Technical Reports: Paper

PDA Technical Report No. 67, (TR 67) Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics (paper ship version)

The purpose of TR 67 is to provide guidance to the nonsterile product manufacturing industry on how to manage the microbial risks associated with manufacturing and storage as well as how to determine what isolates would be deemed an objectionable microorganism in nonsterile products.

This document is intended to be globally applicable. When country-specific regulations are cited, they are meant to serve as examples of such and are not binding to the industry stakeholders outside the country's jurisdiction.

The absence of a list of objectionable microorganisms from this technical report acknowledges that the manufacturer of the product has all of the variable information, about a product and its intended use, needed to make an informed decision regarding the product's disposition. This belief is consistent with the U.S. cGMP regulations, which assign the responsibility for excluding objectionable microorganisms specifically to the manufacturer.

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Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Regulatory, Compendial and Scientific Environment
  4. Industry Benchmarking
  5. Product Types and Formulation
  6. Mitigating Risk through Process Design, Manufacturing and Packaging Operations
  7. Laboratory Testing — Microbial Enumeration, Detection and Identification
  8. Clinical Considerations for Selecting Isolates for Assessment of their Status as Objectionable or not
  9. Risk Assessment and Mitigation
  10. Conclusions
  11. References

Figures and Tables Index

Date of Publication: October 2014
ISBN Number: 9780939459704
Number of Pages: 70
Binding: paper