X hits on this document

95 views

0 shares

0 downloads

0 comments

4 / 42

7.5.1.1 7.5.1.2 7.5.1.3

Production Instructions and Records.................................................................................14 Equipment Cleaning .......................................................................................................... 15 Recovery of Solvents, Mother Liquors and Second Crop Crystallisations.......................15

7.5.1.4 7.5.1.5 7.5.1.6 7.5.1.7

In-process Blending or Mixing .........................................................................................15 In-process Control ............................................................................................................. 16 Packaging and Labelling ...................................................................................................16 Records of Equipment Use................................................................................................16

        • 6.3.2.3

          Computer Systems............................................................................................................. 10

      • 6.3.3

        Utilities ................................................................................................................................... 10

      • 6.3.4

        Water ...................................................................................................................................... 10

    • 6.4

      Work Environment .......................................................................................................................10

      • 6.4.1

        Air Handling........................................................................................................................... 10

      • 6.4.2

        Controlled Environment .........................................................................................................11

      • 6.4.3

        Cleaning and Sanitary Conditions..........................................................................................11

      • 6.4.4

        Pest Control ............................................................................................................................11

      • 6.4.5

        Lighting .................................................................................................................................. 11

      • 6.4.6

        Drainage ................................................................................................................................. 11

      • 6.4.7

        Washing and Toilet Facilities.................................................................................................12

7

PRODUCT REALISATION .......................................................................................................12

    • 7.1

      Planning of Product Realisation ...................................................................................................12

    • 7.2

      Customer-related Processes .......................................................................................................... 12

      • 7.2.1

        Determination of Requirements Related to the Product.........................................................12

      • 7.2.2

        Review of Requirements Related to the Product....................................................................12

      • 7.2.3

        Customer Communication...................................................................................................... 12

    • 7.3

      Design and Development .............................................................................................................13

    • 7.4

      Purchasing .................................................................................................................................... 13

      • 7.4.1

        Purchasing Process ................................................................................................................. 13

      • 7.4.2

        Purchasing Information ..........................................................................................................13

      • 7.4.3

        Verification of Purchased Product..........................................................................................13

    • 7.5

      Production and Service Provision ................................................................................................14

      • 7.5.1

        Control of Production and Service Provision.........................................................................14

      • 7.5.2

        Validation of Processes for Production and Service Provision ..............................................16

      • 7.5.3

        Identification and Traceability ...............................................................................................17

        • 7.5.3.1

          Traceability ....................................................................................................................... 17

        • 7.5.3.2

          Inspection and Test Status.................................................................................................17

        • 7.5.3.3

          Labelling ........................................................................................................................... 17

      • 7.5.4

        Customer Property.................................................................................................................. 17

      • 7.5.5

        Preservation of Product ..........................................................................................................18

        • 7.5.5.1

          Handling, Storage and Preservation ..................................................................................18

        • 7.5.5.2

          Packaging Systems ............................................................................................................ 18

        • 7.5.5.3

          Delivery and Distribution..................................................................................................18

    • 7.6

      Control of Measuring and Monitoring Devices............................................................................18

Copyright © 2006 The International Pharmaceutical Excipients Council and Copyright © 2006 Pharmaceutical Quality Group

Page iii

8

MEASUREMENT, ANALYSIS AND IMPROVEMENT .........................................................19

    • 8.1

      General ......................................................................................................................................... 19

    • 8.2

      Monitoring and Measurement ......................................................................................................19

      • 8.2.1

        Customer Satisfaction............................................................................................................. 19

      • 8.2.2

        Internal Audit .........................................................................................................................19

      • 8.2.3

        Monitoring and Measurement of Processes............................................................................19

      • 8.2.4

        Monitoring and Measurement of Product...............................................................................20

        • 8.2.4.1

          Laboratory Controls ..........................................................................................................20

Document info
Document views95
Page views95
Page last viewedMon Dec 05 17:13:22 UTC 2016
Pages42
Paragraphs1010
Words14978

Comments