Pre-Assessment for Regulatory Inspections
By conducting a thorough pre-assessment for regulatory inspections, MASUU can proactively identify and address compliance issues, enhance readiness for inspections, minimize risks of non-compliance, and demonstrate a commitment to regulatory compliance and quality assurance. Pre-assessment for regulatory inspections involves conducting a comprehensive evaluation of a facility’s compliance status, readiness, and preparedness for an upcoming regulatory inspection. This proactive approach helps identify potential areas of non-compliance, weaknesses, or deficiencies that need to be addressed before the official inspection takes place. Overview of ‘Pre-assessment for Regulatory Inspections’ is Review of Regulatory requirement, establish inspection readiness team, conduct self-assessment, Document review, physical inspection, Training and awareness, Mock inspections, Corrective actions, documentation and record keeping, Continuous improvement.
MASUU has a robust track record of conducting pre-assessment for regulatory inspections, successfully managing approximately 150 audits per annum. This consistent performance underscores MASUU’s dedication to maintaining high standards of regulatory compliance and operational excellence. By integrating these practices into its operations, MASUU can not only ensure compliance with regulatory standards but also build a reputation for reliability and quality in the industry.
Act as a Plant representative during Regulatory Inspections
By effectively fulfilling our role as a plant representative during regulatory inspections, MASUU contribute to the plant’s compliance with regulatory requirements, demonstrate commitment to quality and safety, and uphold the reputation and integrity of the organization. Our proactive approach, attention to detail, and professionalism are essential in ensuring a successful outcome of the inspection process. As a plant representative during regulatory inspections, our role is crucial in ensuring that the inspection process runs smoothly, that regulatory requirements are met, and that the interests of the plant and its stakeholders are protected. Responsibilities and actions of MASUU are preparation, coordination, accompaniment, Documentation Management, Response to findings, Facilitation of interviews, Adherence to procedures, Resolution of issues, Maintaining professionalism, post-inspection follow-up.
With several decades of experience in facing regulatory inspections, the MASUU team ensures that the inspection process runs smoothly, regulatory requirements are met, and the interests of the plant and its stakeholders are protected. By fulfilling these responsibilities with diligence and professionalism, MASUU contributes significantly to the plant’s compliance efforts and upholds the organization’s standards of quality and safety.
Gap Assessment Audit
A Gap Assessment Audit is a systematic evaluation conducted to identify discrepancies, deficiencies, or “gaps” between current practices and desired standards, requirements, or best practices. This type of audit is crucial for organizations aiming to enhance their compliance, mitigate risks, and improve overall performance. Following are the advantages of GAP assessment Audit.
- Regulatory Compliance:
Gap assessments are often performed before regulatory audits to ensure that organizations meet the necessary compliance standards. For instance, MASUU has a strong team that has successfully helped companies prepare for and comply regulatory audits. - Performance Improvement:
By comparing current practices to industry benchmarks, organizations can identify areas for improvement. This can lead to better performance, increased efficiency, and achieving organizational objectives more effectively. - Enhanced Compliance:
By identifying and addressing gaps, organizations can ensure they meet regulatory requirements and avoid potential penalties. - Risk Mitigation:
Addressing deficiencies reduces the risk of operational failures, compliance issues, and other negative outcomes. - Improved Performance:
Systematically addressing gaps can lead to more efficient processes, better resource utilization, and overall performance enhancement. - Strategic Planning:
Gap assessments provide valuable insights that can inform strategic planning and decision-making processes.
Gap Assessment Audits play a vital role in helping organizations align their practices with desired standards and requirements. By conducting thorough evaluations and implementing recommended improvements, organizations can significantly enhance their compliance, mitigate risks, and improve their overall performance. MASUU’s expertise in identifying gaps has been instrumental in helping companies prepare for and succeed in regulatory audits, demonstrating the critical impact of effective gap assessment.
