Live eLearning - PDA 221.1 Regulatory Aspects of Microbiology in a Non-Sterile Environment

Non-sterile microbiology offers many challenging regulatory issues often not considered in aseptic manufacturing because the rules are minimal when compared to aseptic manufacturing. These include the handling and evaluation of non-sterile components, the environment and final product.

This training course discusses various regulations and how they impact non-sterile manufacturing to include the setting of specifications, development of processes, holding times, preservation issues, cleaning, sanitization and the requirements for the testing of recovered microorganisms. Thoughts regarding in-house microorganisms that may be considered as “specified” will also be discussed. A case study will be included where teams will discuss some of the various regulatory issues that are encountered in a plant environment and report their findings to all of the participants.

Participants will benefit having a basic background in the sciences including biology (microbiology) or chemistry, and having basic familiarity with various regulations to include: 21 CFR 211, FDA Guidance documents, EMA and Health Canada guidance, and/or ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients – ICH Harmonized Tripartite Guideline, November 2000.

1. Identify microbiological regulatory concerns with non-sterile incoming components, in-process, active pharmaceutical ingredients (API) and finished product
2. Discuss key microbiological issues involved in the manufacturing of non-sterile products
3. Review the establishment of a non-sterile microbiological control program
4. Identify gaps with current regulatory and industry expectations
5. Explain how USP<1115>, Bioburden Control of Non-Sterile Drug Substances and Products, complements the development of non-sterile products