Tuesday January 31, 2023
What are the compliance guidelines for the pharmaceutical industry?
The Food and Drug Administration (FDA) ensures the quality of drug products by carefully monitoring pharmaceutical compliance with Current Good Manufacturing Practice (cGMP) regulations. The cGMP provides the basis for FDA guidelines for pharmaceuticals looking to maintain the minimum requirements for the methods, facilities, and controls used in the manufacturing, processing, and packing drug products or medical devices. The pharmaceutical quality resources and pharma regulations set by the FDA aim to ensure that a product is safe for use and has the ingredients and strength intended. The World Health Organization (WHO) provides Good Manufacturing Practice (GMP) guidelines for pharmaceuticals, including but not limited to computer system validation and the qualification of systems and equipment for the pharmaceutical industry.
How does the FDA regulate pharmaceutical companies?
The role of the FDA in the pharmaceutical industry is to ensure the public is safe by regulating essential aspects of production, from manufacturing processing to labeling products. Why is FDA approval important to the pharmaceutical industry? The FDA impacts the pharmaceutical industry as FDA approval is necessary to release drug products or medical devices to the public. FDA approval includes the requirement for validation of software that impacts the drug product. Also, ongoing maintenance of the compliance process is required to meet validation principles. Pharmaceuticals must comply with 21 CFR part 11, Electronic Records; Electronic Signatures, wherein security and access control, electronic signature authority, and audit trails are tested as part of a software validation effort. Computer software validation provides documented evidence to the FDA that systems are compliant with regulatory requirements. Providing the FDA with validation deliverables that include a validation summary report helps identify to regulators that computer systems work to their intended specifications. Pharmaceutical companies risk a pause in production or a complete shutdown if the FDA is not provided with adequate proof of compliance, like testing documentation.
How does the pharmaceutical industry address FDA regulations?
Pharmaceutical validation and compliance services are essential when assisting the pharmaceutical industry in FDA compliance. Validation testing is an integral commitment to business risk management directly related to pharmaceutical software systems. Software testing evaluates regulatory compliance, recognizes risk factors, enhances productivity, capitalizes on the investment in software systems, improves schedule visibility, and provides a qualified, third-party analysis of software systems. To further discuss FDA pharmaceutical regulations, contact us to learn more about FDA Guidelines for the pharmaceutical industry.