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Pharm Inspector :D > Good documentation practice and data integrity > Flashcards

Good documentation practice and data integrity Flashcards

1
Q

Steps in a documentation system complying with GMP

A
  1. Document what you do
  2. Do what you document
  3. Keep records to prove that the SOPs are followed
  4. Improve the process continually guided by PIC/S GMP standard/quality policy
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2
Q

What does ALCOA stand for?

A 
A: Attributable 
L: Legible 
C: Contemporaneous 
O: Original
A: Accurate
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3
Q

How long should records be kept/retained?

A

Batch manufacturing records: 1 year after batch expiry

Investigational medicinal products: 5 years after clinical trial

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4
Q

What is an SOP in an instructional document?

A

Document describing the 5Ws and 1H of procedures

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5
Q

What is a record in evidential document?

A

Document providing evidence of actions taken to demonstrate compliance such as:

  • Temperature/RH monitoring records
  • Pest Control Records
  • Cleaning Records
  • Batch Manufacturing records
  • Others such as records of QC, starting materials and distribution
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6
Q

What is a report in evidential documents, and what are some of its components?

A

Document capturing conduct of studies, projects or investigations together with results, conclusions and recommendations, such as:

  • Stability testing reports
  • Process Validation reports
  • OOS reports
  • IQA reports
  • CAPA reports
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7
Q

What is pharmaceutical data integrity?

A

Degree to which pharmaceutical data are ALCOA

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8
Q

What is pharmaceutical data?

A

Include all original records (raw and metadata) generated during GMP activity and subsequent transformation for complete reconstruction of GMP activity, covers evidential and instructional documents

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9
Q

What is critical pharmaceutical data?

A

Mass of APIs, volume of solvents, batch manufacturing records, analytical results, chromatograms, stability testing reports

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10
Q

What is raw data?

A

Original records retained either in paper or electronic format

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11
Q

What is meta data?

A

Attributes describing data and providing context to better understand pharmaceutical data

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12
Q

What comprises a computerised system?

A
  • Hardware and software
  • Includes associated people, 3rd party suppliers and service providers
  • Customised computerised systems (MRPS, LIMS)
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13
Q

Objectives of computerised systems validation:

A

It ensure:

  • Accuracy
  • Consistency
  • Reliability

of the Computerised system

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14
Q

What are some examples of intentional falsification?

A
  • Tampering with system clock
  • Switching off/tampering with audit trails
  • Injections and sequences of HPLC system not documented
  • Chromatograms and analytical record/CoA do not match
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15
Q

What are the requirements in periodic audit trail review by manufacturer?

A
  1. All Original data and records
  2. Any modification of data
  3. Date and time stamps of all actions
  4. Identify of operators performing such actions
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16
Q

What is an audit trail?

A
  • Form of meta data containing information relating to creation, change or deletion of GMP/GXP record
  • Date/time stamp of audit trails should be computer generated –> defined international time zones and date standards
17
Q

Which chapter of GMP is documentation under?

A

4

18
Q

Which annex is computerised systems under?

A

11

19
Q

What are the two types of documents involved in pharmaceutical data documentation?

A
  1. Instructional documents

2. Evidential documents

20
Q

What are the components that make up the instructional documents?

A
  1. SOP that describes 4W1H
  2. Batch manufacturing formula which describes manufacturing process (e.g. amount of starting materials, equipment, etc.)
  3. Site Master file: describes GMP-related activities of manufacturer
21
Q

What are the components that make up the evidential documents?

A
  1. Records: provides evidence of action taken to demonstrate compliance
  2. Reports: Capture conduct of studies, projects or investigations with results, conclusion and recommendations
22
Q

During an inspection, the manufacturer hands you a print out of a chromatogram from a HPLC. Would you consider the print out to be raw data?

A

No. With the use of computerised systems, printouts are NOT considered as raw data, as the electronic data could have been tampered with before printing

23
Q

The content of a data include the model of weighing balance that the manufacturer is using. What type of data is this?

A

Meta-Data

24
Q

What are some of the current regulations and GMP standards to assure adequate DI?

A
  1. Contraventions to falsifications
  2. PIC/S GMP Standard Chapter 4 and Annex 11
  3. industry guidance notes on Computerised systems (E.g. ISPE, GAMP5)
25
Q

What are falsified medicines?

A

Medicinal products with FALSE REPRESENTATION

26
Q

What are some information about falsified medicines may be false?

A
  1. Manufacturer’s Name/Batch Number
  2. Product Composition
  3. Packaging/Labels
  4. Manufacturing records and certs of analysis
  5. Stability testing & Process validation reports
27
Q

An original chromatogram is stored inside a computer. What type of data is that chromatogram?

A

Raw Data

28
Q

How long should an audit trail be retained?

A

At least 1 year after batch expiry

Pharm Inspector :D (8 decks)

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