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GMP Publications - Code of Federal Regulation Handbooks by the FDA

EU GMPs

EU GMPs Chapter 1 - 9
EU and US GMPs with Q7 API
US and EU GMPs with ICH Q7, Q8(R2), Q9(R1), Q10
EU GMPs with Annex 11, 15, 16 and ICH Q7
EU GMPs with Annex 11, 15, 16, 18, 19
EU GMPs with Annex 1 Sterile Medicinal Products
EU GMPs with Annex 2 Biological
EU GMPs with Annex 3 RadioPharma
EU GMPs with Annex 4 Vet. products other than Immuno
EU GMPs with Annex 5 Immunolgical Vet. Products
EU GMPs with Annex 7 Manufacture of Herbal Medicinal Products
EU GMPs with Annex 8 Sampling of Starting and Packaging Materials
EU GMPs with Annex 9 Manufacture of Liquids, Creams and Ointments
EU GMPs with Annex 10 Inhalation Products
EU GMPs with Annex 11 Computerized Systems
EU GMPs with Annex 12 Ionizing Radiation
EU GMPs with Annex 13 Investigational medicinal Products
EU GMPs with Annex 14 Human Blood or Plasma Products
EU GMPs with Annex 15 Qualification and Validation
EU GMPs with Annex 16 Qualified Person and Batch Release
EU GMPs with Annex 17 Parametric Release
EU GMPs with ICH Q7
EU GMPs with Annex 19 Reference and Retention Samples
EU GMPs with Annex 11, 15 - Computerized Systems and Validation
EU and US GMPs with Annex 1
EU GMPs with Annex 6 Manufacture of Medicinal Gases
EU GMPs with ICH Q7, Q8(R2), Q9(R1) and Q10
Electronic Systems Master Handbook 1
US, EU and Canadian Medical Device Combination
EU cGMPs for ATMP with EU GMP Chapters 1-9 and Annexes 1, 8, 11, 13, 14, 15, 16 & 19
US FDA, Canadian and European MDR
EU and US GMPs with Annexes 11 and 15
US, EU and Japanese GMPs
ICH Q7 with Q7 Auditors Check List
EU cGMPs for ATMP with EU GMP Chapters 1-9
ICH Q12 Pharmaceutical Product Lifecycle Management
In Vitro Diagnostics 2017/746 Medical Devices
ICH Q7, Q8(R2), Q9(R1), Q10 and Q11
EU Medical Device Regulation 2017-745
ICH Q7, ICH Q8(R2), ICH Q9(R1), ICH Q10 and ICH Q12 Combination
Standard Sterile Product Manufacturing Handbook
EU cGMPs for ATMP - 2018: Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products
VICH GL9 Animal GCP
ICH Q2(R2) and ICH Q14 Analytical Validation
Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs
GMP International Master Reference Guide
GMP Manufacturing Handbook
Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14
GMP Boot Camp Training Certificate and GMP Handbook
Title 21 CFR Parts 1 - End Nine Volume Set
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
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