{"id":114369,"date":"2024-01-08T10:15:20","date_gmt":"2024-01-08T09:15:20","guid":{"rendered":"https:\/\/webserver.gfps.de\/quantitative-determination-and-absence-of-microorganisms\/"},"modified":"2025-09-03T15:45:19","modified_gmt":"2025-09-03T13:45:19","slug":"quantitative-determination-and-absence-of-microorganisms","status":"publish","type":"page","link":"https:\/\/www.gfps.de\/en\/quantitative-determination-and-absence-of-microorganisms\/","title":{"rendered":"Quantitative determination and absence of microorganisms"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;60&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; back_color=&#8221;color-nhtu&#8221; back_image=&#8221;115369&#8243; back_position=&#8221;center bottom&#8221; overlay_color=&#8221;color-983180&#8243; overlay_alpha=&#8221;51&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; enable_bottom_divider=&#8221;default&#8221; bottom_divider=&#8221;gradient&#8221; shape_bottom_h_use_pixel=&#8221;true&#8221; shape_bottom_height_percent=&#8221;100&#8243; shape_bottom_color=&#8221;accent&#8221; shape_bottom_opacity=&#8221;90&#8243; shape_bottom_index=&#8221;0&#8243; row_height_pixel=&#8221;280&#8243; row_name=&#8221;Intro&#8221; uncode_shortcode_id=&#8221;147230&#8243; back_color_type=&#8221;uncode-palette&#8221; shape_bottom_color_type=&#8221;uncode-palette&#8221; overlay_color_type=&#8221;uncode-palette&#8221;][vc_column column_width_percent=&#8221;100&#8243; position_horizontal=&#8221;left&#8221; position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;1&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; style=&#8221;dark&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; align_medium=&#8221;align_left_tablet&#8221; medium_width=&#8221;0&#8243; align_mobile=&#8221;align_left_mobile&#8221; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_speed=&#8221;1000&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;857023&#8243;][vc_custom_heading heading_semantic=&#8221;h3&#8243; text_size=&#8221;h4&#8243; text_weight=&#8221;300&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-210350&#8243; sub_lead=&#8221;yes&#8221; sub_reduced=&#8221;yes&#8221; uncode_shortcode_id=&#8221;141995&#8243;]Non-sterile products[\/vc_custom_heading][vc_custom_heading heading_semantic=&#8221;h1&#8243; text_size=&#8221;fontsize-155944&#8243; text_weight=&#8221;800&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-111509&#8243; sub_lead=&#8221;yes&#8221; sub_reduced=&#8221;yes&#8221; uncode_shortcode_id=&#8221;171471&#8243;]Quantitative determination and absence of microorganisms[\/vc_custom_heading][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; back_color=&#8221;color-lxmt&#8221; overlay_alpha=&#8221;0&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; style=&#8221;inherited&#8221; uncode_shortcode_id=&#8221;106173&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;2&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; style=&#8221;light&#8221; back_color=&#8221;color-lxmt&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; align_medium=&#8221;align_left_tablet&#8221; medium_width=&#8221;0&#8243; align_mobile=&#8221;align_left_mobile&#8221; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_delay=&#8221;200&#8243; width=&#8221;3\/4&#8243; uncode_shortcode_id=&#8221;116340&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_column_text uncode_shortcode_id=&#8221;243342&#8243;]Determining the microbial load and testing for the absence of specific microorganisms are crucial steps in ensuring the safety and efficacy of non-sterile pharmaceutical preparations and substances for pharmaceutical use.[\/vc_column_text][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; overlay_alpha=&#8221;0&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_visibility=&#8221;yes&#8221; medium_width=&#8221;0&#8243; mobile_visibility=&#8221;yes&#8221; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_delay=&#8221;400&#8243; zoom_width=&#8221;0&#8243; zoom_height=&#8221;0&#8243; width=&#8221;1\/4&#8243; uncode_shortcode_id=&#8221;184491&#8243;][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;55&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; back_color=&#8221;color-nhtu&#8221; overlay_alpha=&#8221;0&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; style=&#8221;inherited&#8221;][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; back_color=&#8221;color-rgdb&#8221; back_image=&#8221;114055&#8243; back_position=&#8221;center