All necessary aspects related validation procedure shall be explained in this training programme. Identification of Executors: All the identified executors involved with this Protocol are to Record Name, Designation, Signature and Date.Īll concerned personnel shall be given training on validation of hold time study of media after sterilization. Review of the Validation report, documents and its compliance to meet the acceptance criteria of the protocol. Scheduling and conducting of validation runs. Quality Assurance Verification of protocol completeness, accuracy and suitability for application. Quality Control Review of the Validation report To ensure that environmental conditions of all areas met the requirements. To ensure that the related instruments and equipment’s are in calibrated and validated status. Microbiologist shall be responsible for performing the validation activity.Įngineering & Utility To ensure that all the required utilities are working as per respective SOPs. Recording of observation, collection of data and filling of report. Microbiology Execution of Protocol & Report. The scope is limited to evaluate the sterilized media storage in microbiology laboratory. The purpose of this activity is to evaluate the sterilized media storage in microbiology laboratory. The Objective is to perform the validation of storage of sterilized media which shall be stored in the Microbiology laboratory. ![]() ![]() The purpose of this study is to verify and establish the hold time for sterilized media before their actual usage. ![]() The media testing at different time intervals for check the fertility & sterility level. The validation study consists of sterilization of media, holding them for a specified length of time after sterilization. The media are stored at room temperature in microbiology laboratory. After the sterilization process, they are unloaded in the aseptic area. The media are sterilized in the validated Steam Heat Sterilizer. Media are used for the product analysis testing and environment monitoring. This is a specific protocol for the validation of storage of sterilized media which shall be stored in the Microbiology laboratory. ![]() 12.0 Discrepancy And Corrective Action Report
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