Data integrity is assuming greater importance in current Good Manufacturing Practices in FDA regulated industry with increased emphasis by other regulatory agencies like the EMA. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. As FDA increases its focus on data integrity and reliability, inspectors are examining data based on multiple regulations and standards including CGMP, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and the Application Integrity Policy (AIP) in addition to FDA-recognized consensus standards.
This presentation discusses data integrity regulations and enforcement trends that have led to increased scrutiny of pharmaceutical laboratories by inspectors.
Trends changed from Non compliance to RR --> Gap to RR --> Data Integrity --> DIB --> Smart Audit & Smart Data.
RR = Regulatory Requirements
DIB = Data Integrity Breach
Take a serious Note for Data Integrity whether you are small or big organization. Your Data is the Heart of your business. Regulatory bodies are highly conscious about such issues. For beginners in this path, my small note can help you a lot.
What is 21 CFR Part 11?:
21 CFR Part 11:
Allow the industry to use electronic records and signatures alternatively to paper records and hand-written signatures
21 CFR Part 11 applies:
To all FDA regulated environments
When using computers in the creation, modification, archiving, retrieval or transmission of data or records
To records required by predicate rules – GLP, GCP, GMP – that impact patient safety
To new and old systems
Purpose of Part 11
Ensure data is not corrupted or lost
Data is secure
Approvals cannot be repudiated
Changes to data can be traced
Attempts to falsify records are made difficult and can be detected
Types of Systems
Two types of systems that come under 21 CFR Part 11 – closed and open systems
Closed and Open Systems:
What is a Closed system?
A system to which access is controlled by person responsible for electronic records stored on it
What is an Open system?
A system to which access is not controlled by those responsible for the electronic records stored on it
21 CFR Part 11 Requirements:
21 CFR Part 11 lists the following controls for closed systems:
Validation
Device checks
Operational system checks
Accurate and complete copies
Accurate and steady retrieval
Limited access to systems and data
Authority checks
Electronic audit trail
Training/qualification of personnel
Accountability of signatures
Control over system documentation
Digital Signatures :
Use of digital signatures for open systems
Electronic Signatures
Requirements for signed electronic records
Linking records to signatures
Trends changed from Non compliance to RR --> Gap to RR --> Data Integrity --> DIB --> Smart Audit & Smart Data.
RR = Regulatory Requirements
DIB = Data Integrity Breach
Take a serious Note for Data Integrity whether you are small or big organization. Your Data is the Heart of your business. Regulatory bodies are highly conscious about such issues. For beginners in this path, my small note can help you a lot.
What is 21 CFR Part 11?:
21 CFR Part 11:
Allow the industry to use electronic records and signatures alternatively to paper records and hand-written signatures
21 CFR Part 11 applies:
To all FDA regulated environments
When using computers in the creation, modification, archiving, retrieval or transmission of data or records
To records required by predicate rules – GLP, GCP, GMP – that impact patient safety
To new and old systems
Purpose of Part 11
Ensure data is not corrupted or lost
Data is secure
Approvals cannot be repudiated
Changes to data can be traced
Attempts to falsify records are made difficult and can be detected
Types of Systems
Two types of systems that come under 21 CFR Part 11 – closed and open systems
Closed and Open Systems:
What is a Closed system?
A system to which access is controlled by person responsible for electronic records stored on it
What is an Open system?
A system to which access is not controlled by those responsible for the electronic records stored on it
21 CFR Part 11 Requirements:
21 CFR Part 11 lists the following controls for closed systems:
Validation
Device checks
Operational system checks
Accurate and complete copies
Accurate and steady retrieval
Limited access to systems and data
Authority checks
Electronic audit trail
Training/qualification of personnel
Accountability of signatures
Control over system documentation
Digital Signatures :
Use of digital signatures for open systems
Electronic Signatures
Requirements for signed electronic records
Linking records to signatures
Data Integrity in pharmaceutical laboratories is a must, the attached ppt shall help the QC members to understand and develop an integral analytical culture
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
CCK Discussion Forum held at ICCBS, University of Karachi, attended by over hundred of registered experienced pharmaceutical professionals participants belonging from dozen of pharmaceutical manufacturing facilities
Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. It would be helpful for data management.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
Data Integrity Issues in Pharmaceutical CompaniesPiyush Tripathi
Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data.
