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 |
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