Despite facing similar challenges to many other global industries seeking to deliver sustained growth, the pharmaceutical industry is far more regulated and capital intensive than most others. Minimising time to market whilst meeting increasingly stringent pharmacovigilance legislation including the US Drug Supply Chain Security Act (DSCSA), the EU Falsified Medicines Directive (FMD) and Identification of medicinal Products (IDMP) are essential in a market often characterised by aggressive new entrants and patent expirations.
Growth strategies focusing on emerging markets, portfolio transformation, increased use of 3rd party manufacturing and supply chains plus ongoing M&A activity are commonplace across the industry. One thing these strategies have in common is the need for consistency and quality during the turmoil often created by change. Nowhere is this more important than at the point of dispensing to the patient. Accurate and compliant product labelling is therefore essential.
Abiding by diverse and continually evolving regulatory requirements, providing country-specific variants and translations, whilst ensuring compliance and consistency right across the global supply chain are critical. However, managing submission, packaging and labelling processes is often complex and open to the risk of errors. A common factor across many of the submission and artwork processes associated with labelling across pharma is that these are often manually driven and document centric. This approach impedes variation management, audit reporting and accuracy.
They key to getting this right is to ensure labelling content submitted as part of the marketing authorisation process and that used for creating labelling and artwork for finished products shows clear lineage to the Company Core Data Sheet (CCDS). Equally important is the need to track and manage deviations between content held in local submission documents (e.g. the SmPC) and the CCDS. Whilst some solutions exist to help Labelling Operations and their regional affiliates better manage the submission and approval process, these typically exclude end-to-end oversight of product & packaging labelling content. This introduces an unnecessary disconnect that prevents a clear line of sight between finished product labelling and statements contained within the CCDS. This is where Kallik helps.
Alignment across all regulatory driven content drives efficiencies down through to the artwork creation process, ultimately reducing costs of expensive reworks and risk of product recalls. Artwork teams (whether internal or external) are no longer working from an interpretation of requirements as they are consuming content direct from an approved source.
Kallik brings this to life from an entirely new angle by providing a single cloud based solution for all labelling content independent of when and where this might be used across the organisation and its affiliates. With Kallik, there is always only ever one single master copy of approved labelling content. Local market variants, including locale specific languages and translations are stored as versioned controlled derivatives of master phrases held within the CCDS. This provides all stakeholders across the organisation with the assurance that all regulatory and/or market-driven labelling content changes are tracked, visible and auditable.
Understand more about Labelling Content Collation.