Quiz requirements ISO 22716 version 2007

1/106

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

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Quiz requirements ISO 22716 version 2007

2/106

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

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3/106

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

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

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

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

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

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8/106

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

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9/106

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

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10/106

10 All personnel should comply with personal hygiene requirements

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11/106

11 All personnel should know their position in the organizational structure

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12/106

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

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

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

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15/106

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

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

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

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

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

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20/106

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

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

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22/106

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

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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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24/106

24 Cleaning and sanitization should be validated by an authorised person

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25/106

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

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26/106

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

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27/106

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

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28/106

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

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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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30/106

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

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31/106

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

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32/106

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

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33/106

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

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34/106

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

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35/106

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

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

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

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38/106

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

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39/106

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

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40/106

40 Finished products should meet the defined acceptance criteria

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41/106

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

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

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

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44/106

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

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45/106

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

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46/106

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

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47/106

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

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48/106

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

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49/106

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

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50/106

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

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51/106

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

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

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53/106

53 Maintenance operations should not affect the quality of the product

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54/106

54 Major equipment should be readily identifiable

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55/106

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

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56/106

56 Measures should be set up to ensure stock turnover

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57/106

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

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58/106

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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60/106

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

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61/106

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

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

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

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

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65/106

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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66/106

66 Physical or alternative systems should be set up to ensure that only released raw materials and packaging materials are used

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67/106

67 Premises should be located, designed, constructed and utilized so as to ensure protection of the product

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68/106

68 Premises used in activities described in these guidelines should be maintained in a good state of repair

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69/106

69 Principles described for personnel, premises, equipment, subcontracting and documentation should apply to the quality control laboratory

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70/106

70 Product recall operations should be capable of being initiated promptly and in a timely manner

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71/106

71 Product release should be carried out by the authorized personnel responsible for quality

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72/106

72 Purchasing of raw materials and packaging materials should be based on the evaluation and selection of the supplier

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73/106

73 Raw materials and packaging materials should be identified in an appropriate way according to their status such as accepted, rejected or quarantined

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74/106

74 Raw materials and packaging materials that are purchased should meet defined acceptance criteria relevant to the quality of finished products

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75/106

75 Reagents, solutions, reference standards, culture media, etc., should be identified by the following information: the name, its strength or concentration, when appropriate, and others

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76/106

76 Recalled products should be placed in a secure area

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77/106

77 Relevant documentation should be available at each stage of the manufacturing operations

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78/106

78 Retain samples of finished product should be kept in their primary package for an appropriate time under the recommended storage conditions

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79/106

79 Returns should be identified in an appropriate way and stored in defined areas

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80/106

80 Sampling should be performed by authorized personnel

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81/106

81 Separate or defined areas should be provided for storage, production, quality control, ancillary and toilets

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82/106

82 Specially designated competent personnel staff should conduct internal audits in an independent and detailed manner, regularly or on demand

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83/106

83 Storage conditions should be appropriate for each raw material and packaging material

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84/106

84 Sufficient space should be provided to facilitate operations such as receipt, storage and production

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85/106

85 The company should define the different types of waste (from production and from the quality control laboratory) that could affect the quality of the product

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86/106

86 The company should have an adequate number of properly trained personnel with regards to the defined activities in these guidelines

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87/106

87 The contract acceptor should ensure that they have the means, experience and competent personnel to meet the contract requirements

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88/106

88 The contract giver should assess the contract acceptor’s ability and capacity to carry out the contracted operations

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89/106

89 The design and the installation of equipment should ease its draining in order to facilitate cleaning and sanitization

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90/106

90 The disposal of waste should be performed in an appropriate way with an adequate level of control

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91/106

91 The effectiveness of the training should be evaluated

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92/106

92 The flow of waste should not impact on the production and laboratory operations

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93/106

93 The implementation of Good Manufacturing Practices should be the responsibility of top management

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94/106

94 The organization chart should show the independence, from the other units of the plant, of each quality unit, such as quality assurance and quality control unit

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95/106

95 The organizational structure should be defined such that the organization and functioning of the staff of the company be understood

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96/106

96 The purchase order, the delivery note and the delivered materials should match

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97/106

97 The quality control laboratory should use all test methods necessary to confirm that the product complies with acceptance criteria

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98/106

98 The title, nature and purpose of documents should be stated

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99/106

99 The water treatment system should provide a defined quality of water

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100/106

100 There should be a pest control program appropriate to the premises

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101/106

101 This clause concerns subcontracting of manufacture, packaging, analysis, cleaning, sanitization of premises, pest protection and equipment and premises maintenance

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102/106

102 Training should be regarded as a constant and on-going process that is subject to regular updates

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103/106

103 Ventilation should be sufficient for the intended production operations

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104/106

104 Visitors and untrained personnel should be closely supervised

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105/106

105 Wastes should be disposed of in a timely and sanitary manner

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106/106

106 Water treatment equipment should be set up so as to avoid stagnation and risks of contamination

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Quiz requirements ISO 22716 version 2007