Company Name
RP Name
RP Email

GDP Questionnaire

Does your company operate to current EU guidelines on GDP?   Yes     No
Does your company have a Quality Manual and/or a Site Master File?   Yes     No
Does your company have a formal Quality Management System in place?   Yes     No
Is your company allowed to distribute narcotic & psychotropic drugs (Controlled Drugs)?
If yes, please attach a copy.
  Yes     No
Does your company operate to Standard operate Procedures?   Yes     No
Is your company allowed to distribute Cold Chain products?   Yes     No
Is there a formal process for the control, review and updating of SOPs?   Yes     No
Will you allow a company representative to perform an inspection of your facility?   Yes     No
Has any health authority or regulatory body inspected your facility within the past 24 months?   Yes     No
If yes, what date was the inspection?
What is the name of the Regulatory Body that performed the inspection?
Does your company carry out self-inspections of your facility and systems?   Yes     No
Does your company maintain an Approved Suppliers List?   Yes     No
Does your system allow you to use Unapproved Suppliers?   Yes     No
Is your warehouse Temperature Controlled?   Yes     No
Does your company use Temperature Monitoring Equipment?   Yes     No
Is your Temperature Monitoring Equipment calibrated?   Yes     No
Does your company keep Temperature records?   Yes     No
Are products checked for Falsification/Counterfeit medicines?   Yes     No
Does your company have an emergency plan for Product Recalls?   Yes     No
Does your company have a Quarantine system in place?   Yes     No
Does your company use a system to maintain the Traceability of products?   Yes     No
Does your company operate a "First expiry, First Out" system?   Yes     No
Does your company provide GDP training to staff?   Yes     No
Is your staff trained to handle cold chain products?   Yes     No
Does your company have a pest control system in place?   Yes     No
How often is your facility inspected for pests?
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