{"id":89864,"date":"2026-04-23T10:50:47","date_gmt":"2026-04-23T10:50:47","guid":{"rendered":"https:\/\/teeptrak.com\/batch-manufacturing-record-pharma-france-2026\/"},"modified":"2026-04-23T10:50:49","modified_gmt":"2026-04-23T10:50:49","slug":"batch-manufacturing-record-pharma-france-2026","status":"publish","type":"post","link":"https:\/\/www.teepchina.com\/fr\/batch-manufacturing-record-pharma-france-2026\/","title":{"rendered":"Batch Manufacturing Record (BMR) : le guide 2026 pour l&rsquo;industrie pharma fran\u00e7aise"},"content":{"rendered":"<p>[et_pb_section fb_built=\u00a0\u00bb1&Prime; _builder_version=\u00a0\u00bb4.27&Prime;][et_pb_row][et_pb_column type=\u00a0\u00bb4_4&Prime;][et_pb_text]<\/p>\n<h1>Batch Manufacturing Record (BMR) : le guide 2026 pour l&rsquo;industrie pharma fran\u00e7aise<\/h1>\n<p>Le Batch Manufacturing Record (BMR), ou Dossier de Lot dans la terminologie ANSM fran\u00e7aise, est le document qui formalise l&rsquo;int\u00e9gralit\u00e9 des op\u00e9rations r\u00e9alis\u00e9es pour produire un lot pharmaceutique. Chaque \u00e9tape de production \u2014 pes\u00e9e des mati\u00e8res premi\u00e8res, param\u00e8tres de granulation, conditions de mise en forme, contr\u00f4les qualit\u00e9 en cours, tests lib\u00e9ratoires \u2014 doit \u00eatre enregistr\u00e9e avec horodatage, signature de l&rsquo;op\u00e9rateur, et tra\u00e7abilit\u00e9 des \u00e9quipements utilis\u00e9s. En cas d&rsquo;incident sur un lot commercialis\u00e9, le BMR est le document que l&rsquo;autorit\u00e9 r\u00e9glementaire (ANSM, EMA, FDA) demandera en premier.<\/p>\n<p>Cet article s&rsquo;adresse aux directeurs industriels, directeurs qualit\u00e9 et responsables production des industriels pharmaceutiques fran\u00e7ais \u2014 Sanofi, Servier, Pierre Fabre, Ipsen, et les dizaines de fa\u00e7onniers CDMO qui produisent pour comptes. Il couvre la structure r\u00e9glementaire du BMR, les exigences BPF\/GMP sp\u00e9cifiques, la transition en cours des BMR papier vers les BMR \u00e9lectroniques (eBMR), et l&rsquo;int\u00e9gration des donn\u00e9es de production temps r\u00e9el dans le dossier de lot.<\/p>\n<h2>Le cadre r\u00e9glementaire du BMR en France<\/h2>\n<p>Le BMR fran\u00e7ais est encadr\u00e9 par trois r\u00e9f\u00e9rentiels qui se superposent : les Bonnes Pratiques de Fabrication (BPF) publi\u00e9es par l&rsquo;ANSM, les EU GMP (Good Manufacturing Practice) europ\u00e9ennes, et \u2014 pour les produits export\u00e9s vers les \u00c9tats-Unis \u2014 la 21 CFR Part 211 de la FDA. Les trois r\u00e9f\u00e9rentiels sont largement harmonis\u00e9s via les accords internationaux ICH (International Council for Harmonisation), mais pr\u00e9sentent des nuances que les \u00e9quipes qualit\u00e9 fran\u00e7aises doivent conna\u00eetre.<\/p>\n<p>Le r\u00e9f\u00e9rentiel EU GMP Chapitre 4 (Documentation) et l&rsquo;Annexe 11 (Computerised Systems) d\u00e9finissent les exigences structurelles du BMR : contenu obligatoire (formule de fabrication, instructions, enregistrements ex\u00e9cutifs, donn\u00e9es brutes), signatures et responsabilit\u00e9s (op\u00e9rateur de production, pharmacien responsable, QA), tra\u00e7abilit\u00e9 compl\u00e8te sur au moins 5 ans post-p\u00e9remption du produit, int\u00e9grit\u00e9 des donn\u00e9es (principes ALCOA+ : Attributable, Legible, Contemporaneous, Original, Accurate, + Complete, Consistent, Enduring, Available).