BPOG Response to Annex 2

References

1. 1.↵
   EudraLex—Volume 4. Good Manufacturing Practice (GMP) Guidelines: http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm. Annex 1: http://ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf. Annex 2: http://ec.europa.eu/health/files/eudralex/vol-4/vol4-an2__2012-06_en.pdf.
2. 2.↵
   1. Gill P.,
   2. Rogalewicz J.,
   3. Chalk S.,
   4. Probst S.,
   5. Palberg P.,
   6. Kennedy M.,
   7. Johnson J.,
   8. Green K.

   Challenging the Cleanroom Environment for Biopharmaceutical Manufacture of Bulk Drug Substances. BioPharm. Int. 2011, 24, (8), http://www.biopharminternational.com/challenging-cleanroom-paradigm-biopharmaceutical-manufacturing-bulk-drug-substances.
3. 3.↵
   1. Probst S.,
   2. Chalk S.,
   3. Zicaro M.,
   4. McDuff P.,
   5. Pranzo L.,
   6. Dooley L.,
   7. Moser R.,
   8. Urbanski F.,
   9. Smock P.,
   10. Green K.

   New Challenges to the Cleanroom Environment for Multi-Product Facilities. BioPharm. Int. 2013, 26 (5). http://www.biopharminternational.com/new-challenges-cleanroom-paradigm-multi-product-facilities.
4. 4.↵
   Concept Paper on the Revision of Annex 1 of the Guidelines on Good Manufacturing Practice—Manufacture of Sterile Medicinal Products: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/02/WC500181863.pdf.
5. 5.↵
   ICH Q9—Quality Risk Management, November 2005: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf.
6. 6.
   1. Moody P.

   Irish Medicines Board GMP Information Seminar, September 27, 2012.
7. 7.↵
   Aide mémoire Bio- und Gentechnologie 071210BN, Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, June 16, 2004.
8. 8.↵
   1. Aranha H.

   Virus Safety of Biopharmaceuticals. Contract Pharma 2011, 13.
9. 9.↵
   ISPE Baseline® Guide. Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP), 1st ed.; 2010; Volume 7.