GAMP
GAMP

GAMP 5 Categories, V Model and 21 CFR Part 11, EU Annex 11

What is GAMP 5? Good Automated Manufacturing Practice, Founded in 1991. International Society for Pharmaceutical Engineering (ISPE) sets the guidelines for manufacturers and the current Version is GAMP 5. GAMP describes a set of principles and procedures that help ensure that pharmaceutical Software (Like QMS Software, LMS software, DMS software etc.) has required quality. Computer system validation (CSV) following GAMP guidelines require users and suppliers to work together so that responsibilities regarding the validation process are understood. For users: GAMP provides a documented assurance that a system is appropriate for the intended use before it goes “live.” Suppliers can use GAMP to test for avoidable defects in the supplied system to ensure quality products are produced. Why GAMP 5? Facilitates the interpretation of regulatory requirements. Establishes a common language and terminology. Promotes a system life cycle approach based on good practice. Clarifies roles and responsibilities. Focus attention on those computerized systems with the most impact on patient safety, product quality, and data integrity Avoid duplication of activities There are five key concepts to GAMP 5: Product and Process Understanding Lifecycle approach within QMS Scalable Lifecycle Activities Science Based Quality Risk Management Leveraging Supplier Involvement GAMP 5 Categories Difference between Category 4 and Category 5 in GAMP 5 Configuration and customization of software are terms that are poorly defined in the validation world and frequently used interchangeably, especially in a vendor’s marketing literature. It is important to understand the difference between these two terms as they mean entirely different things and consequently can have a dramatic impact on the amount of validation work that you could undertake. Configuration: The modification of the function of a software product to meet the business process or user requirements using tools supplied by the supplier. These tools can include the input of user-defined text strings for drop-down menus, turning software functions on or off, graphical dragging and dropping of information elements, and creation of specific reports using the standard functionality of the package. Customization: The writing of software modules, scripts, procedures, or applications to meet business requirements. This can be achieved using an external programming language (such as C++ or .NET or PL*SQL for database procedures), macro instructions, or an internal scripting language specific for a commercial application. Depending on the user requirements the same implementation can be Category 4 or 5 What is SDLC Model?  What model GAMP 5 Suggests? The software development life cycle (SDLC) is a framework defining tasks performed at each step in the software development process. SDLC is a structure followed by a development team within the software organization. It consists of a detailed plan describing how to develop, maintain and replace specific software. The life cycle defines a methodology to deliver the quality of software and the overall development process. What is 21 CFR Part 11 and EU Annex 11? 21 CFR (Code of Federal Regulations) Part 11 has defined by the US FDA regulations that set forth the criteria applies to electronic records and electronic signatures that persons create, modify, maintain, archive, retrieve, or transmit under any records or signature requirement set forth in the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or any FDA regulation Annex 11 is part of the European GMP Guidelines and defines the terms of reference for computerized systems software used by organizations in the pharmaceutical industry. Queries? Any relation between GAMP 5 or v Model with 21 CFR Part 11? Both are the set of guidelines which are used to validate a computer-based software used in pharma manufacturing companies. The guidelines are predefined, and software should comply with the guidelines. GAMP talks about “the How” and the 21 CFR talks “the What” during the Validation of computer-based software for Pharma companies. GAMP is a methodology and 21 CFR are a regulation 21 CFR Part 11 is US FDA and Annex 11 is EU guidelines. A Company is delivering software to the banking sector they never heard of part 11 but when the Pharma customer wants them to map Part 11 requirements will the solution comply with them? Even if a company is delivering software to the banking sector, the solution will generally comply with part 11 requirements. In banking software’s there may not be the reference of Part 11, but the requirements of Part 11 will be met by the banking software’s A software company is following SDLC models from the past 8 years. For the first time, they are delivering a pharma software solution. When the customer team comes for an audit what software development methodologies they need to demonstrate to win the auditor. Whenever there is an audit of the customer need to explain the detailed procedure followed to develop software right from the beginning of User requirement gathering to the maintenance and support. Even if the company does not know the standard guidelines, we can map the existing followed procedure with the guidelines and standards to comply with client requirements. The company which comes to audit have a set of guidelines or criteria which the supplier should comply to pass the audit. The pharma companies investigate whether the software follows GAMP, or Part 11 or EU annexure 11. To win the auditor the company must have followed an SDLC Methodology with Proper Reviews and Tracking. A software company doesn’t want to follow the V model, still wanted to deliver pharma software (Quality Management Software, Document Management System, ANDA and DMF tracker etc.). Will this be acceptable to Pharma Company? Acceptable if Software Company follows standard SDLC models and follows the Standards for developing and managing the code. Explore Our GMP Solutions eQMS DMS LMS RIMS QC Planning eLogbook LIMS APQR Asset Management EMS eBMR UMS View All Solutions Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard

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Top 7 Queries Addressed: Data Integrity and CGMP Compliance

This article provides a clear insight into the significance of data integrity within the framework of current good manufacturing practice (CGMP) for pharmaceuticals, as mandated by 21 CFR parts 210, 211, and 212. These parts encompass the regulations for Current Good Manufacturing Practices in Manufacturing, Processing, Packing, or Holding of Drugs in general (part 210), Current Good Manufacturing Practices for Finished Pharmaceuticals (part 211), and Current Good Manufacturing Practices for Positron Emission Tomography Drugs (part 212). This guidance outlines the Agency’s perspective on the creation and management of data in accordance with CGMP requirements. Therefore, the core principle this guidance upholds is the insistence on reliability and accuracy in data. The FDA emphasizes the need for data to be dependable and precise. To address data integrity concerns, the CGMP regulations and associated guidance advocate for adaptable and risk-based approaches. These approaches are intended to prevent and detect issues related to data integrity. In doing so, pharmaceutical firms are encouraged to implement strategies that effectively manage data integrity risks, leveraging their comprehension of processes, technological insights, and business models. It’s important to note that the guidance documents issued by the FDA express the Agency’s current perspectives and beliefs. These documents do not establish legally binding obligations. Rather, they offer recommendations based on the FDA’s present understanding. However, using terms like “should” in these guidances indicates suggestions and recommendations, but they are not obligatory unless specific regulatory or statutory mandates are explicitly cited. Let’s take a deep dive into the top 7 questions below 1. When is it permissible to exclude CGMP data from decision-making?   Every data formed within the context of a CGMP record needs to be evaluated by the quality unit for release criteria and preservation per CGMP objectives. Electronic data generated to satisfy CGMP obligations should encompass pertinent metadata. To omit data from the decision-making process for release criteria, a valid and well-documented for its exclusion should exist. The prerequisites for retaining and reviewing records remain consistent irrespective of the data format; paper-based and electronic data record-keeping systems are subject to identical stipulations. 2. Why is the FDA concerned with using shared login accounts for computer systems?  It is essential to enforce suitable measures to guarantee that alterations to computerized Master Production and Control Records (MPCRs) or other records and the inputting of laboratory data into computerized records are conducted solely by authorized personnel. Concurrently, implementing documentation controls is imperative to ascertain that actions can be unequivocally attributed to specific individuals. In instances where login credentials are shared, the distinct identification of an individual through the login is rendered unfeasible, resulting in non-conformance with the CGMP requisites delineated in parts 211 and 212. FDA mandates that the design of system controls, including documentation controls, adhere to CGMP principles to ensure the preservation of product quality. 3. How often should audit trails be reviewed?  FDA advises conducting reviews of audit trails that document alterations to vital data for every record before granting final approval to the record. Audit trails that necessitate consistent reviews should encompass various aspects, such as: Modification history of test results for finished products Amendments to sample run sequences Revisions to sample identification and significant alterations to process parameters To ensure effective oversight, the FDA advocates for scheduled, routine audit trail evaluations, which should be determined based on factors like the system’s complexity and its designated purpose. 4. Who should review audit trails? Audit trails are integral components of the correlated records. Those tasked with reviewing records in accordance with CGMP should concurrently examine the audit trails that document modifications to vital data linked with the record. To illustrate, the quality unit is responsible for scrutinizing and endorsing all production and control records, encompassing audit trails. This parallels the anticipation that handwritten alterations on paper records should be evaluated during data reviews. 5. Can electronic copies be used as accurate reproductions of paper or electronic records?  