Pre-Inspection Readiness
Master Compliance with our Mock Inspections for Your Seamless Pre-inspection Readiness
Master Compliance with our Mock Inspections for Your Seamless Pre-inspection Readiness
The pharmaceutical manufacturing industry requires rigorous audit and inspection readiness to ensure compliance with quality standards. These inspections are crucial for ensuring the quality and safety of pharmaceutical products. Therefore, pharmaceutical companies must approach these inspections with careful planning, attention to detail, and a proactive mind-set.
Zenovel acknowledges the demanding and time-consuming nature of preparing for audit and inspection. Our team of professionals offers comprehensive simulated inspection services to help prepare your facility for US-FDA, EMA, and MHRA inspection. We conducts audit or mock inspection, review your documentations and quality systems, validate your process, and provide valuable feedback on areas for improvement.
To effectively prepare, first acquaint yourself with the inspection procedure. The following phases are involved:
The FDA field inspector’s conducts inspection at facilities, reviewing records, interviewing personnel, and assessing compliance with regulations.
The FDA releases an inspection report outlining any observations or conclusions.
The FDA informs pharmaceutical company of an upcoming inspection, which can be given as little as five days or weeks in advance, even sometimes a surprised visit happens
Pharmaceutical company should conduct a comprehensive self-assessment, evaluate all SOP’s and regulatory documentation, and thoroughly examine processes to ensure easy accessibility of all relevant material.
To pass an FDA inspection, a proactive, risk-based strategy is necessary for effective quality system, process, and regulatory adherence, requiring crucial preparatory actions.
The implementation of internal mock inspections can identify readiness gaps, familiarize staff with the inspection procedure, and offer practical experience in handling inquiries. Our mock inspection readiness services offers simulate real inspection scenarios, reviewing processes, quality management system, documentation, and compliance levels. We identify gaps and provide targeted recommendations, ensuring your team is well-prepared for regulatory audits, reducing non-compliance risks, and enhancing inspection outcomes.
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