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2r02017 Tackling Breaches in Data integrity ~ GMP VIOLATIONS. HOME —OWNLONS» —FARETCTEORY © EATURED HEAT GMP VIOLATIONS GMP News, GMP guidlines, GMP Vato Sloba News Portal MP warnings A Public Heeth our ema heal Subscribe Home » ALCOA, Dats ntegty, News » Tackling Breaches in Data ntegety Search Tackling Breaches in Data Integrity Leo Group nla 979:00 AM No comments ita ALCOA: FDA's Data Integrity Focus ray ss =o Robust data integr ity begins with both management and employees embracing a quality culture and successful implementation of data governance measures. “The iseue of data integiy in pharmaceuticals ls now becoming a hot topic among regulators ‘and the industry, particularly in Europe and North America. The number of casos of poor data being submited to inspectors and auciters of good manufacturing practice and other HATO 207% OFF FASHION SALE manufacturing standards has been increasing rapidly. This problem is happening in particular ‘among API producers in India and China, As a result, products have been banned ‘rom the European market because their manufacturers have failed to maintain adequate levels of data integrity. The amount of lapses, however, has also been rising among manufacturers of APIS ‘and frished medicines in Europe ital. Causes of failures “[We ane our] intemational regulatory partners are continuing o see significant data integrty flues enna, aerators, end cnc esearch oraiztone aepekesman ie | =a. the United Kingdors Medicines and Heatheare prosue's Reguitory Agency (MHRA) ae ; 40°38 tad Pharmaceutical Technology Europe. SALE arr sept “inthis expres soe there compares av ated ahaa cous sues ee des ofreh hoconnuss.Te ton ants oro Sunita eyce ted beta cance eterno | imtoo fecal antec sma ss gromance POPULAR POSTS Oe i annie ncceptle state-of ‘Other factors behind breaches of data standards include intensifying competition, shorter someent dalvery times, the need to cut costs, and inadequate training. Stctr regulations ao also a ee putting greater pressure on manufacturers to provide satisfactory data, particularly through scaly hous Conner lactone means. ung the Secon wal wart European national medicines agencies have been considering banning the use of APIS se produced by an indian manufacturer after an inspection in June 2016 found a lack of quality FDA cGMP violations which teach ‘assurance oversight on GMP-televant data in is enterprise resource planning (ERP) computer she SOME tron vere non GMP ‘systems (1). The inspection was carried out by the European Counci's European Directorate ctfective CAPA system for te Quality of Medicines (EDQM), responsible forthe European Pharmacopoeia DDACGMP velations which tae Guidance on data integrity hit Him! 6 2r0017 “The scope of data integrity--generally defined as the extent to which data are complete, ‘consistent, and accurate, tiroughout the datas Iifeoycle-has been broadened to include other coritria of data qualty, such as ALCOA and ALCOA+. ALCOA stands for data that aro atributable, legible, contemporaneous, orginal, and accurate, while ALCOAt adds the qualties ‘of being complete, consistent, enduring, and availa. “The degree of concern about the quay of data related to GMP and other manufacturing and related standards has been reflected in the rumber of new guidelines on data integy being issued by the word's leading regulatory bodies. So far in 2016, new or proposed guidelines have been pubished by the United Stales Food and Drug Administration (FDA) (2), World Health Organization (WHO) (3), and the European Medicines Agency (EMA) (4). In addtion, the Geneva-based Pharmaceutical Inspection Co-operation Scheme (PICIS), representing health authorties and GMP inspectorates, issued draft guidance in August 2016 (5). Among European national agencies, the MHRA was among the fist to publish guidance in 2018 (6), hile a number of pharmaceutical industry groups and consultancies have been drawing up suggested voluntary codes of best practices in data integrity. “The objective behind the regulators’ guidelines has been to describe in detail what levels of data integtty ae expected from pharmaceutical manufacturers and suppliers to ensure adequate product quality.The guidelines, however, also show an awareness that a crucial factor behind the achievement of data integrin today’s global pharmaceutical market is the presence ofa qualty cuture embracing both management and employees, “Organzational behaviour is key to the successful implementation of data governance measures,” said the MHRA spokesman. This was a view echoed by EMA, which sees dlicuties with data stemming from the way itis contralled. “In most cases, the