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Regulation > Documentation & Data Integrity > Flashcards

Documentation & Data Integrity Flashcards

1
Q

Chapter __ in the PIC/S Guide to Medicinal Products covers documentation

A

4

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2
Q

What is included in Chapter 4

A

1) Good documentation practice
2) Generation and control of documentation
3) Retention of documentation
4) Types of documents (SOPs, specifications, batch manufacturing records etc.)
5) Comprises of 32 clauses

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3
Q

What does ALCOA stand for

A 
Attributable
Legible
Contemporaneous 
Original
Accurate
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4
Q

Clause 4.3 - Attributable

A

Documents should be approved, dated and signed by authorized persons
Effective date of document should be defined

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5
Q

Clause 4.7 - Legible

A

Entries should be made in clear, indelible, legible way

Should be permanent, not easily removed

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6
Q

Clause 4.8 - Contemporaneous

A

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

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7
Q

Clause 4.9 - Original

A

Any alterations to document should:

1) Permit reading of original information
2) Signed and dated
3) Capture reason(s) for alteration

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8
Q

Clause 4.10 - Accurate

A

Integrity of records should be ensured throughout retention period
Accurate: Reliable, valid, correct data

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9
Q

Clause 4.11 & 4.12 - Retention periods

A

Batch manufacturing records should be kept 1 year after batch expiry
For investigational medicinal products, batch records should be kept 5 years after clinical trials

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10
Q

Types of documents

A

1) Instructional documents

2) Evidential documents

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11
Q

Types of instructional documents

A

1) Standard operating procedures (SOPs)
2) Batch manufacturing formula
3) Site master file

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12
Q

What do SOPs document

A

Describes who, what, when, where & how

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13
Q

What does batch manufacturing formula document

A

Describes manufacturing process
Includes amount of starting materials, equipment used, test methods used, acceptance criteria for IPQC/final QC, batch release

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14
Q

What does site master file document

A

Describes GMP-related activities of manufacturer

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15
Q

Types of evidential documents

A

1) Records

2) Reports

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16
Q

What are records

A

Documents that provide evidence of actions taken to demonstrate compliance

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17
Q

Types of records

A

1) Records of starting materials
2) Cleaning records
3) Pest control records
4) Temperature & RH monitoring records
5) QC testing records
6) Batch manufacturing records
7) Distribution records

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18
Q

What are reports

A

Documents capturing studies, investigations or projects, including results, conclusions and recommendations

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19
Q

Types of reports

A

1) Stability testing records
2) Process validation records
3) Process deviations / OOS reports
4) Internal quality audit (IQA) reports
5) CAPA reports

20
Q

What is pharmaceutical data

A

All original records (raw data & metadata) generated during GMP activity, and their subsequent transformation for complete reconstruction of GMP activity
Includes both evidential and instructional documents

21
Q

What is critical pharmaceutical data

A

Any manufacturing data which affects product quality

22
Q

What is raw data

A

Original records

23
Q

Raw data can be presented in the form of

A

1) E-records (modern computerized systems)

2) Print-outs (legacy electronic equipment)

24
Q

With the use of modern computerized systems today, ____ are NOT considered raw data

A

Print-outs

25
Q

Limitation of electronic data

A

May be tweaked/falsified without the knowledge of manufacturer / regulator / stakeholders, who do not have commensurate understanding

26
Q

What is metadata

A

Attributes that describe data to provide context for a better understanding of the pharmaceutical data

27
Q

Types of metadata

A

1) Units of measurement
2) Date/Time of measurement
3) Name of analyst
4) Type and model of equipment used

28
Q

PIC/S Guide to GMP Annex __ provides information on computerized systems

A

11

29
Q

Objective of computerized system validation (CSV)

CSV includes ___

A

Ensures accuracy, reliability and consistency of computerized system

Includes associated people (operators, system owners, process owners)
Includes 3rd party suppliers and service providers

30
Q

What is data integrity

A

Degree to which pharmaceutical data are ALCOA, making them reliable, accurate, valid and complete

31
Q

Current regulations & GMP standards to ensure DI are adequate

A

1) Pharmaceutical legislations (Health Products Act, Medicines Act)
2) PIC/S GMP Standard Chapter 4 & Annex 11
3) Industry guidance notes on computerized systems (e.g. ISPE GAMP5)

32
Q

DI issues and challenges

A

1) Globalization of pharmaceutical industry and increased outsourcing
2) Industry 4.0 (Pharma 4.0), driven by big data and new technology

33
Q

Falsified medicines: Medicines with ____, which may include false:

A

False representation

1) Manufacturer’s name / Batch no.
2) Composition of product
3) Packaging/Labelling
4) Batch manufacturing records
5) Certificate of analysis (CoA)
6) Stability testing reports / Process validation reports

34
Q

Types of data integrity violations

A

1) Intentional falsification

2) Bad practices / Poor data management

35
Q

__% of data integrity violations is due to bad practices/poor data mangagement, while __% is due to intentional falsification

A

75

25

36
Q

Bad practices/Poor data management can be reduced with ____

A

Education

37
Q

Examples of intentional falsifications

A

1) Tamper with system clock
- Falsify date/time stamp
- Non-contemporaneous recording of manufacturing / QC activities

2) Switching off / Tampering with audit trails

3) Injections and sequences of HPLC system not documented
- Can carry out repeat analyses of samples to cherry pick best results

4) Chromatograms and CoA/analytical records do not match (due to unauthorized tweaking of chromatogram peaks)

38
Q

What is an audit trail

A

Metadata containing information on addition / deletion / change to GMP/GXP records
Used to reconstruct manufacturing event, including who, what, where, when of action

39
Q

Requirements of audit trail

A

1) Should be presented in human readable form
2) Retained at least 1 year after batch expiry
3) Independently recorded

40
Q

Audit trail must include:

A

1) All original data/records
2) Any modifications/additions/deletions to data
3) Date and time of commitment/action of the data
4) Identity of operator(s) performing action

41
Q

All data should be ____

A

ALCOA

42
Q

Attributable data

A

Must have unique identification of creator of data/records
Paper data: Signature, date, personal seal
Electronic data: Personal login password & ID / Biometrics, electronic date and time

43
Q

Legible data

A

Data must be clear, permanent, traceable
Paper data: Use of indelible ink, single-line cross-outs with signature & date, no correction fluid/pencil
Electronic data: Use of computer systems with audit trails

44
Q

Contemporaneous data

A

Data must be recorded at time of generation
Paper data: Records entered immediately at time of generation, with date & time
Electronic data: Use computer systems with enforced saving of data, date & time stamps, ‘temporary folder’ should be disabled

45
Q

Original data

A

Data should not be tempered with throughout product life-cycle
Only authorized personnel allowed to modify/create/delete data
Paper data: No correction fluid/pencil/eraser, original paper records should be retained in secure area
Electronic data: No switching off/tampering with audit trail, original e-records should be routinely backed up with off-site storage in case of disasters

46
Q

Accuracy

A

Data must be accurate i.e. correct, complete, valid, reliable
Accuracy can be assured through:
1) Process and analytical methods validation
2) Investigation of process deviations / OOS
3) Keeping comprehensive batch manufacturing records
4) Robust CSV, calibration & maintenance programs

Regulation (6 decks)

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