Data integrity, Pharmaceutical industry, Good Manufacturing Practice, GMP, Guidelines, Data management, DI and GMP Compliance, paper and electronic data, Archive and back up
Data integrity is a Fundamental in a pharmaceutical quality system. It ensures that medicines are of required quality. This presentation is based on MHRA Guidance and provides MHRA expectations. Guidance complements existing EU GMP relating to active substances and dosage forms. This guidance should be d in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
Data Integrity in a GxP-regulated Environment - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, December 6, 2016, our colleague Angelo Rossi, Senior Regulatory Compliance Consultant, gave an interesting presentation about “Data Integrity in a GxP-regulated Environment” at the Brussels Office of Pauwels Consulting in Diegem.
In his presentation, Angelo covered definitions and concepts of data integrity, the change in regulatory focus, lessons learned from recent FDA warning letters, importants highlights of regulations and guidelines. Angelo also presented a practical example of data integrity for a computerized system.
Please contact us at contact@pauwelsconsulting.com or +32 9 324 70 80 if you have any further questions regarding our consulting services in this area.
Data Integrity in pharmaceutical laboratories is a must, the attached ppt shall help the QC members to understand and develop an integral analytical culture
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
CCK Discussion Forum held at ICCBS, University of Karachi, attended by over hundred of registered experienced pharmaceutical professionals participants belonging from dozen of pharmaceutical manufacturing facilities
Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. It would be helpful for data management.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
Data Integrity Issues in Pharmaceutical CompaniesPiyush Tripathi
Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data.
Data integrity, Pharmaceutical industry, Good Manufacturing Practice, GMP, Guidelines, Data management, DI and GMP Compliance, paper and electronic data, Archive and back up
Data integrity is a Fundamental in a pharmaceutical quality system. It ensures that medicines are of required quality. This presentation is based on MHRA Guidance and provides MHRA expectations. Guidance complements existing EU GMP relating to active substances and dosage forms. This guidance should be d in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
Data Integrity in a GxP-regulated Environment - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, December 6, 2016, our colleague Angelo Rossi, Senior Regulatory Compliance Consultant, gave an interesting presentation about “Data Integrity in a GxP-regulated Environment” at the Brussels Office of Pauwels Consulting in Diegem.
In his presentation, Angelo covered definitions and concepts of data integrity, the change in regulatory focus, lessons learned from recent FDA warning letters, importants highlights of regulations and guidelines. Angelo also presented a practical example of data integrity for a computerized system.
Please contact us at contact@pauwelsconsulting.com or +32 9 324 70 80 if you have any further questions regarding our consulting services in this area.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
Data Integrity; Ensuring GMP Six Systems Compliance Pharma TrainingMarcep Inc.
As per the USFDA guidelines there are about 38 drugs has banned in India due to poor handling of DATA INTEGRITY SYSTEMS. We at Marcep Inc. proud to announce the need of an hour by organizing the above mentioned training program.
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Presentation: Data Integrity – an international regulatory perspectiveTGA Australia
This presentation will provide an overview of the international regulatory perspective on data integrity and discuss some of the key points highlighted in recently released guidance documents from across the globe.
TGA presentation: Data Integrity - an international regulatory perspectiveTGA Australia
An exploration of the topic of Data Integrity including consequences of international regulatory collaboration on the subject, highlights of recent overseas and international guidance documents, as well as common misconceptions.
A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Tr...Target Health, Inc.
DIA 2019 presentation by Dr. Jules Mitchel with Michelle Eli (Lilly) and Tom Haag (ex-Novartis) based on their experience with Lilly collaborating on Target Health's paperless clinical trial system.
Provide recommendations and background information concerning computerised systems
Information will be of assistance to inspectors for training purposes and during the inspection
Where automated systems and electronic records are used in warehouses and similar establishments where GDP requirements are applicable, controls and disciplines outlined in this document, or a best practice alternatives are expected to be in place.
Vertically integrated companies (R&D, manufacturing and distribution) will already apply such controls and compliance measures.
International regulatory agencies have collaborated to produce this guidance.
Intended as a reference for regulated users, including their suppliers, in addition to regulatory inspectors and investigators.
