How to cover regulatory and pharmacopeial updates – at Rechon

At Rechon we always strive to be in compliance and in order to cover regulatory and pharmacopeial updates we have established two groups consisting of members from different departments. 

The GMP compliance group consists of members from production, validation, QA and Regulatory Affairs. The group meets monthly to review GMP-updates presented by relevant authorities and organisations. Applicable new regulations and guidelines are selected and concerned employees identified and informed.

The group also organises the GMP-compliance folder, which is available for all employees. In this folder, links to Eudralex, CFR, EMA, FDA, PIC, ICH and other useful organisations are saved.

The GMP-compliance folder also contains regulations and guidelines organised with regard to specific areas like aseptic processing/ sterility, validation, packaging and distribution.  

The Pharmacopeia compliance group consists of members from the QC laboratories and QA. The group has initially selected a responsible person for each chapter and monograph applicable for Rechon. This person is responsible for reviewing updates of his/her specific chapter/ monograph and, if needed, to initiate a Corrective Action for implementation of a new requirement.

The group meets each time a new Pharmacopeia or a new supplement is published. Applicable new chapters and monographs are identified and a responsible person is selected.

Applicable chapters/ monographs, responsible persons and references to corrective actions are found in the Pharmacopeia- compliance folder, which is available for all employees. 

We feel confident that this way of organising the work will help us to keep updated with new regulations.    


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