Companies from the pharmaceutical industry conduct business on a tight legal leash, ensuring that a drug is safe, effective, and of good quality. To carry out an FDA audit, well an FDA audited facility must fulfill the requirements stipulated in the guidelines of the U.S. Food and Drug Administration (FDA). Audits help maintain public health and ensure that a company’s operations run according to Good manufacturing practices (GMP).
Essential Requirements for an FDA Audited Facility
Good Manufacturing Practice or GMP Compliance
All pharmaceutical facilities are obliged to comply with GMP regulations as per the FDA. International regulations cover numerous criteria, including personnel qualifications, cleanliness of the facility, validation of equipment, and preservation of records. Total compliance with GMP assures that medicines are produced and controlled constantly by quality standards.
Proper Documentation and Record Keeping
Correct and sufficient documentation is valuable as it has statutory value against FDA compliance. Facilities must maintain detailed records of manufacturing, batch testing, and deviations from the standard. Any documentation discrepancy may lead to serious violation charges and regulatory actions.
Validation and Qualification of Equipment
All equipment used in pharmaceutical manufacturing would be validated for accuracy and reliability. Moreover, the FDA mandates that calibration, maintenance, and performance qualification of machinery be done. All this would minimize the occurrence of errors, thus ensuring the integrity of the product.
Quality Control and Assurance Systems
Major performance requirements for a facility audited by the FDA include an elaborate quality control (QC) and quality assurance (QA) structure. Routine product testing, stability studies, and process validations are included in this. Said QA properly identifies and corrects deviations and non-conformances early on.
Employee Training and Competence
Periodic training programs should be conducted in an FDA audited facility to train the staff on regulatory changes about the compliance of the facility or best practices in the industry. It is an important expectation of the FDA from companies to organize training programs for employees so that they understand their respective roles and responsibilities in compliance.
Environment and Contamination Control
The plant should have adequate contamination control systems in place to avoid cross-contamination and produce pure products. These include air handling systems, sterilization protocols, and controlled entry into critical manufacturing zones.
Advantages of an FDA Audited Facility
Improved Credibility and Access to Markets
FDA auditing increases a firm’s credibility and stature. The public, regulatory bodies, and medical professionals all have more faith in companies that follow FDA guidelines. It also opens access to international markets with recognition of FDA regulations.
Lower Risk of Regulatory Action
FDA audits regularly identify and resolve compliance gaps before worsening into major violations. Non-compliance may lead to warning letters, product recalls, or facility closure. FDA-audited status reduces such risks.
Better Product Quality and Safety
An FDA-audited facility maintains high-quality standards, resulting in better drug efficacy and safety. This guarantees consumers high-quality drugs that are in line with regulatory standards.
Competitive Edge in the Industry
Those with FDA-audited facilities enjoy a competitive advantage over those that are not compliant. Most business partners and customers prefer doing business with producers compliant with FDA requirements, resulting in increased business.
Need Help?
Mak Pharma at The FDA Group possess a deep bench of experts, many of whom are former FDA staff, who perform rigorous mock FDA inspections and remediation support and ongoing guidance to help your organization remain in compliance on an ongoing basis.