Provides a logical explanation of the basic requirements for the implementation, validation and operation of computerised systems.
May be adapted to identify the criteria for a regulated user, or a regulatory agency, in an inspection of GxP computer systems.
National legislation should to be referred to when determining the extent to which the provisions laid down in this document may be applicable.
This presentation gives a summary of this guidance.
Quick Overview: Pharmaceutical Data IntegrityPeter Dellva
Brief overview of the most important aspects of pharmaceutical data integrity. Slideshare includes pharmaceutical and biopharmaceutical industry key resources.
Leveraging UDI Database Requirements to Drive Data GovernancePTC
Delivered at the event “UDIs and Traceability for Medical Devices 2014” in Munich, May 21 – 22, 2014, Europe's only UDI-dedicated event for the medical device industry – with keynotes from the FDA and European Commission– this slideshare presents a Solution Provider’s perspective on the impact of Master Data on the UDI submission to the FDA UDI data base. In detail, the presentation highlights the following subjects:
- A checklist for compliance – What to consider when selecting a solution for UDI data submission
- Data management as a lever for streamlined submissions – Current situation, challenges, and best practices for establishing data governance within an organization
- How PTC solutions support UDI and data governance – PTC’s UDI solution and the broader approach for central product data management
In March 2011, the EMA and FDA launched a pilot program that aims at a parallel assessment by both agencies of certain quality/CMC sections which are relevant to Quality by Design (QbD). This voluntary pilot program is open. This presentation gives a summary of the FDA and EMA expectation for QbD submissions based on the pilot programme.
This presentation highlights the reasons which lead to the withdrawal of the 2002 Guidance of the FDA and the current issue with Blend Uniformity and Content Uniformity Determinations.
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations.
Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring.
This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring.
This presentation is compiled from freely available resources like the websites of FDA, EMA ,WHO and research papers published by experts in this field like Sandle, T Reinmüller, B , Hyde, W,, Costello, E.K., Lauber, C. L., Hamady, M., Fierer, N., Gordon, J.I., Knight, R.
Paper published by T. Sandle on clean room contamination was referred extensively for this presentation. “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.
This presentation gives an overview of : Validation of microbiological methods , Considering some of the limitations and
Key criteria that may be applicable for assessment.
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A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
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Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
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Importance of Memorandum of Association:
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Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
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Global Interconnection Group Joint Venture[960] (1).pdf
Data Integrity in FDA Regulated Labs
1. This presentation is compiled by “ Drug Regulations” a
non profit organization which provides free online
resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
5/15/2014 1
2. This presentation is compiled from resources
available on the world wide web.
“Drug Regulations” is a non profit organization
which provides free online resource to the
Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of
Pharmaceuticals.
5/15/2014 2
Drug Regulations : Online
Resource for Latest Information
3. Data Integrity is assuming greater importance in cGMP’s
Quality of raw materials, in process materials and finished
goods can not be assured with out data integrity.
Data integrity issues are 21 CFR Part 11 and severe CGMP
violations
If the integrity of laboratory data is compromised
◦ Products may not comply with regulatory authorization terms
◦ Products can not be released for sale
5/15/2014 3Drug Regulations : Online Resource for Latest Information
4. In recent past FDA has increased its focus on data integrity and
reliability
Similarly MHRA and Other regulatory bodies have increased
focus on data integrity
Inspectors are examining data based on multiple regulations and
standards :
◦ CGMP
◦ Good Laboratory Practices (GLP),
◦ Good Clinical Practices (GCP) and
◦ The Application Integrity Policy (AIP)
5/15/2014 4Drug Regulations : Online Resource for Latest Information
5. “Guilty until proven innocent” approach
Historical approaches based on technical
justification and scientific rationale not
adequate
Emphasis on providing evidence that the
analytical results are not fraudulent
5/15/2014 5Drug Regulations : Online Resource for Latest Information
6. Data integrity is the assurance that data records
are accurate, complete, intact and maintained
within their original context, including their
relationship to other data records.
This definition applies to data recorded in
electronic and paper formats or a hybrid of both.
