Objectives: New EU Medical Device and In-Vitro Diagnostic Regulations
New Annex 1
The highly anticipated draft of Eudralex Volume 4 Annex 1 “Manufacture of Sterile Medicinal Products” was released on the 20th December 2017 and since this date the pharmaceutical industry has compiled and communicated significant feedback on the wording and content of the augmented and enlarged document. Potential wording changes notwithstanding, it is anticipated that the general intention of the new draft will remain intact. The significant number of clarifications and additions to the guidelines brings consequences for all QPs currently involved in batch disposition of sterile products. One of the major changes contained in the new document is the reference to the Contamination Control Strategy and its function which was first introduced in the updates to Eudralex Volume 4 Part 1 Chapter 3 and Chapter 5 in 2015. The new Annex 1 states “A contamination control strategy should be implemented across the facility in order to assess the effectiveness of all the control and monitoring measures employed. This assessment should lead to corrective and preventative actions being taken as necessary” and further states that “Sole reliance for sterility or other quality aspects must not be placed on any terminal process or finished product test.” The intention of these statements is to initiate a move away from reliance on finished product tests such as sterility testing as a marker of overall batch sterility and a move towards prospective sterility assurance and contamination control which is firmly rooted in QRM principles with all relevant elements brought together holistically in one overall strategy of control and monitoring. This intention is further emphasised in the document where it is states that a “…site’s environmental and process monitoring program forms part of the overall contamination control strategy” and that “the information from these systems should be used for routine batch release…..” giving clear direction that the contamination control strategy and review of the controls and monitoring of the elements contained therein should form the basis for batch disposition of sterile products. In addition to focus on the contamination control strategy the new Annex 1 provides guidance and clarification on some of the items that need to be considered as part of the batch release process and one example of this is the requirement as per the new Annex 1 to confirm the integrity of the final sterilisation gas filter on compressed gas systems used in aseptic manufacturing and in direct contact with the product or product container [7.19]. The current Annex 1 guideline does not make specific reference to the role of the QP and this has changed somewhat in the new Annex 1 where reference is made to the “Persons responsible the quality release of sterile medicine” and the additional requirement that they “should have appropriate access to manufacturing and quality information and possess adequate knowledge and experience in the manufacture of sterile dosage forms and their critical quality attributes” which comes under a new section entitled “Pharmaceutical Quality System” [3]. The title of QP is not explicitly used however due to the intention that the new Annex 1 will not be an independent EU document but will also replace PIC/S document PE009-11 “Manufacture of Sterile Medicinal Products” when it comes into effect. Ultimately the introduction of the new Annex 1 guideline will bring change and will necessitate a change of focus for QPs currently working in the industry on sterile medicinal product batch disposition. This change will place a specific emphasis on Quality Risk Management and possession of the necessary skills for engagement in the QRM process as well as a willingness to actively engage in the implementation and ongoing management of the contamination Contact our team to discuss more – please connect with us +353 1 846 47 42 or contactirl@pharmalex.com.
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