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GMP for Active Ingredient Manufacturers: Documentation Mobile App

The GMP for Active Ingredient Manufacturers: Documentation mobile app is part of a GMP Program. A good documentation system is an essential element of GMP for the manufacture of A.I.s. A systematic and well designed documentation system not only contributes to reproducible product quality but assists in investigations into product and process deviations and minimizes errors due to verbal instructions or lack of records. In automated plants some or all of the required documentation, such as the manufacturing instructions, may not exist as separate text documents, but may be integrated into the programming code of the operating system. The app covers General considerations, General considerations and Test records, Test records. The ability to skip screens is called "conditional branching."

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

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

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    Principle

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    A good documentation system is an essential element of GMP for the manufacture of A.

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    9.1 General considerations

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    All documents used in the manufacture of A.

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    Documents should be drawn up by persons with knowledge of the process or controls and approved, ...

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    All documents should be drawn up and maintained in compliance with any commitment made to any re...

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    When entries need to be made in documents, sufficient space should be available for the entry, t...

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    Manual entries in documents should generally be made directly after performing the activity, be ...

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    9.2 Specifications and test procedures

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    Principle

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    Specifications describe the requirements to which materials should conform.

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    Specifications should be available for raw materials, intermediates where necessary, A.

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    Written, approved and dated test procedures should be available for checking if the specificatio...

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    Test procedures which are critical for measuring product quality should be validated.

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    9.3 Test records

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    Principle

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    Records of tests carried out should be so documented that these can be easily compared with the s...

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    9.3.1 Records of tests, should include:

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    - the name and batch number of the material being tested,

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    - reference to the relevant specification and the test procedure used,

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    - an identification of the standard when used,

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    - any weighing, measurements or reading carried out,

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    - any observations and calculations and the results obtained, and should be dated and signed by t...

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    Records of tests should be independently checked for accuracy, and critical records countersigne...

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    Records of tests including charts generated by instruments should be adequately identified and r...

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    9.4 Production documentation

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    Principle

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    Documentation used in production should include written instructions for producing batches of eac...

  • ...and More!

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