it is reasonably possible
	6.8	Quality of water used in production
129	6.8.1	Ensure that the water treatment system provides water of defined quality	Cf. article 9
130	6.8.2	Check water quality through testing	Or by monitoring of process parameters
131	6.8.3	Ensure that the water treatment system allows for sanitization	Cf. article 9
132	6.8.4	Set up water treatment equipment so as to avoid stagnation	And risks of contamination
133	6.8.5	Select materials for water treatment equipment	In order to ensure that water quality is not affected
	7	Production	D (Dérouler)
	7.1	Principle
134	7.1	Take measures to produce a finished product that meet the defined characteristics	At each stage of manufacturing operations and packaging operations
	7.2	Manufacturing operations
	7.2.1	Availability of relevant documents
135	7.2.1.1	Ensure the availability of relevant documentation	At each stage of manufacturing operations, cf. article 17
136	7.2.1.2 a	Carry out manufacturing operations according to manufacturing documentation	Including suitable equipment, cf. article 17
137	7.2.1.2 b	Carry out manufacturing operations according to manufacturing documentation	Including formula for the product, cf. article 17
138	7.2.1.2 c	Carry out manufacturing operations according to manufacturing documentation	Including list of all raw materials and batch numbers and quantities, cf. article 17
139	7.2.1.2 d	Carry out manufacturing operations according to manufacturing documentation	Including manufacturing operations, such as addition of raw materials, temperatures, speeds, mixing times, sampling, cleaning and, if necessary, sanitizing of equipment, and bulk product transfer. All this information is part of the flow chart, cf. article 17
	7.2.2	Start-up checks
140	7.2.2 a	Ensure that before starting any manufacturing operation	All documentation relevant to the manufacturing operations is available
141	7.2.2 b	Ensure that before starting any manufacturing operation	All raw materials are available (and released)
142	7.2.2 c	Ensure that before starting any manufacturing operation	Suitable equipment is available for use, in working order, cleaned and, if necessary, sanitized
143	7.2.2 d	Ensure that before starting any manufacturing operation	Clearance of the area has been performed to avoid mixing with materials from previous operations
	7.2.3	Assignment of batch number
144	7.2.3	Assign a batch number	To each batch of manufactured bulk product
145	7.2.3	Associate the batch number of manufactured bulk product	With the batch number that appears on the label
	7.2.4	Identification of in-process operations
146	7.2.4.1	Measure or weigh all raw materials into clean and suitable containers, labeled with appropriate identification or directly into the equipment used for manufacturing	In accordance with the formula
147	7.2.4.2	Be able to identify major equipment, raw material containers and bulk product containers	At all times
148	7.2.4.3 a	Identify for bulk product containers	Name or identifying code
149	7.2.4.3 b	Identify for bulk product containers	Batch number
150	7.2.4.3 c	Identify for bulk product containers	Storage conditions when such information is critical to assure the quality of the product
	7.2.5	In-process control
151	7.2.5.1	Define in-process controls	And acceptance criteria
152	7.2.5.2	Perform in-process controls	According to a defined program
153	7.2.5.3	Report any result outside the acceptance criteria	And appropriately investigated
	7.2.6	Bulk product storage
154	7.2.6.1	Store bulk product in suitable containers	And in defined areas, and under appropriate conditions
155	7.2.6.2	Define the maximum bulk product storage duration	Of a bulk product
156	7.2.6.3	Re-evaluate the bulk product	When the maximum storage duration is reached
	7.2.7	Re-stocking raw materials
157	7.2.7	Close and properly identify containers when raw materials remain unused after weighing	And these materials are deemed acceptable to return to stock
	7.3	Packaging operations
	7.3.1	Availability of relevant documents
158	7.3.1.1	Ensure availability of relevant documentation	At each stage of packaging operations, cf. article 17
159	7.3.1.2 a	Carry out packaging operations according to packaging documentation	Including suitable equipment, cf. article 17
160	7.3.1.2 b	Carry out packaging operations according to packaging documentation	Including list of packaging materials defined for the intended finished product, cf. article 17
