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Before moving on to best practices for compliance, it’s important to understand the importance of compliance. Compliance with regulations is a guarantee of quality and safety of pharmaceutical products. It shows that the products are safe and effective. While non-compliance can lead to serious problems such as product recall, regulatory actions, and can also damage the company’s reputation. Non-compliance can create serious public health problems by allowing substandard products to enter the market.
Regulatory requirements
There are many FDA regulatory guidelines available to implement in a pharmaceutical company, but there are some key requirements that must be met.
One of the most important requirements is the implementation of the quality management system (QMS), which means that there must be a system to implement the policies and procedures to ensure that the products manufactured by the company are safe and effective. A QMS system must have the system to implement risk management and corrective and preventive actions.
Compliance with regulatory guidelines for documentation, record keeping, labeling of areas and equipment is also required. Documents must be up-to-date and error-free according to current guidelines. Data integrity must be maintained in accordance with the guidelines. If any company meets all of these requirements, then it provides evidence of regulatory compliance.