underlying problems arise from weaknesses inthe way the control of data is assessed and managed,” an [EMA spokesperson told Pharmaceutical Technology Europe. Consequently, with some of the guidelines, the regulators have been straying into new teeilory by trying to intuence corporate cultural strategies and polices. They point out that senior ‘management must show commitment to daa reliability by leading by example. Business targets on data qualty should be sel, which are consistent with a manufacturer's process Ccapabilties. Employees should not only be empowered to provide accurate data but to report to management breaches of data qualty by other personnel A quality culture Inits guidance on good data and record management practices (3), published in May 2016, the WHO's expert committee on specications for pharmaceutical preparations emphasized the importance of a qualty culture, The gudance was only finalized alter extensive consultation with national GMP and other qualty performance inspectors. Robust data integrity begins at the top, “Leadership is essential to establish and maintain a ‘company-wide commitment to data reliably a8 an essential element of the quay system,” the document says (3). Staf must also be given responsibilities by being unrestrained in their provision of data. “An essential element ofthe qualiy culture isthe transparent and open reporting of deviations, errors, omissions, and aberrant resus at al levels ofthe organization, imespective of hierarchy” the guidance says (3). “Senior management should actively siscourage any management practices that might reasonably be expected to inhibit the active ‘and complete reporting of such issues, for example, hierarchical constrain, and blame cultures." ‘The PICIS guidance (6) provides advice to GMP and other inspectors, primarily those working {or the organization's 49 member authortes in Europe, North America, and Asia Pacific, as wall as Argentina and South Arca. Ithas been drawn up in draft form for review early next year mainly to ensure a document was issued relatively quickly in response to the deep interest in data integrty in pharmaceuticals across the work. “The PICIS data integrity working group decided to “make the inital daft of convergent ‘idence available to PICIS partcipating authorities as a soon as possible to ensure a ‘consistent approach to regulatory expectations," explained David Churchward of the MHRA and Matthew Davis of Australia's Therapeutic Good Administration (TGA), the group's co~ chars. ‘The 14 authorities making up the group identifed out-of-date practices and technologies as a major cause of data intogrity falures. “Examples include an increasing use of IT in manufacture ‘and analysis, andthe challenges of remote supervision of sites in a global supply chain,” CChurchward and Davis told Pharmaceutical Technology Europe. “The guidance addresses the itp "tackling beaches in data-integrity Hil “Tackling Breaches in Data Integrity ~ GMP VIOLATIONS Popular Tage Blog Archives. Fouowers Followers (0) nents Coy Cross Leave he boring stuffto us. forenai test] [Sabaera. | serves Enter youre a (Siteiba: Davered by FeedBumer OOo Fires to“Accepale Sate: . Controtof QMS POR comacive Action? was the term fs incopted bythe US Goverment uring the second wor war to adress none Revision of PIC/S GMP Guide PE 008-13 GUIDE TO (GOOD MANUFACTURING PRACTICE Geneva, 22 December 2076: the fellowing Chapters of the PIC/S GMP Gulge have been reveee: Cnapter ‘nual Management” (which ha Importance of Corrective action and 4. Preventive action (CAPA) FOA von Warning Letter on GMP Violations ith thie FDA wating eter you os Team about Importance of 2r0017 “The guidance acknowledges the positive influence of qualy cultures within companies but concedes the dificuties of making inspection citations based on abservations af organizational behaviour. Nonetheless, inspectors can use behaviour as an indicator of risks for further investigation. ‘Companies should draw up a code of valies and ethics that reflects managements philosophy ‘on quality and provides an environment of ust, where al individuals are responsible and ‘accountable for ensuring patent safely and product qualty. “The company's general ethics and integrity standards need tobe estabished and known to each employee and these ‘expectations should be communicated frequently and consistent,” the guidance says (5) Management should aim to create a qualty culture in which “personnel are encouraged to ‘rely communica fallures and mistakes, including potential data reliably issues, (with an] ‘organizational reporting structure permiting the information flow between personnel at all levels, the document adds, Harmonizing