• 350- Research and Development

350.1 Documentation

  • Is the documentation validated conform ?

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  • Procedures: 750-PRC-0008
    Instructions: -
    Forms/validation: See the DMS Complete Document list to verify the revision of 5 documents
    BRC REF: Section 3.1,3.2.1, section 3.3

350.2 Training

  • Is the training up to date according to training plan ? Validate the training for 5 employees (position, GMP´s, allergens, etc.)

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  • Procedure: 150-PRC-0001
    Instructions: 150-INS-0009
    Forms/validation: 150-FRM-0003 to 150-FRM-0018, 150-FRM-0021,Integration forms
    BRC REF: 1.1.5, section 7.1

350.3 non-conformities raised during the last audit are corrected adequately?

  • Validate the last audit´s CAR. Are they solved? Are effective measures in place to prevent the recurrence of the NC? Action plan submit for long term CAR?

350.4 Specific Procedures

  • 350.4.1 Design and development planning

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  • Procedure: 350-PRC-0001 section 1.0
    Instructions: -
    Forms/validation : 350-FRM-0007 or SAP transaction zprj
    BRC REF: 5.1.1 to 5.1.4
  • 350.4.2 Development process for a new product

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  • Are all steps of the new product development process followed such as established by the procedure 350-PRC-0001?
    Procedure: 350-PRC-0001 section 2.0
    Instruction: 750-INS-0023, 750-INS-0020,750-INS-0110, 750-INS-0104, 750-INS-0105, AC standards, SAI Standards, 750-PRC-0010
    Forms/ validation: 350-FRM-0004, 350-FRM-0006, Collaboration Chambers, 350-FRM-0005 , 350-FRM-0008, 350-FRM-0009,
    BRC: 5.1.1, 5.1.3, 5.1.4
  • 350.4.3 Miscellaneous

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  • Choose 2 or 3 documents in the list and audit them
    Procedures : 450-PRC-0001, 350-PRC-0001
    Instructions : 350-INS-0002, 350-INS-0011
    Forms/validation: 450-FRM-0004, 450-FRM-0006, 350-FRM-0010, 350-FRM-0011, 350-750-PRC-0005, 820-PRC-0001, 350-FRM-0017, 350-FRM-0018
    BRC: -
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