Documentation and recording of changes during development.docx

1. 3.L References
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Regulatory Requirements Europe
1. EU Directive 2003/94/EC (Chapter C.2)
2. EU GMP Guide Part I, Basic Requirements for medicinal products (Chapter C.4)
3. EU GMP Guide Annex 1, Manufacture of Sterile Medicinal Products (Chapter C.6.1)
4. EU GMP Guide Annex 11, Computerised Systems (Chapter C.6.11)
5. EU GMP Guide Annex 15, Qualification and Validation (Chapter C.6.15)
6. European Pharmacopoeia, EDQM Council of Europe, Strasbourg
7. EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different
medicinal products in shared facilities (Chapter C.19)
Regulatory Requirements USA
8. Food and Drug Administration FDA, 21 CFR 210: Current Good Manufacturing Practice in manufacturing,
processing, packing, or holding of drugs, -General, Washington DC/USA (Chapter D.1.1).
9. Food and Drug Administration FDA, 21 CFR 211: Current Good Manufacturing Practice for finished
pharmaceuticals, 2008, Washington DC/USA -(Chapter D.1.2).
10. Food and Drug Administration FDA, Guidance for Industry: Sterile drug products produced by aseptic processing –
current Good Manufacturing Practice, 2004, Rockville MD/USA (Chapter D.10).
11. Food and Drug Administration FDA, Guidance for Industry – Part 11, -Electronic Records, Electronic Signatures –
Scope and Application, Rockville MD/USA, 2003 (Chapter D.12).
12. FDA General Principles on Software Validation; Final Guidance for Industry and FDA Staff (Chapter D.7)
13. U.S. Pharmacopeia, Informational Chapter <1116> Microbiological evaluation of aseptic processing environment.
ISPE (www.ispe.org)
14. ISPE, Baseline Pharmaceutical Engineering Guides, especially Vol. 1: Active pharmaceutical ingredients Vol. 2:
Oral solid dosage forms Vol. 3: Sterile manufacturing facilities Vol. 5: Commissioning and Qualification Vol. 6:
Biopharmaceutical manufacturing facilities Vol. 7: Risk-based manufacture of pharmaceutical products Tampa
FL/USA
15. ISPE, GAMP 5 – A risk-based approach to compliant GxP computerized systems, Tampa FL/USA (2008).
PDA (www.pda.org)
16. PDA Technical Report No. 13 (Revised): Fundamentals of an Environmental Monitoring Program (2014); ISBN:978-
0-939459-67-4
PIC/S
17. PIC/S PI 006-3: Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile
Process Validation and Cleaning Validation (Chapter F.1)
18. PIC/S PI 009-3: Aide Mémoire Inspection of Utilities; 2007 (Chapter F.6)
19. PIC/S PI 014-3: Isolators used for aseptic processing and sterility testing; 2007 (Chapter F.19)
20. PIC/S PI 032-2: Recommendation – GMP Annex 1 revision 2008, interpretation of most important changes for the
manufacture of sterile medicinal products; 2010 (Chapter F.8)
WHO
21. WHO Technical Report Series no. 957, Annex 3: WHO good manufacturing practices for pharmaceutical products
containing hazardous substances (2010)
International Standards (www.beuth.de)
22. DIN 1946-4 Ventilation and air conditioning – Part 4: Ventilation in buildings and rooms of healthcare; 2008
23. DIN 12980, Laboratory furniture – Safety cabinets for handling cytotoxic substances; 2005
24. DIN 31051 Fundamentals of maintenance; 2012
25. DIN EN 779, Particulate air filters for general ventilation – Determination of the filtration performance; 2012
26. DIN EN 1822, High efficiency air filters (EPA, HEPA and ULPA), parts 1–5; 2011
27. DIN EN 12128 Biotechnology – Laboratories for research, development and analysis – Containment levels of
microbiology laboratories, areas of risk, -localities and physical safety requirements;1998
28. DIN EN 12469 Biotechnology – Performance criteria for microbiological safety cabinets; 2000
29. DIN EN 13306, Maintenance – Maintenance terminology; 2010
30. DIN EN ISO 14644, Cleanrooms and associated controlled environments, Parts 1–10; 1999–2013
31. DIN EN ISO 14698, Cleanrooms and associated controlled environments – Biocontamination control, Parts 1 and 2;
2004
32. EN 12469, Biotechnology – Performance criteria for microbiological safety cabinets; 2000

2. 33. EN 12128, Biotechnology – Laboratories for research, development and analysis – Containment levels of
microbiology laboratories, areas of risk, localities and physical safety requirements; 1998
