Writing easy to follow manufacturing instructions can more difficult than it initially seems.
How do you ensure your documented processes become more structured, are fully defined and aligned with cGMP?
How are your batch records formatted to ensure operators can follow them in a logical and chronological order?
An important first step in the writing of an instructional document for the manufacture of a new process, or design of a form to record data, is to map the detailed steps from start to finish. Create a process flow diagram that defines each key manufacturing stage, set out in the order in which each stage occurs. Be sure to involve the operators in the design of your process map – they have the expert knowledge in the process and are key to the success of your instructional document generation.
Develop a template in which to structure your instructional documents and include your process map in the early part of your new process instruction document.
Eudralex Vol 4 Chapter 4 calls for ‘detailed stepwise processing instructions [e.g. checks on materials, pre-treatments, sequence for adding materials, critical process parameters (time, temp etc)]’ to be in place. Use the top level process flow to develop each manufacturing stage in more detail, brainstorming with operators to determine and define the critical control points within each stage of manufacture. A well designed, easy to follow set of instructions derived from a carefully thought through process map will work well to ensure operators perform and record all key elements of your manufacturing process in the correct order. The added advantage will be that your customers, and internal and regulatory reviewers will be happy too!
Call us for more information on how we can help you develop these key documents.