Batch Record Review-What to Look For скачать в хорошем качестве

Batch Record Review-What to Look For

A video excerpt from The Windshire Group's webinars on demand: How To Create an Effective and Compliant Batch Record Review Process. This 60-minute webcast reviews best practices for how to create an effective and compliant batch record review process. - Read More: https://windshire.com/shop/ Batch Record Review…What to look for…Transcription: So what do we look for in a Batch Record Review? There are certain things called Critical Processing Parameters and Critical Quality Attributes. Their initials are CPP and CQA. They are assigned as each product is being manufactured or researched or developed. They are things that are necessary for the proper manufacture of the batch. So when you’re developing a new product or a new product is in the pipeline, you’re going to want to develop some of these CQA’s and CPP’s and basically say, you know what, the product cannot be made compliantly without these parameters in place. In addition, obviously as we go through our daily lives in the biopharmaceutical industry or medical device industry, you always want to make sure that you institute Good Documentation Practices. Good Documentation Practices always need to be followed when dealing with batch records, any type of documentation. Even things you are doing electronically. So if you have a hard copy paper batch record, obviously the good documentation parameters and practices actually do apply. We will go through those a little bit next in our few slides. But electronically as well. You want to make sure that all of your test scripts include good documentation practices when you are validating your program for electronic batch records as well.