The absence, 79 removal or inactivation of viruses, mycoplasma and other adventitious agents, which could 80 contaminate a product, are not considered. 81 3. Legal basis 82 This guideline should be read in conjunction with Directive 2001/83/EC on the community code relating 83 to medicinal products for human use Directive 2001/82/EC on medicinal products for veterinary use as 84 amended and also the current Ph. Eur. 85 In addition, this guideline should be read in conjunction with all other relevant directives and 86 regulations, and all relevant Commission, (V)ICH and CXMP guidelines, Q&A documents and other 87 documents as linked to or published on the EMA website 88 4. General requirements 89 The guideline concerns only specific requirements relating to sterility and sterile products. For other 90 considerations on the manufacturing of the medicinal product, reference is made to other guidance 91 documents such as Guidelines on Manufacture of the Finished Dosage Form. 92 4.1. Manufacturing of sterile medicinal products 93 Documentation regarding sterilisation and aseptic processing to be included in the quality dossier, 94 Module 3, sections 3.2.P.2 Pharmaceutical development and 3.2.P.3 Manufacture for human products 95 or Part 2 A.4 Development pharmaceutics and Part 2 B Description of the manufacturing method for 96 veterinary products is presented below.

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The documentation should be provided for all sites performing 97 sterilisation or aseptic processing related to the medicinal product, regardless of whether the processes 98 are performed in-house or outsourced. 99 The choice of method of sterilisation or aseptic processing should be justified, see section 4.3 Selection 100 of sterilisation method. 101 All sterilisation processes should be carried out according to the instructions of the Ph. Eur. unless 102 justified. 103 All sterilisation procedures for the active substance, the excipient(s) or the primary containers should 104 be described and the name and address of the site responsible should be stated. Validation data should 105 be provided as described below for each sterilisation process. The required validation data for terminal 106 microbial reduction processes is the same as for the sterilisation processes, except for the demonstration of a SAL of 10-6 107 or better. 108 When parametric release of sterility is proposed, the Guideline on real time release testing (formerly 109 Guideline on parametric release), EMA/CHMP/QWP/811210/2009-Rev1 (human products only), the 110 Guideline on Parametric release, EMEA/CVMP/QWP/339588/2005 (veterinary products only) and the 111 text of Ph. Eur. Chapter 5.1.1 should be taken into account. Guideline on sterilisation of the medicinal product, active substance, excipient and primary container EMA/CHMP/CVMP/QWP/BWP/850374/2015 Page 5/15 112 The levels of bioburden and bacterial endotoxins in the components (active substance, excipients and 113 primary package), as well as those introduced during manufacture and sterilisation can have an impact 114 on the level of bacterial endotoxins in the finished drug product.


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