GMP aspects of Electronic Batch Recording - Part 3: Managing Master Data

​This article is the third part of a series based on applying the new GAMP GPG Data Integrity - Manufacturing Records
Continuing our article on the GMP aspects of Electronic Batch Records (EBR) we look into a set of questions about controlling Master Recipe, Material Control, Equipment Control and Users
Based on GAMP GPG Data Integrity Manufacturing Records Appendix 2, this is related to Manufacturing Execution Systems (MES) and so in some cases (Equipment Control) is not relevant for BatchLine EBR.

Question	Answers
Questions about Master Recipes
Does the master recipe mange BOM, formula, sequencing, set points or parameters, required equipment, workflows, important product data such as shelf life, SOP	​Yes in the EBR master recipe manages BOM, formula, sequencing, parameters, equipment and workflows. When a batch is created this sets the expiry data. Batchline requires some important SOPs and templates are available
Who has User access for control of recipes, who, and how	All users in the EBR have unique ID and passwords, users set up their access controls based on roles of operator, supervisor, manager, QA etc
Is there a secure management process with review and approval	​All master data has to be reviewed and approved before use, the EBR ensures this has happened according to procedure
​Controls over changing recipes, how to manage old and new versions	New versions of recipes in the EBR have to be reviewed and approved before use. Old versions are archived. All recipes versions are retained.
​Product definition includes recipes, material management, equipment, personnel, scheduling, are how is all this information controlled	​Batchline retains all the information in the EBR including recipe, material ID, equipment ID, personnel ID, and workflow. EBR stores the batch record safely for as long as required typically 5 years from date of manufacture for formulated products, the data cannot be changed once it is entered.
​Is the product definition traceable to the production record	​The EBR contains all the information to link the batch record to the product

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Author
​Dr. Tony Margetts, Principal Consultant at Factorytalk
Dr. Tony is considered a global expert in the fields of GMP compliance and validation with +30 years working experience in the Pharmaceutical, Medical device, and regulated industries. Dr. Margetts has also been involved in producing several of the GAMP/ISPE good practice guides including leading roles in GAMP5, and recent document “The ISPE Good Practice Guide to Electronic Record & Data Integrity” which was published in 2017.

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