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GDP Consultancy: Selecting Support and Organising Operational Handover
When selecting GDP consultancy, define the entity, premises, medicines, storage conditions and outsourced transport. Ask for a written preparation scope: initial gap review, responsibility mapping, procedure development, record checks and staff handover. Clarify which national authority process the work supports.
When selecting GDP consultancy, define the entity, premises, medicines, storage conditions and outsourced transport. Ask for a written preparation scope: initial gap review, responsibility mapping, procedure development,…
Choose support for the actual distribution operation
When selecting GDP consultancy, define the entity, premises, medicines, storage conditions and outsourced transport. Ask for a written preparation scope: initial gap review, responsibility mapping, procedure development, record checks and staff handover. Clarify which national authority process the work supports.
Assess the proposed team's relevant distribution experience and the evidence it will actually examine. A template folder and a promised certificate do not show that warehouse or transport controls work. Separate consultancy, private assessment and an official inspection or authorisation.
Resolve outsourced record access before accepting the handover
The EU human-medicine GDP guideline addresses written arrangements and responsibilities for outsourced activities. The contract giver remains responsible for the contracted activities. Use this European framework to examine responsibilities and monitoring; confirm the applicable national rules separately.
Hypothetically, a carrier holds temperature records but the contract allows access only after a monthly invoice. A consultant offers a completed GDP folder without addressing this delay. Identify who can retrieve records for a deviation or inspection, agree access and escalation arrangements with the carrier and test the handover using a genuine shipment.
Specify deliverables and decisions
The agreed output should show the reviewed records, unresolved issues, responsible people and practical next actions. Verify that warehouse staff and the outsourced carrier understand their respective tasks. Do not invent old monitoring records to make the file appear complete.
Kayra can coordinate the agreed preparation and evidence review. The business remains responsible for its actual operation and contracts; the competent authority determines public authorisation and official compliance. Consultancy does not decide medicine usability or guarantee an inspection result.
Official sources
Choose consultancy by operational deliverables and a verifiable handover. Public authorisation, official compliance and medicine-disposition decisions remain with the responsible parties.
What should a GDP consultancy proposal specify?
The actual activities, records to be reviewed, responsibilities, deliverables and exclusions.
Does outsourcing remove the business's responsibility?
No. Responsibilities, oversight and record access must remain clear under applicable requirements.
Can consultancy guarantee official GDP certification?
No. The competent authority controls its applicable inspection and authorisation process.
Tell us what you need and our specialists will contact you.
The exact records for GDP Consultancy: Selecting Support and Organising Operational Handover depend on the confirmed scope. Current, consistent and traceable information reduces avoidable revisions.