ISO 22716 version 2007 – Requirements (recommendations) and comments
No
Article, paragraph
Requirement (recommendation)
Comments, PDCA, links
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
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
5.1
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
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
7.1
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
8.1
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
9.1
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
11.1
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
12.1
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
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
14.1
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.
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
16.1
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
287
16.3
Confirm the satisfactory completion or implementation of corrective action
By audit follow-up
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