161	7.3.1.2 c	Carry out packaging operations according to packaging documentation	Including packaging operations such as filling, closing, labeling, and coding, cf. article 17
	7.3.2	Star-up checks
162	7.3.2 a	Ensure before the start of any packaging operation that the area has been cleared of materials	In order to avoid mixing with materials from previous operations
163	7.3.2 b	Ensure before the start of any packaging operation that all documentation relevant to the packaging operation is available	Cf. article 17
164	7.3.2 c	Ensure before the start of any packaging operation	All packaging materials are available
165	7.3.2 d	Ensure before the start of any packaging operation that suitable equipment is available for use	In working order, cleaned and, if necessary, sanitized
166	7.3.2 e	Ensure before the start of any packaging operation that any coding is defined	In order to permit identification of the product
	7.3.3	Assignment of batch number
167	7.3.3.1	Assign a batch number	To each unit of finished product
168	7.3.3.2	Associate the batch number of bulk product	With the batch number that appears on the label of the bulk product
	7.3.4	Packaging line identification
169	7.3.4	Ensure that the packaging line can be identified at any time with its name or identifying code	Including the name or identification code of the finished product and the lot number
	7.3.5	Checks of on-line control equipment
170	7.3.5	Check regularly on-line control equipment, if used	According to a defined program
	7.3.6	In-process control
171	7.3.6.1	Define in-process controls	And their acceptance criteria
172	7.3.6.2	Perform in-process controls	According to a defined program
173	7.3.6.3	Report any result that is outside the acceptance criteria	And investigate appropriately
	7.3.7	Re-stocking of packaging materials
174	7.3.7	Close and properly identify containers when packaging materials remain unused after packaging operations	And these raw materials are intended to be returned to stock and are considered acceptable
	7.3.8	Identification and handling of work-in-process
175	7.3.8	Apply special measures when filling and labeling is not a continuous process	Include segregation and identification in order to avoid mix-ups or mislabeling
	8	Finished products	D (Do)
	8.1	Principle
176	8.1	Ensure that the finished products meet the defined acceptance criteria	The finished product (see definition 2.15) is a cosmetic product that cannot be ingested, inhaled, injected or implanted into the body
177	8.1	Manage storage, shipment and returns	In a manner so as to maintain the quality of finished products
	8.2	Release
178	8.2.1	Control all finished products before being placed on the market	In accordance with established test methods
179	8.2.1	Control all finished products before being placed on the market	In order to verify if they comply with acceptance criteria
180	8.2.2	Carry out product release	By the authorized personnel responsible for quality
	8.3	Storage
181	8.3.1	Store finished products in defined areas under appropriate conditions	For an appropriate length of time
182	8.3.1	Monitor finished products while stored	If necessary
183	8.3.2	Permit organized storage	In storage areas
184	8.3.3	Store released, quarantined or rejected finished products in their respective physical locations	Or by using any other system providing the same level of assurance
185	8.3.4 a	Ensure that the identification of finished product containers includes	Name or identifying code
186	8.3.4 b	Ensure that the identification of finished product containers includes	Batch number
187	8.3.4 c	Ensure that the identification of finished product containers includes	storage conditions when such information is critical to assure the quality of the product
188	8.3.4 d	Ensure that the identification of finished product containers includes	Quantity
189	8.3.5	Set up measures to ensure stock turnover	As FIFO, cf. article 6.6
190	8.3.5	Ensure stock rotation, except in special circumstances	The oldest released stock is used first
191	8.3.6 a	Perform periodic inventory checks	In order to ensure inventory accuracy
192	8.3.6 b	Perform periodic inventory checks	In order to ensure that acceptance criteria are met
193	8.3.6	Investigate any significant discrepancy	If need be, set up a corrective action
	8.4	Shipment
194	8.4	Take appropriate measures	In order to ensure the shipment of the defined finished product
195	8.4	Take precautions, when appropriate	In order to maintain the finished product quality
	8.5	Returns
196	8.5.1	Identify returns in an appropriate way	And store returns in defined areas ("prison").
