Compliance Issues In Pharmaceutical Industry

Regulatory compliance is essential in the pharmaceutical, healthcare, and medical device industries. Companies should comply with the regulations of regulators, including the FDA. Thus, it is required to ensure the products’ quality.       

Why is regulatory compliance important? 

Regulatory compliance is important for pharmaceutical companies to reduce risks in manufacturing their products. It also helps to improve investor and customer confidence that the products they purchase are safe and effective. 

Pharma companies that comply with regulatory requirements can save costs on the product’s lifecycle. Regulatory compliance can be associated with high costs, but non-compliance can lead to higher costs. 

Now that you have learned about the importance of regulatory compliance let us proceed with the common compliance issues in the pharmaceutical industry. 

Common compliance problems in the pharmaceutical industry 

Failure to have clear SOPs 

One of the common compliance issues in the pharma industry is the lack of a clear Standard Operating Procedure (SOP). SOP offers clear written instructions about conducting routine activities. With SOP, everyone can easily understand the operations essential for work. 

Lack of clear SOP can be a big compliance issue. The following factors can affect the usage of SOP.

Lack of cooperation across departments 

SOP needs a regular update to remain relevant. The maintenance and creation of these documents are not limited to one department. Various departments need to update and collaborate to keep SOP relevant. 

Complex language 

SOP needs to be written in a direct and concise language. Thus, it reflects the company’s quality and serves as a blueprint for success. 

Improper use of data 

Another compliance issue is the improper use of data. Real-time data is beneficial for monitoring compliance changes. It can also improve the performance of the pharma company. Meanwhile, improper use of data can result to non-compliance. Some of the possible reasons why an organization use data improperly include:

Lack of compliance reporting

Lack of compliance reporting can lead to errors. It is also not cost-effective, which can bring consequences to the company.

Outdated technology 

Collecting data from outdated systems can be challenging. They can’t provide correct data. Therefore, the company should use updated technology to promote the proper use of data. 

Bad maintenance 

Bad maintenance, cleaning, and sanitizing can also be a big compliance issue. FDA requires companies to maintain, sanitize, and clean equipment and utensils to prevent malfunctions or contamination. 

Failure in lab control 

Failures in lab control are also among the common compliance issues in the pharma market. Companies should maintain and monitor laboratory controls since it offers crucial lab data. 

Improper production record reviews 

Failure to review production records can also be a compliance issue. A clear workflow for investigations and review is necessary to make sure that nothing was omitted. A company can be non-compliant if they commit the following:

Procedural failures

Failure in logs review

Failure to review cleaning logs, downtime logs, and clearance logs

Lack of shared procedures and more 


Failure to comply with regulatory requirements can bring consequences to pharmaceutical companies. A pharma company should be responsible for complying with the regulations to enhance the consumers’ lives. In addition, compliance can also help a company to increase its good reputation in the industry. 

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