Let’s get back to basics
This process map represents a back to basics, simple, robust process that, if implemented effectively, builds the RIGHT quality into any product type.
A product that is safe, fit-for-purpose and consistent from batch to batch.
Driving the process too quickly from left to right, without a thorough understanding of what the customer needs, or what is required from a safety or regulatory point of view, can be risky.
Good Manufacturing Practise is often just common sense, but poor or rushed design of processes can often prove expensive in the long run.
Pushing through any gates that are built into the process can cause expensive delays or product rejection if we allow the gates to be opened too early. The depth or scope of knowledge that we need to build into the “What is Required?” Phase determines the timeframe to production and release and ultimately the cost of the product.
Can you trace back to documentation representing all the research work that justifies your current product specifications?
Product Quality relies on Planning and Good Organisation. A well-structured knowledge file that can be referenced by all company departments is an effective means of ensuring that specifications, batch instructions and release requirements are all aligned for an efficient cost-effective release of manufactured product.
How do you Structure Your Product Knowledge File?
At JWQC we believe that carefully organised Product Knowledge Files are central to an effective GMP process.
Call us on 01858 469 636 for a free, no-obligation conversation.