{"id":10396,"date":"2026-09-30T13:38:52","date_gmt":"2026-09-30T11:38:52","guid":{"rendered":"https:\/\/www.qualipharmagroup.com\/?p=10396"},"modified":"2026-09-30T13:39:59","modified_gmt":"2026-09-30T11:39:59","slug":"beyond-validation-what-to-expect-from-the-revision-of-annex-15-duplicado-10384","status":"publish","type":"post","link":"https:\/\/www.qualipharmagroup.com\/en\/blog\/beyond-validation-what-to-expect-from-the-revision-of-annex-15-duplicado-10384\/","title":{"rendered":"Beyond Validation: What to Expect from the Revision of Annex 15"},"content":{"rendered":"<p><span data-contrast=\"auto\">Validation has always been a cornerstone of GMP compliance. However, the recently published EMA\/PIC\/S Concept Paper on the revision of Annex 15 suggests that regulators are now looking beyond the successful execution of qualification and validation activities.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The focus is increasingly shifting towards three key elements:<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"14\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Stronger process knowledge<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"14\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Better use of Quality Risk Management<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"14\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Greater control throughout the product lifecycle<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Although the revision was triggered by the lessons learned from the nitrosamine contamination cases, its impact is expected to extend far beyond that specific issue. The proposal addresses how manufacturers develop, qualify, validate, monitor and continuously improve their processes over time.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Why is Annex 15 being revised?<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">According to the Concept Paper, inspections and regulatory assessments performed after the nitrosamine events identified recurring weaknesses in areas such as process understanding, investigation of quality issues and contamination control. These findings led regulators to conclude that additional guidance and greater consistency are needed across the industry.<\/span><\/p>\n<p><span data-contrast=\"auto\">The objective is not to create a completely new framework. Instead, the revision aims to reinforce existing GMP principles while aligning Annex 15 with the latest expectations from ICH Q9(R1) on Quality Risk Management.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">A major driver of this revision is also the proposed extension of Annex 15 from optional supplementary guidance to a mandatory expectation for manufacturers of chemical and biological active substances.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Validation is a lifecycle activity<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">One of the clearest messages emerging from the Concept Paper is that validation should not be treated as a one-time exercise.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Regulators are placing increasing emphasis on maintaining a validated state throughout the lifecycle of a process. This includes not only the initial qualification and validation activities, but also ongoing monitoring, periodic review and continuous process understanding.\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The draft revision is expected to reinforce concepts such as:<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"15\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Robust process development<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"15\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Understanding critical process parameters<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"15\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Continuous Process Verification (CPV)<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"15\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Periodic review of validated systems and processes<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">In other words, demonstrating that a process worked during validation may no longer be enough. Companies will also need to demonstrate how they continue to understand and control that process over time.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">A stronger role for Quality Risk Management<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">Risk-based thinking is already embedded in GMP, but the revised Annex 15 is expected to further integrate Quality Risk Management into qualification and validation activities.\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The Concept Paper specifically refers to the application of ICH Q9(R1) principles and the use of risk reviews to support lifecycle management decisions. This reflects a broader industry trend towards making quality decisions based on science, knowledge and data rather than relying solely on procedural compliance.\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">For many organisations, the challenge will not be conducting risk assessments. The challenge will be demonstrating how those assessments influence real decisions throughout the lifecycle of equipment, systems and processes.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Looking beyond process validation<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">Annex 15 is not only about validating manufacturing processes. The revision is expected to reinforce how companies define, purchase, qualify and control equipment, systems, suppliers and outsourced services that may impact product quality.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">It also reflects a broader view of validation, covering activities that have traditionally received less attention, such as recovery processes, transportation verification and the investigation of results that fail predefined acceptance criteria.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The message is clear: manufacturers are expected to understand and control not only the production process itself, but also the wider activities that may affect product quality.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">What happens next?<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">At this stage, only the Concept Paper has been published and drafting activities are ongoing. While the original timeline was ambitious, the industry does not expect the draft guideline to be available before late 2026, with the final version likely to follow thereafter.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">This means there is still time for companies to prepare.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Rather than waiting for the final text, manufacturers can already start reviewing whether their current systems adequately support:<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"17\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Process knowledge management<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"17\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Validation lifecycle management<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"17\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Change control effectiveness<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"17\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Supplier and contractor oversight<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"17\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\"><span data-contrast=\"auto\">Quality Risk Management integration<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">These topics are already closely aligned with current inspection expectations and are unlikely to disappear from the final revision.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Final thoughts<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">The proposed revision of Annex 15 is about much more than making the guideline mandatory for certain manufacturers.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">It is another step towards a lifecycle-based approach where validation, qualification, risk management and process knowledge are tightly connected.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The companies that will navigate this transition most successfully are unlikely to be those with the largest number of protocols. They will be the ones that can clearly demonstrate understanding, control and continuous oversight of their processes.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">How Qualipharma can help<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">Many of the themes highlighted in the Concept Paper are already common topics during GMP inspections.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">At Qualipharma, we support manufacturers in:<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Gap assessments against evolving GMP expectations<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Validation and qualification strategy reviews<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Validation Master Plan development and remediation<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Risk management integration in validation activities<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\"><span data-contrast=\"auto\">Supplier and contractor qualification programmes<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"6\" data-aria-level=\"1\"><span data-contrast=\"auto\">Inspection readiness and response to regulatory findings<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">The final text may still be some time away. However, strengthening validation and lifecycle management systems now can reduce future compliance risks and help organisations approach upcoming inspections with greater confidence.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:120,&quot;335559739&quot;:120}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Validation has always been a cornerstone of GMP compliance. However, the recently published EMA\/PIC\/S Concept Paper on the revision of Annex 15 suggests that regulators are now looking beyond the successful execution of qualification and validation activities.\u00a0\u00a0 The focus is increasingly shifting towards three key elements:\u00a0 Stronger process knowledge\u00a0 Better use of Quality Risk Management\u00a0 [&hellip;]<\/p>\n","protected":false},"author":40,"featured_media":10389,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[120],"tags":[],"class_list":["post-10396","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cqv"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Beyond Validation: What to Expect from the Revision of Annex 15 | Qualipharma<\/title>\n<meta name=\"description\" content=\"Validation has always been a cornerstone of GMP compliance. 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