Compliance Audits
In general, Compliance Audit is being done once the Audit is over and to see compliance to Critical observations. MASUU has a very good relationship with many of the Pharma Companies to access to perform Compliance Audits with 100% effectiveness checking. Compliance audits help organizations ensure that they meet legal and regulatory requirements, uphold ethical standards, mitigate risks, and maintain public trust and confidence. By identifying areas of non-compliance and implementing corrective actions, organizations can strengthen their compliance programs, reduce legal and regulatory risks, and demonstrate their commitment to responsible and ethical business practices. Compliance audits are systematic reviews and assessments conducted to evaluate an organization’s adherence to applicable laws, regulations, policies, standards, and contractual obligations. The primary focus of compliance audits is to verify that the organization is operating in accordance with legal requirements and established guidelines, and to identify areas of non-compliance or areas needing improvement. Compliance audits may cover various aspects of an organization’s operations, including financial reporting, data privacy, environmental practices, health and safety protocols, human resources policies, and quality management systems. Key aspects of Compliance Audits are Legal and Regulatory requirements, Documentation review, Process evaluation, Internal controls, Data analysis, Stake holder engagement, Reporting & Follow-up.
Vendor Audits
Vendor Audit is a basic regulatory requirement for Starting Materials & Primary Packaging Materials, APIs in case of Formulations. But many of the Companies do not show interest in doing Internal Audits because of lack of awareness, financials, etc. There MASUU came into existence and did several Vendor Audits. Vendor audits play a crucial role in assessing and managing the performance, quality, and compliance, helping organizations maintain supply chain integrity, mitigate risks, and ensure the delivery of high-quality products and services to customers. Vendor audits are conducted by organizations to evaluate the performance, capabilities, quality management systems, and compliance of their Vendors, Sub-contractors, or business partners. Vendor audits aim to ensure that Vendors meet the organization’s requirements, standards, and expectations for quality, reliability, and regulatory compliance. Key aspects of Vendor Audits are Vendor selection, Documentation review, Site visit and inspection, QMS, Product or Service Quality, Compliance with Standards & Regulations, Performance measurement and monitoring, Reporting & follow-up.
System Audits
System audits provide valuable insights into the performance, effectiveness, efficiency and compliance of specific systems within an organization, helping to identify areas for improvement, mitigate risks, enhance controls, and optimize processes to support organizational objectives and achieve desired outcomes. These audits focus on assessing the processes, controls, and performance of the systems in achieving their intended objectives and supporting organizational goals. System audits can encompass various types of systems, including management systems, information systems, quality management systems, environmental management systems, and financial systems. Key aspects of System Audit are Documentation Review, Process evaluation, Controls assessment, Data Analysis, Risk Management, Stake holder engagement, Reporting & Follow-up. MASUU’s basket is full of six Systems Audit which has proven to be successful as we get repeat requests.
Facility Audits
MASUU has expertise people who were trained by ex-Regulatory Auditors in performing Facility Audits. A big team of Certified Auditors who have vast experience in auditing to evaluate the Facilities whether they are suitable for Regulatory / Statutory Audits or not. Facility audits help organizations identify areas for improvement, mitigate risks, enhance operational performance, ensure regulatory compliance, and maintain a safe, secure, and sustainable working environment for employees and stakeholders. It is a comprehensive assessment of a physical location, such as a manufacturing plant, Warehouse, office building, or other facilities, to evaluate compliance with Regulatory requirements, Safety standards, Quality assurance protocols, and Organizational policies and Procedures. Facility audits are conducted to identify risks, assess operational performance, and ensure the effective management of resources and assets within the facility. Key aspects of Facility Audits are Regulatory Compliance, Safety & Health, QMS, Physical infrastructure, Documentation & Record keeping, Environmental Management, Security & Access control, Emergency preparedness, Reporting & Follow-up.
