1. Pharma ERP
  2. Process
  3. Batch review and stability
Process · Batch review and stability

Batch review and stability

Review batch certificate and expiry evidence, then retain dated stability follow-up.

Step by step

  1. Prepare the batch context Industry Reviewer or Quality Inspector

    Industry Reviewer inspects the selected lot record and the available production or supplier context. Check product, work order, expiry date and status. Quality Inspector prepares relevant certificates and inspection evidence within their own permissions. Specialty capture must retain the selected batch reference.

    • Evidence context reviewed
    • Updates Lots, Certificates, Quality inspections
  2. Prepare the attributed review Industry Reviewer

    Industry Reviewer checks the selected batch and quality reviewer before asking the permitted capture account to submit the review. Configure capture to validate the batch and reviewer, reject repeated source evidence, and preserve event attribution. Agree which account submits capture and rehearse that access separately from the release decision.

    • Attributed review checked before capture
    • Updates Batch release reviews, People, Users
  3. Evaluate testing evidence Industry Reviewer

    Industry Reviewer uses the Batch Release Reviews screen to inspect Pending and Testing records, certificate and expiry evidence, and selected-record history. Match the recorded certificate number to the supporting certificate and the selected batch.

    • Testing evidence examined
    • Updates Batch release reviews, Certificates
  4. Approve batch release Industry Reviewer

    Industry Reviewer approves only after evidence is sufficient through a verified decision route. Move the review through Pending and Testing to Approved after review. Agree how an adverse decision is recorded as Rejected and rehearse it with the quality owner. Preserve quality reviewer attribution and avoid creating stock or accounting effects from this specialty decision.

    • Permitted decision recorded
    • Updates Batch release reviews
    ApprovalA person approves before the work moves on.
  5. Record the stability pull Industry Specialist

    Industry Specialist records the linked batch, storage condition, pull date, result and disposition. Pending, Accept and Investigate distinguish the evidence state. Keep the actual pull date when capture occurs later; do not substitute the time the record was entered.

    • Dated stability evidence retained
    • Updates Stability studies, Lots
  6. Review a correction or investigation Industry Reviewer or Industry Specialist

    Industry Reviewer examines an Investigate disposition with Industry Specialist. The configured correction route must retain original evidence and add attributed successor evidence. Agree the external controlled-document requirements with the quality owner and retain the approved evidence reference.

    • Original and successor evidence preserved
    • Updates Stability studies, Batch release reviews

Where it usually breaks

And how to keep it from happening.

  • The selected reviewer's person record resolves to the wrong user account.
  • A certificate number is accepted for an unrelated lot or with conflicting expiry evidence.
  • A stability correction overwrites the original result or triggers another inventory effect.
Industry Reviewer
, Industry Specialist, Quality Inspector.

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