To meet regulatory expectations, the role of the microbiologist is essential. To add to this, the input from quality assurance personnel, engineers, and process specialists is required. Whilst there is a continuing need for monitoring of the environment and conducting standardized laboratory tests, industrial Pharmaceutical Microbiology has moved a great deal in the past decade to embrace microbiological audits; rapid microbiological methods; conducting risk assessments, both proactive in terms of minimizing contamination and reactive, in terms of addressing microbial data deviations; and also ensuring that processes meet ‘quality by design’ principles.
This is the introduction to an article by Tim Sandle for the Journal of GxP Compliance (a special edition devoted to Microbiology).
The reference is:
Sandle, T. (2017) Pharmaceutical Microbiology: Current and Future Challenges, Journal of GxP Compliance, 21 (4): 1- 5: http://www.ivtnetwork.com/article/pharmaceutical-microbiology-current-and-future-challenges
The article, which looks at key factors set to influence the future of pharmaceutical microbiology, can be accessed here.
The special edition contains the following articles:
Approach for the Qualification of a Pharmaceutical Facility Autoclave by Tim Sandle
This paper discusses the key criteria for autoclave cycle development; the use of a matrix approach for qualifying an autoclave and the key parameters (thermometric and biological) for evaluating the success of the validation.
Establishing a Library of In-House Isolates by Jeanne Moldenhauer
For many companies, there have been questions on why an in-house library is necessary and how to set up this library of isolates. This paper describes the basis for needing this type of library as well as a way to establish this type of library.
Microbial Identification Strategy for Pharmaceutical Microbiology by Tim Sandle
This article addresses these points and provides a basis of the microbiologist in each pharmaceutical or healthcare organization to develop a microbial identification strategy.
Developing or Updating your Environmental Monitoring Program to Meet Current Regulatory Expectations by Jeanne Moldenhauer
Since the early 1990’s there has been an increased emphasis on the need for environmental monitoring by many different regulatory agencies. Learn what a total environmental monitoring program is to see where yours can improve.
Setting Environmental Limits for Mold Contamination by Jeanne Moldenhauer
Many individuals come into contact with airborne mold on a daily basis. In some facilities, employees travel between buildings on a campus going through the environment and are exposed to airborne contaminants.
The special edition can be accessed here.
Posted by Dr. Tim Sandle