- Supervision of an environment focuses on the outcome of the Environmental Control program – the particulate and microbiological nature of the clean room.
- The FDA Policy on Aseptic Processing GMP (2004) declares:
- Aseptic handling, one of the major essential laboratory regulations is the environmental control program. This program gives important information on the nature of the aseptic handling condition for instance when a given batch is being produced and in addition environmental patterns of auxiliary clean territories. Environmental control ought to expeditiously recognize possible ways of pollution, taking into account the execution of improvements before the products get contaminated.
- In this manner, current environmental control of a clean room condition is important to guarantee the quality and security of the pharmaceutical items.
- Likewise, an appropriate comprehension and testing of the clean room environment as indicated by international controlling standards is vital from a compliance point of view.
Why should you attend ?
- Firstly, this webinar will clarify the diverse US and international regulatory necessities for the diverse clean room categories and the environmental supervision of clean room conditions.
- Next, the demonstration specifies the advantages, the administrative prerequisites, and the testing necessities for an exhaustive Environmental Control Program.
- A portrayal of Action and Alert Levels takes place alongside a conversation on how these levels are verified for a specific facility. Remedial and Preventive Actions are characterized.
- All the existing air supervision systems for the estimation of non-feasible particulate are completely examined.
- All existing air and surface checking systems for the estimation of microbial pollutants in the clean room are examined in detail.
- The subject of clean room pollutant as a result of personnel is talked about. This incorporates both gowning system and aseptic practices.
- The current supervision practices for the clean room condition are talked about in regards to sampling recurrence, sampling areas, and the examination of activity level excursions.
- Immediately after this a discussion on how environmental supervision information is studied for the release of a product.
- Finally, an extensive view is taken of the present contemplation on the production and study of Environmental Monitoring Data Trend Reports.
Areas Covered in the Session :
- Clean Room Monitoring Practices - Frequency, Locations, and Investigations
- Environmental Monitoring Program
- Environmental Monitoring Data Trend reports
- Action and Alert Levels
- Product Release
- Non-Feasible Particulate Monitoring Systems
- Microbial Monitoring Systems
- Personnel Gowning and Aseptic Practices in Clean Room
- GMP Compliance of Clean Room Environment
- Regulatory Clean Room Organization and Necessities
Who will benefit :
This webinar will give profitable help to all staff in:
- Quality Assurance
- Environmental Monitoring