OSD
The pharmaceutical industry has a responsibility to guarantee drug safety and quality, safeguarding patient health and remaining compliant with legal requirements and guidance such as the Federal Food, Drug, and Cosmetic Act and the US Food and Drug Administration’s (FDA) current good manufacturing practice (cGMP) regulations.
Inspections of overseas facilities play a key role in upholding the safety and effectiveness of therapies destined to enter the US market. Successful FDA audits are critical to demonstrate that the manufacturer safeguards the high-quality standards needed to operate within the US market. Facilities that fail inspections may face import bans or warnings, potentially impacting the manufacturers’ ability to sell drugs in the US. In recent years, the FDA has ramped up inspections of overseas facilities due to concerns about quality control lapses and drug shortages.
In March 2024, Recipharm’s Bengaluru, Karnataka, India, facility underwent a routine cGMP inspection carried out by the FDA. With the site adopting robust strategies to ensure compliance with FDA regulations, the inspection was successfully completed without any observations.
Exploring Recipharm Bengaluru
Recipharm Bengaluru is a large site featuring four stand-alone development and manufacturing facilities offering manufacturing technologies for solid, semi-solid and oral liquid dosage forms. It also provides stand-alone analytical services and formulation support for developing new drugs to be marketed in the US. The site has a GMP manufacturing area for small batches and material for clinical trials.
Starting on March 18, 2024, Recipharm’s Bengaluru site underwent a routine cGMP inspection by the FDA, covering the Oral Solid Dosage Unit (OSU), the OSU extended facility, quality control and analytical services.
Key elements that were inspected included:
- Building and facilities
- HVAC, water, compressed air and nitrogen systems
- Equipment design, construction, cleaning and maintenance, calibration and qualification
- Material handling, receipt, testing and issue
- All key standard operating procedures (SOPs)
- Personnel training, qualification and monitoring
- Packaging and labelling control
- Laboratory control
- Control of microbiological contamination
- Controls for data integrity
- Quality management systems
Strategies for routine inspection success
Successful investigation relies on robust strategies to ensure compliance. Without these, drug development and manufacturing facilities risk receiving observations. These relate to conditions inspectors deem to be objectionable that will be listed on an FDA Form 483. The FDA will consider the form, along with a written report, all evidence or documentation collected on-site, and any responses made by the company to determine what further action is appropriate to protect public health.
Common issues that could result in a 483 observation include:
- Data integrity issues
- Contamination and cross-contamination
- Deviating from written procedures
- Gaps in training or qualifications
- Inadequate root cause assessment
It is very rare for the FDA to complete a routine cGMP inspection of a manufacturing facility without any 483 observations.
Leveraging Recipharm’s regulatory excellence
Recipharm has a long history of delivering regulatory excellence, strengthened by a team of regulatory affairs experts committed to meeting manufacturing requirements across all its facilities. As part of its strategy to ensure compliance with FDA regulations and prepare for successful inspections, Recipharm maintains audit readiness at all times. This includes training team members regularly and having appropriate controls for data integrity, automation and digitisation. It also reviews past observations from other manufacturing facilities to optimise the compliance approach with these in mind.
Inspection success without any observations
After four days, the inspection at Recipharm Bengaluru was successfully completed on March 22, 2024, without any observations. Accomplishing a rare feat in manufacturing, Recipharm highlighted its commitment to upholding the highest standards of quality and regulatory compliance and ensuring therapeutics manufactured are safe and effective. Clients with therapeutics destined for the US market can therefore rely on the Bengaluru site to mitigate quality issues and regulatory hurdles that could cause delays, and bring their therapies to patients seamlessly.
Recipharm’s inspection success also reinforces its reputation as a trusted partner in the development of pharmaceutical drug products — including oral solid dosage (OSD) therapeutics — and helps to instil confidence among customers and enhance US market credibility.
Discover how Recipharm can help you deliver compliantly, with confidence.