Covid-19
 

Label Tracking: An Important Aspect In Production Distribution

July 30, 2020

Drug labelling has changed over time because of evolving regulations and has increased in content and length, with a standard format to guide the safe and effective use of the drug. Product labels (drug or devices) contain comprehensive information enriched with product details, such as disease indications, target populations, drug-drug interactions, and ADRs. The labels and labelling documents prepared by manufacturers and approved by the Health Authorities, in its final form, reflect the collective input from regulators, drug manufacturers, and scientific experts. Drug-labelling data is an important resource for diverse applications, including support for policy development.

The global labelling management process continues to be a burden on the life sciences industry and is multiplying at a pace that is already becoming increasingly difficult to manage. Firms’ R&D ambitions are growing, businesses are expanding into multiple markets, and regulators are steadily strengthening safety requirements to protect patients and public health. The pharmaceutical industry operates on a global scale, and regulatory compliance across multiple geographies is fundamental to ensuring that the supply chain remains safe and secure.

As part of the dossier registration, all manufacturers must submit labelling support documents (USPI, SmPC, PIL, IFU, etc.) to HAs to grant marketing approval. Each time the benefit and risk profile or safety factors change, or as regional or local regulatory agencies update their standards, international biopharmaceutical firms must react swiftly with accurate, compliant labelling for all affected markets. This is a real-time and hectic process for multinational companies as there are major content interdependencies. Moreover, managing the local label changes (CCDS vs USPI, SmPC & other local labels) with company core safety information i.e. how a change anywhere along the safety-regulatory-manufacturing-supply chain continuum will affect all label content, from the global core datasheet, to patient-facing product information in each marketed country.

Though the manufacturers shall update and distribute the final updated labels where the products are being marketed. Where submissions are bundled and/or split at the country level to comply with local regulations or company’s internal needs and strategies, there are further considerations as companies try to maintain trace ability especially as changes trickle down to dependent countries. The traditional way of managing all of this has been via a combination of specific systems and manual processes. Typically, tracking of label status and changes are done in Excel spreadsheets internally, and content has been updated on a country-by-country basis using dedicated, often standalone labelling tools.

Triggers for labelling changes can occur at different points during product life cycle. Changes to the benefit/risk profile of a drug that require revised labelling requirements from the company's global core data sheet or local regulatory changes to specific countries can drive the need for a two-way amendment in the supply chain.. As a result, central labelling teams have not found it easy to build up a clear, accurate, and comprehensive picture of all labelling activities. Nor are they able to manage these systematically, end to end, irrespective of where the trigger for a change to the content might come from. In other words, it is difficult for them to efficiently map country/label interdependencies so that changes can be rolled out promptly and reliably wherever the new requirements apply.

In addition to the risk of non-compliance, all of this adds up to a laborious and cost-laden workload for life sciences organisations, as they try to keep track of the latest implemented labels in all of their markets and roll out each new set of changes, as applicable, within the required timeframe. To keep up with the ever-changing emerging safety regulations, companies must upgrade their approach to labelling management with some urgency now.

A modern label management system manages the entire label lifecycle, offers complete transparency throughout the label production process, and facilitates quality control procedures during its distribution. The best modern label management systems now allow business users to design, review, track, and control label data from a document management system. This increases traceability and eliminates scope for errors in the labelling documents for compliance procedures.

Many bio-pharma companies are now looking to ensure compliance, minimize the need for relabeling, and reduce the number of label templates, and transition from paper-based catalogues to digital document management systems. It makes sense to ensure labelling technology is a priority so it can address inconsistencies in processes, mitigate human errors. Timely tracking thus improves business agility for companies to produce compliant, high-quality labels in a cost and time-efficient manner.

Pharma companies, especially those operating from a particular geographical source, will need to rearrange and upgrade their existing labelling processes and compliance structures to conform to the constantly evolving regulatory guidelines. Since details vary from region to region, companies must facilitate tracking units across the supply chain.

LABELai: A Complete Labelling Solution

Automation reduces human intervention and ensures the development of high-quality deliverables that significantly reduce overall operational costs and improve the time-to-market across regions. Some organizations have developed and streamlined the labelling process to minimize the errors, but they often lack the automation required to build a robust and error-free process.

LABELai uses advanced technology to offer end-to-end product labelling by leveraging artificial intelligence (AI) for 90% of the activities. LABELai has been developed with the intention of meeting regulatory requirements in labelling documents, as well as clients’ prospects during the product life cycle management. Our Labelling tool can do the effective process (tracking) for multiple versions of the same document. LABELai has a provision to track the status of labelling documents from production to final distribution and its life cycle management. By using the LABELai tool you can know the label status at any time during drafting, review, approval, and distribution. Corresponding changes to labels along with justifications for changes can also be tracked using this system.

