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Quiz requirements ISO 22716 version 2007

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1/106

ISO 22716

       1       A batch number should be assigned to each batch of manufactured bulk product

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2/106

ISO 22716

       2       A batch number should be assigned to each unit of finished product

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3/106

ISO 22716

       3       A contract or agreement should be drawn up between the contract giver and the contract acceptor which specifies their respective duties and responsibilities

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4/106

ISO 22716

       4       A decision to reprocess in order to obtain the defined quality should be approved by personnel responsible for quality

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5/106

ISO 22716

       5       A written contract or agreement should be established, mutually confirmed and controlled between the contract giver and the contract acceptor

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6/106

ISO 22716

       6       Acceptance criteria should be established to specify the requirements to be met for raw materials, packaging materials, bulk products and finished products

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7/106

ISO 22716

       7       Adequate facilities for showering and changing clothes should be provided when appropriate

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8/106

ISO 22716

       8       Adequate, clean, washing and toilet facilities should be provided for personnel

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9/106

ISO 22716

       9       All equipment should be subject to an appropriate cleaning and, if necessary, sanitization program

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10/106

ISO 22716

     10     All personnel should comply with personal hygiene requirements

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11/106

ISO 22716

     11     All personnel should know their position in the organizational structure

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12/106

ISO 22716

     12     All results should be reviewed and after this review, a decision should be made, notably in terms of approval, rejection or pending

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13/106

ISO 22716

     13     An internal audit is a tool which is designed to monitor the implementation and the status of these cosmetic Good Manufacturing Practices and, if necessary, to propose corrective actions

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14/106

ISO 22716

     14     Any results outside the acceptance criteria should be reported and appropriately investigated

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15/106

ISO 22716

     15     Appropriate Good Manufacturing Practices training relative to the defined activities of these guidelines should be provided for all personnel

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16/106

ISO 22716

     16     At all times, it should be possible to identify major equipment, containers of raw materials and containers of bulk products

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17/106

ISO 22716

     17     At all times, it should be possible to identify the packaging line with its name or identifying code of the finished product and the batch number

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18/106

ISO 22716

     18     At each stage of manufacturing operations and packaging operations, measures should be taken to produce a finished product that meets the defined characteristics

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19/106

ISO 22716

     19     Before starting any manufacturing operations, it should be ensured that all raw materials are available and released

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20/106

ISO 22716

     20     Before starting any packaging operation, it should be ensured that suitable equipment is available for use, in working order, cleaned and, if necessary, sanitized

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21/106

ISO 22716

     21     Bulk product containers should be protected from air contaminants, such as dust and moisture

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22/106

ISO 22716

     22     Bulk products should be stored in suitable containers, in defined areas, and under appropriate conditions

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23/106

ISO 22716

     23     Changes that could affect the quality of the product should be approved and performed by authorized personnel on the basis of sufficient data

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24/106

ISO 22716

     24     Cleaning and sanitization should be validated by an authorised person

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25/106

ISO 22716

     25     Cleaning and, if necessary, sanitization should be carried out to achieve the objective of protecting each product

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26/106

ISO 22716

     26     Complaint investigations and follow-up should include steps to prevent recurrence of the defect

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27/106

ISO 22716

     27     Consumables used for equipment should not affect the quality of the product

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28/106

ISO 22716

     28     Consumables used for premises should not affect the quality of the product

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29/106

ISO 22716

     29     Containers of raw materials and packaging materials should be labelled in order to identify the material and the batch information

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30/106

ISO 22716

     30     Containers of waste should be properly identified as to contents and other information, as appropriate

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31/106

ISO 22716

     31     Corrective actions should be made to prevent recurrence of the deviation

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32/106

ISO 22716

     32     Documents can be hard-copy papers or electronic data processing records

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33/106

ISO 22716

     33     Documents should be updated, when necessary, and the revision number is indicated

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34/106

ISO 22716

     34     Drains should be kept clean and should not allow back flow

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35/106

ISO 22716

     35     Each company should establish, design, install and maintain its own system of documentation that is appropriate to its organizational structure and to the type of products

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36/106

ISO 22716

     36     Equipment should be suitable for the intended purpose and capable of being cleaned and, if necessary, sanitized and maintained

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37/106

ISO 22716

     37     Every person entering production, control and storage areas should wear appropriate clothing and protective garments

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38/106

ISO 22716

     38     Finished product status should appear in plain text on a label affixed to the container

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39/106

ISO 22716

     39     Finished products should be stored in defined areas under appropriate conditions for an appropriate length of time

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40/106

ISO 22716

     40     Finished products should meet the defined acceptance criteria

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41/106

ISO 22716

     41     Floors, walls, ceilings and windows in production areas should be designed or constructed for ease of cleaning and, if necessary, sanitization

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42/106

ISO 22716

     42     Flow of materials, products and personnel through the building or buildings should be defined in order to prevent mix-ups

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43/106

ISO 22716

     43     Hygiene programs should be established and adapted to the needs of the plant

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44/106

ISO 22716

     44     Identification of finished product containers should indicate: name or identification code

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45/106

ISO 22716

     45     If used, on-line control equipment should be regularly checked according to a defined program

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46/106

ISO 22716

     46     In the case of contracted operations, the contract giver should agree on the process for managing complaints

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47/106

ISO 22716

     47     In-process controls and their acceptance criteria should be defined

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48/106

ISO 22716

     48     Internal audit follow-up should confirm the satisfactory completion or implementation of corrective action

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49/106

ISO 22716

     49     Investigations of rejected product or materials should be performed by personnel authorized personnel to do so

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50/106

ISO 22716

     50     Knowledge accumulated by personnel should be evaluated during and/or after training

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51/106

ISO 22716

     51     Laboratory and production measuring instruments that are important for the quality of the product, should be calibrated regularly

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52/106

ISO 22716

     52     Lighting should be installed in a manner to ensure containment of any debris from potential breakage

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53/106

ISO 22716

     53     Maintenance operations should not affect the quality of the product

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54/106

ISO 22716

     54     Major equipment should be readily identifiable

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55/106

ISO 22716

     55     Manufacturing operations should be carried out according to the manufacturing documentation, including suitable equipment

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56/106

ISO 22716

     56     Measures should be set up to ensure stock turnover

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57/106

ISO 22716

     57     Measures should be taken to ensure the shipment of the defined finished product

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58/106

ISO 22716

     58     Only experts from external organizations should design and conduct training courses

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59/106

ISO 22716

     59     Only original documents should be archived and only controlled copies should be used

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60/106

ISO 22716

     60     Out-of-specification results should be reviewed by authorized personnel and properly investigated

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61/106

ISO 22716

     61     Packaging operations should be carried out according to packaging documentation including the list of packaging materials defined for the intended finished product

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62/106

ISO 22716

     62     Periodic inventory checks should be performed to ensure inventory accuracy and to ensure that acceptance criteria are met

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63/106

ISO 22716

     63     Personnel involved in production, control, storage and shipment should have skills based on relevant training and experience acquired, or any combination thereof

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64/106

ISO 22716

     64     Personnel should receive relevant training to enable them to carry out the tasks assigned to them

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65/106

ISO 22716

     65     Persons involved in the implementation of the activities described in these guidelines should have appropriate training to produce, control and store products with a defined quality

Is it a requirement of the ISO 22716 version 2007 standard?