Certainly, electronic duplicates can function as authentic replicas of paper or electronic records, assuming they retain the substance and significance of the initial data, encompassing linked metadata and the constant or fluctuating attributes of the original records. For dynamic electronic records, authentic reproductions may be generated and upheld in either the original or a compatible format, contingent upon the conservation of the content and meaning of the primary records. Appropriate reader and copying equipment (such as software, hardware, and media readers) must remain conveniently accessible. Note: “Static” denotes an unchanging data document, such as a paper-based record or an electronic image. In contrast, “dynamic” refers to a record format that enables interaction between the user and the record’s content. For instance, a dynamic chromatographic record might permit the user to alter the baseline and reprocess chromatographic data, potentially causing adjustments in the appearance of resulting peaks. Additionally, it might enable users to amend formulas or input within a spreadsheet used for calculating test outcomes or other data, such as calculated yields. 6. When does electronic data become a CGMP record? When data is generated to meet CGMP requirements, it becomes a CGMP record. It’s important to save or document this data during creation, following CGMP rules. Quality data must not be changed, so processes should ensure that. For example, save chromatograms right after a run. Using temporary paper or storing data electronically manipulably isn’t allowed. Use a mix of technical and procedural controls. Computer systems like LIMS can auto-save after each entry, like recording on paper. This keeps CGMP practices intact. 7. How does FDA recommend data integrity problems identified during inspections, in warning letters or other regulatory actions be addressed?  FDA advises demonstrating effective problem resolution by: Engaging a third-party auditor. Identifying the issue’s extent. Executing a global corrective action plan. Replacing those responsible for problems in CGMP roles. FDA could inspect to confirm data integrity CGMP violations are resolved. These align with Application Integrity Policy standards. For detailed guidance, refer to the “Points to Consider for Internal Reviews and Corrective Action Operating Plans” public document on the FDA website. Schedule a Free Consultation

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7 Common Compliance Issues Faced by the Pharmaceutical Industry

The pharmaceutical industry is critical in safeguarding public health by researching, developing, and manufacturing life-saving drugs. However, this sector operates in a highly regulated environment due to the potential risks associated with drug production and distribution. Compliance with regulatory standards is vital to ensure patient safety and maintain the industry’s integrity. This article will explore 7 common compliance issues the pharmaceutical industry encounters and discuss their implications. Good Manufacturing Practices (GMP) Violations: One of the most significant compliance challenges is adhering to Good Manufacturing Practices. GMP violations can contain inadequate quality control, inappropriate documentation, and failure to follow standard operating procedures. Such breaches can lead to product recalls, fines, and damage to a company’s reputation. Data Integrity: Data integrity is crucial for maintaining pharmaceutical records’ accuracy, completeness, and consistency. Compliance issues occur when companies fail to establish robust data management systems, leading to data manipulation, unauthorized access, or data loss. These breaches can harm product quality, clinical trials, and regulatory submissions. Adverse Event Reporting: Pharmaceutical companies must report any adverse events associated with their products promptly. Compliance issues arise when companies fail to identify and report adverse events within the required timeframes. Inadequate adverse event reporting not only poses risks to patients but also undermines the pharmaceutical industry’s transparency and credibility. Supply Chain Compliance: The pharmaceutical supply chain is complex, involving numerous stakeholders, including manufacturers, distributors, and pharmacies. Ensuring compliance across the supply chain can be challenging, especially when dealing with counterfeit drugs, unauthorized distribution, or improper handling and storage of pharmaceutical products. Failure to maintain supply chain compliance can lead to substandard or counterfeit drugs reaching patients. Fraud and Corruption: The pharmaceutical industry meets risks related to fraud and corruption, such as illegal kickbacks, off-label promotion, and bribery. Unethical practices can compromise patient safety and distort fair competition. Compliance issues in this area can result in severe legal consequences, damage to a company’s reputation, and financial losses. Intellectual Property Protection: Intellectual property (IP) is the cornerstone of innovation in the pharmaceutical industry. Compliance challenges arise when companies fail to adequately protect their IP rights or engage in patent infringement. IP non-compliance can hinder innovation, discourage investments, and lead to costly legal battles. Regulatory Compliance in Research and Development: Pharmaceutical companies must comply with regulations throughout the research and development (R&D) process. Failure to follow ethical guidelines, obtain proper participant consent, or accurately report clinical trial results can result in compliance issues. Non-compliance in R&D can delay drug approvals, harm patient safety, and damage a company’s reputation. Wrap up Compliance issues in the pharmaceutical industry are multifaceted and can have far-reaching consequences. To mitigate these challenges, pharmaceutical companies must prioritize compliance by implementing robust quality systems, data management protocols, and supply chain controls. A proactive approach to compliance ensures patient safety, strengthens trust in the industry, fosters innovation, and paves the way for the development of life-saving drugs.  