 

Reluctance of Regulatory teams embracing AI

July 20, 2020
Regulatory Automation

One of the key regulatory problems that are hindering the acceptance of AI in Bio-Pharma is the apocalyptic prediction about Human jobs being traded by machine intelligence and the other Key Problem is the siloed regulatory infrastructure. Although the technological advancements in the field of healthcare have grown heavily, the regulatory ecosystem has bungled to keep up.

One more aspect is that AI, particularly neural nets, is a Pandora box; while we can program it, we really don’t know how it rests with the existing technologies within the Organization. That creates the dilemma of explicability. More than the regulatory Reluctance Forebear AI, regulatory authorities are trying to keep pace.

Another core regulatory challenge is in administrating data accessibility in a way that is lean, balanced for benefits between the data-sources and data-users, and assures confidentiality and prevention of misuse.

How to Regulate AI in Bio-Pharma

  • “Display of orthodox AI solutions with regulatory frameworks absorbs new standards to be developed that align with and Support existing regulatory structure while keeping pace with sprouting technologies.”
  • Collaborating Machine intelligence & humans in the loop compliment strengths to achieve a common goal, solve problems, gain insights, and create value.

Pivoting Ahead:

Leading organizations are taking a new tack, and are at a crossroads with respect to AI strategy despite the apocalyptic prediction about Human jobs being traded by machine intelligence,many life sciences companies are behind the maturity curve in the adoption of automation.

By understanding these considerations, Bio-Pharmaceutical Organizations can pursue Automation opportunities more assertively and potentially trounce the risks of falling behind competitors in technology adoption.

 

Challenges with Labeling Content, QC & Tracking - The Way Out

July 9, 2020
Labeling Automation

The complexity surrounding labeling often leads to errors, product mix-ups, and even misbranding. Labeling being an integral part of the quality management system, such errors often lead to product recalls which might have a negative impact on both the image and the finance of the company. The best way out of this might be through digitization and automation. Moreover, as the current scenario asks for remote working, this turns out to be the new normal.

Labeling Content Challenges

Latest studies have shown that labeling content accounts for almost 33% of the product recalls. Some of the challenges are:

  • Delays in safety changes submission
  • Delay in availability and updates of label superseded version and patient information
  • Updating delays in national labels from core data sheet
  • Issues with review and approval of Label change request
  • Failure to timely update safety information and comments from Health Authorities
  • Challenges with local and global RA teams’ priority issues

Labeling Automation and Digitization Tool

Content Management & Lifecycle Automation

Manual labeling and comparison of documents is a laborious task and due to the number of documents, the chances of error are quite high. Hence, automation will not only assist you in reducing errors but also is beneficial in managing the content and updating them within a given time frame.

Managing CCDS

Company Core Data Sheets (CCDS) need to be reviewed, edited and updated with time and this process generally needs to be automatic as the data becomes innumerable at the regional level. Automation tools help you in the version management to ensure regular updates.

Compliance

Choose a tool that has in-built local and foreign country regulations. This will allow you to have a comparison of the labels and understand the violations so that there is no need of any future manual reconciliation.

Generating Reports

Report generation helps in global marketing and a tool can easily support you in generating labeling change reports related to administration, safety, compliance, version, and HA updates.

Formatting, Reviewing and Publishing

Modern tools can ensure comparison of documents of various formats. Moreover, a tool reviews any document 75% faster than in manual QC. All HAs have a different labeling format and to maintain that manually is difficult. If you can take the help of a tool with all such inbuilt data then it can make the task easier. The labels get published through automation in the desired format leaving a lesser scope for formatting issues.

Digitization and automation can give you the much needed results and let you move ahead towards an error free labeling and thereby preventing the repeated recalls and ensuring a proper approval.

 

Importance of DSCM in Managing Clinical Supplies during COVID

July 10, 2020
Clinical Trial Supplies Management

It's a known fact that the Pandemic Effect of Covid-19 apart from creating the hurdles in Clinical Research has also fetched a possibility to many of the new innovations. Supply Chain Management is one of the majorly effected streams due to pandemic which lead to low stock of the API to pursue the Manufacturing of the IMP for clinical trials.

It's time to invest additional efforts on strategy development for managing the clinical supply activities in more efficient way. The scope of the supply chain management can be made efficient by creating solutions to the current and anticipated challenges.

