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Do you worry about getting an FDA 483 letter?
Your situation is not unique. Regulations in the pharma industry have never been more strict. According to FDA data, 3,344 observations were written to pharmaceutical firms last year. However, the best time to stay in compliance with cGMP for quality is before you feel the consequences of a failing inspection.
The best way to ensure you don’t get a 483 is to focus on the most likely areas to cause the problem.
Let’s look at the seven most common compliance issues and how you can handle them.
The US FDA releases an annual report summarizing observations from inspections by industry. The pharma industry in 2018 received 3,344 observations for 390 categories of noncompliance. Almost a third of these observations (39% of them) can be divided into just ten categories, thus illustrating the common challenges of pharmaceutical compliance.
However, the results become even more apparent when you group the data into categories based on the top ten reasons.
The four-and-a-half-dozen organizations received a 483-letter relating to noncompliance for creating or following procedures or problems with record-keeping. Additionally, 322 of the pharmaceutical industries had difficulty designing and implementing adequate controls, and 137 had trouble maintaining their products.
Whenever a pharmaceutical startup or scale-up approaches market approval, it is customary to go through growing pains. A laboratory manager may discover that a batch of maintenance records was not reviewed the week before he went on vacation, for example, even though your means of doing things seem to be working. Fortunately, there is an easier way to handle an FDA inspection than simply hoping for the best.
In a Standard Operating Procedure (SOP), clear steps are outlined for carrying out specific tasks in the workplace. Using an SOP simplifies communication and makes it easier to perform the necessary functions for the work to move forward. However, compliance issues tend to arise due to a lack of effective SOPs/Written Procedures.
Various issues prevent creating and using SOPs, including complicated language, lack of standardization, and inadequate training.
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During 2018, more than 2 percent of the FDA observations were for inadequate cleaning, sanitizing, and maintenance. Sanitizing, maintaining, and cleaning equipment and utensils appropriately must comply with the FDA Code of Federal Regulations.
The company should clearly outline the methods for cleaning and maintaining hygienic conditions. For example:
Additionally, it is essential to maintain cleaning activities logs and update them as often as other operational logs.
Real-time access to data allows companies to stay abreast of changes in compliance and improve performance. By doing this, an organization can minimize the effects of non-compliance effectively. Unfortunately, one of the key reasons that organizations cannot utilize the available data is outdated technology.
Compiling data from legacy systems is challenging. Most legacy systems provide incorrect data, and integrating new data is a complex process. It further keeps pharma companies from compliance reporting. Organizations often lack adequate reporting systems. To solve this problem, they use manual reporting systems, but they are susceptible to error. Additionally, the long-term costs are high. Companies should prioritize compliance needs and failing to do so could have dire consequences.
About 4% of all FDA observations in 2018 concerned failed laboratory controls. To maintain the laboratory data, it is necessary to monitor and maintain the laboratory controls. In addition, raw data can help determine many items, from instrument calibration to employee compliance to SOP adherence- which can prevent problems from arising.
A SOP without clarified roles and responsibilities creates ambiguity. The employee is better able to perform their duties and remain compliant with standards if they correctly understand what is expected of them. Moreover, providing compliance training at regular intervals keeps them prepared for the unforeseen challenges they may face in their tasks. It would be best if you equip them with tools so they can communicate, collaborate, and learn new skills. For example, you can utilize a next-generation training management software to manage employee training while giving them a centralized platform to communicate and collaborate.
Developing an SOP isn’t a linear process. You must update it to keep it current. It shouldn’t be the responsibility of one department to create and maintain these documents. To ensure that the SOPs remain relevant, departments that use them need to collaborate and update them as required. In addition to encouraging feedback, employees will offer suggestions for improvements. It will help maintain a culture of quality and continuous improvement. You may need a good Change Control Software to manage changes in processes, documents, facilities, and more.
To avoid omissions, the review and investigation processes must be clearly defined. Several ways are available for organizations to become out of compliance with CFR 211.192, which include:
An operational team and the quality control unit should use a single set of standards and standard operating procedures for batch record review to prevent any misunderstandings.
It is unacceptable for a pharmaceutical company to receive a 483-letter due to its first FDA inspection. The 483 letter signifies that your organization is out of compliance, even if you have corrected the problem. The long-term costs of uncorrected quality and operational issues outweigh the cost of continuously following FDA best practices.
The causes of noncompliance with cGMP are rarely willful. Typically, 483 observations are the result of oversights. This may be the case as the laboratory manager forgot to review maintenance records after a week on vacation. An older copy of the SOP may be used by lab employees who lost the updated document. A broken workflow or collaboration may result in noncompliance issues or simply human error. Fortunately, your quality management system can help you avoid many of these issues.
The Qualityze Enterprise Quality Management System (eQMS) is a cloud-based eQMS built specifically for fast-growing startups and scale-ups, regardless of their industry focus.
Feel free to contact our customer success team by calling 1 877 207-8616 or by email at info@qualityze.com for more information or a free demo of Qualityze EQMS Suite.
Author
Qualityze Editorial is the unified voice of Qualityze, sharing expert insights on quality excellence, regulatory compliance, and enterprise digitalization. Backed by deep industry expertise, our content empowers life sciences and regulated organizations to navigate complex regulations, optimize quality systems, and achieve operational excellence.