34. ISO 8573, Compressed air, Parts 1 to 9; 1999–2010.
35. ISO 29463, High-efficiency filters and filter media for removing particles in air – Parts 1 to 5; 2011
36. VDI 2083, Cleanroom technology, Parts 1–18 (german/english); 1998–2014
37. VDI 6022 Blatt 1, Ventilation and indoor-air quality – Hygiene requirements for ventilation and air-conditioning
systems and units (VDI Ventilation Code of Practice); 2011
38. VDI 2519 Blatt 1, Procedures for the compilation of tender and performance specifications, 2001
39. British Standard BS 5726, Part 2; 1991
Publications
40. Bässler H.-J.: Biodecontamination of isolators in pharmaceutical production with hydrogen peroxide vapour in low
concentrations; Swiss Pharma 4-S/1994, 31–36.
41. Coleman L. C.: Cleanroom Ceilings, Floors and Walls, in: Cleanrooms (1995) 12
42. Akers J. E., Agalloco J. P., Kennedy E. M.: Experience in the design and use of isolator systems for sterility testing.
In: PDA Journal of Pharmaceutical Science and Technology 49 (1995) 3, 140–144.
43. Sirch E. C.: Construction Materials und Surface Finishes for Cleanrooms. In: W. Whyte (Editor) Cleanroom Design.
Second Edition, J. Willey & Sons, UK Chichester (1999)
44. Design and validation of isolator systems for the manufacturing and testing of healthcare products; PDA Journal of
Pharmaceutical Science and Technology 55 (2001) 5, Supplement TR 34
45. Lysfjord J.; The ISPE RABS definition – an introduction; Pharmaceutical Engineering 27 (2005) 11/12, 116–117
46. Rauschnabel J.; Zwischen Isolator und Sterilraum – Restricted Access Barrier System (RABS); Pharm. Ind. 68
(2006) 6, 767–773
47. Neiger J.; European guidelines for sterile manufacture; In: Cleanroom Technology 13 (2007) 6, 14–15
48. Agalloco J., Akers J., Madsen R.; Choosing technologies for aseptic filling. "Back to the future, forward to the past?";
Pharmaceutical Engineering 27 (2007) 1, 8–16
49. Lysfjord J.; Using RABS and isolators in pharmaceutical applications; CleanRooms 21 (2008) 1, 24–26
50. Unger-Bimczak et al.; The influence of humidity, hydrogen peroxide concentration, and condensation on the
inactivation of geobacillus stearothermophilus spores with hydrogen peroxide vapor; Journal of Pharmaceutical
Innovation 3 (2008) 2, 123–133
51. Hallworth M.; EU GMP Annex 1 clears the air for sterile manufacturing; In: CleanRooms 22 (2008) 6, 32–35
52. Jiang J.P.: How instantaneous microbial detection can be used by pharmaceutical manufacturers. Eur J Parenter
Pharm Sci 14 (2009) 4, 103–109
53. PHSS Technical Monograph no. 15: Restricted access barrier systems. The Pharmaceutical & Healthcare Services
Society PHSS, Swindon/UK (2011)
54. Bjerner G. et al.: Real-time microbiological air monitoring. Eur J Parenter Pharm Sci 17 (2012) 2, 52–55
55. Sandle T., Raju Saghee M (editors): Cleanroom Management in Pharmaceuticals and Healthcare. Euromed
Communications, Passfield/UK (2013)
56. Farquharson G. et al.: ISO 14644 series of standards: Reports on progress at the October 2013 meetings of ISO TC
209 and its Working Groups in Reno. Clean Air and Containment Review issue 17 (2014), 16–18
57. Moldenhauer, J. (edit.): Environmental Monitoring – A comprehensive Handbook (PDA/DHI Publication)
Last update: November 2016