197	8.5.2	Evaluate returns	Against established criteria to determine their disposition
198	8.5.3	Release returns	Before placing them on the market again
199	8.5.4	Establish measures	In order to distinguish any reprocessed return
200	8.5.4	Take measures	In order to avoid the inadvertent redistribution of unreleased finished product
	9	Quality control laboratory	D (Dérouler)
	9.1	Principle
201	9.1.1	Apply the principles described in ISO 22716 to the quality control laboratory	Relating to personnel, cf. article 3, to premises, cf. article 4, to equipment, cf. article 5, to subcontracting, cf. article 12 and to documentation, cf. article 17
202	9.1.2	Carry out the relevant controls during sampling and testing by the laboratory	So that materials are released for use
203	9.1.2	Carry out the relevant controls during sampling and testing by the laboratory	In order to release products for shipment only if their quality meets the required acceptance criteria
	9.2	Test methods
204	9.2.1	Use all necessary test methods (by the quality control laboratory)	In order to confirm that the product complies with acceptance criteria
205	9.2.2	Perform controls on the basis of defined test methods	Appropriate and available
	9.3	Acceptance criteria
206	9.3	Establish acceptance criteria	In order to specify the requirements to be met by raw materials and packaging materials, see Article 6, bulk products and finished products, cf. article 8
	9.4	Results
207	9.4	Review all results	In order to make a decision
208	9.4	Make a decision	Approval, rejection or pending
	9.5	Out-of-specification results
209	9.5.1	Review out-of-specification results by authorized personnel	And conduct a proper investigation to find the root causes
210	9.5.2	Provide sufficient justification	For any re-testing to be performed
211	9.5.3	Make a decision by authorized personnel, after the investigation	Deviation, rejection or pending
	9.6	Reagents, solutions, reference standards, culture media
212	9.6 a	Identify reagents, solutions, reference standards, culture media and others with clear information	Name
213	9.6 b	Identify reagents, solutions, reference standards, culture media and others with clear information	Strength or concentration, when appropriate
214	9.6 c	Identify reagents, solutions, reference standards, culture media and others with clear information	Expiration date, when appropriate
215	9.6 d	Identify reagents, solutions, reference standards, culture media and others with clear information	Name or signature of the person who realized the preparation, when appropriate
216	9.6 e	Identify reagents, solutions, reference standards, culture media and others with clear information	Opening date
217	9.6 f	Identify reagents, solutions, reference standards, culture media and others with clear information	Storage conditions, when appropriate
	9.7	Sampling
218	9.7.1	Perform sampling by authorized personnel	From laboratory or quality department
219	9.7.2 a	Define sampling in terms of	Sampling method
220	9.7.2 b	Define sampling in terms of	Equipment to be used
221	9.7.2 c	Define sampling in terms of	Amounts to be taken
222	9.7.2 d	Define sampling in terms of	Any precautions to be observed to avoid contamination or deterioration
223	9.7.2 e	Define sampling in terms of	Identification of sample
224	9.7.2 f	Define sampling in terms of	Frequency
225	9.7.3 a	Identify samples by	The name or identifying code
226	9.7.3 b	Identify samples by	The batch number
227	9.7.3 c	Identify samples by	The date of sampling
228	9.7.3 d	Identify samples by	The container from which the sample was taken
229	9.7.3 e	Identify samples by	The sampling point, if applicable
	9.8	Retain sample
230	9.8.1	Retain samples of finished product in an appropriate manner	And in designed areas
231	9.8.2	Carry out analyses in accordance with local regulations	The size of the samples of finished products should allow it
232	9.8.3	Keep retain samples of finished products in their primary package	For an appropriate time under the recommended storage conditions
233	9.8.4	Retain samples of raw materials, if necessary	According to company practice or in accordance with local regulations
	10	Treatment of product that is out of specification	C (Check)
	10.1	Rejected finished products, bulk products, raw materials and packaging materials
234	10.1.1	Perform investigations of rejected product or materials	By personnel authorized to do so
235	10.1.2	Approve decisions to destroy or to reprocess	By the personnel responsible for quality
	10.2	Reprocessed finished products and bulk products
236	10.2.1	Approve the reprocessing decision to obtain the defined quality for a batch that does not meet the defined acceptance criteria	By the personnel responsible for quality
237	10.2.2	Define the method of reprocessing	And approve the method
238	10.2.3	Perform controls on the reprocessed finished products	And also on the reprocessed bulk products
239	10.2.3	Review results by authorized personnel	In order to verify the conformity of the finished product or bulk product with the acceptance criteria
	11	Wastes	A (Act)
	11.1	Principle
240	11.1	Dispose of wastes in a timely manner	And also in a sanitary manner
	11.2	Types of waste