<\/p>\n<p>Les inspections ANSM et EMA qui se tiennent en France portent particuli\u00e8rement attention \u00e0 trois points du BMR : la coh\u00e9rence horodatage entre enregistrements (d\u00e9tection d&rsquo;entr\u00e9es r\u00e9troactives), la tra\u00e7abilit\u00e9 mati\u00e8re (lien sans rupture entre lot fini et mati\u00e8res premi\u00e8res), et la gestion des d\u00e9viations (tout \u00e9cart par rapport \u00e0 la formule approuv\u00e9e doit \u00eatre document\u00e9, justifi\u00e9, et valid\u00e9 par QA avant lib\u00e9ration).<\/p>\n<div style=\"background:#fff5f5;border:2px dashed #EB352C;border-radius:8px;padding:28px;margin:32px 0;text-align:center;\">\n<div style=\"font-size:18px;font-weight:bold;color:#232120;margin-bottom:8px;\">T\u00e9l\u00e9chargement gratuit \u2014 Benchmark TRS Pharma 2026<\/div>\n<div style=\"font-size:14px;color:#555;margin-bottom:20px;\">Donn\u00e9es de r\u00e9f\u00e9rence industrielle sur 40+ usines pharma \u2014 pertinent pour toute production r\u00e9glement\u00e9e fran\u00e7aise.<\/div>\n    <div class=\"teeptrak-asset-container tta-style-default\">\n                    <h3 class=\"tta-title\">T\u00e9l\u00e9chargement gratuit<\/h3>\n                            <p class=\"tta-subtitle\">T\u00e9l\u00e9chargement imm\u00e9diat. Aucune confirmation par e-mail requise.<\/p>\n        \n        <form id=\"tta-form-69ec9fef596e1\" class=\"teeptrak-asset-form\" data-asset-id=\"pharma-benchmark\">\n            <div style=\"position:absolute;left:-9999px;top:-9999px;width:1px;height:1px;overflow:hidden;\" aria-hidden=\"true\"><input type=\"text\" name=\"website_url\" tabindex=\"-1\" autocomplete=\"off\"><input type=\"text\" name=\"fax_number\" tabindex=\"-1\" autocomplete=\"off\"><\/div>\n            <input type=\"hidden\" name=\"asset_id\" value=\"pharma-benchmark\">\n            <input type=\"hidden\" name=\"asset_label\" value=\"Benchmark TRS Pharma 2026\">\n            <input type=\"hidden\" name=\"pdf_url_en\" value=\"https:\/\/www.teepchina.com\/wp-content\/uploads\/2026\/04\/teeptrak-pharma-oee-benchmark-2026-en.pdf\">\n            <input type=\"hidden\" name=\"pdf_url_fr\" value=\"\">\n            <input type=\"hidden\" name=\"pdf_url_cn\" value=\"\">\n            <input type=\"hidden\" name=\"pdf_url_de\" value=\"\">\n            <input type=\"hidden\" name=\"pdf_url_es\" value=\"\">\n            <input type=\"hidden\" name=\"pdf_url_nl\" value=\"\">\n            <input type=\"hidden\" name=\"page_url\" value=\"https:\/\/www.teepchina.com\/fr\/batch-manufacturing-record-pharma-france-2026\/\">\n\n            <div class=\"tta-row tta-row-half\">\n                <div class=\"tta-field\">\n                    <label>Pr\u00e9nom <span class=\"tta-required\">*<\/span><\/label>\n                    <input type=\"text\" name=\"first_name\" required autocomplete=\"given-name\">\n                <\/div>\n                <div class=\"tta-field\">\n                    <label>Nom <span class=\"tta-required\">*<\/span><\/label>\n                    <input type=\"text\" name=\"last_name\" required autocomplete=\"family-name\">\n                <\/div>\n            <\/div>\n\n            <div class=\"tta-row\">\n                <div class=\"tta-field\">\n                    <label>E-mail professionnel\n <span class=\"tta-required\">*<\/span><\/label>\n                    <input type=\"email\" name=\"email\" required autocomplete=\"email\">\n                <\/div>\n            <\/div>\n\n            <div class=\"tta-row tta-row-half\">\n                <div class=\"tta-field\">\n                    <label>Entreprise <span class=\"tta-required\">*<\/span><\/label>\n                    <input type=\"text\" name=\"company\" required autocomplete=\"organization\">\n                <\/div>\n                                <div class=\"tta-field\">\n                    <label>Intitul\u00e9 du poste<\/label>\n                    <input type=\"text\" name=\"job_title\" autocomplete=\"organization-title\">\n                <\/div>\n                            <\/div>\n\n                        <div class=\"tta-row\">\n                <div class=\"tta-field\">\n                    <label>T\u00e9l\u00e9phone (facultatif)<\/label>\n                    <input type=\"tel\" name=\"phone\" autocomplete=\"tel\">\n                <\/div>\n            <\/div>\n            \n            <div class=\"tta-row\">\n                <label class=\"tta-consent\">\n                    <input type=\"checkbox\" name=\"consent_marketing\" value=\"1\">\n                    <span>J'accepte de recevoir occasionnellement des actualit\u00e9s de TeepTrak (d\u00e9sabonnement possible \u00e0 tout moment).<\/span>\n                <\/label>\n            <\/div>\n\n            <div class=\"tta-row\">\n                <button type=\"submit\" class=\"tta-submit\">\n                    <span class=\"tta-submit-text\">T\u00e9l\u00e9charger le rapport<\/span>\n                    <span class=\"tta-submit-loading\" style=\"display:none;\">Traitement en cours\u2026<\/span>\n                <\/button>\n            <\/div>\n\n            <div class=\"tta-legal\">\n                En soumettant ce formulaire, vous acceptez notre politique de confidentialit\u00e9. Nous utilisons votre adresse e-mail uniquement pour assurer le suivi de ce t\u00e9l\u00e9chargement.            <\/div>\n\n            <div class=\"tta-message\" style=\"display:none;\"><\/div>\n        <\/form>\n    <\/div>\n    <\/div>\n<h2>Structure type d&rsquo;un BMR pharma fran\u00e7ais<\/h2>\n<p>Un BMR de production pharma fran\u00e7aise comporte typiquement huit sections :<\/p>\n<p><strong>1. En-t\u00eate de lot :<\/strong> num\u00e9ro de lot, date de fabrication, produit, dosage, formule approuv\u00e9e r\u00e9f\u00e9renc\u00e9e, quantit\u00e9 cible.<\/p>\n<p><strong>2. Formule de fabrication :<\/strong> liste des mati\u00e8res premi\u00e8res avec quantit\u00e9s th\u00e9oriques et tol\u00e9rances, num\u00e9ro de lot de chaque MP utilis\u00e9e, certificats d&rsquo;analyse r\u00e9f\u00e9renc\u00e9s.<\/p>\n<p><strong>3. Instructions de fabrication :<\/strong> s\u00e9quence des op\u00e9rations unitaires (pes\u00e9e, granulation, s\u00e9chage, mise en forme, conditionnement) avec param\u00e8tres critiques (temp\u00e9ratures, dur\u00e9es, vitesses, humidit\u00e9s) et points de contr\u00f4le.<\/p>\n<p><strong>4. Enregistrements d&rsquo;ex\u00e9cution :<\/strong> valeurs r\u00e9elles mesur\u00e9es pendant la production, avec \u00e9cart par rapport aux tol\u00e9rances, horodatage et signature op\u00e9rateur pour chaque \u00e9tape.<\/p>\n<p><strong>5. Contr\u00f4les en cours (IPC) :<\/strong> r\u00e9sultats des tests qualit\u00e9 r\u00e9alis\u00e9s pendant la production (uniformit\u00e9 de masse, duret\u00e9, d\u00e9sagr\u00e9gation, teneur en eau).<\/p>\n<p><strong>6. D\u00e9viations :<\/strong> toute anomalie rencontr\u00e9e pendant la production, sa cause racine pr\u00e9sum\u00e9e, l&rsquo;action corrective imm\u00e9diate, et la d\u00e9cision QA sur l&rsquo;impact lib\u00e9ratoire.