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  5. 9.5 - Records and Reports - Complaints Files
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    AdobeStock_526326275
  • <Female customer wearing a yellow short sleeve top at home in a minimalistic white living room, sat at a pale wooden table, blue glass of water, visibly shocked hand to mouth reading the response by e-mail to a complaint she made on a white laptop. Credit> AdobeStock_78493419
    AdobeStock_78493419
  • <Close up of large dark blue button easy dial light blue telephone for making or taking complaints. Credit> 1240610 by tnimalan @ freeimages
    1240610 by tnimalan @ freeimages
  • <Female consumer wearing cream coloured top, sitting on white sofa in living room, shelving and plant behind her, visibly shocked with hands in the air and mouth open at the box she has opened from an online pharmacy. Credit> AdobeStock_345250156
    AdobeStock_345250156
  • <Artist impression of a complaint iceberg, where only 5% of the complaints are visible and are on the surface, and yet more than 50% are unreported and invisible beneath the surface. Credit> AdobeStock_576243370
    AdobeStock_576243370
By GMP-SOP-Download Drug

9.5 - Records and Reports - Complaints Files

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Quality Control must review all complaints to determine the potential failure of a drug product to meet any of its specifications and whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to competent authorities in the country where it is marketed

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GMP-SOP-Download Drug9.4 - Records and Reports - Quality Records
<Male employee with back to camera scratching the back of his head looking for some quality records in a shelving full of blue lever arch folders. Credit> AdobeStock_146037976
<Male warehouse operator searching through a pile of fallen and damaged boxes. Credit> Freepik
GMP-SOP-Download Drug10.0 - Returned and Salvaged Drug Products
<Tabby cat sat on grey sofa not happy with the drug products on the white coffee table in front of him, a nasal spray, some tablets in blisters, and a cough syrup, batting them with his paw. Credit> AdobeStock_526326275
$26.00 USD
$26.00 USD