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GMP for Active Ingredient Manufacturers: Materials Management Mobile App

The GMP for Active Ingredient Manufacturers: Materials Management mobile app is part of a GMP Program. Although most processes used in the production of A.I.s are robust enough to cope with variations in the raw materials used, this should not be assumed. It is therefore necessary to ensure that there is an adequate system in place for dealing with raw materials particularly when changes in these are made. The closer the raw material is to the A.I. the more important it is to adequately control the material. Materials used in the production of A.I.s should be purchased against an approved specification. A programme to evaluate suppliers can supplement purchasing against a specification. Changes in the supplier may need to be evaluated for the effect upon the production and/or control of A.I.s. The app covers purchasing and control, receipt and quarantine of materials, issuing or distribution of materials and S\specific management of A.I.s. Almost any GoCanvas app can be enabled for Dispatch.

  • Lendlease
  • The Cooperative
  • PG&E
  • Red Bull
  • Mirvac

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Take a peek inside the GMP for Active Ingredient Manufacturers: Materials Management Mobile App

Included Features

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    Principle

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    Although most processes used in the production of A.

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    13.1 Purchasing and control

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    Raw materials should be purchased against an agreed specification from an approved supplier or s...

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    If there is adequate evidence that the supplier can reproducibly provide material meeting the sp...

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    Manufacturers of A.

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    Changing the source of supply of critical raw materials should be treated according to Change Co...

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    13.2 Receipt and quarantine of materials

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    Written procedures should be available for checking materials and packaging materials on receipt...

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    Solvents used in the production of A.

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    If bulk deliveries are made in non-dedicated tank trucks, then there should be written confirmat...

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    If a delivery consists of more than one lot from the supplier, each lot should be assigned a sep...

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    Written procedures should be available to ensure that materials are quarantined until a decision...

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    Before incoming materials are mixed with existing stocks, e.

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    Raw materials susceptable to change with time, e.

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    Secure storage should be available for printed labels to prevent intermingling.

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    Rejected materials should be physically separated from all other materials unless there is an eq...

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    13.3 Issuing or distribution of materials

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    Materials should not normally be issued for use until the appropriate testing has been completed...

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    Should it be necessary to use materials before evaluation is complete, procedures should be avai...

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    If materials are weighed or sub-divided before use, such activities should be carried out in an ...

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    Specific management of A.

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    Finished A.

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    In addition to the measures applicable to all materials, written procedures should be available ...

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    Records of the distribution of batches of A.

  • ...and More!

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