Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

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

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

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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

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10 All personnel should comply with personal hygiene requirements

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Quiz requirements ISO 22716 version 2007

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11 All personnel should know their position in the organizational structure

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Quiz requirements ISO 22716 version 2007

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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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Quiz requirements ISO 22716 version 2007

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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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Quiz requirements ISO 22716 version 2007

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

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

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Quiz requirements ISO 22716 version 2007

16/106

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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Quiz requirements ISO 22716 version 2007

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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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Quiz requirements ISO 22716 version 2007

18/106

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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Quiz requirements ISO 22716 version 2007

19/106

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

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Quiz requirements ISO 22716 version 2007

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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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Quiz requirements ISO 22716 version 2007

21/106

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

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Quiz requirements ISO 22716 version 2007

22/106

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

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Quiz requirements ISO 22716 version 2007

23/106

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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Quiz requirements ISO 22716 version 2007

24/106

24 Cleaning and sanitization should be validated by an authorised person

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Quiz requirements ISO 22716 version 2007

25/106

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

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Quiz requirements ISO 22716 version 2007

26/106

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

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Quiz requirements ISO 22716 version 2007

27/106

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

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Quiz requirements ISO 22716 version 2007

28/106

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

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Quiz requirements ISO 22716 version 2007

29/106

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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Quiz requirements ISO 22716 version 2007

30/106

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

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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

34/106

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

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Quiz requirements ISO 22716 version 2007

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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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Quiz requirements ISO 22716 version 2007

36/106

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

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Quiz requirements ISO 22716 version 2007

37/106

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

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Quiz requirements ISO 22716 version 2007

38/106

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

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Quiz requirements ISO 22716 version 2007

39/106

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

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Quiz requirements ISO 22716 version 2007

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40 Finished products should meet the defined acceptance criteria

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Quiz requirements ISO 22716 version 2007

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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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Quiz requirements ISO 22716 version 2007

42/106

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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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

44/106

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

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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

47/106

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

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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

49/106

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

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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

52/106

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

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Quiz requirements ISO 22716 version 2007

53/106

53 Maintenance operations should not affect the quality of the product

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Quiz requirements ISO 22716 version 2007

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54 Major equipment should be readily identifiable

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Quiz requirements ISO 22716 version 2007

55/106

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

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Quiz requirements ISO 22716 version 2007

56/106

56 Measures should be set up to ensure stock turnover

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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

59/106

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

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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

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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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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

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

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Quiz requirements ISO 22716 version 2007

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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

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