standards Regulators seem to agree that inthe long term, the content of guidelines on data integrity wil have to be changed forthe sake of harmonizing standards for data qualty across the world, with PICIS perhaps becoming a hub for sorting out diferences of approaches tothe issue, “EMA intends to work with PICIS to pubish more permanent intematonal guidance,” said the ‘agency's spokesperson. PICIS believes that through the 14 authorities participating in its data integrity group, including FDA and nine EU agencies, and the rest of ts membership, i has the structure for taking account of a broad range of views. “In the future itis foreseen that harmonized inspectorate focused guidance wil be availabe through the PICIS network,” said Chapman and Davis. WHO views its guidance (3) as being of ‘an evolutionary, ilustative nature and wil therefore, be subject to periodic review based upon experience wit its implementation and usefulness, ‘as wellas the feedback provided by the stakeholders, including national regulatory authorities (NRAS)" ‘One major barrier to etfective application of guidelines in an area such as data integrity isthe regional and national cultural variations that generate different viewpoints on whats, for ‘example, efficient leadership. “Depending on culture, an organization's control measures may be: ‘open’ (where hierarchy can be challenged by subordinates, and ful reporting ofa systemic or individual falur isa business expectation) or closed’ (where reporting failure o challenging hierarchy is culturally more dificult,” PICIS says inits guidance. Good data governance in ‘oper’ cultures may be faciltated by employee empowerment fo identify and report issues. "In ‘closed’ cultures, a greater emphasis on oversight and secondary review may be required to achieve an equivalent level of control due tothe social barrier of ‘communicating undesirable information,” the dacument (5) explains. The task of reconcting these diferences has hardly yet begun Iwill require input from a much wider spectrum of agencies than at present. References 1. EMA, Eudra GMP, “Statement of Non-Compliance with GMP,” Report No DE_SHINCSIAPUO1/2016 (London, June 206). 2. FDA, Draft Guidance for Industry: Data Integrty and Compliance with CGMP (Washington, ‘Apel 2016), 3, World Health Organization, Guidance on Good Data and Record Management Practices, WHO Export Committe for Pharmaceutical Preparations~-Annex 6, Fifteenth Report (Geneva, May 2018), 4, EMA, Questions and Answers on Good Manufacturing Practice--Data Integrity (London, ‘August, 2016). ‘5. Pharmaceutical Inspection Co-operation Scheme (PICIS). Good Practices for Data Management and Integy in Regulated GMP/GDP Environments (Geneva, 10 Aug. 2016) 6. MHRA, GMP Data Integity Definitions and Guidance for Industry (London, March 2015). Citation When referring to this article, please cite tas S. Milmo, “Tackling Breaches in Data Integity,"Pharmaceutical Technology Europe 28 (11) 2016, Source: pharmtech (This sory has not been edited by GMP Violations staf nd is auto-generated {rom a syndicated feed ) Disclaimer: The Lgos/Images posted here are belongs to respective to Authority itp "tackling beaches in data-integrity Hil “Tackling Breaches in Data Integrity ~ GMP VIOLATIONS interpretation of existing GMP norms in the context of current technology, and discusses the key elements of effective data controls throughout the data lfecycle,” they added. rrective action and Pravetive Regus A oberon AAS contormtis ath respectveto TET GS ATA iteoity and Quality 5 tring cain vaaton Seach dts nepty asvere Sten ite 21 CFR PART 620.3 Quay System Definitions {AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H- MEDICAL DEVICES. ‘GMP Violations FDA Waring letter Issue: GV/0T17/001 {GMP Voltone lke to highlighted few key Violations with respective (COMP for ease of understancing The Mot FDA cOMP violations which teach bout cGMP from where non GMP ‘ctvties went Learn about ‘tective CAPA system FOA cGMP violations which eae bout SCM from here non GMP setvles went Learn about effective CAPA, “Lifecycle Approach to Process SRIA Tahaan ar-2 PROCESS DESIGN Ttinking Ceol Material Atte PROCESS DESIGN| PROCESS ? ERFORMANCE QUALIFICATION | ‘VERIFICATION | CHANCE MANAGEMENT FDA cGMP violations and Quality ‘assurance has took fllure decisions "S wih wis arte we would ke to share you about 2 of 4 FDA cGMP leone which teach about e&MP from were non GMP. ice regarding Up sets of persons rma mantacturing ‘nite Dated 26.08 2016 SCO Notice regarding Up lation of Sel sete of persons emplosedin pharma manufacturing unite Dates 25.0820%6 The Com Home ‘CONTACT FORM Message (et) Menu: [Choose cagoy Powered by Blogger [srs