GOOD DISTRIBUTION PRACTICE COMPLIANCE ASSESSMENT REPORT英文资料.docVIP

GOOD DISTRIBUTION PRACTICE: COMPLIANCE ASSESSMENT REPORT Please complete all relevant sections of this form. Please complete in block capitals legibly using black ink. Electronic submission of forms is preferable where possible. Complete one Self Assessment Report for each Wholesale Dealers Licensed site. Incomplete submissions will be returned. The report should be returned at least 2 weeks before your inspection. Failure to submit this document by this date will lead to a higher risk category being applied to your Licence and may lead to an earlier inspection of your site. Guidance notes (in Italics) are provided for some sections. Section 1. General Details Wholesale Dealer’s Licence number Copy details of your WL number and site number from the notice of inspection letter Section 2. Changes Please list any significant changes in processes, facilities, equipment, personnel or workload since the last inspection that was conducted by the MHRA. Processes – Advise any new product ranges handled. Facilities – Advise any significant modifications to buildings in which GDP Activities are undertaken. Equipment – Advise any new or modified equipment used for storage, control of records, picking/packing and environmental monitoring. Personnel – Advise changes of senior staff key to GDP activities. Workload – Advise of any significant increase or decrease in the amount of GDP work undertaken. Where necessary ensure a variation to your licence is submitted. Section 3. Future activities Please list any known significant changes in processes, facilities, equipment, personnel or workload proposed for implementation within the next 2 years. DECLARATION To the best of my knowledge and belief, the particulars I have given in this form are correct, truthful?and complete. ? ? Signed: Date: Name: Position: (BLOCK CAPITALS) (see note below *) Signed: Date: Name: Position: (BLOCK CAPITALS) (see note below *) The signatory