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PR3145 > Lecture 5 Good Documentation Practice & Data Integrity > Flashcards

Lecture 5 Good Documentation Practice & Data Integrity Flashcards

1
Q

What does ALCOA stand for?

A 
Attributable
Legible
Contemporaneous 
Original
Accurate
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2
Q

What is the PICS Chapter on Documentation?

A

Chapter 4

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3
Q

Why were the National and International GMP standards revised in the 1980s-2000s?

A

It was necessary due to developments in:

  • pharmaceutical sci and tech
  • computer industry, computerization also due to the introduction of ISO9000 quality system standard
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4
Q

How can one develop a documentation system that complies with GMP?

A
  1. Document what you do (Write SOPs)
  2. Do what you document (follow yr SOPs)
  3. Prove it (keep records to prove that you follow SOPs)
  4. Improve it (improve SOPs by PICS GMP standard)
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5
Q

What does Attributable in ALOCA mean?

A
  1. Documents should be approved, dated and signed by authorized persons
  2. Effective date of a document should be defined

paper data: signature, dates, personal seals
electronic data: time stamps, personal login IDs and passwords, biometrics

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6
Q

What does Legible in ALOCA mean?

A

Entries should be made in clear, legible, indelible (permanent, not easily erased) way

paper data: indelible ink
electronic data: use of computer systems w audit trail

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7
Q

What does the 4th Chapter of the PICS guide to GMP for medicinal products cover?

A
  • Good documentation practices
  • Generation and Control of documents
  • Retention of Documents
  • Types of Documents (What to document)
  • 32 Clauses
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8
Q

What does Contemporaneous in ALOCA mean?

A

Records should be made at the time of action and be traceable

  • i.e. Disable Temp Folders that allowing saving of data at a later time
  • Computer system with enforced saving data & time, time/date stamps used
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9
Q

What does Original in ALOCA mean?

A
  • Alteration of records should permit reading of original information
  • Any alteration of records should be signed and dated
  • Reason(s) for alteration of records should be captured
  • i.e. Routine backups with off-site storage, no tampering with audit trail
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10
Q

What does Accurate in ALOCA mean?

A
  • Integrity of records should be ensured throughout retention period
  • for electronic and paper data: i.e. method validations, investigation of deviations/OOS, keeping comprehensive Batch manufacturing records
  • for computerised system: accuracy assessed through CSV, Regular calibration and maintenance
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11
Q

What are the retention periods for Batch manufacturing records and investigational medicinal products?

A
  • Batch manufacturing Records should be kept for 1 year after batch expiry
  • IMP batch records should be kept for 5 years or more, after clinical trial

IMP = investigational medicinal pdt

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12
Q

What is an SOP?

A

A document that describes the 4Ws (who, what, when, where) and 1H

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13
Q

What is the Batch Manufacturing Formula?

A
  • A document which describes manufacturing process , including amount of starting materials to be added, equipment used, test methods employed, together with acceptance criteria for IPQC/final QC and batch release
  • It forms the basis of batch manufacturing record
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14
Q

What is the site master file?

A

A document which describes GMP related activities of the manufacturer

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15
Q

What are the 2 main classes of evidential documents?

A

Records and Reports

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16
Q

What are Records?

A

Documents that provide evidence of action taken to demonstrate compliance

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17
Q

What are some examples of Records?

A
  • Environmental measurements
  • Cleaning
  • Pest control
  • Starting materials
  • Batch manufacturing records
  • QC
  • Distribution
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18
Q

What are Reports?

A

Documents that capture conduct of studies , projects or investigations, together with results, conclusions and recommendations

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19
Q

What are some examples of Reports?

A
  • Stability Testing Reports
  • Process Validation Reports
  • Process Deviations/OOS Reports
  • IQA Reports
  • CAPA Reports
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20
Q

Why are Records/Reports of the greatest concern from a Data Integrity perspective?

A
  • Reports/Records are evidence of QC tests conducted/GMP Compliance and may be tweaked!
  • They are pharmaceutical data that pose the most data integrity issues
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21
Q

What does Data Integrity mean?

A

The degree to which pharmaceutical data are ALCOA, making the set of data, accurate, valid, reliable and complete!

22
Q

What constitutes Pharmaceutical Data?

A
  • All original records (raw data and metadata) generated during a GMP activity, and their subsequent transformation for complete reconstruction of GMP activity.
  • Also cover evidential and instructional documents
23
Q

What does Critical Pharmaceutical Data refer to?

A

Any Manufacturing Data which affects Product Quality

24
Q

What are some examples of Critical Pharmaceutical Data?

A
  • Mass of APIs
  • Volume of Solvents
  • Batch Mfg Records
  • Analytical Results
  • Chromatograms
  • Stability Testing Reports
25
Q

What is considered Raw Data?

