Medium

Available on

Apple Android Windows

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
  • Red Bull
  • Mirvac

Want to learn more about GoCanvas?

Request a Demo

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

Included Features

Our App Builder gives you the power to easily add and remove the ones you want. {{controller.show_all ? 'See included features.' : 'See more features.'}}

  • {{data.title}}

Included Fields

Customize to add, remove, or edit any of the fields below.

  • Ico statictext

    Principle

  • Ico statictext

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

  • Ico statictext

    9.1 General considerations

  • Ico checkbox

    All documents used in the manufacture of A.

  • Ico checkbox

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

  • Ico checkbox

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

  • Ico checkbox

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

  • Ico checkbox

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

  • Ico statictext

    9.2 Specifications and test procedures

  • Ico statictext

    Principle

  • Ico statictext

    Specifications describe the requirements to which materials should conform.

  • Ico checkbox

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

  • Ico checkbox

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

  • Ico checkbox

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

  • Ico statictext

    9.3 Test records

  • Ico statictext

    Principle

  • Ico statictext

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

  • Ico statictext

    9.3.1 Records of tests, should include:

  • Ico statictext

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

  • Ico statictext

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

  • Ico statictext

    - an identification of the standard when used,

  • Ico statictext

    - any weighing, measurements or reading carried out,

  • Ico statictext

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

  • Ico statictext

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

  • Ico statictext

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

  • Ico statictext

    9.4 Production documentation

  • Ico statictext

    Principle

  • Ico statictext

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

  • ...and More!

Related Manufacturing Apps... and they're all free for GoCanvas subscribers!

App Name

Manufacturing Assembly Area Safety Rules

The Manufacturing Assembly Area Safety Rules mobile app is intended to help workers follow company safety rules. The app c...

App Name

GMP for Active Ingredient Manufacture...

The GMP for Active Ingredient Manufacturers: Equipment and Production mobile app is part of a GMP Program. Equipment and p...

App Name

EPA's Lean and Environment Toolkit: V...

The EPA Lean and Environment Toolkit Value Stream Mapping mobile app is one of the industry’s most helpful management tool...

App Name

GMP for Active Ingredient Manufacture...

The GMP for Active Ingredient Manufacturers: Quality Management mobile app is part of a GMP Program. Quality Assurance is ...

App Name

Manufacturing Safety Program/Type of ...

Use the Manufacturing Safety Program/Type of Work Matrix mobile app to identify the type(s) of work that your company pr...

App Name

Industrial Safety Handbook: General S...

The Industrial Safety Handbook: General Safety Rules mobile app provides an simple to follow checklist for General Safety ...

App Name

GMP for Active Ingredient Manufacture...

The GMP for Active Ingredient Manufacturers: Sampling mobile app is part of a GMP Program. Samples must be truly represent...

App Name

Office 5S Maturity Matrix

The Office 5S Maturity Matrix mobile app covers 5 maturity models: just beginning, focus on basics, making it visual, focu...

More Information


Related Blog Posts