Why Global Pharma Expects CDMOs to Be Ready for Joint Inspections

In an exclusive interaction with Thiruamuthan, Correspondent at India Pharma Outlook, Ashutosh K. Sinha, Chief Quality Officer at Neuland Laboratories Limited, shares his perspectives on how Indian CDMOs are strengthening their global competitiveness through robust quality systems, regulatory alignment, and operational excellence.

Ashutosh brings over 29 years of experience in quality management systems within the pharmaceutical industry. His expertise spans designing and implementing comprehensive quality frameworks for CDMO and generic pharmaceutical organizations, with core skills in FDA–EMA joint inspection readiness, multi-regulator compliance integration, process digitization, technology transfer standardization, and workforce upskilling.

As FDA and EMA increase coordination, how are Indian CDMOs aligning with dual inspection protocols to remain globally preferred for high-value outsourced manufacturing?  

To remain globally competitive, Indian CDMOs are aligning with dual inspection protocols by integrating both FDA and EMA expectations into their systems. There is coordination between the FDA and EMA when they are considering their audits. If the FDA conducts an audit of certain facilities, they share their observations with the EMA, and the EMA shares with the FDA. They moved away from earlier practices when they had separate processes, but now they share audit observations with each other. There is a mutual agreement between the agencies; therefore, CDMOs preparing for audits have to consider both guidelines.  

Whatever is applicable for the EMA—for European authorities like the ICH guidelines or the EU GMP guidelines detailed in EudraLex Volume-4, especially in part-II and for FDA guidance, all applicable guidelines from both FDA and the European authority are considered when designing procedures, QMS, and risk assessments. During internal audits, both guidelines are considered as part of compliance checks to ensure all requirements are met. 

This is a challenge, but CDMOs are considering requirements of both agencies and accordingly bringing in digitization and automation, which take care of a lot of data. If digitization is implemented, many human-based errors that can lead to data integrity issues can be avoided. 

With sponsors demanding synchronized compliance, how critical has joint inspection readiness become in determining CDMO participation in late-phase and commercial-stage contracts? 

Customers are innovators, and they are bringing their early phase, late phase, and commercial molecules for development, validation, and commercialization. They have their plan to file in the FDA, Europe, or multiple countries, and therefore when they plan, they discuss which country they are filing, and protocols are created accordingly. 

During validation, it is ensured that all relevant requirements from the European authority, FDA, Brazil, or any other country—each with different expectations—are included. So, validation protocols are designed to meet all the requirements of all the regulators' expectations. 

During internal assessments, all the market's requirements are ensured to be complied. Customers also come for audits, and many times, they want to review the system before submitting to the agency or as part of a mock inspection. 

Mock inspections are also conducted by experts like ex-FDA officials, who evaluate the quality system and documentation to ensure both regulators' requirements are met. 

Furthermore, internal audits, QMS systems, CQA reviews, self-inspections, and external mock inspections are focused on the dual requirement. While regulatory experts are trained on dual requirements, they also coach QA teams, and protocols are designed accordingly. 

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Many CDMOs struggle with harmonizing documentation across jurisdictions. How are top players building centralized quality systems to satisfy overlapping FDA–EMA expectations? 

Small CDMOs actually struggle, but large CDMOs have a central quality system (CQS), and the CQA team takes care of the entire system. They ensure all systems are created to meet regulatory requirements from bodies like Brazil, China, and Japan in addition to US and Europe, each having different expectations. When working with large pharmaceutical companies, developing and manufacturing for different filings, protocols, SOPs, documents, and tech transfer documents are designed to meet those requirements. Also to note, personnel are trained on the requirements, and it is ensured that all expectations related to different regulatory guidelines are met. 

Timely execution of projects for innovators is important because any delay in filing or approval can stop future plans and these products are meant to address patient needs. If any issue occurs during validation or filing, or a query comes from regulators, it can delay approval and impact the customer’s business and patient needs. They expect that there should not be any showstopper during filing and approval. Critical resources are retained through retention policies to ensure knowledge continuity and to keep meeting customer requirements. 

Joint inspections often scrutinize tech transfer controls. How are Indian CDMOs standardizing their practices to avoid variation risks across product lifecycle stages? 

Tech transfer is very important because when innovators do the technology transfer, R&D teams need to understand the complete technology, and then manufacturing has to be done. All information is critical for successful first-time-right manufacturing. A good SOP for technology transfer is maintained, covering the requirements from the development point of view and development data required. Process engineers assess equipment and safety requirements before manufacturing begins. The safety team also evaluates risks related to hazards, and process engineers ensure the right equipment design is available. The quality team ensures development data shows the process is robust so there is no failure or deviation. 

An exhaustive checklist with all requirements is maintained to ensure the tech transfer is accurate and successful. Any CDMO should have a good SOP and checklist and should train people to ensure proper assessment. Once technology transfer is done correctly, meeting USFDA and EMA requirements becomes less challenging. 

Staff preparedness is a major audit variable. How are CDMOs upskilling QA teams to interpret dual regulatory language and respond in real time?

These processes are handled by the QA team because they are responsible for interfacing with regulators during audits and filings. Regulatory teams give requirements to QA, and knowledge sharing ensures all regulatory expectations are transferred and understood. QA teams must understand the additional requirements for each regulator, like US, Japan, Brazil, and Europe, which all differ. For example, Japan focuses on extraneous matter-free products (Particle-free products), Brazil is on stability as per Zone-IV conditions (Hot and humid), and Europe expects detailed risk assessments for compliance. FDA audits focus on documentation, while European regulators focus on floor practices, equipment design, and laboratory procedures. QA teams receive training based on guidance from the regulatory function and senior leadership to ensure readiness. 

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As joint audits become the norm, how will CDMOs with proactive, audit-aligned systems gain strategic positioning in the next wave of global pharma partnerships? 

Since CDMOs must be ready for joint inspections, quality systems are designed to align with all regulators' requirements, and this proactive approach, through internal audits and mock inspections, strengthens global positioning and partnership readiness; more digitization and automation will help in meeting the requirements because manual dependency will reduce significantly, people are the asset so they should be trained and qualified with proper qualification processes for those working on the floor, and regulators, during audits, often talk to the people working directly and not just the managers or seniors because they want to understand actual practices and how much the floor-level staff are qualified, with their focus on how much training is given, so heavy focus is placed on training and education, and if equipment or the design of buildings is not adequate, it will create problems during audits. 

Therefore, three parts are critical—good infrastructure, strong systems, and trained people—and all three should be focused on, and audit readiness should be proactive and ongoing, not something prepared for at the last moment.