241	11.2	Define the different types of waste from production and the laboratory	Waste that could affect the quality of the product
	11.3	Flow
242	11.3.1	Ensure that the flow of waste does not affect production operations	And laboratory operations
243	11.3.2	Take appropriate measures concerning wastes	Including collection, storage and disposal of
	11.4	Containers
244	11.4	Identify properly containers of waste	As to contents and other information, as appropriate
	11.5	Disposal
245	11.5	Perform the disposal of waste in an appropriate way	With an adequate level of control
	12	Subcontracting	D (Dérouler)
	12.1	Principle
246	12.1	Establish a contract or agreement for subcontracted activities	The contract or agreement being mutually confirmed and controlled (between the contract giver and the contract acceptor)
247	12.1	Obtain a product or service that complies with the requirements defined by the contract giver	This is the objective of this step
	12.2	Types of subcontracting
248	12.2 a	Take into account subcontracting such as	Manufacturing
249	12.2 b	Take into account subcontracting such as	Packaging
250	12.2 c	Take into account subcontracting such as	Analysis
251	12.2 d	Take into account subcontracting such as	Cleaning, sanitization of premises
252	12.2 e	Take into account subcontracting such as	Pest control
253	12.2 f	Take into account subcontracting such as	Equipment and premises maintenance
	12.3	Contract giver
254	12.3.1	Assess the ability and capacity of the contract acceptor	To carry out the contracted operations
255	12.3.1	Ensure that the contract acceptor has all the necessary means at its disposal	To carry out the contract
256	12.3.1	Assess the subcontractor's ability to comply appropriately	With ISO 22716 guidelines
257	12.3.1	Assess the subcontractor's ability to ensure the operations can be performed	As agreed. The contract acceptor shall comply with the requirements of cosmetic Good Manufacturing Practices that apply to it
258	12.3.2	Provide the contract acceptor with all the information required	In order to carry out the operations correctly
	12.4	Contract acceptor
259	12.4.1	Ensure that the contract acceptor has the means, experience and competent personnel	In order to meet the requirements of the contract
260	12.4.2	Ensure that the contract acceptor does not subcontract work to a third party	Without the prior agreement and consent of the contract giver
261	12.4.2	Make arrangements between the third party and the contract acceptor	In order to ensure that all information about operations is made available to the contract giver in the same way as in the original contract
262	12.4.3	Facilitate any checks and audits defined by the contract giver	Activities at the contract acceptor
263	12.4.4	Inform the contract giver of any changes prior to implementation, unless otherwise specified in the contract	Any changes that may affect the quality of the services or products provided
	12.5	Contract
264	12.5.1	Draw up a contract or agreement specifying respective duties and responsibilities	Between the contract giver and the contract acceptor
265	12.5.2	Keep all data	Or they shall be made available to the contract giver
	13	Deviations	C (Check)
266	13.1	Authorize deviations from the specified requirements (waivers)	On the basis of sufficient data to justify the decision. Analyze and evaluate the consequences. Control changes, cf. article 15
267	13.2	Make corrective actions	In order to prevent recurrence of the deviation
	14	Complaints and recalls	A (Act)
	14.1	Principle
268	14.1.1	Review, investigate and follow up, as appropriate, all complaints that are communicated to the plant	Complaints fall within the scope of ISO 22716 guidelines
269	14.1.2	Take appropriate steps when a product recall decision is made	In order to carry out the recall within the scope of the ISO 22716 guidelines
270	14.1.2	Take appropriate steps when a product recall decision is made	And to implement corrective action
271	14.1.3	Agree on how to handle complaints	In the case of contracted operations, cf. § 12
	14.2	Product complaints
272	14.2.1	Centralize all complaints	By authorized personnel
273	14.2.2	Keep any complaints concerning a product defect	Including original details and follow-up information, cf. article 17
274	14.2.3	Complete an appropriate follow-up of the batch concerned	To the end of its term
275	14.2.4 a	Include in complaints investigations and follow-up	Steps to prevent recurrence of the defect
276	14.2.4 b	Include in complaints investigations and follow-up	checking other batches in order to determine whether they are also affected
277	14.2.5	Review periodically complaints	In order to check for trends or recurrence of a defect
	14.3	Product recalls
278	14.3.1	Coordinate the recall process	By authorized personnel
279	14.3.2	Initiate product recall operations	Promptly and in a timely manner
280	14.3.3	Notify the competent authorities of any recall	Which could have an impact upon consumer safety
281	14.3.4	Identify and store the recalled products separately in a secure area	While awaiting a decision. The secure area is "the prison", area with restricted access
282	14.3.5	Evaluate periodically the product recall process	Cf. § 14.1.2. This process is most often a simulation test.
