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Pharmaceutical & Medical Packaging News, May/June 2015

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Viewpoint • Pharmaceutical & Medical Packaging News May/June 2015 20 audits as outlined in the recommenda- tion and as it is reflected in the respec- tive directives. The purpose of the recommen- dation is "to facilitate the consistent application of the conformity assess- ment provisions contained in [the medical device directives], the noti- fied bodies should apply the provisions of this Recommendation when they perform product assessments, quality system assessments and unannounced audits." ⁸ 2013/473/EU recommends that manufacturers: •  "Have  to  fulfill  their  obligations  themselves regardless of any partial or total outsourcing of the production. •  Do  not  fulfill  their  obligation  to  have at their disposal the full techni- cal documentation and/or of a qual- ity system by referring to the technical documentation of a subcontractor or supplier and/or to their quality system. •  Should  integrate  the  quality  sys- tem of critical subcontractors and of crucial suppliers with their quality system. •  Need  to  control  the  quality  of  services provided and of components supplied and the quality of produc- tion thereof regardless of the length of the contractual chain between the manufacturer and the subcontractor or supplier." ⁸ NATURE OF THE AUDIT Article 2(c) of the Commission rec- ommendation requires that Notified Bodies "(…) verify the day-to-day com- pliance with legal obligations, notified bodies should, in addition to the initial, surveillance or renewal audits, visit the manufacturer or, if this is likely to ensure more efcient control, one of its subcontractors in charge of pro- cesses which are essential for ensuring compliance with legal requirements ('critical subcontractor') or a supplier of crucial components or of the entire devices (both: 'crucial supplier') with- out prior notice ('unannounced audits') in accordance with Annex III." ⁸ Annex III of the recommenda- tion outlines the modality of unan- nounced audits. Notified Bodies need to carry out these audits at least every third year. The audits frequency will be increased if the devices in ques- tion bear high risks, if the audits are related to frequent noncompliance, or if the Notified Body receives oth- er information that leads it to suspect nonconformities of the devices or the quality management system of their manufacturers. Indicators for increase of the audit frequency could be: •  Postmarket  feedback  that  the  Notified Bodies receive, such as vigi- lance cases or field safety corrective actions at an unusually high frequency. •  Complaint  rates  observed  by  the  Notified Body during the regular audit schedule. •  Nonconforming  products  in  man- ufacturing observed during the regular audit schedule. •  Incidents with high severity. In general, the unannounced audits will be performed by two auditors and will last at least one day. Large and multiple-site companies should be aware that the audit will be carried out on more days or with more auditors on the sites. Depending on the manufacturing process, the Notified Bodies will visit the facilities of the manufacturer and/ or the premises of the manufactur- er's critical subcontractors or crucial suppliers. As critical subcontractors and crucial suppliers are not defined concepts, the interpretation is largely unharmonized. BSI utilizes the follow- ing concepts: •  Critical  Subcontractor:  e.g.,  man- ufacturer of finished devices, key sub- assembly, or significant components. Regulatory responsibility or activities are essential for ensuring compliance with legal requirements. Includes design or software development, steril- ization, sterile packaging. •  Crucial  Supplier:  e.g.,  critical  raw  materials such as silicone gel compo- nent for an implant, animal tissue for use in heart valve. Includes proprietary items. Manufacturers shall implement and improve the quality assurance con- tracts with their critical subcontractors or crucial suppliers in such a way that the Notified Body in charge has the right to access the premises of critical subcontractor or crucial supplier and is able to review the respective docu- ments and records. The nature of the audit is more product oriented than the regular audits, which mainly focus on the quality management system of the manufacturer. The assessment con- centrates on a recently manufactured device and its conformity with its technical documentation. Part of the verification is that the raw materials and components are the same as those specified in the technical documenta- tion of the approved device or device family, including the equipment used in the manufacturing process. More- over, assessments review whether incoming, in-process, and final con- trols are the same as specified, includ- ing comparison of test result with results from design verification and validation of the medical device in question. Manufacturers are advised to orga- nize their technical files and design dossiers so that they are easily acces- sible during the audit. Often the device might be tested to show compliance. For testing, either the Notified Body may witness the manufacturer testing the product, or the Notified Body may take the product and test it itself in its Assessment of the processes and the conformity of the product will include the verifcation of the traceability of all critical components.

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