Landmark Celebration of UBM India’s 11th edition of CPhI & P-MEC India gets underway today

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...
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UBM India, India’s leading B2B exhibition organizer saw the launch of the grand 11th edition of the signature event, CPhI & P-MEC India 2017, one of the world’s leading pharma networking expos.

The marquee expo is being held at two venues in Mumbai – MMRDA Grounds, Bandra Kurla Complex (27th to 29th November) and Bombay Exhibition Centre (28th to 30th November).

This year’s marquee event has more than 1,500 + exhibitors, 40 + countries’ participation. The inauguration of CPhI-P-MEC 2017 occurred at MMRDA Grounds, Bandra Kurla Complex today in the presence of an august gathering of industry leaders including Shri. Satish Wagh, Chairman, Chemexcil, Mr. Rahul Deshpande, Group Director, UBM India, Mr. Jime Essink, Chief Executive Officer, UBM Asia Ltd, Mr. Aasif Khan, Director, Fabtech Technologies, Mr. Rajendra Khimsaria, Director, Khimsaria Associates, Mr. Khaja Nizamuddin, Director, Pharmapack Packaging Equipment, Mr. Yogesh Mudras, Managing Director, UBM India and other key dignitaries

Alongside the expo, UBM India launched the second edition of the India Pharma Week (IPW), an attractive platter of more than ten trend-setting events that got off to a flying start on November 25. Focusing on the pillars of business, knowledge, leadership, innovation, recognition and networking in the pharma domain, the IPW includes a Plant Visit, Pharma Leaders’ Golf, Pre-Connect Congress, Women in Pharma – Power Breakfast, the India Pharma Awards, Networking Evening, a closed door CEO Roundtable and many more activities. The IPW has transformed the CPhI & P-MEC exhibition from a wall-bound show to one with considerable intellectual value addition.

Originating from CPhI Worldwide, the CPhI & P-MEC India was first introduced in 2006. Today, it has become South Asia’s leading pharma meeting place, covering every step of the supply chain, from drug discovery to finished dosage. CPhI India is an industry platform encompassing CROs, CMOs and manufacturers of API, Generics, Excipients and Drug formulation, Fine chemicals, Biosimilars, Finished Formulations, Lab chemicals and Biotechnology. P-MEC, on the other hand, includes manufacturers of Pharma Machinery and Equipment, Analytical Equipment, Automation & Robotics, Packaging Equipment & Supplies, Plant/Facility Equipment, Automation & Controls, Processing Equipment, RFID, Tableting / Capsule fillers, Clean room equipment, Filling equipment and Laboratory products.

The show has grown exponentially over the years, with domestic and foreign exhibitors and visitors engaging over significant levels of business. This year, the expo comprised exciting facets such as the Supplier-Finder Desk (a digital floor plan that enabled visitors find exhibitors based on services or company names), Innovation Gallery (an arena where participating pharma companies were encouraged to showcase innovations on an international platform) and Exhibitor Showcase (a platform where exhibitors demonstrated how their new product launches are going to be efficacious.)

The key companies exhibiting in the 2017 edition at CPhI include Aurobindo Pharma Ltd., Granules India Pvt. Ltd., Hetero Labs Limited, Signet Chemical Corporation Pvt. Ltd, DKSH India Pvt. Ltd., Morepen Laboratories Limited, N V Organics Pvt. Ltd. amongst others. On the other hand, some of the leading companies such as West Pharmaceuticals Packaging India Pvt. Ltd., Cadmach Machinery Co. Pvt. Ltd., Brothers Pharmamach (I) Pvt. Ltd, NPM Machinery Pvt. Ltd., Jekson Vision Pvt. Ltd., ACG Worldwide Solid Dosage Consumables and Machinery, Ace Technologies & Packaging Systems Pvt. Ltd, Fabtech Technologies International Ltd., Jagson Engineers, Bosch Limited, Agilent, Food & Pharma Specialities amongst others will exhibit at P-MEC.

Renowned as the pharmacy of the world, the Indian pharma economy has been lauded for its rapid growth in recent decades. This has cooled down in recent years, but the industry is again growing strongly. Compounded annual growth is 17.6%; Indian pharma is expected to be worth 55 billion USD by 2020. In line with this, the life science sector in India is also expected to employ close to 3.5 million people by 2022, a 100% increase in under a decade. The Indian pharma industry owes its success to its bold, ambitious approach, history of innovative and an ability to constantly adapt to the dynamic global market.

Over the past five years, India has become the leading API and finished dose drug exporter to the Western markets and has rapidly moved up the pharmaceutical value chain. Drug approvals given by the US Food and Drug Administration (USFDA) to Indian companies have nearly doubled from 109 (2014-2015) to 201 (2015-2016), stimulating further growth in exports to the United States and Western economies. Additionally, the Indian government is now providing more support working hand-in-hand with its businesses to develop incentives to further boost growth.

More generally, the country is now rapidly emerging as a major contributor across the pharma supply chain from R&D through to generics.

Speaking at the inauguration of CPhI & P-MEC India 2017, Mr. Yogesh Mudras, Managing Director, UBM India said, “India is among the fastest-growing pharmaceutical markets in the world and has established itself as a global manufacturing and research hub. A large raw material base and the availability of a skilled workforce give the industry a definite competitive advantage over other countries. A platform like CPhI & P-MEC India provides a most comprehensive industry platform for every company that deals with pharmaceuticals in India. This year too, we have the expo held at two venues, commencing at BKC today. CPhI and P-MEC India is widely used as a barometer of Pharma’s overall health in India. Being the only platform that brings together Indian and global companies, the mammoth expo is a strong event reflecting and enhancing the value of the prosperous pharma industry.”

About UBM India:
UBM India is India’s leading exhibition organizer that provides the industry with platforms that bring together buyers and sellers from around the world, through a portfolio of exhibitions, content led conferences & seminars. UBM India hosts over 25 large scale exhibitions and 40 conferences across the country every year; thereby enabling trade across multiple industry verticals. A UBM Asia Company, UBM India has offices across Mumbai, New Delhi, Bangalore and Chennai. UBM Asia is owned by UBM plc which is listed on the London Stock Exchange. UBM Asia is the leading exhibition organizer in Asia and the biggest commercial organizer in mainland China, India and Malaysia. For further details, please visit ubmindia.in.

About UBM plc:
UBM plc is the largest pure-play B2B Events organiser in the world. In an increasingly digital world, the value of connecting on a meaningful, human level has never been more important. At UBM, our deep knowledge and passion for the industry sectors we serve allow us to create valuable experiences where people can succeed. At our events people build relationships, close deals and grow their businesses. Our 3,750+ people, based in more than 20 countries, serve more than 50 different sectors – from fashion to pharmaceutical ingredients. These global networks, skilled, passionate people and market-leading events provide exciting opportunities for business people to achieve their ambitions.

For more information, go to www.ubm.com

 

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

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