<\/p>\n<p><strong>7. Rapport de rendement :<\/strong> quantit\u00e9 produite, pertes, r\u00e9conciliation mati\u00e8re.<\/p>\n<p><strong>8. Revue QA et lib\u00e9ration :<\/strong> validation par le pharmacien responsable que le lot est conforme et lib\u00e9rable pour commercialisation.<\/p>\n<h2>La transition BMR papier \u2192 eBMR (BMR \u00e9lectronique)<\/h2>\n<p>En 2026, la majorit\u00e9 des sites pharma fran\u00e7ais ont entam\u00e9 ou achev\u00e9 la migration du BMR papier vers le BMR \u00e9lectronique (eBMR). Cette transition est port\u00e9e par plusieurs pressions : exigences d&rsquo;int\u00e9grit\u00e9 des donn\u00e9es ALCOA+ qui deviennent tr\u00e8s difficiles \u00e0 d\u00e9montrer sur du papier, pression r\u00e9glementaire croissante (les inspections ANSM et FDA p\u00e9nalisent d\u00e9sormais le papier), et gains d&rsquo;efficacit\u00e9 op\u00e9rationnelle mesurables (divisions par 3-5 du temps de revue QA).<\/p>\n<p>Les plateformes eBMR dominantes en France : Werum PAS-X (d\u00e9sormais K\u00f6rber), MasterControl Manufacturing Excellence, Dassault Syst\u00e8mes Apriso, Rockwell FactoryTalk ProductionCentre pour pharma, et des solutions fran\u00e7aises sp\u00e9cialis\u00e9es comme Qubes. Ces plateformes couvrent l&rsquo;int\u00e9gralit\u00e9 du workflow BMR avec signatures \u00e9lectroniques conformes 21 CFR Part 11.<\/p>\n<p>Le mode d&rsquo;\u00e9chec typique de la transition eBMR : l&rsquo;organisation ach\u00e8te la plateforme, la configure pour reproduire exactement le BMR papier existant, et ne capitalise pas sur les capacit\u00e9s additionnelles (capture automatique des donn\u00e9es \u00e9quipement, d\u00e9tection automatique des d\u00e9viations, int\u00e9gration temps r\u00e9el avec les contr\u00f4les qualit\u00e9). Le projet livre un eBMR qui fonctionne mais qui n&rsquo;a pas transform\u00e9 l&rsquo;op\u00e9ration \u2014 et dont le ROI reste marginal face \u00e0 l&rsquo;investissement.<\/p>\n<div style=\"background:#fff5f5;border:2px dashed #EB352C;border-radius:8px;padding:28px;margin:32px 0;text-align:center;\">\n<div style=\"font-size:18px;font-weight:bold;color:#232120;margin-bottom:8px;\">T\u00e9l\u00e9chargement gratuit \u2014 Checklist acheteur MES (42 questions)<\/div>\n<div style=\"font-size:14px;color:#555;margin-bottom:20px;\">La checklist vendor-neutre utilis\u00e9e par les consultants BCG, McKinsey et Bain pour \u00e9valuer les syst\u00e8mes MES\/OEE chez leurs clients industriels fran\u00e7ais.<\/div>\n    <div class=\"teeptrak-asset-container tta-style-default\">\n                    <h3 class=\"tta-title\">T\u00e9l\u00e9chargement gratuit<\/h3>\n                            <p class=\"tta-subtitle\">T\u00e9l\u00e9chargement imm\u00e9diat. Aucune confirmation par e-mail requise.<\/p>\n        \n        <form id=\"tta-form-69ec9fef5977e\" class=\"teeptrak-asset-form\" data-asset-id=\"mes-checklist\">\n            <div style=\"position:absolute;left:-9999px;top:-9999px;width:1px;height:1px;overflow:hidden;\" aria-hidden=\"true\"><input type=\"text\" name=\"website_url\" tabindex=\"-1\" autocomplete=\"off\"><input type=\"text\" name=\"fax_number\" tabindex=\"-1\" autocomplete=\"off\"><\/div>\n            <input type=\"hidden\" name=\"asset_id\" value=\"mes-checklist\">\n            <input type=\"hidden\" name=\"asset_label\" value=\"Checklist acheteur MES\">\n            <input