In the realm of Good Manufacturing Practices, if it isn't documented, it didn't happen. This adage underscores the paramount importance of comprehensive and accurate documentation in GMP audits. Documentation serves as objective evidence of adherence to established procedures, quality standards, and regulatory requirements. Zenovel places a strong emphasis on the critical role of documentation in ensuring successful GMP audits.
During a good manufacturing practices audit, auditors meticulously review a wide range of documents, including master batch records, executed batch records, standard operating procedures (SOPs), validation protocols and reports, training records, deviation investigations, and change control records. These documents provide a historical account of manufacturing activities and demonstrate the effectiveness of your quality management system. Any inconsistencies, omissions, or inaccuracies in documentation can lead to significant findings during an audit.
Zenovel's GMP audit services include a thorough assessment of your documentation practices. Our experienced auditors evaluate whether your documentation is complete, accurate, legible, contemporaneous, and readily available. We assess whether your SOPs are clear, concise, and followed consistently. We review your batch records to ensure that all critical steps are documented and that any deviations are properly investigated and resolved.
Furthermore, Zenovel can provide guidance on establishing and maintaining a robust documentation system that aligns with GMP requirements. We understand the complexities of managing pharmaceutical and medical device documentation and can offer best practices to ensure compliance and facilitate smooth GMP audits. Well-maintained and accurate documentation not only satisfies regulatory expectations but also serves as a valuable tool for internal knowledge transfer, process improvement, and demonstrating a strong commitment to quality. Trust Zenovel to help you build a documentation system that stands up to the scrutiny of a Good Manufacturing Practices audit.