As industry is also focused more on ‘Direct-to-Patient’ model, Drug Supply Chain Management has a primary role in this.

Few areas of focus for DSCM include:

  • Quality: Quality is of course one of the first and foremost key point that needs to be focused. In DtP the concept basically relies on providing the Right Quantity of Supplies to a Right Subject at the Right Time in Right Condition. This shall enable the progress of the study more effectively. Even though it’s not easy to perform these type of tasks during a pandemic, but can be handled efficiently using newer technologies.
  • Cost Effectiveness: The cost and the liability of the labor, logistics, and energy shall increase globally due to the current constraints. Even though the budget of the running project is approved upfront,to run the operations effectively with quality, within the set budget, proper cost control plans should be executed through constant monitoring of the logistics and wastage
  • Risk Management: To meet the needs of the subject according to the protocolcriteria proper Risk Management Plans shall be implemented. Whereas for DtP in clinical research, shipping of supplies direct to subjects involves several risks right from shipping to storage to compliance and accountability. Each of these steps need to assessed with proper risk minimization or mitigations plans
  • Qualified Resources: DSCM need to focus more on the qualification and training of the staff as DtP is not a simple logistic task. Manpower should be qualified, trained and accountable. They shall be trained and educated more on their responsibilities and action plans to be performed in DtP scenario. While supplying Direct to Patients, teams should develop interaction with the subjects in confirming their demographics, addresses and maintain a good relationship. Should also be trained to collect any return samples left at the subject in order to meet the accountability of the supplies.
  • Delay in Delivery: In clinical research the delay in the Treatment Assignment leads to several consequences. Teams should be more cautious in planning the activities related to supplies by anticipating the unforeseen risks that shall lead to delay in supply delivery.
  • Adaptation to Needs: It is not easy to adapt to changes but sometimes we cannot abandon the clinical or patent requirements if we need to stand in the race of the research. It is now mandatory to take up the challenge of delivering the supplies direct to patients to withstand the need of the hour.

DSCM should use an effective IRT system that can handle most of these activities to help save time. IRT can help in managing the risks by leveraging automation, supply options, timely alerts and maintain regulatory compliance

 

Ensuring Drug Accountability Compliance with IRT

June 22, 2020
Clinical Trial Supplies Management

Drug Accountability of the Investigation Medication begins from the selection of location for its storage. Issues with drug accountability are major and the majority of warning letters from regulators are a result of this. Major delays are faced by sites for non-conformity and it often leads to non-acceptance of trial data. Drug accountability is of utmost importance and it is the clinical investigator who remains responsible for the entire process taking place at the clinical site. If the supplies are controlled substances then more attention shall be needed from the Investigator in terms of its storage and disposition. IRT systems allow in streamlining such processes by keeping a single source of data and hence the process of Drug Accountability tracking becomes easier.

Paper-based Drug Accountability Challenges

It is the complexity surrounding the paper-based systems that makes them more prone to errors. Drug accountability shall be maintained at sponsor level and site level. The Investigational medication documented as shipped should reconcile with the documentation of used and unused. The Drug Accountability at site begins once an investigational drug reaches the site. Records need to be maintained and staffs need to confirm that the contents that have been shipped match its previous record. The authorized person needs to put his signature with date after thorough verification. Once these have been completed, the investigational drug needs to be stored securely maintaining the standards specified in the protocol. Entire details need to be updated in the drug accountability log and with the commencement of trials; drug dispensing records are to be updated in writing in multiple documents. Site shall maintain all the data of the drugs right from drug dispensing to final disposition. Paper-based drug accountability never ends with the end of study, discrepancies in accountability logs need to be resolved, and its copies are to be returned with the original shipment records. The sponsor should receive the reconciled log along with the returned investigational drugs. Any discrepancy in drug accountability not only violates the regulations but also points the integrity of the study and public health.

Mitigating Challenges through IRT

Utilizing electronic medium for data collection and tracking helps in mitigating the challenges associated with data accountability. When data associated with a trial gets centralized, then the visibility gets doubly enhanced and a single accountable system improves the process of reporting. This entire method eases regulatory compliance achievement process and accountability audit issues get resolved immediately. As the use of the IRT system increases the pace, end-of-study documents are prepared in no time using the single system as the source.

mIRT has a special feature to track Drug Accountability where the reconciliation of the supplies that are used, lost, damaged and returned shall be captured which enables the system to calculate the compliance of the drug automatically.

Future of Drug Accountability

With the current advancements, as the world is moving ahead and accepting technology, there is an increased level of visibility in the supply chain for both the regulators and sponsors.


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