Table compares old vs new EU GMP Guide Part I, Chapter 5 - effective as of 1 March 2015
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Starting with the 1 March 2015 the revised Chapter 3 (Premises and Equipment) and Chapter 5 (Production) of the EU GMP Guide Part I for Medicinal Products for Human and Veterinary Use will become effective (see also our GMP news from 12 February 2015). Until then the versions issued with the entire GMP Guide in the Nineties are still valid.
The following table provides you with a compact overview of the changes in both Chapters. The changes in Chapter 3 are actually easy to compare. The principles and the Chapters 3.1 - 3.5 and 3.7 - 3.27 are identical. Only Chapter 3.6 now mentions quality risk management for the risk control as well as requirements for the use of Dedicated Facilities. In addition there are indications on other passages to be considered in Chapter 5 and in the Annexes 2-6. Further, a footnote also refers to the EMA Guideline on Shared Facilities.
A little more difficult to compare is Chapter 5. The following table is a concise summary of the changes - comparing them by the numbers of both the new and the old document. It allows you to quickly compare it with an existing QM system and can thus be used for a "GAP" analysis, a self inspection or for audits.
| EU GMP Guide Part I, Chapter 5 | EU GMP Guide Part I, Chapter 5, Version effective until 28 Feb 2015 (old Version) |
| Principles | Principles |
| General Requirements | General Requirements |
| 5.1 - 5.16 | 5.1 - 5.16 |
| Prevention of Cross Contamination in Production | Prevention of Cross Contamination in Production |
| 5.17 | 5.17 |
| 5.18 (supplemented by - Genetic material, APIs or raw materials) - Mention of hormones, cytostatic drugs, highly effective substances are omitted) | 5.18 |
| 5.19 (supplemented by: - Prevention of cross contamination through the design, with reference to Chapter 3) | 5.19 |
| 5.20 (with reference to EMA Guideline on Shared Facilities) | - |
| 5.21 | - |
| 5.22 | 5.20 |
| Validation | Validation |
| 5.23 -5.26 | 5.21-5.24 |
| Raw Materials | Raw Materials |
| 5.27 (supplemented by: - Supplier qualification) | 5.25, 5.26 |
| 5.28 (supplemented by: - Quality agreement - Discussion of specifications with the supplier are omitted) | 5.26 |
| 5.29 | - |
| 5.30 (supplemented by: - Documentation of tests) | 5.27 |
| 5.31 - 5.34 | 5.28 - 5.31 |
| 5.35 | - |
| 5.36 | - |
| 5.37 - 5.39 | 5.32 - 5.34 |
| Processing Steps: Intermediates and Bulk Ware | Processing Steps: Intermediates and Bulk Ware |
| 5.40 - 5.44 | 5.35 - 5.39 |
| Packaging Materials | Packaging Materials |
| 5.45 (supplemented by: - Selection, qualification, support of suppliers of primary and printed packaging materials) | 5.40 |
| 5.46 - 5.48 | 5.41 - 5.43 |
| Packaging Processes | Packaging Processes |
| 5.49 - 5.62 | 5.44 - 5.57 |
| Finished Products | Finished Products |
| 5.63 - 5.65 | 5.58 - 5.60 |
| Rejected, recycled and returned Materials | Rejected, recycled and returned Materials |
| 5.66 - 5.70 | 5.61 - 5.65 |
| 5.71 | - |