Procedures and Specifications for Media Fills
- The procedures and specifications used for media fills shall be described
- Summaries of results for validation using the same container- closure system shall be described
- Filling process that is to be used for the product should be described.
- The microbiological testing method(s) used should be described.
- Any procedural differences between the media fill and the routine production process should be indicated.
- A summary of recent media fill results, including failures, should be provided.
- These data should be obtained using the same filling line(s) that are to be used for the drug product.
The following are recommended to be included with the data summary for each media fill run described:
- The filling room identifies the aseptic filling area used and relates this to the floor plan.
- Container-closure type and size
- Volume of medium used in each container
- Type of medium used
- Number of units filled
- Number of units incubated
- Number of units positive
- Incubation parameters – The incubation time and temperature for each group of units incubated and specifications for any group of units subjected to two (or more) different temperatures should be specified.
- Date of each media fill
The procedures used to simulate any steps of a normal production fill should be described. This might include, for example, slower line speed, personnel shift changes, equipment failure and repair, mock lyophilization and substitution of vial headspace gas.
- Microbiological monitoring
The microbiological monitoring data obtained during the media fill runs should be provided (see section IV.F. of this guidance).
- Process parameters
The parameters used for production filling and for media fills (e.g., line speed, fill volume, number of containers filled, or duration of fill) should be compared.
Actions Concerning Product When Media Fills Fail
The disposition of product made before and after a failed media fill should be described. The description should include details of investigations, reviews, and how decisions are made to reject or release product.