Paper Audits
Paper Audit takes place without physical inspection of facilities or direct observation of activities. In some circumstances, we cannot go to the Vendor’s Site and do audit, ex. During Corona times / Overseas Audits / Lack of time / etc. In those situations, we send Audit Checklists in Paper form and ask the Vendor to fill them in and send them to us. We review the Checklists and assess the GMP compliance levels. Paper Audits are typically supplemented with on-site inspections and observations to validate findings and assess actual practices. Paper audits conducted by organizations to evaluate the compliance, accuracy, completeness, Traceability, Effectiveness of controls, Gaps and opportunities for improvement. MASUU takes this activity on behalf of our Clients and fulfils their needs. Trained GMP team under Former Regulatory Agency personnel from US FDA, MHRA, EMA, ENVISA, TGA, ENVIMA etc. is readily available in MASUU.
Virtual Audits
Virtual audits conducted by MASUU using digital communication and collaboration tools without the need for physical presence at the audit site. Virtual audits have become increasingly common, especially in situations where on-site visits are not feasible or practical, such as during travel restrictions, remote work arrangements, or when conducting audits across multiple locations. Overview of Virtual Audits are Digital Communication Platform, Remote Document Review, Virtual Site Tours, Interviews and Discussions, Data Analysis and Remote Access, Recording and Documentation, follow-up and Verification. Virtual audits offer several benefits, including cost savings, time efficiency, flexibility, and reduced environmental impact associated with travel. MASUU does effective planning, preparation, communication, and coordination to make successful virtual audits.
Overseas Audits
Many of the Companies cannot bear to perform ‘Overseas Audits’. To help the Pharma Industry, MASUU initiated the ‘Overseas Audits’ which has a big team of Auditors spread across the Globe who are Qualified to do Audits. Some of them are retired Regulatory Auditors too. We charge a very minimal fee. Overseas audits play a vital role in ensuring the integrity, transparency, and accountability of global business operations, facilitating risk management, and driving continuous improvement across international business activities. It refers to audit activities conducted by an organization in locations outside of its primary operating country or jurisdiction. These audits may involve assessing the operations, processes, controls, and compliance of subsidiary companies, affiliates, Suppliers, or other business partners located in foreign countries. Overseas audits are typically conducted to ensure consistency, quality, and compliance with organizational standards, policies, and regulatory requirements across global operations. Key aspects of overseas audits are Risk assessment, Legal & Regulatory Compliance, Cultural sensitivity, Language & Communication, Logistics & Travel, Technology & Remote Auditing, Cultural exchange and Knowledge sharing.
Internal Audits
On behalf of the Company’s internal CFT (Cross Functional Team), MASUU does Internal Audits in your Firm. This will help in identifying un-biased internal audit observations and more scope to go deeply to observe gaps. Internal Audit concept is a regulatory requirement and Management’s need also. Internal audits play a crucial role in providing assurance to management, the board of directors, and stakeholders that risks are effectively managed, controls are in place and operating effectively, and the organization is achieving its objectives efficiently and ethically. An internal audit is an independent, objective assurance and consulting activity designed to add value and improve an organization’s operations. It focusses on evaluating and improving the effectiveness of risk management, control, and governance processes. Internal audits provide valuable insights and recommendations to help organizations achieve their objectives, manage risks, and ensure compliance with policies, regulations, and standards. Key aspects of Internal Audit which MASUU ensures Independence and Objectivity, Risk based approach, Evaluation of controls, wwwing and Sampling, Reporting and Communication, Follow-up and monitoring, Continuous improvement.
For Cause Audit
For cause audits are conducted in response to specific events, repeat incidents, or concerns that warrant an immediate or focused examination of a particular area, process, or aspect of an organization’s operations. For cause audits trigger the following scenarios: Repeat Quality events, Complaints, Supplier issues, Changes in Operations, etc. ‘For cause audits’ are typically conducted with a sense of urgency and focus on addressing the specific issues or concerns that triggered the audits which involves targeted assessments, investigations, interviews, document reviews, and data analysis to gather relevant information and evidence. MASUU takes this activity on behalf of our clients and fulfils their needs. This is just a door away to knock. Please click to utilize this service.