Injunction of the ANSM to the company Prodene Klint
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It is because of “non-compliances and significant deficiencies” that the ANSM has just sent to Prodene Klint company a compliance injunction concerning its Alby-sur-Chéran facility. The cause: several deviations relating to compliance with the requirements of ISO 22716 on Good Manufacturing Practices.
This injunction, dated 8 November 2018, follows an inspection by the ANSM carried out at the company’s facilities from 26 to 28 June 2018.
The alleged facts
• The absence of controls on receipt and control of the status of raw materials and packaging items, in accordance with Chapter 6 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices
• Certain raw materials released from the analysis report without physico-chemical and/or microbiological control, which is insufficient with regard to Chapters 6 and 9 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices
• Insufficient quality documentation management, in particular with regard to the treatment of non-specification products, in accordance with Chapter 7 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices
• The absence of contracts for all main contractors and subcontractors in accordance with Chapter 17 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices.
The ANSM enjoins the company Prodene Klint to:
• Implement incoming controls to identify raw materials and packaging items and manage the status of these products within 3 months
• Implement appropriate controls for certain raw materials according to defined methods in order to release the raw materials in accordance with the defined acceptance criteria within 3 months
• Review the organisation and presentation of the documentation system, and in particular ...