Likewise, Amplelogic is the First Low Code driven product company for life sciences. It speeds up compliance and quality assurance with integrated solutions to the pharma business process. Moreover, it includes 18+ COTS products compliant with 18+ products like eQMS, LMS, DMS, eLogs, Calibration Schedules, Stability, APQR, and more, serving 100+ Pharma companies worldwide. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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Pharma 4.0 Adoption in India: A Catalyst for Modernization in the Pharmaceutical

As the Indian pharma sector embraces digitalization and advanced technologies, several key transformations are expected: 1. Global Competitiveness: By going digital and incorporating Pharma 4.0, Indian pharmaceutical companies can enhance their global competitiveness by being at the forefront of technological innovation and efficiency. 2. Regulatory Compliance: Implementing Pharma 4.0 technologies helps streamline regulatory compliance, making audits and inspections smoother and more efficient. 3. Continuous Manufacturing: Pharma 4.0 facilitates continuous manufacturing processes, enabling seamless production with reduced downtime. This approach increases efficiency and reduces waste. 4. Accelerated Drug Discovery: Advanced computational methods and machine learning algorithms can analyze vast amounts of data, accelerating drug discovery and reducing the time required to bring new drugs to market. 5. Real-time Monitoring and Control: Pharmaceutical companies can monitor manufacturing processes and critical parameters in real-time with IoT and data analytics. This proactive approach allows for early detection of deviations and immediate corrective actions. Also check – How can Pharma companies stay in control of their QMS? To sustain this progress, the industry must focus on several key areas: 1. Enhanced Communication: Establishing a direct shop floor to higher management connectivity ensures seamless collaboration. 2. Paperless Operations: Minimizing paper usage mitigates data integrity risks and ensures compliance. 3. Investing in Quality: Increasing the quality budget fortifies a commitment to excellence. 4. Embracing Emerging Technologies: Adapting to emerging technologies fosters innovation and efficiency. 5. Continuous Improvement: Pursuing a culture of continuous improvement drives progress and quality enhancement. 6. Patient-Centric Approach: Prioritizing patient needs promotes better healthcare outcomes. 7. Regulatory Compliance: Upholding compliance standards is crucial for sustained growth. Digital transformation is the key to future success, enabling the Indian pharmaceutical industry to navigate the evolving global landscape. By embracing innovation, fostering regulatory excellence, and investing in technology, the industry can confidently embrace a brighter future. As we reflect on the future, we invite our readers to share their thoughts on the industry’s challenges and opportunities. The impact of digitalization on drug development, manufacturing, and patient care is an important conversation. We welcome your insights and queries, and together, we can drive the Indian pharmaceutical industry towards a prosperous tomorrow. –Vijay Patil, Product Manager – AmpleLogic Empowering the future of pharma through digitalization, innovation and reshaping the processes” Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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Tweaking V Model to Accelerate GMP Automation’s and Address Data Integrity Issues

A long list of data integrity warnings received by pharma companies has made them train their focus on building and fortifying their tracking mechanisms to prevent things from going wrong. One of the solutions is digitization and building a data repository to make it easily available to analyze issues and predict challenges. However, the current challenge is that the digital transformation is going slower than expected, resulting in the engagement of quality resources for a longer time. Implementation of pre-validated software’s like LIMS, DMS, QMS, LMS are taking longer than 12 months and electronic batch manufacturing records (eBMR) are taking more than three years. Most implementations are going beyond the scheduled time due to rework and mid-way requirement changes. This impacts all the documents and hence requires repeated updations with the latest changes. These complications should be addressed with smooth and flexible methods. In general, the OQ duration is 60 percent of the total effort of a project. It is questionable whether such an effort is constructive for configurable software packages (GAMP category 4 & 5). Even after investing a good amount of money and resources, they are not able to realize the expected outcomes. Key challenges On the pharma industry front Business user requirements are not documented properly Unstable senior management. Functional requirements are not detailed enough and do not have traceability to user requirements Very expensive change request. (Cost of change) Traceability matrix is not maintained or updated On the supplier front Rigid