	15	Change control	D (Dérouler)
283	15	Approve and perform changes that may affect the quality of the product (product evolution)	By authorized personnel on the basis of sufficient data
	16	Internal audit	C (Comparer)
	16.1	Principle
284	16.1	Monitor the implementation and the status of cosmetic Good Manufacturing Practices and, where appropriate, propose corrective actions	This is the main objective of the internal audit
	16.2	Approach
285	16.2.1	Conduct independent and detailed internal audits, on a regular basis or upon request	By competent, specially designated personnel
286	16.2.2	Evaluate all observations made during the internal audit	And shared with appropriate management
	16.3	Follow-up
287	16.3	Confirm the satisfactory completion or implementation of corrective action	By audit follow-up
	17	Documentation	D (Dérouler)
	17.1	Principle
288	17.1.1	Establish, design, install and maintain its own documentation system	For each company, the system is appropriate to its organizational structure and product type. The system can be in paper or electronic format
289	17.1.2	Integrate documentation into Good Manufacturing Practices	There's no way around it.
290	17.1.2	Describe activities defined in the ISO 22716 guidelines in order to relate the history of these activities	In order to avoid any risk of interpretation, loss of information, confusion or errors inherent to verbal communication
	17.2	Type of document
291	17.2.1	Include documents such as procedures, instructions, specifications, protocols, reports, methods and records	All relevant to the activities of the ISO 22716 guidelines
292	17.2.2	Choose between paper or electronic format	Or a mix of the two formats
	17.3	Writing, approval and distribution
293	17.3.1	Define documents with appropriate detail in relation to ISO 22716 guidelines	Describing the operations to be carried out, precautions to be taken and measures to be applied in all cosmetic activities
294	17.3.2	State the title, nature and purpose of the documents	Including a code
295	17.3.3 a	Write documents that are	Written in a legible and comprehensive way
296	17.3.3 b	Write documents that are	Approved, signed and dated by authorized persons before being used
297	17.3.3 c	Write documents that are	Prepared, updated, withdrawn, distributed, classified
298	17.3.3 d	Write documents that are	Referenced to ensure that obsolete documents are not used
299	17.3.3 e	Write documents that are	Accessible to appropriate personnel
300	17.3.3 f	Write documents that are	Removed from the job area and destroyed if they are out-dated
301	17.3.4 a	Indicate what is to be entered	For records that require data entry (handwritten or electronic)
302	17.3.4 b	Write legibly with permanent ink	For records that require data entry (handwritten or electronic)
303	17.3.4 c	Sign and date	For records that require data entry (handwritten or electronic)
304	17.3.4 d	Correct, if necessary, by allowing the original text to be read; where appropriate, record the reason for the correction	For records that require data entry (handwritten or electronic)
	17.4	Revision
305	17.4	Update documents when necessary	And indicate the revision number
306	17.4	Retain the reason for each revision	On the document or on an archive file
	17.5	Archiving
307	17.5.1	Archive only original documents	And use only controlled copies
308	17.5.2	Define the duration of archiving original documents	According to applicable laws and regulations
309	17.5.3	Secure properly the storage of original documents	Appropriately
310	17.5.4	Ensure the legibility of archived documents	In paper or electronic format
311	17.5.5	Save data at regular intervals	In separate and secure location