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a PR3145 > LEC 5 > Flashcards

LEC 5 Flashcards

1
Q

How to comply with GDP?

A
  1. Document what you do
    - instructional documentation
  2. Do what you document
  3. Prove it
    - evidential documentation (records & results)
  4. Improve it
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2
Q

What is GDP?

A

Good Documentation Practice

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3
Q

GDP = GMP ?

A

No.
GMP = Good Manufacturing Practice
GDP = Good Documentation Practice

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4
Q

DI and Documents must be _ _ _ _ _

A

ALCOA

Attributable 
Legible
Contemporaneous
Original
Accurate (complete, correct, valid & reliable)

BUT their descriptions and examples are different

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5
Q

Chapter 4 of PICs on Documentation coverage (5)

A
  1. Good Documentation Practices
  2. Generation & Control of documents
  3. Retention of documents
  4. Types of documents (instructional & evidential)
  5. 32 clauses
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6
Q

Attributable meaning (documentation)

A
  • documents must be dated, approved & signed by authorised persons
  • effective date of the document must be defined
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7
Q

Legible meaning (documentation)

A
  • entries must be made in a clear, legible & indelible way
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8
Q

Contemporaneous meaning (documentation)

A
  • record should be made at time of action

- must be traceable (do not switch off audit trails)

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9
Q

Original meaning (documentation)

A
  • any alterations made to the document must permit the reading of the original information
  • any alterations must be dated & signed with reasons
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10
Q

Accurate meaning (documentation)

A
  • integrity of records should be ensured throughout retention period
  • accurate : complete, correct, valid & reliable
  • batch manufacturing records (1y after expiry)
  • Investigational Manufacturing Products (IMP) & batch records (5y after clinical trials)
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11
Q

Types of documents (2)

A
  1. Instructional
    - SOP (who, what, when, where & how)
    - Batch Manufacturing Formula
    - Site Master File (document describing GMP-related activities)
  2. Evidential
    - records to prove compliance to GDP/GMP
    eg temperature/RH monitoring records
    - reports for validation (capture conduct of studies)
    eg CAPA reports, stability testing reports
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12
Q

From DI perspective, which kind of documents are of greatest concern?

A

Evidential documents (reports & records)

  1. They are evidence of QC tests conducted & compliance to GMP
  2. They can be tweaked
    Hence, they pose most data Integrity issues
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13
Q

Pharmaceutical data definition

A
  • includes all original records (raw & meta data) generated during a GMP activity and their subsequent transformation for complete reconstruction of GMP activity
  • includes instructional & evidential documents
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14
Q

Critical pharmaceutical data definition

A
  • any manufacturing data that can affect product quality

eg mass of API, volume of solvents

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15
Q

Data integrity definition

A

It is the degree to which pharmaceutical data are ALCOA, making the set of data complete, correct, valid and reliable.

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16
Q

Raw data definition

A

They are original records retained either in paper or electronic format

With the use of modern computerised systems, printouts should not be considered raw data

17
Q

Meta data definition

A

They are attributes that describe data & provide the context to better understanding of pharmaceutical data
eg mass unit (g)

18
Q

Can printouts be considered raw data?

A

No because with modern computerised system, data can be tweaked in the system & the printout may only reflect the corrected data (lack Original)

19
Q

Objective of Computerised System Validation (CSV)

A

To ensure computerised systems are :

  1. accurate
  2. reliable
  3. consistent
20
Q

What are the current regulations & GMP standards for manufacturers & inspectors? (3)

A
  1. HPA & Med Act
  2. PICs
  3. Industry Guidance Notes on Computerised Systems
21
Q

Are the current regulations & GMP standards adequate?

A

Yes

22
Q

Reason for concerns on DI

A
  1. Globalisation of pharma industry
    eg adulterated glycerin syrup (with diethylene glycol) was manufactured in China & repeatedly exported to other countries. Panama city children died from the adulterated syrup.
  2. Emergence of industry 4.0 driven by big data & new technology
23
Q

Reason for data integrity violations (2)

A
  1. Intentional falsifications (25%)
  2. Bad practice habits (75%)
    - education can help to eliminate data integrity violation
24
Q

Good practice in Data management should include _

A

Periodic review of Audit Trails by manufacturers & inspectors

25
Q

Requirements of an audit trail (4)

A
  1. all original data
  2. any alterations (changes, deletions & additions)
  3. date and time of action
  4. identity of operator(s) performing the act
  • today, it must be readable by human
  • retained for 1y after batch expiry
  • must be independently recorded (not under the control of the user)
26
Q

Can an audit trail be recorded by its user?

A

No, it must be independently recorded.

27
Q

Reason for audit trail

A

It facilitates the reconstruction of manufacturing events (who, where, what, when & how)

28
Q

What does DI depend on? (3)

A 
1. People
eg lack knowledge on GMP, bad behaviours
2. System/hardware
eg lack robust CSV, sharing of IDs 
3. Organisation culture
eg harsh punishments for mistakes committed
29
Q

Attributable meaning (data)

A
  • there must be unique identifications of creator of data/records
    eg user ID
30
Q

Legible meaning (data)

A
  • data must be clear, permanent & traceable

eg computer w audit trails

31
Q

Contemporaneous meaning (data)

A
  • data must be recorded at time of action

eg computer system with enforced saving of data/time

32
Q

Original meaning (data)

A
  • data has not been tampered

- original records should be retained

33
Q

Accurate meaning (data)

A
  • data has to be complete, correct, valid & reliable
34
Q

ALOCA data is about _

A

compliance to GDP & GMP

35
Q

Meaningful data

A

Must include both

  • raw data
  • meta data
36
Q

DI to ALCOA to GMP

A

DI is the degree to which data are ALCOA

Achieve ALOCOA data through GMP/GXP and good documentation practices

a PR3145 (14 decks)

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