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 companies 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.
1. Lack of Clearly Defined Procedures and SOPs
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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2. Inadequate Maintenance Facilities
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:
Providing clear instructions for cleaning.
Indicating who is responsible.
Planning your cleaning schedule.
Providing the guidelines for maintaining the equipment properly.
Ensuring regular inspections and protective measures for equipment.
Additionally, it is essential to maintain cleaning activities logs and update them as often as other operational logs.
3. Not properly utilizing data
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.
4. Inadequate laboratory control
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.
5. A lack of communication and collaboration
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.
6. Participation among departments is low.
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.
7. Faulty Product Review Records
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:
Failure to perform a thorough log review
Reviewing downtime, cleaning, and clearance logs is a must
Process failures
Lab workers can’t examine their records
Lack of standardization
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.