5/15/2014 6Drug Regulations : Online Resource for Latest Information
7. Protecting original data from
◦ Accidental modification
◦ Intentional Modification
◦ Falsification
◦ Deletion
5/15/2014 7Drug Regulations : Online Resource for Latest Information
8. Data Integrity key to
◦ Reliable and trustworthy records
◦ Record that will withstand scrutiny during
regulatory inspections
According to FDA, which uses the acronym
ALCOA, data need to be “attributable, legible,
contemporaneous, original, and accurate.”
5/15/2014 8Drug Regulations : Online Resource for Latest Information
9. Attributable Who performed an action and when? If a record is
changed, who did it and why? Link to the source
data.
Who did it?
Source data
Legible Data must be recorded permanently in a durable
medium and be readable.
Can you read it?
Permanently recorded
Contemporaneous The data should be recorded at the time the work
is performed and date / time stamps should follow
in order
Was it done in “real time”?
Original Is the information the original record or a certified
true copy?
Is it original or true copy?
Accurate No errors or editing performed without
documented amendments.
Is it accurate?
5/15/2014 9Drug Regulations : Online Resource for Latest Information
10. Complete All data including repeat or reanalysis performed
on the sample.
21 CFR 211.194
Consistent Consistent application of data time stamps in the
expected sequence.
Date time stamps
Enduring Recorded on controlled worksheets, laboratory
notebooks or electronic media.
Medium used to record
data
Available Available / accessible for review / audit for the life
time of the record.
For the life time of the
record
10
Additional terms based on the European Medicines Agency’s concept paper on
electronic data in clinical trials
11. FDA inspects for electronic data integrity during the
pre- and post market product approval process
◦ 21 CFR Part 11 commonly referred to as the “data integrity
regulation.” Four goals listed by FDA
Assess the industry’s comprehension or continuing
misinterpretations of Part 11.
Determine how firms are ensuring the integrity of electronic
records.
Extend scrutiny of data, quality-related and computerized
system validation-related Form 483 inspectional observations
since 2007.
5/15/2014 11
12. Comparisons between secure electronic data and data in
paper format.
◦ For software compliant to 21 CFR Part 11 (9) & with
appropriate technical controls
Electronic data are more secure, more difficult to
manipulate or change, and any changes are easier to
detect
◦ Changes to paper data, such as a printed chromatogram,
are simpler to make, but much harder to detect.
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13. Comparisons between secure electronic data and data
in paper format.
◦ Defining paper records as “raw data” (the so-called
typewriter rule) does not satisfy the predicate rules
◦ Printed paper copy of the chromatogram will not be
considered a true copy
◦ Although this comment was made about
chromatographic data, the principles have much wider
implications.
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14. Able Labs ( 2005)
◦ Paper copies of records differed, sometimes
radically, from the electronic records contained
within a chromatography data system.
◦ Massive record falsification
◦ Efforts to avoid detection of several defective
medicines
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15. Leiner Health Products ( 2007)
Serious deviations,
Data manipulation
Inadequate testing procedures
Allowed the nonconforming drugs to be shipped to a
customer
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16. Ranbaxy Labs ( 2008)
Faked drug quality data
30 products banned from the US market
Company required to hire both data integrity
and manufacturing experts to watch operations
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17. Common passwords Analysts share passwords, it is not possible to identify who creates or
changes records.
User privileges The system configuration for the software does not adequately define or
segregate user levels and users have access to inappropriate software
privileges such as modification of methods and integration.
Computer system
control
Laboratories have failed to implement adequate controls over data, and
unauthorized access to modify, delete, or not save electronic files is not
prevented; the file, therefore, may not be original, accurate, or complete.
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18. Processing methods Integration parameters are not controlled and there is no procedure to
define integration. Regulators are concerned over re-integration of
chromatograms.
Incomplete data. The record is not complete in this case. The definition of complete data
is open to interpretation
Audit trails In this case, the laboratory has turned off the audit-trail functionality
within the system. It is, therefore, not clear who has modified a file or
why.
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19. Post-Inspection Responses Program ( 2009)
◦ Concerns handling of FDA Form 483s.
◦ Requires a complete response to all 483
inspectional observations within 15 business days
◦ Prompts a redefinition of inspection-ready
◦ However, as evidenced by ongoing data integrity
issues, this is not happening in a number of
laboratories.
