What are the current pharma regulatory compliance requirements?

The requirements set forth in guidelines such as ISO 9001, 21 CFR Part 11, and 21 CFR Parts 210-211 were developed to ensure that new therapies can be produced according to the highest possible standards of quality, safety, and effectiveness. This overview offers a summary of these regulations and standards that have broader applications to regulated products. The surest way to meet the requirements is to first get familiar with these regulations and standards, then to invest in purpose-built pharmaceutical compliance software. 

FDA and ISO Compliance Management FAQ

What are the consequences of noncompliance in the pharmaceutical industry?

For pharma manufacturers, achieving and maintaining regulatory compliance comes with obstacles like inefficient processes, a lack of quality standardization, and poor visibility into manufacturing operations. Failure to comply with regulatory requirements can result in consequences like FDA warning letters or Form 483s, the loss of ISO certification, product recalls, or damage to a company’s reputation and bottom line. 

How can I stay updated on changing regulatory requirements?

It’s beneficial to pay attention to announcements from regulatory bodies like the FDA and ISO to stay abreast of any changes to regulations and standards that may occur. A good first start is reading this e-book which summarizes the current regulatory guidelines that apply to pharma manufacturers and details the ways that modern pharmaceutical compliance software can streamline your compliance journey. 

How can I integrate regulatory compliance into existing workflows seamlessly?

Purpose-built pharmaceutical compliance software makes it easier to meet FDA and ISO guidelines for the pharmaceutical industry. By implementing a modern digital solution that simplifies FDA and ISO compliance management, pharma companies can improve their competitive positioning, build stronger customer relationships, and confidently navigate the complexities of today’s regulatory environments. 

How can I demonstrate compliance to regulatory authorities effectively?

Modern digital solutions play a significant role in helping companies prove that they understand and comply with regulatory expectations. Advanced pharmaceutical compliance software allows pharma manufacturers to show that their operations are modernized, efficiency is maximized, and high-quality products can be consistently produced. Purpose-built digital tools also give you the ability to instantly provide regulatory inspectors and auditors with the precise information they’re seeking.  

Fagron Case Study: Unifying Compliance Efforts

See how MasterControl’s modern pharmaceutical compliance software enables Fagron to meet a variety of global regulatory requirements and helps the pharmaceutical compounding leader achieve higher levels of efficiency and impressive quality performance metrics. 

See What Users Say About MasterControl

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