PDA Technical Report No. 13-2 (TR 13-2) Fundamentals of an Environmental Monitoring Program Annex 1: Environmental Monitoring of Facilities Manufacturing Low Bioburden Products (single user digital version)

PDA Technical Report No. 13-2 (TR 13-2) Fundamentals of an Environmental Monitoring Program Annex 1: Environmental Monitoring of Facilities Manufacturing Low Bioburden Products, is an addendum to PDA Technical Report No. 13 (TR 13, Revised 2014): Fundamentals of an Environmental Monitoring Program, which focuses on the environmental requirements for sterile product manufacturing. This addendum complements the existing TR 13 by providing elements to consider when designing a risk-based EM program to support the manufacture of low bioburden products using low bioburden processes.

This new resource offers a means of determining the critical aspects, assessing the associated risks, and designing the appropriate environmental monitoring program for areas where bioburden control of manufacturing processes is required.

TR 13-2 provides recommendations for the development of an environmental control and monitoring program for classified areas and the associated GMP processes used for manufacturing operations requiring bioburden control in the biotechnology and pharmaceutical industries. A review of regulatory requirements and the development of risk assessments based on the criticality and complexity of processes is included, along with industry examples of these risk-based approaches. This TR is not intended to address environmental monitoring programs for traditional aseptic or sterile manufacturing, which are covered in TR-13, nor does it address traditional nonsterile dosage forms.

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