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20. Part 11 audits alongside normal CGMP inspections
(2010)
FDA’s Pre-Approval Inspection Program 7346.832,
◦ Audit the raw data, hard copy or electronic, to authenticate
the data submitted in the CMC section of the application,
and
◦ Verify that all relevant data (e.g., stability, biobatch data)
submitted can rely on the submitted data as complete and
accurate.”
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21. EU has published similar regulations relating to data
integrity.
Released in January 2011
Effective on 30 June 2011
Increased requirements for computerized systems
regulation in Annex 11.
Requires raw data for batch release is defined for both
homogeneous and hybrid systems.
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22. The new records retention requirements state that
if the records are supporting a Marketing
Authorisation (MA), then the records have to be
maintained, including the data integrity for as long
as the MA is in force.
The recently published EU GMP Annex for
computerized systems 11, effective 30 June 2011,
has several sections dealing with data integrity.
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23. Utilization of hybrid systems : If both are used, paper and electronic records
need to be synchronized.
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24. Computerized systems
◦ Potential for electronic data manipulation.
◦ Human errors
◦ Intentionally falsified data
◦ Selection of good or passing results
◦ Exclusion of poor or failing data
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25. Computerized systems
Manual entry of critical data.
◦ Manual entry of the critical data
A verification of the data entry by a second person
Verified with the use of a validated computerized
verification process
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26. Use of system interfaces
◦ Reduces human error
◦ Increases validation burden
◦ Higher effort to maintain a validated state
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27. FDA’s emerging expectations for data integrity
Demonstrate data integrity
Demonstrate security of laboratory data, records,
results and information
Meet regulatory and compendial requirements
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28. Analytical instrumentation is computerized either
via firmware inside the instrument or via software
installed on a workstation situated next to the
instrument.
All analytical instruments must be qualified
All computerized systems must be validated
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29. The current regulatory guidance regarding the qualification of
analytical instrumentation and validation of computerized
systems is conflicting;
qualification and validation are typically considered separate
activities with little, if any, interaction between the two
disciplines.
The American Association of Pharmaceutical Scientists (AAPS)
produced guidance on analytical instrument qualification (AIQ) in
the form of a white paper,
This has been incorporated as General Chapter <1058> within
the United States Pharmacopoeia (USP).
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30. The current regulatory guidance regarding the qualification of analytical
instrumentation and validation focuses on the instrument with little
emphasis on computerized system validation.
In contrast, the Good Automated Manufacturing Practice (GAMP) Good
Practice Guide for Validation of Laboratory Computerized Systems from
the International Society for Pharmaceutical Engineering (ISPE) looks
exclusively at the computerized system
This guidance ignores instrument qualification.
The major problem and practical reality are that a computerized system
cannot be validated without qualifying the analytical instrument, and vice
versa.
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31. FDA and other global regulatory agencies now oversee the
pharmaceutical product lifecycle from early development to
final product release more thoroughly
Therefore R & D labs have come under increased scrutiny
within recent years
Regulations have been in place since the 1970s,
However historically, FDA has concentrated its review process
on the manufacturing aspect of pharmaceutical products
This has changed with the added scrutiny on data integrity
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32. Focus on resources : Personnel, Equipment and Facilities.
Qualify all testing equipment to ensure its suitability for the
testing
Implement a regular maintenance and calibration schedule
Document all activities and record in logbooks or electronic
systems dedicated to each instrument and activity.
Implement traceability for laboratory samples, test samples,
reagents
Document the life of the laboratory sample until final
disposal, including all test samples and test portions
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33. Characterization Testing
Keep detailed records
◦ Any raw materials used in development and
◦ Any intermediate process steps.
Records should include as much information as
possible
◦ Raw material manufacturer
◦ Lot numbers
◦ Descriptions of the testing performed
◦ Any equipment used
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34. Protocols
Protocols facilitate reproducibility of test methods and data to
strengthen the validity of generated data
Establish protocols for both the studies and the testing
Follow protocols consistently
Establish procedures for handling non-trending data and
deviations from the approved procedures
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35. Results and Record Retention
Data should be recorded
◦ In a timely manner
◦ Ideally in real time
◦ In bound notebooks
◦ Electronic systems.
