Thursday, October 22 2020

ISO 22716 REQUIREMENTS (Recommendations) Cosmetics Good Manufacturing Practices VERSION 2007

Requirements ISO 22716 version 2007

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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!

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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
 
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
up
 
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
up
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
up
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
up
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
 
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
 up
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
up
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
 up
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
 
5.1
Principle
 up
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
up
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
up
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
up
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
 
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
up
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
 up
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
 up
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
up
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
 up
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
up
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
up
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
up
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
up
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
 
8.1
Principle
up
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
up
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
 
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
up
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
up
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
up
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
  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
  11.1
Principle
 
240
11.1
Dispose of wastes in a timely manner And also in a sanitary manner
 
11.2
Types of waste
up
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
 
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
up
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
up
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
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
 
14.1
Principle
up
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
up
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
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
 
16.1
Principle
up
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 
  17.1
Principle
up
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
up
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 
up
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