PMPN_Pharmaceutical & Medical Packaging News

Pharmaceutical & Medical Packaging News, May/June 2015

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21 May/June 2015 Pharmaceutical & Medical Packaging News • facilities. For detailed information on testing in relation with unannounced audits, please refer to Notified Body Recommendation Group DRAFT document "Testing during Unan- nounced Audits." ⁹ The Notified Bodies will verify the on-going manufacturing activities with respect to the associated documenta- tion to ensure that both are in compli- ance with legal requirements. At least two of the following critical processes will be evaluated: •  Design control. •   E s t a b l i s h m e n t   o f   m a t e r i a l  specifications. •  Purchasing  and  control  of  incom- ing material or components. •  Assembling. •  Sterilization.  •  Batch-release.  •  Packaging.  •  Product quality control. Section 5 of the recommendation requires that the notified bodies choose a critical process, "which has a high likelihood of non-conformity and one which is particularly safety relevant." ⁸ The assessment of the processes and the conformity of the product will include the verification of the trace- ability of all critical components and materials and of the manufacturer's traceability system from the entry into the premises of the manufactur- er or his suppliers and subcontractors to the delivery of the final product. Risk management is essential when exchanging raw material, changing manufacturing processes, etc. Manufacturers of medical devices shall prepare themselves for unan- nounced audits, at least through: •  Implementation  of  an  appropri- ate process for receipt of unannounced audits. •  Generate  awareness  for  unan- n o u n c e d a u d i t s t h r o u g h o u t t h e organization. •  Preparation  of  all  subsidiaries  for  potential unannounced audits. •  Internal  auditing  of  the  processes,  products, and technical files in order to detect weaknesses and critical spots. •  Determination  of  critical  subcon- tractors or crucial suppliers. •  Reviewing  and  revising  of  all  quality assurance contracts of critical subcontractors or crucial suppliers. •  Budgeting  of  the  costs  related  to  unannounced audits. A manufacturer and its critical sub- contractors or crucial suppliers can deny or terminate an unannounced audit at any time. However, they will still be liable for the costs, and by doing so manufacturers put their EC-Certificates at risk with the

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