The expanding global footprint of pharmaceutical manufacturers brings about great opportunities, but it's not without the challenges faced by pharma companies in drug development. Compliance hurdles in emerging markets are causing a stir. The United States Food and Drug Administration (US FDA) has published many warning letters of significant FDA violations by manufacturers under their jurisdiction. Lack of lab controls (13%) and non-adherence to procedures (21%) are among the top compliance issues cited by the FDA. But the stakeholders are determined to overcome the challenges in pharmaceutical industry to ensure safe and effective medicines reach patients worldwide. This blog will discuss the common compliance issues in pharmaceutical industry and how to avoid them, including FDA Pharma Violations and FDA penalties.

Despite the significant benefits of expanding their global network of facilities, pharmaceutical manufacturers are encountering compliance issues in new regions, particularly with culturally varied beliefs about safety, risk, and quality. Carefully designed methods are required to achieve modernize procedures and facilities while managing post-approval adjustments. Improving procedures for efficiency impacts the supply, increases company sustainability, and aids in the prevention of medicine shortages.

Drug companies face the pharma industry challenges of adhering to varying approaches for quality and compliance across regions for GMP compliant manufacturing. As a result, there is a growing need for global harmonization and convergence of regulations and inspections to meet diverse requirements. On June 19, 2022, the FDA received three thousand, three hundred and forty-four (3,344) observations from pharmaceutical companies. However, the optimum time to maintain Pharma GMP compliance for quality and avoid cGMP violations is before experiencing FDA fines and penalties for a failed inspection. The easiest method to avoid a warning letter or 483 is to concentrate on the most likely sources of the problems, which are also the key challenges facing the pharmaceutical industry today. These are as follows:

  • Drug Shortages.
  • Ambiguity in Job Roles.
  • Lack of Laboratory Controls.
  • Regional Differences and Approaches.
  • Non-adherence to Written Procedures.

Common Compliance Issues in the Pharmaceutical Industry

 Clarity in Procedures and SOPs

Not having a clear practice and Standard Operating Procedure (SOP) are the prominent challenges in pharma manufacturing. An SOP outlines processes for carrying out certain duties in the workplace. Using an SOP improves communication and makes it simpler to fulfill the activities required for a specific job. On the other hand, GMP compliance in the pharmaceutical industry  occur because of a lack of adequate SOPs/written procedures. Creating and implementing SOPs is hampered by various challenges, including complex wording, a lack of standardization, and insufficient training.

  • Lagging in the Maintenance Facilities

More than 2% of FDA observations in 2020 were for poor cleaning, sanitizing, and maintenance. Sanitizing, maintaining, and cleaning equipment and utensils per the FDA Code of Federal Regulations is required. The organization should explicitly describe the procedures for cleaning and maintaining sanitary conditions to follow the FDA GMP compliance/FDA cGMP compliance. Following are a few examples:

  • Giving specific cleaning guidelines.
  • Identifying who is to blame.
  • Create a cleaning routine.
  • Providing advice for proper equipment maintenance.
  • Maintaining frequent equipment checks and preventive measures.

Furthermore, cleaning activity records must be updated regularly, much like other operating logs.

  • Insufficiency in Data Utilization

Companies may remain up to date on changes in compliance and enhance their performance by having real-time access to data. By meeting these GMP compliance requirements, an organization can successfully mitigate the repercussions such as FDA fines for noncompliance. Unfortunately, outdated technology is one of the primary reasons why organizations are unable to make use of the existing data. Data collection from previous technologies is challenging. The majority of old systems give erroneous data, and integrating new data is a difficult procedure. It also prevents pharmaceutical corporations from reporting compliance. Many organizations do not have sufficient reporting systems and a GMP compliance audit in place. They employ human reporting methods to overcome this problem, which may lead to inaccuracy. Furthermore, the long-term expenses are considerable. Companies must prioritize compliance requirements such as the FDA pharmaceutical audits. And failure to do so might have serious implications.

  • Indefinite Communication and Collaboration

An SOP that does not define the roles and duties promotes uncertainty. When employees know what is expected of them, they are better equipped to accomplish their jobs and remain compliant with the standards. Furthermore, providing compliance training at regular intervals keeps the employees prepared for unexpected problems in their duties. It is preferable if you provide them with tools that will allow them to interact, cooperate, and acquire new skills. You may, for example, use next-generation training management software to manage staff training while providing a centralized platform for communication and collaboration.

  • Inaccuracy in Product Review Records

Review and investigation procedures must be established to avoid omissions. Companies can fall out of compliance with CFR 211.192 in several ways, including:

  • Failure to conduct an in-depth log review.
  • It is essential to go over downtime, cleaning, and clearing records.
  • Failures in the process.
  • Lab staff are unable to review their records.
  • Lack of standardization.

To avoid misunderstandings, the operational team and the quality control unit should adopt a single set of standards and SOPs for batch record review.

It is unacceptable for a pharmaceutical company to receive a 483 from 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 unresolved quality and operational issues outweigh the cost of continuously following FDA best practices and avoiding FDA violation penalties. Noncompliance concerns or just human mistakes occur from a disrupted workflow or cooperation. Thus, a seasoned partner like Freyr is your one-stop solution that delivers impeccable compliance and audit services to help your organization avoid such obstacles promptly. To know more about our bucket list of services, visit


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