type=\"hidden\" name=\"pdf_url_en\" value=\"https:\/\/www.teepchina.com\/wp-content\/uploads\/2026\/04\/teeptrak-mes-buyers-checklist-en.xlsx\">\n            <input type=\"hidden\" name=\"pdf_url_fr\" value=\"\">\n            <input type=\"hidden\" name=\"pdf_url_cn\" value=\"\">\n            <input type=\"hidden\" name=\"pdf_url_de\" value=\"\">\n            <input type=\"hidden\" name=\"pdf_url_es\" value=\"\">\n            <input type=\"hidden\" name=\"pdf_url_nl\" value=\"\">\n            <input type=\"hidden\" name=\"page_url\" value=\"https:\/\/www.teepchina.com\/fr\/batch-manufacturing-record-pharma-france-2026\/\">\n\n            <div class=\"tta-row tta-row-half\">\n                <div class=\"tta-field\">\n                    <label>Pr\u00e9nom <span class=\"tta-required\">*<\/span><\/label>\n                    <input type=\"text\" name=\"first_name\" required autocomplete=\"given-name\">\n                <\/div>\n                <div class=\"tta-field\">\n                    <label>Nom <span class=\"tta-required\">*<\/span><\/label>\n                    <input type=\"text\" name=\"last_name\" required autocomplete=\"family-name\">\n                <\/div>\n            <\/div>\n\n            <div class=\"tta-row\">\n                <div class=\"tta-field\">\n                    <label>E-mail professionnel\n <span class=\"tta-required\">*<\/span><\/label>\n                    <input type=\"email\" name=\"email\" required autocomplete=\"email\">\n                <\/div>\n            <\/div>\n\n            <div class=\"tta-row tta-row-half\">\n                <div class=\"tta-field\">\n                    <label>Entreprise <span class=\"tta-required\">*<\/span><\/label>\n                    <input type=\"text\" name=\"company\" required autocomplete=\"organization\">\n                <\/div>\n                                <div class=\"tta-field\">\n                    <label>Intitul\u00e9 du poste<\/label>\n                    <input type=\"text\" name=\"job_title\" autocomplete=\"organization-title\">\n                <\/div>\n                            <\/div>\n\n                        <div class=\"tta-row\">\n                <div class=\"tta-field\">\n                    <label>T\u00e9l\u00e9phone (facultatif)<\/label>\n                    <input type=\"tel\" name=\"phone\" autocomplete=\"tel\">\n                <\/div>\n            <\/div>\n            \n            <div class=\"tta-row\">\n                <label class=\"tta-consent\">\n                    <input type=\"checkbox\" name=\"consent_marketing\" value=\"1\">\n                    <span>J'accepte de recevoir occasionnellement des actualit\u00e9s de TeepTrak (d\u00e9sabonnement possible \u00e0 tout moment).<\/span>\n                <\/label>\n            <\/div>\n\n            <div class=\"tta-row\">\n                <button type=\"submit\" class=\"tta-submit\">\n                    <span class=\"tta-submit-text\">Obtenir la checklist<\/span>\n                    <span class=\"tta-submit-loading\" style=\"display:none;\">Traitement en cours\u2026<\/span>\n                <\/button>\n            <\/div>\n\n            <div class=\"tta-legal\">\n                En soumettant ce formulaire, vous acceptez notre politique de confidentialit\u00e9. Nous utilisons votre adresse e-mail uniquement pour assurer le suivi de ce t\u00e9l\u00e9chargement.            <\/div>\n\n            <div class=\"tta-message\" style=\"display:none;\"><\/div>\n        <\/form>\n    <\/div>\n    <\/div>\n<h2>L&rsquo;int\u00e9gration TRS temps r\u00e9el dans l&rsquo;eBMR<\/h2>\n<p>Le pattern qui produit le ROI le plus \u00e9lev\u00e9 dans les d\u00e9ploiements eBMR fran\u00e7ais 2026 : int\u00e9gration native entre l&rsquo;eBMR et la plateforme de mesure TRS temps r\u00e9el (type TeepTrak PerfTrak avec les capteurs IIoT externes adapt\u00e9s aux environnements GMP). Les donn\u00e9es d&rsquo;\u00e9tat \u00e9quipement (production\/arr\u00eat\/maintenance), les temps de cycle r\u00e9els par lot, et les param\u00e8tres proc\u00e9d\u00e9 critiques sont captur\u00e9s automatiquement et int\u00e9gr\u00e9s dans le BMR \u00e9lectronique sans intervention op\u00e9rateur.<\/p>\n<p>Les gains :<\/p>\n<p><strong>R\u00e9duction de la charge documentaire op\u00e9rateur.<\/strong> Les op\u00e9rateurs pharma fran\u00e7ais passent typiquement 20-35% de leur temps de production sur de la documentation papier. La capture automatique r\u00e9duit cette charge \u00e0 5-10%, lib\u00e9rant du temps pour le vrai travail de production et r\u00e9duisant les erreurs de transcription qui constituent une part significative des d\u00e9viations mineures.<\/p>\n<p><strong>D\u00e9tection pr\u00e9coce des d\u00e9viations.<\/strong> Un param\u00e8tre proc\u00e9d\u00e9 qui d\u00e9rive en temps r\u00e9el est d\u00e9tect\u00e9 imm\u00e9diatement par la plateforme TRS, qui d\u00e9clenche une alerte vers l&rsquo;op\u00e9rateur et QA avant que le lot ne soit compromis. En mode papier, la d\u00e9rive n&rsquo;est souvent d\u00e9tect\u00e9e qu&rsquo;\u00e0 la revue QA post-production \u2014 parfois 72h apr\u00e8s la fin du lot, avec les parties douteuses d\u00e9j\u00e0 en stock.<\/p>\n<p><strong>Acc\u00e9l\u00e9ration de la revue QA.<\/strong> Les BMR \u00e9lectroniques complets avec donn\u00e9es \u00e9quipement int\u00e9gr\u00e9es permettent une revue QA largement automatis\u00e9e sur les points standard, le QA se concentrant sur les vraies d\u00e9viations plut\u00f4t que sur la v\u00e9rification de 300 signatures op\u00e9rateur. Gain typique : r\u00e9duction du d\u00e9lai de lib\u00e9ration de 3-5 jours \u00e0 24-48 heures.<\/p>\n<p><strong>Pr\u00e9paration renforc\u00e9e aux inspections.<\/strong> Un site pharma qui peut produire un BMR complet avec donn\u00e9es \u00e9quipement int\u00e9gr\u00e9es en 5 minutes pendant une inspection ANSM ou FDA transmet un signal de maturit\u00e9 op\u00e9rationnelle qu&rsquo;un site en mode papier ne peut pas produire.<\/p>\n<h2>Recommandations pour les directeurs industriels pharma fran\u00e7ais en 2026<\/h2>\n<p>Si votre site pharma est encore en BMR papier, la transition eBMR est d\u00e9sormais une question de calendrier, pas de d\u00e9cision. L&rsquo;inspection suivante qui trouvera des d\u00e9viations d&rsquo;int\u00e9grit\u00e9 papier g\u00e9n\u00e9rera des observations inacceptables ; la pression r\u00e9glementaire s&rsquo;intensifiera dans les 24-36 mois.<\/p>\n<p>Si vous d\u00e9marrez un projet eBMR, priorit\u00e9 \u00e0 l&rsquo;int\u00e9gration TRS temps r\u00e9el d\u00e8s le p\u00e9rim\u00e8tre initial. L&rsquo;ajout ult\u00e9rieur d&rsquo;une couche TRS sur un eBMR d\u00e9j\u00e0 d\u00e9ploy\u00e9 est techniquement possible mais co\u00fbteux (duplication de capteurs, r\u00e9int\u00e9gration partielle). Le bon sens est d&rsquo;architecturer d\u00e8s le d\u00e9part les deux couches comme un syst\u00e8me unifi\u00e9.