Online Safety Community

Relationship Between an EM Excursion Program and CAPA

The FDA’s regulations on cleanroom environmental monitoring (EM) are based on the assumption that any person who enters a cleanroom is likely and almost certain to have brought contaminants in one or another form with him. The FDA’s regulations on cleanroom environmental monitoring are built on the thinking that microorganisms can assail even the cleanest of systems, which is why its regulations on cleanroom environmental monitoring are stringent and scientific. The FDA proceeds on the thinking that nil contamination of not only cleanrooms, but all locations involved in aseptic processing is not possible.

Picture1

Based on this thinking, the FDA has formulated its guidelines on cleanroom EM taking into consideration the limitations of obtaining completely microorganism-free environment for cleanrooms. It seeks to bring about a consistent EM system that meets high environmental quality requirements all the time, being able to detect changes and deviations in this consistency level and bring the level to control limits.

Regulations that cover all areas of cleanroom environmental monitoring

Keeping this in mind, the FDA has formulated regulations that cover all aspects of cleanroom environmental monitoring, starting from the buildings and facilities, right up to the qualification and training required for personnel manning these cleanroom facilities to what should go into closures to validation of the aseptic processing and sterilization techniques. These cGMP regulations are found in 21 CFR Parts 210 and 211.

All the disciplines of cleanroom monitoring, such as quality, manufacturing, engineering, quality, environmental monitoring, sterilization and cleaning and many others need to be taken into full consideration while building an FDA-compliant monitoring program. These should be included all along, into all these phases:

  • Planning phase
  • Design phase
  • Construction phase
  • Commissioning phase
  • Qualification phase
  • Submission phase
  • Operational phase

A complete understanding of the FDA’s regulations

The ways of understanding and implementing the FDA’s regulations for environmental monitoring program will be the topic of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Cleanroom 2356496

The speaker at this webinar is Joy McElroy, who in over the 20 years of total experience she has had in the pharmaceutical and biotech industries has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous companies.

Want to learn the ways of understanding FDA regulations for environmental monitoring? Then, please register for this webinar by visiting

Ways of ensuring compliance

Joy will highlight the importance of compliance with the FDA regulations on environmental monitoring, as the costs of noncompliance are much more exorbitant than those of compliance. Participants who take part in this training will be able to get a proper grasp of how to implement a cleanroom Environmental Monitoring (EM) program that complies with the FDA’s regulations.

She will describe the basis of the four phases of cleanroom transitional monitoring (Pre-qualification through post-qualification EM) and explain what each type stands for. In addition to describing what has to be the basic content of a well-designed, effective and compliant EM Program; Joy will also go on to help participants comprehend the relationship between an EM Excursion Program and CAPA.

Testing 845196515689516

This training session is of high value to Quality Control, Quality Assurance, Microbiologist, Facilities, Chemist, Analysts, Manufacturing, Validation, Engineering, Sterility Assurance, Compliance, Testing Technicians, Environmental Testing Personnel, Raw Materials Manufacturers, Clinical, Research and Development, and Laboratories.

Joy will cover the following areas at this webinar:

  • Applicable Regulations – Where does the EM Program fit in the Regulation? – Role of Clean room Environmental Monitoring Program?
  • Basics of Setting a Robust and Effective EM Program – Key Considerations – Relevant Material Verification Processes – Steps and Content of an EM Program Testing Procedure
  • Processing a Completed Environmental Monitoring Test Media – Sample Handling and Incubation – Documentation and Data Management of EM Test Results – What is the EM Test Data used for? – Retention of EM Test Results – Interpretation of EM Test Results
  • Basics of Designing an Effective and Compliant EM Trend Reports – Types; Content – Using Trend Report as a Critical Tool and Quality Metrics
  • Basics of Designing an Effective and Compliant EM Excursion Program – Types; Content – Handling EM Excursion Investigation – Handling Impacted Manufactured Batches – Disposition of Affected Products with Failed Clean room EM Test Results
  • Corrective and Preventative Action (CAPA) – Relationship between CAPA and EM Test Data Excursion Investigations Question and Answer Session.

Views: 17

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

nicolewells posted a discussion

Security Storage SAN Performance

Hello All,Have a question regarding SAN performance specifically EMC VNX SAN. I have a significant number of processes spread over number of blade servers running concurrently. The number of processes is typically around 200. Each process loads 2 small files from storage, one 3KB one 30KB. There are millions (20) of files to be processed. The processes are running on Windows Server on VMWare. The way this was originally…See More
yesterday
Rebecca Lewis posted a discussion

What safety signs should I acquire for my shop’s construction?

Hello everyone! The construction of my new flower shop will start next month, and it’s a big project for me. Since the shop’s location is near the main road, I want to make sure that everyone is safe during the work. I can’t afford any accident like people getting injured. So I’m thinking of purchasing construction health and safety signs from a supplier that my friend recommended.…See More
yesterday
Rebecca Lewis joined Safety Community's group
Thumbnail

Construction

For those working in Carpentry, Drywall, Electric, General Labor, HVAC, Landscaping, Masonry and Plumbing.
yesterday
Adam Fleaming posted a blog post

FMEA in medical devices can work better when mated with ISO 14971

Failure Mode and Effects Analysis (FMEA) is a core aspect of risk management and risk analysis in medical devices. FMEA is essentially about analyzing the reasons for which a problem arises and the effects it has on the system. In the field of medical devices, it is absolutely critical to understand the failure mode and effects because the consequences of not doing this can be disastrous and many times, even…See More
Friday

Forum

Security Storage SAN Performance

Hello All,Have a question regarding SAN performance specifically EMC VNX SAN. I have a significant number of processes…Continue

Tags: san, vmware, emc

Started by nicolewells yesterday.

What safety signs should I acquire for my shop’s construction?

Hello everyone! The construction of my new flower shop will start next month, and it’s a big project for me. Since the shop’s location is near the main road, I want to make sure that everyone is safe…Continue

Started by Rebecca Lewis yesterday.

Gig Economy

The career world has rapidly changed and these days, long-term careers and people working in just one job are slowly but steadily becoming a thing of the past. In fact, according to research, in the…Continue

Tags: field, engineer, IT, freelance, economy

Started by Mohd Azher on Wednesday.

How to Repair MySQL InnoDB Table That Has Issues?

When trying to run: delete IdentityRequest *I get an error of sailpoint.tools.GeneralException: null index column for collection: sailpoint.object.IdentityRequest.itemsDoing a select * from…Continue

Tags: course, sailpointonline, sailpoint

Started by Soujanya Naganuri on Tuesday.

Occupational Health and Safety 7 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tony Ferraro Feb 18.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service