Validation Master Plan in Pharmaceuticals


The first thing to understand before embarking on the process of creating and following up on a validation master plan, is to understand what it is. Simply put, it is a plan that shows the process of qualifying a facility, outlining the areas that require validating and ultimately, outlining the process of maintaining a facility, once it has been validated. This process is absolutely key in the pharmaceutical industry as there are certain standards to be met, as set up by the government. The process itself may be tedious and long, but worth it in the end.

During audits of your pharmaceutical company, the Food and Drugs Authority (FDA) will look through your validation documents. In these, they look for well thought out and practical systems. They also need to see that you’ve included risk assessments that form the basis of including or excluding certain systems. A validation master plan is also required by Good Manufacturing Practice (GMP), as they regulate the pharmaceutical industry.

While there is no particular formal guideline as to what should be included in a validation master plan, there are a few guidelines that ought to help on the same. A validation master plan should include the following things: Validation activities (whether past, present or future), time, location and order of validation activities, the validation policy of the company and a description of the same, the organization’s activities and its processes. There are a few more key things to keep in mind, which can easily be looked up and implemented.

Once you’ve got your checklist of what to include in the plan, you can go ahead and begin the process of writing one. This ought to follow a very organized system and order, as you need the authorities to see a logical flow in your work. The obvious beginning is an introduction. Here, you’ll simply speak briefly about your company, your location and contacts as well as your Quality Assurance Policy. You’ll proceed to give a brief scope of your work. After which you will, in detail, describe your facility. Here you’ll need to speak of your equipment and such. The document then follows such a logical manner up to when it lists the process by which the equipment and systems will be validated. It’ll then be broken down into different sections. You would speak of the computer system validation process, the protocols required for this and finally your standard operating procedures.

The validation master plan is long and tedious to create but necessary in the pharmaceutical industry. For a more efficient plan, you will need to include a number of stakeholders in your company who’re able to produce concrete facts, logical plans and sensible reviews. What you will also need to do is a lot of research on these plans. There are lot of pharmaceutical sites that offer advice and guidelines on validation master plans. You may also look up examples of validation master plans to understand the format better, as there are different approaches to it that work. Good luck writing your validation master plan.

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