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[5] Parenteral Drug Association, Technical Report No. 22, Process Simulation for Asepti-
cally Filled Products, 2011.
[6] Parenteral Drug Association, Technical Report No. 44, Quality Risk Management for
Aseptic Processes, 2008.
[7] Parenteral Drug Association Aseptic Processing Points to Consider Part 1, January 2015
and part 2, in: March, 2016.
[8] PDA Presentation by J. Agalloco, Based on the Myth called sterility, Akers, Agalloco,
Pharmaceutical Technology, Vol. 34, No. 3, Supplement, Nov. 2010, pp. S 44–45.
[9] Evaluation and Improvement of Aseptic Processes, Risk and aseptic process improve-
ment, baseman, Hanff, long, aseptic and Sterie {processing, control, compliance, and
future trends}, Sandell and Tidswell, in: PDA, DHL Publishing LLC, 2017.
[10] US FDA: Guidance for industry an review staff: Target product profile-a strategic de-
velopment process tool. Target product profile—A strategic development process tool,
CDER, Draft, March 2007.
[11] Parenteral Drug Association Technical Report No. 60, Process Validation: A Lifecycle
Approach, 2013.
[12] Parenteral Drug Association Technical Report No. 54–5, Quality Risk Management
for the Design, Qualification, and Operation of.
[13] International Standard ISO 14644-1 Cleanrooms and Associated Controlled
Environments—Part 1: Classification of Air Cleanliness by Particle Concentration, sec-
ond edition, 2015-12-15.
[14] International Standard ISO 14644-2 Cleanrooms and Associated Controlled
Environments—Part 2: Monitoring to Provide Evidence of Cleanroom Performance
Related to Air Cleanliness by Particle Concentration, second edition, 2015-12-15.
[15] Parenteral Drug Association Technical Report No. 13, Fundamentals of an Environ-
mental Program, 2014.
[16] US FDA, Guidance or Industry Process Validation: General Principles and Practices
Process Validation Guidance, January 2011.
[17] EMA, EudraLex, in: EU Guidelines for Good Manufacturing Practice for Medicinal
Products for Human and Veterinary Use, vol. 4, 2015. Annex 15: Qualification and
Validation.
[18] US FDA: Pharmaceutical CGMPS for the 21st Century—A Risk-Based Approach,
September 2004.
[19] US FDA: Guidance for Industry Part 11, Electronic Records; Electronic Signatures—
Scope and Application, August 2003 Pharmaceutical CGMPs.
[20] US FDA: General Principles of Software Validation; Final Guidance for Industry and
FDA Staff, January 11, 2002.
[21] EMA: Quality Risk Management (ICH Q9), 31 January 2011, EMA/INS/GMP/
79766/2011.