Optimize Performance With Internal Audit for Pharmaceutical Company

The pharma industry is highly regulated with strict guidelines governing every step of the manufacturing process. Ensuring the safety, quality, compliance and efficacy of medications is thus crucial. This is where the role of an internal audit for pharmaceutical company becomes indispensable. 

Internal audits involve carefully evaluating processes, controls, and practices to ensure adherence to regulatory requirements, mitigate risks, and drive continuous improvement. Let’s learn more about the regulations influencing internal audits, areas they cover and their contribution to the success and reputation of your pharmaceutical business.  

Regulations Governing Internal Audit for Pharmaceutical Company in India 

The pharmaceutical industry in India is governed by various regulations that impact internal audit practices directly or indirectly. Some of the most important ones are: 

• The Institute of Chartered Accountants of India (ICAI): Provides a “Technical Guide on Internal Audit of Pharmaceutical Industry”. It lays down best practices for conducting internal audits in the sector covering areas like procurement, production, and inventory management.
• The Institute of Cost Accountants of India (ICMAI):  ICMAI released “Exposure Draft Guidance Note on Internal Audit of Pharmaceutical Industry”. It provides additional recommendations for internal audit functions within pharmaceutical companies. 
• ISO Standards: While not mandatory, many pharmaceutical companies in India follow ISO 9001 for their quality management systems. It emphasizes internal audits for ensuring the effectiveness of the quality management system.
• Drugs and Cosmetics Act, 1940 & Rules, 1945: Establishes the framework for regulating the manufacture, sale, and import of drugs in India. It emphasizes the importance of quality control and maintaining proper documentation, which internal audits can verify.
• National Pharmaceuticals Pricing Policy (NPPP), 2012: Maintaining proper financial records and adhering to pricing regulations set by NPPP is crucial for pharmaceutical companies. Internal audits can help ensure compliance in this area.
• Good Laboratory Practices (GLP):  Pharma companies involved in research and development must adhere to GLP to ensure the integrity and reliability of laboratory data. 
• Good Manufacturing Practices (GMP): Compliance with GMP is essential for pharmaceutical companies to ensure the quality and safety of their products. Internal audits must verify adherence to GMP guidelines.

Areas Covered By Internal Audit for Pharmaceutical Company 

Internal audits in a pharmaceutical company can take many forms depending on the need and objectives. Here’s a breakdown of the key areas covered during an internal audit:

Quality Management Systems (QMS): 

An internal audit will assess the effectiveness of the QMS, including adherence to documented procedures, record-keeping practices, and training programs for personnel.

Regulatory Compliance: 

Auditors check if the pharmaceutical companies comply with the regulations set by national and international bodies. They include those related to product safety, efficacy, and anti-counterfeiting measures.

Manufacturing Processes: 

Internal audits verify a company’s adherence to good manufacturing practices set by regulatory bodies. This includes inspecting manufacturing processes, equipment calibration, and proper storage and handling of materials.

Supply Chain Management: 

This includes auditing the selection and qualification of raw material suppliers. It also checks the storage and transportation of materials to ensure quality and prevent contamination throughout the supply chain.

Research and Development (R&D): 

This involves assessment of R&D processes to ensure compliance with good clinical practices (GCP) and ethical standards. It also reviews documentation related to preclinical studies, clinical trials, and regulatory submissions.

Data Integrity and Information Security: 

Auditors verify data integrity controls to prevent unauthorized access, alteration, or deletion of critical data. They check if security measures safeguard sensitive information, including patient data and intellectual property.

Financial Controls: 

Here, a review of financial controls related to budgeting, expenditure authorization, and financial reporting is done. This involves assessment of compliance with accounting standards and regulatory requirements.

Laboratory Controls: 

Internal audits will evaluate laboratory procedures, equipment calibration, and the competence of laboratory personnel. This ensures accuracy and reliability of laboratory testing in pharmaceutical manufacturing. 

Human Resources: 

Internal audits might assess employee training programs, competency evaluations, and adherence to personnel hygiene practices. This is important because skills and qualifications of personnel directly impact product quality. 

 Risk Management: 

This involves evaluating the company’s risk management framework, including its effectiveness in identifying and addressing potential quality or compliance issues.

Environmental, Health, and Safety (EHS): 

This involves evaluation of environmental management practices, including waste disposal and pollution prevention measures. It also assesses occupational health and safety protocols to protect employees and minimize workplace hazards.

Benefits of a Well Conducted Internal Audit for Pharmaceutical Company

A well-conducted internal audit for pharmaceutical company conducted by an internal team or trusted providers like PKC Management Consulting offers many benefits such as: 

Enhanced Product Quality & Safety: 

• Internal audits help maintain and enhance product quality by evaluating manufacturing processes, quality control measures, and adherence to quality standards. 
• They also help identify areas for improvement, which helps companies optimize their processes to consistently deliver safe and effective pharmaceutical products.
• Proactive measures through internal audits can significantly reduce the risk of product recalls, which damage brand reputation.

Increased Efficiency and Cost Savings: 

• Through thorough assessments of processes and procedures, internal audits identify inefficiencies and bottlenecks, enabling companies to streamline operations and reduce costs. 
• By implementing recommendations from internal audits, companies can optimize resource allocation, improve productivity, and enhance overall operational efficiency.

Enhanced Brand Reputation and Trust: 

• Consistent internal audits demonstrate a pharma company’s commitment to quality and patient safety. This builds trust with patients, healthcare professionals, and other stakeholders.

Enhanced Compliance: 

• Internal audits ensure that pharmaceutical companies adhere to regulatory requirements. By pinpointing and addressing compliance gaps, companies mitigate the risk of regulatory penalties and maintain their license to operate.
• Well-documented internal audit reports facilitate external audits and regulatory inspections by demonstrating proactive efforts to ensure compliance and quality. 

Enhanced Decision-Making & Continuous Improvement:  

• Internal audits provide valuable insights into the organization’s performance, strengths, and areas for improvement. This enables informed decision-making which guides strategic planning, resource allocation and investment decisions.
• Internal audits promote a culture of continuous improvement by providing feedback, sharing best practices, and fostering innovation. 

Get Started with PKC’s Expert Internal Audit Services Today!