Leaders in the Regulatory Management of Pharmaceutical Products, Cosmetics and Medical Devices

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(511) 711 - 9070

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(51) 960 - 786 - 558

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Requirements for certifying Good Storage Practices in Peru

Requirements for certifying Good Storage Practices in Peru

To certify Good Storage Practices in Peru, the following documents are required:

– Client list
– Supplier list
– List of products being marketed (including registrations, validity, and storage
conditions)
– Quality manual
– Job description manual
– Organizational chart
– Updated staff list with signatures and initials used by the staff
– Environmental sanitation program, if applicable
– Environmental sanitation certificate, if applicable
– Maintenance certificate for electrical installations, if applicable
– Certificate and/or training records for the use of fire extinguishers, if applicable
– Safety and hygiene regulations
– Computer system validation report, if applicable
– Temperature mapping
– Calibration certificate for instruments or equipment used for temperature control, if
applicable
– Qualification of cold room/freezing room/refrigerators/freezers, if applicable
– Packaging qualification (operational and performance), if applicable, in case of
handling products that require a cold chain
– Temperature monitoring records, if applicable, in case of handling products that
require a cold chain
– Valid storage service contract, if applicable
– Service provider evaluation record, if applicable