Grünenthal voluntary admission: failure to retain certified materials and certificates (AUTH/3733/1/23)

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Key facts

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Case number	AUTH/3733/1/23
Company	Grünenthal
Case type	Voluntary admission (treated as a complaint under Constitution and Procedure)
Issue	Failure to retain/preserve certified documentation (hard copy items and signatures)
Approx. volume affected	Approximately 30 hard copy items
Applicable Code	2021
Breach clauses	Clause 5.1; Clause 8.6
Complaint received	30 January 2023
Case completed	15 November 2023
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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Grünenthal made a voluntary admission that, during a handover for a departing colleague, it was discovered that a number of certified hard copy items and signatures had not been returned and filed.
The issue related to approximately 30 hard copy items.
The company stated it immediately raised a deviation from its SOP in the Quality Management System and conducted a root cause analysis.
Contributing factors identified by the company included human error, organisational change, remote working and potentially the move to a new office.
The matter only came to light at the handover meeting prior to the colleague’s departure.

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Breach of Clause 8.6 (Failing to preserve certificates and material in the form certified).
Breach of Clause 5.1 (Failing to maintain high standards).
No appeal.

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