Indian medical device manufacturers are enhancing their Good Manufacturing Practice (GMP) compliance, reinforcing India’s role as a trusted global supplier in the healthcare and MedTech sectors. This shift is driven by the current political scenario and the China plus one strategy, leading to an increase in US FDA inspections across India. According to the FDA’s FY 2023 Annual Report, the agency conducted 863 inspections globally, including 423 routine surveillance inspections and 102 for-cause inspections.
In India, the FDA performed 110 routine surveillance inspections and 45 for-cause inspections, totalling 155 inspections (drug, food & device) in 2023. While the fiscal year 2024 data is pending, the Government Accountability Office (GAO) indicated a 36% decrease in global inspections compared to pre-pandemic levels, although activities are gradually returning to normal with a projected 40% increase in the fiscal year 2024-25.
To meet FDA expectations and achieve audit success, Indian manufacturers must prioritize compliance with 21 CFR Part 820 now upgraded as QMSR. This involves ensuring data integrity, conducting process and equipment validation, and maintaining consistency and reliability throughout production. Manufacturers should also focus on staff training, develop robust Corrective and Preventive Action (CAPA) systems, and establish stringent supplier and material controls to guarantee traceability and quality. Strengthening complaint-handling systems and implementing mock audits to assess inspection readiness are critical strategies for compliance.
Partnering with regulatory consultants for pre-audit assessments can further enhance readiness and reduce compliance risks. With inspections increasing and regulatory expectations rising, Indian manufacturers must adapt quickly to maintain global standards and leverage India’s position as a key player in the healthcare supply chain.
A systematic and proactive approach to compliance:
As per data 66% of the small and medium FDA 510k approved and establishment Registered facilities in India receive Form 483 observations or fail to respond on time to 483 observations due to a variety of compliance shortcomings. Here are the key reasons explained by the veteran in this field and FDA consultant Soio George from I3CGlobal. Achieving FDA CFR 820 audit success requires a “systematic and proactive approach” to compliance:
1. Management commitment and resource allocation are vital for successful GMP implementation in medical device manufacturing industries. Strong leadership ensures adequate resources—human, financial, and infrastructural—are available to maintain and improve the QMS. A skilled Quality Assurance and Regulatory Affairs (QARA) team is essential for compliance, documentation, and audit readiness. Without proper infrastructure and expertise, maintaining product quality and regulatory adherence becomes challenging.
2. Implement a robust QMS aligned with 21 CFR Part 820. Maintain SOPs, work instructions, and quality records to ensure process control. Employ proper documentation practices and conduct periodic data audits to detect and correct discrepancies.
3. Perform process validations, including cleaning and sterilization protocols, to maintain product consistency and safety. Ensure calibration and maintenance of equipment are conducted regularly and implement risk-based validation protocols aligned with FDA expectations.
4. Train employees on GMP guidelines, CAPA procedures, and inspection readiness. Maintain training records to demonstrate compliance during audits and organize mock audits to prepare staff for real FDA inspections.
5. Implement a strong Corrective and Preventive Action (CAPA) system to address non-conformities. Perform root cause analysis and initiate preventive measures to avoid repeat issues.
6. Qualify and audit suppliers to ensure high-quality raw materials and components. Maintain traceability records for all materials and conduct incoming material testing to verify compliance with specifications and control plan.
7. Establish systems for tracking, investigating, and resolving customer complaints. Report adverse events and implement corrective actions promptly. Continuously monitor product performance through post-market surveillance programs to ensure ongoing compliance.
8. Collaborate and work with firms with previous experience in implementing GMP and pre-audit assessments handling FDA Form 483 responses, and CAPA implementation.
By adopting these strategies, establishments/manufacturers can strengthen compliance, minimize regulatory risks, and achieve sustained FDA audit success.
Indian medical device manufacturers are prioritizing GMP compliance to meet rising global healthcare demands. Success in inspections requires proactive planning, strong management commitment, employee training, process validation, and robust documentation. By embracing continuous improvement and leveraging technology, manufacturers can streamline compliance, ensure audit readiness, and strengthen their global reputation. With the USFDA’s growing presence in India and the impact of the China-plus-one strategy, staying ahead of regulatory expectations is vital for market access and growth.
(This article is part of IndiaDotCom Pvt Lt’s consumer connect initiative, a paid publication programme. IDPL claims no editorial involvement and assumes no responsibility or liability for any errors or omissions in the content of the article.)
