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Compliance & GMP > L5 > Flashcards

L5 Flashcards

1
Q

Data Integrity is a new regulatory expectation. T/F?

A

False.
Data integrity has been an integral component of GMP since the 1st GMP standard in 1962!
Chapter 4 covers documentation.

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2
Q

How do we develop a documentation system that complies with GMP? (Hint: 4 steps)

A
  1. Document what you do - Write SOP
  2. Do what you document - Follow SOP
  3. Prove it = Prove that SOP is followed
  4. Improve it - Improve processes continually guided by PICS GMP Standard/Quality Policy (Improve on SOP)
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3
Q

What does ALCOA stand for?

A 
Attributable 
Legible 
Contemporaneous 
Original 
Accurate
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4
Q

What are the two different types of documents?

A
  1. Instructional

2. Evidential

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5
Q

Between Instructional documents and Evidential documents, which are of greater concern from a data integrity perspective?

A

Evidential documents.

They are evidence of QC tests conducted / GMP compliance, and may be tweaked!

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6
Q

What is critical pharmaceutical data?

A

Manufacturing data that affect product quality.

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7
Q

What is data integrity in the context of pharmaceutical manufacturing?

A

The degree to which pharmaceutical data are ALCOA.

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8
Q

What are records? Give examples of records

A

Documents that provide evidence of ACTIONS TAKEN to demonstrate compliance.

Examples:
Temperature and RH monitoring records, Pest Control Records, Cleaning Records, Records of Starting Materials, Batch Manufacturing Records, QC records, Distribution Records

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9
Q

What are reports? Give examples of reports

A

Documents that capture CONDUCT OF STUDIES, projects or investigations, together with results, conclusions and recommendations.

Examples of Reports:

  1. Stability Testing Reports
  2. Process Validation Reports
  3. Process Deviations/OOS (Outside of Specifications) Report
  4. IQA (Internal Quality Audit) Reports
  5. CAPA Reports (Corrective Action and Preventive Action)
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10
Q

What is raw data?

A

Original records (retained either in paper or electronic format)

Note: Print outs are not considered raw data in today’s context (Availability of e-records that have more proof of originality)

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11
Q

What is meta data?

Give examples of Meta Data

A

Attributes that describe data (Gives the context)

Example: Unit of Weight, Date and time of weighing, name of analyst, type and model of weighing balance etc

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12
Q

A computerised system consists of the computer hardware and software only. T/F?

A

False.
Computerised system comprises:
- Hardware & Software, additionally also
- Associated people
- 3rd part suppliers & service providers

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13
Q

The objective of Computerised Systems Validation (CSV) is to ensure which 3 aspects of the system?
(Hint: CAR)

A
  1. Consistency
  2. Accuracy
  3. Reliability
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14
Q

Why are concerns of data integrity increasing?

A
  1. Industry 4.0 (more data generated and need to be monitored)
  2. Globalisation and Outsourcing (difficult to monitor)
    - e.g. Manufacturers of API located overseas, harder to inspect (Hard to conduct surprise visits etc.)
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15
Q

What is falsified medicine?

A

Medicinal products or API with false representation, and is forms part of data integrity violations

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16
Q

Does intentional falsification or bad practices constitute a larger % of the causes of falsified data?

A 
Bad practices (75%)
Intentional Falsification of data forms only about 25%
Important to single out intentional falsifications from bad practices
17
Q

What should an audit trail include?

Hint: 4W

A

Audit trail is a form of metadata, containing information relating to modification/deletion/creation of GMP/GXP records. It facilitates reconstruction of manufacturing events (4W - Who, When, Why, What)

It should include:

  1. All original data / records
  2. Any alteration, addition, deletion or modification of data (WHAT)
  3. Data & times of the actions (WHEN)
  4. Identity of the operator performing the action (WHO)
18
Q

How long should audit trails be retained for after batch expiry?

A

1 year

19
Q

What are the examples of Evidential Documents? (2)

A
  1. Reports

2. Records

20
Q

List the requirements of an audit trail, and state how long audit trails must be kept for

A

An audit trail must include:

  1. All original data/records
  2. Alterations, additions, deletion or modification of data
  3. Data and times of action of data
  4. Identity of operator performing such actions

All audit trails must be readable, and kept for at least 1 year after batch expiry

21
Q

Audit Trails are meta-data or raw data?

A

Meta-data

22
Q

Purpose of an audit trail?

A

They are meta-data containing information relating to modifications/deletion/creation of GMP/GXP records, and facilitates reconstruction of a manufacturing event (4Ws of an event).

Compliance & GMP (7 decks)

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