{"product_id":"ims-pharmaceutical-gmp-who-trs-986-21-cfr-211-iso-9001-iso-22301-iso-31000-alcoa","title":"IMS Pharmaceutical GMP (WHO TRS 986, 21 CFR 211, ISO 9001, ISO 22301, ISO 31000, ALCOA+)","description":"\u003cp\u003eBuilt for pharmaceutical manufacturers operating under the most demanding global regimes, this Integrated Management System aligns WHO TRS 986 Good Manufacturing Practice and US FDA 21 CFR Part 211 with ISO 9001, ISO 22301, ISO 31000, and ALCOA+ data integrity. It gives quality and regulatory teams a single, internally consistent source of truth spanning production, quality control, quality assurance, and continuity planning. The suite includes a master Quality Manual, a compliance scheme mapping every clause to a control, and a full library of validated procedures — batch manufacturing and packaging, in-process controls, deviation and out-of-specification management, CAPA, change control, complaint handling, recall, and self-inspection. Purpose-built forms and records enforce ALCOA+ so that every entry withstands FDA and WHO scrutiny. Checklists translate inspection expectations into repeatable routines, while structured training modules develop and evidence workforce competence. The kit is designed to carry a facility through pre-approval inspections, WHO prequalification, and routine GMP audits with confidence, dramatically reducing the documentation burden that typically delays licensing. Fully editable and clearly cross-referenced, it adapts to your dosage forms, equipment, and site layout without starting from a blank page. For manufacturers seeking to enter regulated export markets or to remediate observations quickly, it delivers a proven, harmonized compliance architecture. The outcome is stronger product quality assurance, robust data integrity, resilient operations, and a materially faster, lower-cost path to and through regulatory approval.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eIncluded:\u003c\/strong\u003e 53 ready-to-use, fully editable documents (manual, procedures, forms, records, checklists, guidance and training material).\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eLicense:\u003c\/strong\u003e single-organization license; delivered electronically as a ZIP archive.\u003c\/p\u003e","brand":"Apex Global Solutions AGS","offers":[{"title":"Default Title","offer_id":56517066195284,"sku":"AGS-09-009","price":2800.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1052\/4996\/4372\/files\/IMS-Pharmaceutical-GMP-WHO-TRS-986-21-CFR-211-ISO-9001-ISO-22301-ISO-31000-ALCOA.png?v=1784574573","url":"https:\/\/agskits.com\/products\/ims-pharmaceutical-gmp-who-trs-986-21-cfr-211-iso-9001-iso-22301-iso-31000-alcoa","provider":"apex global solutions","version":"1.0","type":"link"}