Labeling findings from FDA and other Agencies audits summary

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With the frequent changes in drug labeling regulations in the emerging markets contribute to regulatory. Several challenges impact product labeling process with respect to global and local regulations.

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Labeling findings from FDA and other Agencies audits summary WHITEP A PER

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Regulatory environment has become increasingly complex and making drug labeling a highly regulated and closely monitored activity. As some of you are aware Health authorities are specific to regulatory requirements for medicinal products on labeling requirements such as patient information leaflets package inserts and prescribing information packaging and artwork. Industry experts estimate that between 35 to 40 percent of all product recalls are attributed to packaging and labeling errors as well as omissions. In fact a recent report by AMR Research cited from Food and Drug Administration statistics which includes 455 product recall notices 51 percent of them are because of mislabeling and 13 percent are because of faulty packaging. Most of the regulatory inspection findings are associated with labeling issues by Health authorities such as US FDA EMA Canada and others. All of them have a basic expectation “Product labeling must be compliant with the applicable local health authorities’ requirements for content format organization and structure. Labels should comprise of information on the safe and effective use of the drug. The label must be informative accurate not promotional false or misleading. No implied claims or suggestions for use if evidence of safety or effective is lacking”. Let us see why this is complex when it comes to implementing the above. The management of both global and local labeling process is a complex process it includes maintaining and updating the CCDS and local labels. If any label deviations or compliance issues it would lead to regulatory actions recalls and fines as well sometimes. So what are the Challenges There are several challenges impacting product labeling process with respect to global and local regulations. Most of Labeling challenges stem from some common events like company acquisitions and mergers multiple products approved in multiple countries changes in the local labeling country specific regulations. The global labeling process is very complex and there are often functional dependencies between different departments such as regulatory affairs medical safety manufacturing supply chain marketing packaging and local affiliates. At present mergers or portfolio acquisitions are frequent among global companies. These activities combined with in-licensing of products at all stages of development and marketing can also disrupt any compliance process as companies try to reallocate global resources and re-adjust processes for the new organizational structures or entities. Compliance gaps and risks internal to these activities may not be immediately identified when teams are restructured resulting in unclear ownership and responsibility for a critical process. The following are extreme challenges during mergers and acquisitions which include inadequate transition process lack of an appropriate tracking system poor communication between head quarter labeling teams local affiliates and regulatory teams. Companies having several products marketed across multiple regions with country specific requirements to comply with their regulations this is complex and also increases costs exponentially. Most importantly labeling challenges in labeling process are regulatory compliance global process standardization automated inspection version control data management and impact of changes. Over a period the label content in different jurisdictions continues to “drift” away from the content presented in CCDS disintegrating the intention of a “core” as the misalignment continues to expand. This is one of the main reasons in large companies that are marketing potentially hundreds of products in multiple markets. In addition the frequent changes in drug labeling regulations in the emerging markets contribute to another important challenge. Local Product Label LPD must comply with local regulations applicable country specific failing to compliance with the regulations would lead to health authority actions product recalls or withdrawal from the market. Local labeling challenges are mainly due to lack of coordination between labeling head quarters and affiliates inconsistency with CCDS and CSI information delays in updating the local label and implementing the new changes content and language translations. Labeling findings from FDA and other Agencies audits summary www.DDIsmart.com | 2

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Package Labeling Compliance With high importance of regulatory compliance data accuracy is one of the most important criteria in drug labeling approximately 51 of auditing issues are related to labeling associated documents from various audits conducted by FDA and MHRA reports. Lack of effective control measures and processes to eliminate labeling errors could result in serious health hazards regulatory actions and a flawed reputation for a company sometimes labeling non compliance issues may lead to product recalls partial or complete withdrawals from the markets as well. The label compliance issues are associated mainly with packaging related defect container miscarton information label mix-ups etc and product related that includes dosage form strength warnings contraindications ADRs and others. Package Labeling must comply with applicable regulatory requirements such as US FDA Health Canada and MHRA. In USA drug product packaging and labeling should comply with US FDA 21 CFR 211 Subpart G. It includes Material examination and usage criteria labeling issuance Packaging and Labeling PL Operations T amper-evident packaging Drug Product DP Inspection and Expiration dating. In the same way for emerging markets packaging and labeling must be done as per applicable country specific Health Authority regulations. Labeling findings from FDA and other Agencies audits summary www.DDIsmart.com | 3 Frequent safety updates in CCDS for newly approved drugs 4 Label content in different jurisdictions 9 Non-consistency in label formats and submission methods 3 34 Tight budgets and schedules 8 Language and content changes 5 Multiple products multiple countries Category Label Challenges Percentage Total Unclear ownership 15 Inadequate transition process 6 45 Lack of an appropriate tracking system 8 Poor communication between head quarter labeling teams 11 Label version history management 5 Mergers Acquisitions MAs Coordination between labeling head quarters and affiliates 11 Delays in updating local labels and implementing new changes 2 23 Inconsistency with CCDS and CSI information 2 Content and language translations 3 Timeline management for label updation and deviations 5 Local regulations Poor strategic plans 5

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www.DDIsmart.com Copyright © 2018 DDI LLC. All rights reserved. Defective container Error in package insert Incorrect or missing lot Error in product strength Label mix-ups Error in carton or packing Errors in color additives Others Packaging Label Product Recall Events 22 8 15 12 9 16 8 10 Inconsistency with core information Updating information Quality issues Administrative issues Version change history Timeline management Product Specific Recall Events 35 15 15 15 10 10 Source: Regulatory Education for Industry REdI: Focus on CGMPs FDA Inspections Silver Spring MD July 15-16 2015

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