Comprehensive GMP Schedule M Pharma Audit Service
Pharmadocx Consultants provide comprehensive and specialised pharma audit service for pharmaceutical companies. We conduct thorough GMP audits, regulatory compliance audits, quality assurance audits, and vendor audits. Furthermore, we prepare comprehensive pharma audit reports with detailed insights highlighting areas for improvement and next actionable steps. By availing our pharmaceutical audit service, your pharma plant and manufacturing process will comply with regulatory and industry quality requirements. Our pharmaceutical auditors are highly qualified and have extensive expertise and industry experience.
What is a Pharmaceutical Audit?
A pharmaceutical audit is an independent and systematic evaluation of compliance of a pharmaceutical company’s operations and processes with industry quality standards and regulatory guidelines. Moreover, compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other regulatory standards is of paramount importance in pharma industry. Hence, pharma audits are of vital importance to ensure the company meets industry requirements for manufacturing safe and effective pharmaceuticals. The pharmaceutical audits are usually conducted internally, by third-party organizations, or by regulatory authorities. Notably, third party pharma audit service can help pharmaceutical companies identify possible gaps in GMP and regulatory compliance.
Importance of pharmaceutical audits:
Audits are of crucial importance in the pharmaceutical industry because:
- They help maintain high standards of product quality, safety, and efficacy.
- They identify potential issues in the production and distribution of pharmaceuticals.
- They help ensure the company is adhering to regulatory requirements.
- They help maintain data integrity.
- They promote continuous improvement within the organisation.
How often pharmaceutical audits are conducted usually depends on regulatory requirements and the complexity of operations. Additionally, previous audit findings and changes in the production process or regulations influence the frequency of the audits. Internal audits are usually conducted annually. On the other hand, regulatory and third-party pharma audits are conducted every two or three years or as required.
Key areas inspected during pharmaceutical audits
A comprehensive review of operations and processes are conducted during pharmaceutical audits to verify the company’s compliance with regulations and industry standards. Certain key areas inspected during pharmaceutical audits are as follows:
- Pharmaceutical manufacturing processes
- Manufacturing facility and infrastructure
- Quality control and quality assurance systems
- Equipment maintenance and servicing status
- Staff training and qualifications
- Documentation
- Data integrity
- Compliance with specific regulations and standards relevant to the products being produced
- Cleanliness and sanitation practices
Auditing is a dynamic and integral part of pharmaceutical companies.
Why Should You opt for Pharma Audit Service?
Opting for pharma audit service can be a gamechanger for pharma companies. A pharma audit service will help ensure regulatory compliance and adherence to industry quality standards. Moreover, it will help increase credibility and trust among consumers and stakeholders.
6 reasons to opt for a third-party pharma audit service
- Identification of potential risks: A thorough evaluation by a third-party service can unravel compliance gaps or quality issues missed by internal audits.
- Impartial assessment: A third-party audit company has no vested interest in the company. Hence, the third-party company will use an objective and impartial approach while conducting the audits.
- Compliance with all regulatory requirements: A pharmaceutical audit company has extensive knowledge of the applicable regulatory guidelines. Hence, they can ensure your pharma company is meeting all necessary regulatory standards and guidelines.
- Improved supplier selection: A third-party pharma audit can provide valuable insights into the quality control practices and reliability of raw material suppliers. Hence, it will help evaluate and select potential suppliers.
- Foster an environment of continuous improvement: Audit reports will help identify areas that need improvement. Hence, the company can implement corrective actions and enhance their overall quality management system.
- Enhanced credibility: A positive report by a third-party audit service will significantly boost the company’s reputation. It will demonstrate the company’s commitment to quality and regulatory compliance to potential clients.
Our Pharma Audit Service Suite
We offer comprehensive third-party pharma audit service. Our services are designed to evaluate your processes and operation, identify lapses, and ensure your organization aligns with regulatory guidelines. Our pharma audit service provides an independent and unbiased assessment of your company’s compliance with regulatory standards and adherence to industry best practices. By opting for our service, you can rest assured that your company is consistently manufacturing high-quality, safe, and effective products. Furthermore, our team of experienced auditors will provide insights and feedback to strengthen your quality management system.
Good manufacturing practice (GMP) compliance audits
We will evaluate whether your pharmaceutical plant and production process complies with GMP guidelines. Our audits will help ensure high-quality products are consistently manufactured. Furthermore, the quality control process will be consistently controlled and regulated as per industry benchmarks. We will evaluate the following components:
- Raw material sourcing and handling
- Manufacturing process
- Quality control system
- Packaging and labelling
- Equipment calibration and maintenance status
- Documentation and record-keeping system
- Employee training and qualification
Supplier or vendor audits
Under our supplier or vendor audit service, we will verify the reliability and quality control processes of raw material suppliers. Additionally, we will evaluate whether the raw materials, active pharmaceutical ingredients, and other components meet the set quality benchmark and comply with GMP guidelines. We will assess the following:
- Supplier’s manufacturing practices and facilities
- Raw material quality control system
- The supplier’s quality management systems
- Moreover, we will audit contract manufacturers, testing laboratories, and packaging vendors
Environmental & safety audits
Under our environmental and safety audit service, we will assess the pharma plant’s environmental impact and waste management system. Additionally, we will also focus on the employee safety program in place. Our audits will help ensure compliance with local environmental laws and occupational safety standards that are applicable for your pharma manufacturing facility. We will thoroughly evaluate the following components:
- Environmental impact (Emissions, Waste management, Water usage) and environmental regulation compliance
- Occupational health standards
- Hazardous material management
- Emergency preparedness and response
- Workplace safety protocols
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Quality assurance audits
We will evaluate the overall effectiveness of the plant’s quality assurance system. Our audits will help ensure your quality management systems are in place to guarantee the safety, efficacy, and quality of the pharmaceuticals being manufactured. We will focus on the following components:
- Quality management systems (QMS)
- Risk management processes
- Product lifecycle management
- Documentation practices (SOPs, change controls, deviations)
- Auditing
- Corrective and preventive action systems
- Continuous improvement programs
Regulatory compliance audits
We will thoroughly evaluate your manufacturing facility and process for compliance with applicable regulatory guidelines. Our regulatory compliance audit service will help ensure your facility abides by CDSCO, FDA, or other applicable regulatory guidelines. We will perform the following evaluations:
- Adherence to all local and international regulatory requirements and quality standards
- Inspection of pharma plant machinery, equipment, and infrastructure
- Review of manufacturing, testing, and validation processes in place
- Review of any prior inspection reports or findings
The pharma industry is highly regulated having stringent guidelines for production processes, quality control, and the pharma plant. Regulatory compliance is mandatory to avoid legal actions and regulatory sanctions. A pharmaceutical audit service can help minimize legal and reputational risks by flagging areas of regulatory non-conformities. We provide expert and in-depth assessments of pharmaceutical operations, manufacturing processes, and plants. Our pharma audit service will identify potential risks, highlight areas for improvement, and provide actionable steps, thereby ensure regulatory compliance. To avail our comprehensive pharma audit service, drop an email at [email protected] or call/Whatsapp on 9996859227.
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We'd love to hear from you! Whether you have questions about our pharmaceutical plant setup consultation services or want to discuss a potential project, our team is here to help. Simply fill out the form below, and we'll get back to you as soon as possible. Alternatively, you can reach out to us directly using the phone number or email address listed on this page. We look forward to connecting with you!
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- Head Office - Opposite Dewan Mill, Old D.C. Road Sonepat - 131001 Haryana, India
- Registered Office - Netaji Subhash Place, Delhi, 110034