{"product_id":"glp-analytical-stability-handbook-4-5x7-5","title":"GLP Analytical Stability Handbook - 4.5x7.5","description":"\u003cp\u003e\u003cspan\u003e\u003cstrong\u003eUS FDA Regulations\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e- 21 CFR Part 11 - Electronic Records with Scope and Application\u003cbr\u003e- 21 CFR Part 58 - Good Laboratory Practice\u003cbr\u003e- 21 CFR Part 210\/211 Drug GMPs\u003c\/p\u003e\n\u003cp\u003e- 42 CFR Part 493 Laboratory Requirements (HHS)\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003cstrong\u003eICH International Council for Harmonisation\u003c\/strong\u003e\u003c\/span\u003e\u003cbr\u003e\u003cbr\u003e- ICH Q1A(R2) Stability Testing of New Drugs\u003cbr\u003e- ICH Q1B Photostability Testing\u003cbr\u003e- ICH Q1C Stability Testing for New Dosage Forms\u003cbr\u003e- ICH Q1D Bracketing and Matrixing Designs for Stability Testing\u003cbr\u003e- ICH Q1E Evaluation of Stability Data\u003cbr\u003e- ICH Q2(R2) Validation of Analytical Procedures\u003cbr\u003e- ICH Q5C Stability Testing of Biological Product\u003cbr\u003e- ICH Q14 Analytical Procedure Development \u003cbr\u003e- ICH M10 Bioanalytical Method Validation and Study Sample Analysis\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003cstrong\u003eOrganisation for Economic Co-operation and Development\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e- OECD - General Principles of GLP Series 1\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003cstrong\u003eFDA Guidance\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e- Guidance for Industry ANDAs: Stability Testing of Drug Substances\u003c\/p\u003e","brand":"GMP Publications","offers":[{"title":"Default Title","offer_id":46993537761515,"sku":"978-1-935131-07-6","price":29.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/1498\/5963\/files\/GLPAnalyticalStability-3.jpg?v=1762994243","url":"https:\/\/gmppublications.com\/products\/glp-analytical-stability-handbook-4-5x7-5","provider":"GMP","version":"1.0","type":"link"}