<\/p>\n<p>TeepTrak a accompagn\u00e9 plusieurs sites pharma fran\u00e7ais (Sanofi, Ipsen notamment) dans l&rsquo;int\u00e9gration de PerfTrak avec leur eBMR existant ou en cours de d\u00e9ploiement. Le POC 48h permet de valider la capacit\u00e9 technique d&rsquo;int\u00e9gration avant engagement.<\/p>\n<p>R\u00e9f\u00e9rences externes : <a href=\"https:\/\/ansm.sante.fr\" target=\"_blank\" rel=\"noopener\">ANSM \u2014 BPF<\/a> \u00b7 <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\" target=\"_blank\" rel=\"noopener\">EMA Good Manufacturing Practice<\/a> \u00b7 <a href=\"https:\/\/fr.wikipedia.org\/wiki\/Bonnes_pratiques_de_fabrication\" target=\"_blank\" rel=\"noopener\">BPF \u2014 Wikip\u00e9dia<\/a><\/p>\n<p>\u00c0 lire aussi : <a href=\"https:\/\/www.teepchina.com\/fr\/gmp-good-manufacturing-practices-france-2026\/\">GMP\/BPF en France 2026<\/a> \u00b7 <a href=\"https:\/\/www.teepchina.com\/fr\/current-good-manufacturing-practice-cgmp-france\/\">cGMP pour les industriels fran\u00e7ais<\/a><\/p>\n<p style=\"text-align:center;margin-top:40px;background:#fff5f5;border:2px solid #EB352C;border-radius:8px;padding:32px;\">\n<strong style=\"font-size:20px;display:block;margin-bottom:8px;color:#232120;\">Vous dirigez une usine en France ? Parlons-en.<\/strong><br \/>\n<span style=\"display:block;margin-bottom:20px;color:#555;\">L&rsquo;\u00e9quipe France TeepTrak est \u00e0 Paris. POC gratuit 48h dans votre atelier \u2014 sans engagement, baseline TRS mesurable en 48h.<\/span><br \/>\n<a href=\"https:\/\/www.teepchina.com\/fr\/demande-de-demonstration\/\" style=\"background-color:#EB352C;color:#ffffff;padding:14px 28px;border-radius:4px;text-decoration:none;font-weight:bold;font-size:15px;\">R\u00e9server un POC 48h<\/a>\n<\/p>\n<p><script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@type\":\"BlogPosting\",\"headline\":\"Batch Manufacturing Record (BMR) : le guide 2026 pour l'industrie pharma fran\u00e7aise\",\"description\":\"BMR pour pharma fran\u00e7aise en 2026.\",\"author\":{\"@type\":\"Organization\",\"name\":\"TeepTrak\"},\"publisher\":{\"@type\":\"Organization\",\"name\":\"TeepTrak\"},\"datePublished\":\"2026-04-23\",\"inLanguage\":\"fr-FR\"}<\/script><br \/>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[et_pb_section fb_built=\u00a0\u00bb1&Prime; _builder_version=\u00a0\u00bb4.27&Prime;][et_pb_row][et_pb_column type=\u00a0\u00bb4_4&Prime;][et_pb_text] Batch Manufacturing Record (BMR) : le guide 2026 pour l&rsquo;industrie pharma fran\u00e7aise Le Batch Manufacturing Record (BMR), ou Dossier de Lot dans la terminologie ANSM fran\u00e7aise, est le document qui formalise l&rsquo;int\u00e9gralit\u00e9 des op\u00e9rations r\u00e9alis\u00e9es pour produire un lot pharmaceutique. Chaque \u00e9tape de production \u2014 pes\u00e9e des mati\u00e8res premi\u00e8res, param\u00e8tres de [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":89858,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","ai_seo_title":"Batch Manufacturing Record (BMR) France 2026 | TeepTrak","ai_meta_description":"Batch Manufacturing Record pour l'industrie pharma fran\u00e7aise : structure, exigences BPF\/GMP, digitalisation, int\u00e9gration TRS et gain de conformit\u00e9.","ai_focus_keyword":"batch manufacturing record","footnotes":""},"categories":[114],"tags":[],"class_list":["post-89864","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-performance-industrielle"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Batch 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