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a PR3145 > LEC 5 > Flashcards

LEC 5 Flashcards

(36 cards)

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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

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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

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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?

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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)

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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)

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

Are the current regulations & GMP standards adequate?

22
Q

Reason for concerns on DI

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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)

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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 _

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A

Periodic review of Audit Trails by manufacturers & inspectors

25
Requirements of an audit trail (4)
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
Can an audit trail be recorded by its user?
No, it must be independently recorded.
27
Reason for audit trail
It facilitates the reconstruction of manufacturing events (who, where, what, when & how)
28
What does DI depend on? (3)
``` 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
Attributable meaning (data)
- there must be unique identifications of creator of data/records eg user ID
30
Legible meaning (data)
- data must be clear, permanent & traceable | eg computer w audit trails
31
Contemporaneous meaning (data)
- data must be recorded at time of action | eg computer system with enforced saving of data/time
32
Original meaning (data)
- data has not been tampered | - original records should be retained
33
Accurate meaning (data)
- data has to be complete, correct, valid & reliable
34
ALOCA data is about _
compliance to GDP & GMP
35
Meaningful data
Must include both - raw data - meta data
36
DI to ALCOA to GMP
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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