Learn how internal audits play a critical role in maintaining compliance and quality management in the life sciences industry. Discover key audit areas including GMP, GLP, and GCP.
One critical necessity looms large throughout the myriad labyrinth of regulations which dictate the world of life sciences: Internal audits.
Pharmaceuticals, biotech and medical devices are life science industries that have their products highly regulated due to them affecting human lives.
Life sciences companies must have systems, processes and controls to fulfill legal requirements and meet regulatory and ethical standards regarding the safety and effectiveness of their products.
Companies must continually develop their processes and systems to keep up with regulatory demands as well as reassure its stakeholders.
Introduction: The Importance of Internal Audits in Life Sciences
Internal audits are an important aspect of compliance and quality management within the life sciences industry. These are performed by independent and objective internal auditors who evaluate the company’s compliance with regulatory requirements and quality management procedures.
They review processes, systems and controls looking for potential areas of non-compliance and suggest ways to enhance them to counter risks.
Internal Audits: Identifying Gaps and Enhancing Compliance
Internal audits are a critical part of ensuring compliance programs remain effective, as they allow companies to identify the “gaps” in their protocols and take necessary action. They also give vital warning signs about compliance risks and assist companies in adopting proactive measures to avoid non-compliance.
GMP, GLP and GCP are important areas to Auditing for Compliance with Regulatory Requirements. Such activities require a Standard Operating Procedures (SOP’s) and training programs in place which can be verified through internal audits.
Regulatory Affairs: Navigating the Regulatory Landscape
A Regulatory affairs and compliance specialist: It is an imperative component to guarantee that life sciences companies abide by the rules and regulations for relocating supplies across boundaries.
They advise on regulation and help companies navigate rules. They also verify that the company’s products are validated and documentation to support regulatory submissions is maintained.
The Importance of Continuous Monitoring and Follow-Up Audits
There is a continuous need to follow up compliance metrics so that the discipline does not lapse and adherence to regulatory mandates remains in shape. Progress and improvements are tracked through audit reports and management review.
Additionally, third-party audits and quality agreements can serve to augment internal audits and help guarantee compliance with regulatory demands.
Conclusion: Internal Audits as a Pillar of Compliance and Quality Management
The life sciences industry is highly regulated to guarantee compliance and quality management processes are followed correctly, especially when it comes to gaining regulatory clearance within the market. Internal audits, therefore, is a critical step in these checks and balances.
All labs including GLP, GMP and GCP should be audited for compliance to regulatory requirements. Regulatory Affairs and Compliance Specialists offer advice about regulatory requirements. Risk assessment and mitigation are important parts of internal audits.
Internal audits could be supplemented with compliance metrics and third-party audits, quality agreements, etc. as a part of the continuous monitoring process.
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