systems (Need to write code for every major change) Lack of domain knowledge and unskilled programmers Traditional software implementation methodologies V Model: Verification and Validation Model Most of the software implementations in the pharma industry will follow this model. The success of the V Model is when requirements are well defined with no ambiguity and acceptance criteria well defined. In the V Model, there are long cycle times from user requirement specification to user acceptance test and requirements may change in the meantime. The modeling of user requirements without seeing a running piece of software is abstract and usually, requirements for modification arise when the final user deals with the running software for the first time. The traditional V model software implementation methodologies will not create an interest among the business teams as it takes longer to address a change. If any changes happen midway, then the test documents, along with requirement documents, have to be updated. The cost of major change/ requirement gaps realized in the OQ stage will turn out to be very expensive and delays the validation process. From the past 10 years, regulatory inspections focus more on software and computer system validation. Deviations have been cited across all steps of computer validation from writing specification and risk assessment to IQ/OQ/PQ, revalidation, reporting, and change control. The traditional V Model: It must be revisited based on our real-time experiences One important aspect is the Configuration and Experimentation phase. The introduction of this phase in between the User Requirement Specification and Functional Requirement Specification of the V model will help the business users in understanding the pre-validated software and relating the software with his problem statement. This approach helps in realizing the requirements before the finalization of functional requirement specifications. The business user’s clear on the software outcome. Adding the Configuration and Experimentation phase in the implementation cycle will address regulatory audit observations related to revalidation, deviations and multiple release management. The Configuration and Experimentation approach cannot be achieved through traditional configurable software. The configurable Software must have visual modeling capabilities which are commonly known as No code/Low Code Development Platforms. These platforms support Visual Modelling (The user can see the making of application) The organizations must ensure that the software service provider agrees to offer configuration and experimentation as part of the V Model. If the pre-validated software or configured software follows this model, implementation times can be reduced by 70 percent. This way, gaps can be easily identified during the Configuration and Experimentation phase and as implementation time gets reduced and allows us to complete OQ in 25 percent of the total project time. No code/ Low code Platform These platforms allow business and IT to collaborate in real-time, using visual models to capture business requirements as well as quickly iterate and scale apps while ensuring nothing gets lost in translation. The platform allows users to quickly turn their ideas into building up applications and transforming their manual processes to digital within days. Low Code or No-code development platform provides drag-and-drop tools that allow business process engineering (BPE) teams to develop software quickly without coding. The platforms provide drag-and-drop components to quickly assemble and design applications at reduced timelines and efforts. They also help increase business productivity and efficiency at the work levels. Both developers and non-developers can use these tools to practice rapid application development with customized workflows and functionality. Global enterprises are looking for No Code Platforms to build actionable digital strategies for every part of their business. When prevalidated GMP software like QMS, DMS, LMS, eBMR and Batch Issuance software were built on using this No Code/ Low code Platforms then addressing the Requirement gaps or change will be faster and minimal time with less no of people involvement. Even change management becomes easy using No Code Platform. Processes can be changed every now and then, even for a small change in the traditional approach will take months’ time, using the No-code platform can happen in days’ time. The platforms offer Visual modeling of business logic and workflows, with the ability to extend with custom code Visual definition of data models Drag-and-drop implementation of modern user interfaces for multiple devices Application change and life-cycle management The way forward for pharma organizations This is the time for pharma organizations to step towards selecting pre-validated software with visual modeling capabilities (No/ Low Code Platforms) that helps business users in appealing digital experiences with human readable application models by keeping the cost constant. Way forward for IT organizations Software suppliers must focus

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TOP 3 Trends Transforming Outlook of Pharmaceutical Industry In 2023