bottom&#8221; overlay_alpha=&#8221;0&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_delay=&#8221;400&#8243; zoom_width=&#8221;0&#8243; zoom_height=&#8221;0&#8243; width=&#8221;1\/4&#8243; uncode_shortcode_id=&#8221;121870&#8243; back_color_type=&#8221;uncode-palette&#8221; mobile_height=&#8221;300&#8243;][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;2&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; style=&#8221;light&#8221; back_color=&#8221;color-xsdn&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; align_medium=&#8221;align_left_tablet&#8221; medium_width=&#8221;0&#8243; align_mobile=&#8221;align_left_mobile&#8221; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_delay=&#8221;200&#8243; width=&#8221;3\/4&#8243; uncode_shortcode_id=&#8221;188419&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_custom_heading text_weight=&#8221;800&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-111509&#8243; text_uppercase=&#8221;&#8221; text_align=&#8221;text-left&#8221; uncode_shortcode_id=&#8221;770766&#8243;]Quantitative determination of the microbial load and testing for the absence of specific microorganisms[\/vc_custom_heading][vc_column_text uncode_shortcode_id=&#8221;134753&#8243;]The quantitative determination of the microbiological load and testing for the absence of specific microorganisms are important components in the quality assurance of non-sterile products. Compliance with applicable standards and the implementation of efficient quality controls are essential to protect the safety of consumers and manufacturers.<\/p>\n<p>The regulations for checking the microbiological quality of pharmaceutical products and raw materials have been harmonized between the European (Ph. Eur.), US-American (USP) and Japanese Pharmacopoeias (JP).<\/p>\n<p>The microbial testing of non-sterile products is carried out according to the procedures described in the general chapters: &#8220;Microbial Enumeration Tests&#8221; and &#8220;Tests for Specified Microorganisms&#8221;<\/p>\n<p>Acceptance criteria for the microbiological quality of non-sterile dosage forms are defined in specific chapters: &#8220;Acceptance criteria for microbiological quality of non-sterile dosage forms&#8221;.<\/p>\n<p>A test with validation (= method suitability test) must be carried out once for each product type and product formulation, i.e. the validity of the quantitative determination of the microorganisms and the validity of the detection method for certain microorganisms must be demonstrated once. A new inspection is only necessary if there are changes to the product or the recipe.<\/p>\n<p>If the product to be tested has antimicrobial activity, this must be detected and neutralized.[\/vc_column_text][vc_empty_space empty_h=&#8221;1&#8243;][vc_separator sep_color=&#8221;color-983180&#8243; uncode_shortcode_id=&#8221;107261&#8243; sep_color_type=&#8221;uncode-palette&#8221;][vc_empty_space empty_h=&#8221;1&#8243;][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text uncode_shortcode_id=&#8221;820309&#8243;]<strong>Guidelines<\/strong><\/p>\n<ul>\n<li>according to Ph. Eur. 2.6.12<\/li>\n<li>according to Ph. Eur. 2.6.13<\/li>\n<li>according to Ph. Eur. 5.1.4<\/li>\n<li>according to USP &lt;61&gt;<\/li>\n<li>according to USP &lt;62&gt;<\/li>\n<li>according to USP &lt;1111&gt;<\/li>\n<li>based on JP 4.05<\/li>\n<li>based on JP 4.05 II<\/li>\n<li>based on JP 12<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text uncode_shortcode_id=&#8221;171812&#8243;][\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_empty_space empty_h=&#8221;1&#8243;][vc_separator sep_color=&#8221;color-983180&#8243; uncode_shortcode_id=&#8221;107261&#8243; sep_color_type=&#8221;uncode-palette&#8221;][vc_empty_space empty_h=&#8221;1&#8243;][vc_column_text uncode_shortcode_id=&#8221;410927&#8243;]We will be happy to assist you with your questions on the quantitative determination and absence of microorganisms at <a href=\"mailto:accountmanagement@gfps.de\"><strong>accountmanagement@gfps.de<\/strong><\/a>.[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;60&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; back_color=&#8221;color-nhtu&#8221; back_image=&#8221;115369&#8243; back_position=&#8221;center bottom&#8221; overlay_color=&#8221;color-983180&#8243; overlay_alpha=&#8221;51&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; enable_bottom_divider=&#8221;default&#8221; bottom_divider=&#8221;gradient&#8221; [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-114369","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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