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Denmark: DMA Releases Guide to GMP Changes Requiring an Inspection

Tuesday, January 23, 2018: The Danish Medicines Agency (DKMA) has released guidance on Good Manufacturing Practices (GMP) changes that informs companies which ones require notification and which need a GMP inspection, before making changes to their production sites.

The guide is broken up into four sections which cover buildings, equipment, plants and products. Companies should notify DKMA with all changes related to plants and products. Some changes to buildings and equipment can occur without sending a notification and examples include the addition of external storage facilities or an autoclave.

To determine if a change requires a notification the guide states a ‘yes’ or ‘no’ answer to a question. In contrast, the answer for whether an inspection is required is not always definitive. There are four changes that definitely require an inspection, which includes new production room, new GMP laboratory, new storage facilities and switch to WFI water. There are seven minor equipment changes that do not require an inspection. For any other changes, the agency will decide if inspections are required on a case-by-case basis.

DKMA created the document to inform companies that are planning to make changes, but it should be borne in mind that the list is not exhaustive and some changes may require the manufacturing authorisation to be changed. For example, the opening of a production room in a new location would need to be authorised as a new site on the authorisation.

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