COVID-19 spurred a sense of urgency in healthcare and pharma professionals, making the entire landscape conducive to change and digital transformation. We’re at a strange crossroads. On one hand, it feels as if the world stopped calculating the passage of time starting in March of 2020. On the other hand, in the healthcare industry, it feels as if we’ve sped ahead by two decades, with the normally slow pace of innovation breaking all kinds of records and expectations. The pharma industry has been slower to embrace technologies such as AI and digital technology however, COVID-19 pandemic has changed the equation, forcing pharma companies to become more agile and open-minded in approaching drug discovery and development. There has been a tremendous amount of growth in the pharmaceutical industry in recent years from embracing new technologies, patient design, and innovations and put a greater focus on prevention and digital health and the outlook continues to be positive for 2023. In this article, we are sharing Top 3 trends that shall transform the outlook of pharmaceutical industry in 2023. 1. Use of Artificial Intelligence Artificial intelligence in Pharmaceutical Industry has an unimaginable potential. Within the next couple of years, it will revolutionize every area of our life, including medicine. A.I. is already on our wrists, in our cars, in the searches we do or what we are offered to buy, Imagine this efficiency in healthcare! Artificial Intelligence will soon revolutionize healthcare through mining medical records, designing treatment plans, speeding up medical imaging, create more affordable drugs ad therapies, and, most importantly, reduce operational costs. A recent report forecasts the global artificial intelligence in pharma is projected to grow from $699.3 million in 2020 to $2,895.5 million in 2025 at a rate of 32.9%. The market is then expected to grow at a CAGR of 25.9% from 2025 and reach $9,142.7 million in 2030. The combination of AI, big data and IoT technologies are creating new innovations, also other eminent technologies like cloud computing, augmented reality, virtual reality and blockchain are being used extensively in the Pharmaceutical industry’s digital transformation. Over the past decade, the FDA has reviewed and authorized a growing number of devices legally marketed with ML across many different fields of medicine—and expects this trend to continue. AI can present a myriad of opportunities for the pharmaceutical industry bringing about a radical shift in the innovation paradigm of the pharma sector. It’s all about the speed and savings that Artificial Intelligence’s myriad of applications can bring in Pharma sector. 2. Digital Health: From a solution to an ecosystem The sink or swim mentality brought on by the Covid pandemic accelerated innovation in every aspect of healthcare. The year 2023 is expected to witness a steep surge in the use of electronic prescriptions with the idea of reduced paperwork and longevity in storage. Digital Prescription is one innovation that is transforming the healthcare landscape to create digital health records of patients which in turn improves patient outcomes as this reduces the chances of human error to interpreting wrong medicines. The concept of Remote Patient Monitoring gained huge popularity during the COVID-19 pandemic when people had to follow movement restrictions and social distancing norms. RPM is slowly becoming the future of delivering healthcare services to patients by providing them with an array of medical devices such as implantable, blood pressure cuffs, sensors, and many others so doctors can access real-time patient data for better treatment. Wearable technology in healthcare allows patients to play a more active role in maintaining their health. Patients, equipped with wearable technologies, can track everything from heart rate to reproductive cycles. Doctors can also use this data to craft individualized healthcare plans. Furthermore, the data mined from wearables is more systematic and accurate in recording all medical details and vitals of the patient. 3. Precision Medicine Precision medicine is a medical model that proposes the customization of healthcare, with medical decisions, treatments, practices, or products being tailored to a subgroup of patients, instead of a one‐drug‐fits‐all model. Tailoring a drug to a specific diagnosis is the first step in personalized medicine. However, a patient’s body may react poorly to the medication. Precision medicine looks to solve this issue by targeting drug development based on more in-depth knowledge about the patient. For example, the use of biomarkers to identify tumors and develop a drug specific to that exact diagnosis. The goal is to create and prescribe the drug with the highest level of effectiveness and positive outcomes for the patient, and it’s an approach that is exploding within the pharma industry. Investment in precision medicine from leading pharmaceutical companies will experience an increase in the next five years  and as per the recent report, the global precision medicine market is expected to grow at a CAGR of over 11.5% from 2021 to 2027. This demonstrates the commitment to acceleration in precision medicine research from the biggest pharmaceutical companies. The challenges facing precision medicine have to do with its manufacturing, which require smaller, more specialized facilities. Despite this challenge, precision medicine still shows an upward trend in the pharma industry.  These top trends are changing the pharmaceutical industry in ways that are transformative and likely to have both a short- and long-term impact. The level of innovation that’s taking place in the industry is likely to create tremendous value in accelerating growth of Pharma Industry towards Pharma 4.0. 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