A

Original records retained either in paper (legacy) or electronic format (modern)

26
Q

In the modern context, can Printouts be considered raw data?

A

No. Printouts cannot be considered as electronic records can be tweaked and modified

27
Q

What is considered Meta Data?

A

Attributes that describe data, and provide the context to a better understanding of the pharmaceutical data
- i.e. SI units, date/time stamps, Name of analyst, equipment model

28
Q

Which Annex of the PICS guide to GMP pertains to computerized systems?

A

Annex 11

29
Q

What does computerized systems validation (CSV) refer to?

A
  • A computerized system comprises hardware and software components
  • Includes associated people (operator, process owner, system)
  • Includes 3 rd party suppliers and service providers
  • Collectively, a computerized system fulfills a specific set of manufacturing (e.g. warehousing, production or QC) function
30
Q

What is the objective of computerized systems validation (CSV) ?

A

We want to ensure the Accuracy, Consistency and Reliability of the computerized system

31
Q

What are the current regulations and GMP standards that assure data integrity?

A
  1. Pharmaceutical Legislations (Health Products Act and Medicines Act)
    - a contravention to supply false information
  2. PIC/S GMP Standard : Chapter 4 and Annex 11
  3. Industry Guidance Notes on Computerized Systems (e.g. ISPE GAMP5)
32
Q

Why does globalization and increased outsourcing, emergence of industry 4.0 increase concerns about data integrity?

A
  • Globalization makes it difficult to have regulatory oversight of an overseas company
  • Alot of data generated by industry 4.0 (big data & new tech)
33
Q

What are some things that can be falsified in falsified medicines?

A
  1. Manufacturer’s Name/Batch Number
  2. Product Composition
  3. Packaging/Labelling
  4. Manufacturing Records/Certificates of Analysis
  5. Stability Testing and Process Validation Reports
34
Q

Are Adulterated Products considered Falsified Medicines?

A

Yes

35
Q

What Percentage of Data Integrity Violations are due to Bad practices?

A

75%

36
Q

What are some examples of intentional falsification in Data Integrity?

A
  • Tampering with System Clock
  • Switching off/tampering with audit trails
  • Injections and Sequences of HPLC system not documented
  • Chromatograms and analytical records/Certificate of analysis do not match
37
Q

Why can data falsification at the analyst level escape detection by the QC manager?

A

Lack of specialized knowledge to cross refer submitted chromatogram against computer record
- Time consuming to check

38
Q

What should inspectors note when examining certificates of analysis?

A
  • Do not take paper records at face value

- Cross refer with electronic data

39
Q

Is Periodic Audit trail review required under good practice in data management?

A

Yes, it is considered a good practice

40
Q

What are the data requirements of Audit Trail?

A
  • All Original data/records
  • Any alteration of data
  • Date/time stamps of actions taken
  • Identity of operator
  • Retained for at least 1 year after batch expiry (audit trails in human readable form)
  • Independently recorded (not be under the control of the user)
41
Q

Why are Audit trails useful?

A

They facilitate reconstruction of manufacturing events, including the 4Ws (who, what, when, why)

42
Q

What are things to note regarding computer clocks in reviewing audit trails?

A
  • Date/time stamps shall be computer generated
  • System to have defined international time zones and date standards (synchronized across facility)
  • Review of Audit trials: Check for evidence of tampering with system clock
43
Q

What are some People factors that lead to poor Data Integrity?

A
  • Ignorance
  • Lack GMP, GDP, QMS knowledge
  • Bad Practices and Behavioural Traits
  • Time Pressure
44
Q

What are some System/Hardware factors that lead to poor Data Integrity?

A
  • Tampering with system clock and audit trails
  • Sharing of login details
  • Manipulation of chromatogram peaks
45
Q

What are some Organization Culture factors that lead to poor Data Integrity?

A
  • Cutting Corners during Economic downturn
  • Not regarding Mistakes as learning opportunities
  • Harsh punishments for mistakes
46
Q

What are some companies that inspectors need to be wary of?

A

Companies motivated by pure greed

- Can tell from Mission/Vision Statements

47
Q

How can the state of economy affect manufacturing companies?

A

It can lead to companies cutting corners

48
Q

ALCOA data is about _________ to GMP/GXP & Good documentation practice

A

compliance

49
Q

Audit trail is a what type of data?

A

it is a metadata containing information relating to the creation, change or deletion of GMP/GXP records

50
Q

why is there suddenly concerns about data integrity (DI)

A

it’s due to globalisation of pharma industry, & increased outsourcing, emergence of industry 4.0, driven by big data & new technology

51
Q

what are some processes in the industry 4.0?

A
  • biotech
  • genetic engineering
  • nanotech
  • process analytical tech (PAT)
  • computerised systems
  • single use technologies (SUT)
  • supply chain integrity
    pharmaceutical DI and & control of falsified medicines

PR3145 (10 decks)

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