The greatest news for any pharma manufacturer organization is approval from regulatory bodies to continue or start manufacturing and market their products for a specific region. This news comes after a great deal of work and effort put together by all sections of a pharma organization to fulfil all regulatory requirements.
This requires a high cost of investment, training, upscaling and changing the current system in an organization according to the requirements of a specific regulatory body or, most commonly, the United States FDA.
A regulatory body is only responsible for outlining detailed guidelines about the body's thinking regarding the drug requirements, expectations from the pharma manufacturer, and procedures to adopt for acquiring accreditation from the regulatory body. However, it is the sole responsibility of the manufacturer to devise methods, procedures and techniques to fulfil these regulations.
Upon notice from the pharma manufacturer about the readiness of the entire facility, the regulatory body will inspect and review each section and minute details of the manufacturer’s readiness. It will inspect to see whether the pharma manufacturer has put together all the requirements necessary for the execution of the pharma manufacturing process.
The regulatory body will only review adherence to their regulations and will not facilitate adherence. After inspection, it will give its final report, indicating whether the manufacturer is allowed to execute manufacturing processes or not. It is the sole responsibility of the manufacturer to fulfill all requirements
List of some common Audit Bodies
When applying to sell/market their products, pharma manufacturers are responsible for adhering to local regulatory body requirements. In addition, adherence to critical or renowned regulatory bodies helps pharma manufacturers increase their portfolio. Some famous and critical audit bodies include the United States FDA and EU GMP.
Let's briefly discuss each of them.
United States FDA GMP
The United States FDA is the drug (along with food) regulatory authority for the United States market. It laid down different guidelines and regulations for pharmaceutical suppliers and manufacturers to follow and implement in their product life cycle.
The specific guidelines for pharma products are known as Good Manufacturing Practice - GMP, which covers all pharma product manufacturing processes, sections and components.
EU GMP
EU GMP is the European version of GMP that provides a detailed guideline for manufacturers of pharma drug products.
Every manufacturer that intends to sell / market in Europe is bound to follow these regulations.
Tips for making your facility audit ready
Let's discuss some tips for making your facility GMP audit-ready. We will not discuss actual regulations but share some tips on optimally implementing them.
Understanding the importance of GMP
Your first step towards implementing audit policies should be understanding GMP and its basic & core ideas. It helps motivate employees and management because acquiring GMP guidelines for the US FDA can become tiresome. In this regard, the following can help us understand the importance of GMP.
· Your facility members must know what GMP is and what it means for implementing GMP in your manufacturing facility. You should know its importance in pharma manufacturing and what benefits it will offer to the organization and personnel. It is also necessary to know about the changes in the existing system, methods and procedures.
· Another area to understand GMP's importance is what area it would cover. Do the current practices implemented in the existing departments, areas, components and systems comply with the GMP regulations, or must they be changed according to the GMP requirements? Knowing what areas it covers and whether implementing GMP in all components of GMP is beneficial for our organization or not?
· Another point of attention in understanding the GMP is why it is necessary to implement GMP in your organization. If pr...
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