These data should be reviewed by personnel who are
knowledgeable about the test performed and the results
generated.
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36. Document in final study report
◦ Research testing outcome
◦ Interpretation of results
◦ Include specific commentary on any deviations that may have occurred
during the course of the study
Archive all records safely yet be accessible
Implement policies and procedures to ensure records are
retained and protected in a manner that ensures activities are
legally defensible
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37. Data integrity Challenges by
◦ sources of variation inherent in the use of computerized systems
◦ intentional falsification
◦ by accidental data loss or corruption.
Several laboratories have a working LIMS
Few laboratories are truly “paperless.”
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38. Common practices and tools for any laboratory computerized
system to control data integrity challenges
◦ User rights administration
◦ Security tools
◦ User access records
◦ Audit trails
◦ Records management
Monitor these properly and
Control to ensure data integrity
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39. Use Revision control for reanalysed data
Enforce operational checks to verify user permissions
Enforce a certain sequence of permitted steps according
to a defined workflow
Use pre-defined workflows so that data cannot be
entered out of context
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40. Define “built-in” validation checkpoints within systems
◦ Input pattern/mask that forces the user to enter data into a
defined format
◦ Checks for valid data entered by the user to avoid data type issues
(classification identifying various types of data, such as real,
integer or Boolean)
◦ Drop-down lists for data selection wherever possible, instead of
data entry by the user
◦ Double entry checks to ensure key fields are not duplicated
◦ Pop-up calendars for date input to avoid entering the incorrect
date format
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41. Understand interrelatedness among the laboratory compliance levels illustrated below
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42. All levels are fundamental parts of the laboratory quality
system.
Qualify Analytical instruments to show they are working
properly before any analytical methods are developed or
validated using them.
Qualify analytical instruments before the computerized
systems managing the resulting data are validated.
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43. Guidance for Industry Part 11, Electronic Records;
Electronic Signatures
◦ Identify all raw data associated with making CGMP
decisions
◦ Determine the format (paper/electronic) in which the data
will be maintained.
◦ If the raw data are to be maintained in electronic format,
the integrity of the record must be assured.
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44. Accreditation to the International Standard ISO/IEC 17025:
2005
Implementation is an advantage to maintaining data
integrity.
Good analytical laboratory uses qualified analysts, checks the
performance of equipment used for testing and validates
analytical methods, many times, the outcome of the tests is
not fully documented.
ISO/IEC 17025 accreditation requires formal documentation
for nearly everything in the laboratory workflow.
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45. Ensure data validity and integrity by
◦ Review raw data produced by the laboratory equipment or
computerized system periodically
◦ Define the raw data to be reviewed
◦ Define the related review task
◦ Link raw data and corresponding records clearly and
immutably
◦ Provide a date and time stamp with the data
◦ Link clearly and immutably to the original condition
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46. Document
◦ Periodic review results,
◦ Any gaps identified
◦ Corresponding remediation activities
An annual assessment of laboratory procedural controls
is best to ensure:
◦ Compliance of laboratory personnel
◦ Proper coverage and implementation of SOPs
◦ “Real life” implementation of SOPs (verified through sample
checks of system documentation)
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47. Develop control points from
◦ System validation deliverables,
◦ System backup
◦ Restore
◦ Audit trail
◦ Electronic records
◦ Electronic signature
◦ Infrastructure requirements
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48. Develop control points
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49. Include control points in an annual
assessment tool
◦ Enable compliance with control points to be
determined through reporting major and minor
findings
◦ Implement remediation of major & minor gaps
◦ Describe whether the system is fit for use
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50. FDA-regulated laboratories are under intense scrutiny
Data integrity enforcement actions are increasing due to violations
in recent years
Ensuring data integrity is critical in both pre- and post marketing
approval activities
Laboratories should document an overall data integrity approach by
outlining informatics based on workflow
This approach can be set forth in a laboratory data integrity strategy
Operational and procedural control points should be monitored
routinely
◦ Audited to identify any need for remediation
◦ Put the laboratory in the most defensible position
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51. This presentation was compiled from resources
available on the world wide web.
“Drug Regulations” is a non profit organization
which provides free online resource to the
Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of
Pharmaceuticals.
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