{"id":1016,"date":"2026-05-19T09:41:03","date_gmt":"2026-05-19T09:41:03","guid":{"rendered":"https:\/\/udqs.co.ke\/en\/?p=1016"},"modified":"2026-05-19T09:54:17","modified_gmt":"2026-05-19T09:54:17","slug":"gmp-expert-in-kenya","status":"publish","type":"post","link":"https:\/\/udqs.co.ke\/en\/gmp-expert-in-kenya\/","title":{"rendered":"GMP EXPERT IN KENYA"},"content":{"rendered":"\n<p><strong>Eng. Thilange Acquilino<\/strong><\/p>\n\n\n\n<p><strong>ULTRA DYNAMIC QUALITY SYSTEMS (UDQS)<\/strong><\/p>\n\n\n\n<p><em>Pharmaceutical, Biopharmaceutical &amp; Vaccine GMP Specialist&nbsp; |&nbsp; Chemical &amp; Process Engineer<\/em><\/p>\n\n\n\n<p>Eng. Thilange Acquilino is a Chemical and Process Engineer with over twenty years of experience in Good Manufacturing Practice (GMP) across pharmaceutical, biopharmaceutical, and vaccine manufacturing. Based in Kenya and active across East Africa and beyond, he supports manufacturers, regulators, and capacity-building programmes to achieve and sustain GMP certification aligned with the Pharmacy and Poisons Board (PPB) Kenya, WHO, EU GMP, US FDA, PIC\/S, and ICH expectations.<\/p>\n\n\n\n<p><strong>Core Strengths<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pharmaceutical GMP \u2014 <\/strong>sterile and non-sterile manufacturing, APIs, and PQS implementation (ICH Q10).<\/li>\n\n\n\n<li><strong>Biopharmaceutical &amp; Vaccine Manufacturing \u2014 <\/strong>upstream, downstream, fill-finish, mRNA-LNP, and modern vaccine platforms (Annex 1).<\/li>\n\n\n\n<li><strong>GMP Capacity Building \u2014 <\/strong>role-based training, train-the-trainer, and regulator inspector capacity programmes.<\/li>\n\n\n\n<li><strong>Quality Control \u2014 <\/strong>QC lab design, ICH Q2(R2) method validation, stability (ICH Q1), and OOS\/OOT investigations.<\/li>\n\n\n\n<li><strong>Validation Expert \u2014 <\/strong>VMP, URS, IQ\/OQ\/PQ, three-stage Process Validation, Cleaning Validation, CSV (GAMP 5).<\/li>\n\n\n\n<li><strong>QMS &amp; ISO Standards \u2014 <\/strong>ISO 9001, ISO\/IEC 17025, ISO 13485, and integrated management systems.<\/li>\n\n\n\n<li><strong>Audits &amp; Inspection Readiness \u2014 <\/strong>internal audits, mock inspections, CAPA, and engagement with PPB, WHO PQ, EMA, FDA, and PIC\/S.<\/li>\n<\/ul>\n\n\n\n<p><strong>Selected Engagements<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Validation and qualification programmes for biopharmaceutical equipment, including bioreactors, clean utilities, and fill-finish lines.<\/li>\n\n\n\n<li>Process risk assessments and FMEA aligned with ICH Q9(R1) and EU GMP Annex 1 for vaccine and biologics manufacturing.<\/li>\n\n\n\n<li>QMS documentation suites and ISO\/IEC 17025 implementation for national standards bureaus, regulatory authorities, and laboratories.<\/li>\n\n\n\n<li>GMP gap assessments, mock inspections, CAPA programmes, and inspection-response support for pharmaceutical and herbal medicine manufacturers.<\/li>\n\n\n\n<li>GMP training and capacity-building programmes for manufacturers and regulators across East Africa and the Horn of Africa.<\/li>\n<\/ul>\n\n\n\n<p><strong>Standards &amp; Frameworks<\/strong><\/p>\n\n\n\n<p>WHO GMP&nbsp; \u2022&nbsp; EU GMP (Annex 1, Annex 15)&nbsp; \u2022&nbsp; US FDA cGMP (21 CFR 210\/211)&nbsp; \u2022&nbsp; PIC\/S&nbsp; \u2022&nbsp; ICH Q7, Q9(R1), Q10, Q2(R2)&nbsp; \u2022&nbsp; ASTM E2500&nbsp; \u2022&nbsp; GAMP 5&nbsp; \u2022&nbsp; PPB Kenya GMP Guidelines&nbsp; \u2022&nbsp; ISO 9001&nbsp; \u2022&nbsp; ISO\/IEC 17025&nbsp; \u2022&nbsp; ISO 13485<\/p>\n\n\n\n<p><strong>Sectors Served<\/strong><\/p>\n\n\n\n<p>Pharmaceutical, biopharmaceutical, vaccine, herbal medicine, medical device, food, cosmetic, and contract manufacturers; QC and calibration laboratories; National Regulatory Authorities and Standards Bureaus; and international GMP capacity-building programmes across Kenya and the wider African region.<\/p>\n\n\n\n<p>Engage Eng. Acquilino through <strong>Ultra Dynamic Quality Systems (UDQS)<\/strong> for GMP gap assessments, validation, QC strengthening, training, and PPB \/ WHO PQ inspection readiness.<\/p>\n\n    <div class=\"xs_social_share_widget xs_share_url after_content \t\tmain_content  wslu-style-1 wslu-share-box-shaped wslu-fill-colored wslu-none wslu-share-horizontal wslu-theme-font-no wslu-main_content\">\n\n\t\t\n        <ul>\n\t\t\t        <\/ul>\n    <\/div> \n","protected":false},"excerpt":{"rendered":"<p>Eng. Thilange Acquilino is a Chemical and Process Engineer with over twenty years of experience in Good Manufacturing Practice (GMP) across pharmaceutical, biopharmaceutical, and vaccine manufacturing. <\/p>\n","protected":false},"author":2,"featured_media":1023,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""},"footnotes":""},"categories":[11],"tags":[93,92,95,94],"class_list":["post-1016","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-udqs-newsroom","tag-core-strengths","tag-gmp-expert-in-kenya","tag-sectors-served","tag-selected-engagements"],"_links":{"self":[{"href":"https:\/\/udqs.co.ke\/en\/wp-json\/wp\/v2\/posts\/1016","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/udqs.co.ke\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/udqs.co.ke\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/udqs.co.ke\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/udqs.co.ke\/en\/wp-json\/wp\/v2\/comments?post=1016"}],"version-history":[{"count":3,"href":"https:\/\/udqs.co.ke\/en\/wp-json\/wp\/v2\/posts\/1016\/revisions"}],"predecessor-version":[{"id":1022,"href":"https:\/\/udqs.co.ke\/en\/wp-json\/wp\/v2\/posts\/1016\/revisions\/1022"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/udqs.co.ke\/en\/wp-json\/wp\/v2\/media\/1023"}],"wp:attachment":[{"href":"https:\/\/udqs.co.ke\/en\/wp-json\/wp\/v2\/media?parent=1016"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/udqs.co.ke\/en\/wp-json\/wp\/v2\/categories?post=1016"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/udqs.co.ke\/en\/wp-json\/wp\/v2\/tags?post=1016"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}