European Pharmacopoeia Chapter 516 Alternative methods for
1 Performing an accuracy test of the alternate method with respect to the compendial method can be used instead of the validati on of the limit of detection test 2 may be needed in some cases S Jouette©2017 EDQM, Council of Europe
REPORT&CHALLENGE&TEST&& METODO& FARMACOPEA)EUROPEA)80)
incollaborazionecon prof P G BalboniUniversitàdegliStudidi Ferrara_Microbiologia S/15/0060 Rev 0 Challengetest Pag 1di7/Page1outof7
Comparison of microbial challenge testing methods for cosmetics
The challenge test, especially the KoKo test, can guaranty the safe production and filling including the storage in the closed package The fixing of the PAO has to include additional data beside the microbiological challenge test for example (19): -Analytical data (e g analyses of preservatives, preferably according to the methods of analysis
32 TEST FOR STERILITY - World Health Organization
Japanese Pharmacopoeia (JP) and United States Pharmacopeia (USP) This internationally harmonized test replaces the current method 3 2 1 Test for sterility of non-injectable preparations and 3 2 2 Sterility testing of antibiotics As a consequence, all references to 3 2 1 and 3 2 2 in Ph Int monographs will be changed
A guidance document on microbiological control of cosmetic
challenge testing is yet available a challenge test based on earlier described methods is presented in this guidance document as a suggestion to how a challenge test can be constructed Unfortunately the proposed challenge test has not been validated or tested in laboratories and therefore we do not
THE EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES
with the test: the product is tested in the presence of the test micro-organisms in the same conditions as for the growth promotion test The organisms should grow This method suitability test is performed: a) when the test for sterility has to be carried out on a new product; b) whenever there is a change in the experimental conditions of the
2613 MICROBIOLOGICAL EXAMINATION OF NON-STERILE
2 6 13 Test for specified micro-organisms EUROPEAN PHARMACOPOEIA 6 0 product passes the test if such colonies are not seen or if the confirmatory biochemical tests are negative Salmonella Prepare the product to be examined as described in the general method 2 6 12, but using broth medium A in place of buffered sodium chloride-peptone solution
514 MICROBIOLOGICAL QUALITY OF NON-STERILE PHARMACEUTICAL
test for other micro-organisms depending on the nature of the starting materials and the manufacturing process If it has been shown that none of the prescribed tests will allow valid enumeration of micro-organisms at the level prescribed, a validated method with a limit of detection as close as possible to the indicated acceptance criterion is
513 EFFICACY OF ANTIMICROBIAL PRESERVATION
test organisms is confirmed by the use of appropriate controls The procedure is validated to verify its ability to demonstrate the required reduction in count of viable micro-organisms ACCEPTANCE CRITERIA The criteria for evaluation of antimicrobial activity are given in Tables 5 1 3 -1/2/3 in terms of the log reduction in the number
USP STERILE PRODUCT - PACKAGE INTEGRITY EVALUATION PDA
CCIT cannot replace initial sterility test CCIT needed to verify absence of package damage or deformation that could result in loss of product or sterility Indirect testing for CCIT may be acceptable e g , headspace content verification 16 USP Package integrity and test method selection
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