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MANU > Documentation and Inspection > Flashcards

Documentation and Inspection Flashcards

1
Q

An essential part of good manufacturing practices. It defines a scheme of information so that risks of characteristic in misconception and/or error in oral communication will be minimized.

A

Documentation

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2
Q

Documentation subsequently supports the ___ , and its ___ , of all goods and services, as those in charge for the specific operations have clear, definite instructions to follow including active drug substances, is legally
mandatory. (OPPI Guideline)

A

quality; uniformity

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3
Q

OPPI

A

Organization of Pharmaceutical Producers of India

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4
Q

COVERAGE

Good documentation encompasses practically all the aspect of pharmaceutical production: (6)

A
  1. Building and Premises
  2. Personnel
  3. Equipment
  4. Materials
  5. Processing
  6. Finished goods

*Complaints

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5
Q

COVERAGE

Good documentation encompasses practically all the aspect of pharmaceutical production:

  1. Building and premises
A
  • Installation
  • Validation
  • Cleaning
  • Maintenance
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6
Q

COVERAGE

Good documentation encompasses practically all the aspect of pharmaceutical production:

  1. Personnel
A
  • Training
  • Hygiene
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7
Q

COVERAGE

Good documentation encompasses practically all the aspect of pharmaceutical production:

  1. Equipment
A
  • Installation
  • Calibration
  • Validation
  • Maintenance
  • Cleaning
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8
Q

COVERAGE

Good documentation encompasses practically all the aspect of pharmaceutical production:

  1. Materials
A
  • Specification
  • Testing
  • Ware-housing
  • Use
  • Rejection/disposal
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9
Q

COVERAGE

Good documentation encompasses practically all the aspect of pharmaceutical production:

  1. Processing
A
  • Individual steps in the process of manufacturing including controls thereof
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10
Q

COVERAGE

Good documentation encompasses practically all the aspect of pharmaceutical production:

  1. Finished goods
A
  • Specifications
  • Testing
  • Storage
  • Distribution
  • Rejection/disposal
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11
Q

COVERAGE

Good documentation encompasses practically all the aspect of pharmaceutical production:

*Complaints

A
  • Investigation
  • Actions (including recall, if necessary) [OPPI Guidelines]
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12
Q

DOCUMENT CHARACTERISTICS

For actual use of documents, they should be planned and prepared with greatest care Each document shall:

A
  1. Have a clear title.
  2. Have an identification number.
  3. Be approved by authorized person.
  4. Have the date of issue
  5. Have a due date of revision.
  6. List to whom it has been issued.
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13
Q

Where the documents carry instructions (e.g. batch processing)

A
  • The instructions shall be precise and not ambiguous.
  • They shall be for each individual step and not combined. E.g. Weigh the materials; charge the weighed materials into the blend
  • Instructions shall be in imperative mood.
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14
Q

Where entry of any data (e.g. temperature, weight) is expected to be made by the person using the document:

A
  • Sufficient space shall be provided for making the entry.
  • Heading shall clearly indicate what is to be entered, and who is responsible.
  • All entries shall be in ink.
  • All entries shall be clear and legible.
  • Person making the entries shall confirm the entry by initialing/signing the same.
  • An error in entry shall be so corrected that the original (wrong) entry is not lost. such correction shall also be initialed and dated. Where necessary, reason for correction shall also be recorded, initialed and dated.
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15
Q

Documentation system should provide for a ___ , and ___ , if necessary, of any document, or part thereof.

A

periodic review; revision

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16
Q

Such revised versions shall also be approved by the ___ .

A

authorized persons

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17
Q

Updated/revised versions shall also be ___ the previous edition, and the document shall clearly indicate this.

A

superseding

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18
Q

___ shall be immediately removed from active use, and copy retained only for reference. If documentation is through electronic data processing system (computerized system) there shall be adequate, reliable systems in place:

A

Outdate/superseded document

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19
Q

For implementing efficient documentation practices, which meet, full ___ requirements.

A

GLP/GMP/ISO and FDA

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20
Q

“DOCUMENTS” model (areas required for GMP document implementation)

D

A

Design,
Development,
Deviations,
Dossiers and Drug Master Files for regulated markets,
Distribution records

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21
Q

“DOCUMENTS” model (areas required for GMP document implementation)

O

A

Operational procedures/techniques/method
Out of specifications (OOS),
Out of trend (OOT)

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22
Q

“DOCUMENTS” model (areas required for GMP document implementation)

C

A

Cleaning,
Calibration,
Controls,
Complaints,
Containers and closures,
Contamination and change control

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23
Q

“DOCUMENTS” model (areas required for GMP document implementation)

C

A

Cleaning,
Calibration,
Controls,
Complaints,
Containers and closures,
Contamination and change control

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24
Q

“DOCUMENTS” model (areas required for GMP document implementation)

U

A

User requirement specifications,
Utilities (water systems, HVAC, AHU etc.)

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25
Q

“DOCUMENTS” model (areas required for GMP document implementation)

M

A

Man,
Materials,
Machines,
Methods,
Maintenance,
Manufacturing operations and controls,
Monitoring,
Master formula, manuals (quality, safety and environment),
Medical records

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26
Q

“DOCUMENTS” model (areas required for GMP document implementation)

E

A

Engineering control and practices,
Environment control,
Equipment qualification documents

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27
Q

“DOCUMENTS” model (areas required for GMP document implementation)

N

A

Non-routine activities,
New products and substances

28
Q

“DOCUMENTS” model (areas required for GMP document implementation)

T

A

Technology transfer,
Training,
Testing,
Trend analysis,
Technical dossiers

29
Q

“DOCUMENTS” model (areas required for GMP document implementation)

S

A

SOPs,
Safety practices,
Sanitation,
Storage,
Self-inspection,
Standardization,
Supplier qualification,
Specifications and standard test procedures and site master file. (Quality Assurance)

30
Q

Reference for Coverage and Document Characteristics: OPP1 Guidelines

A specific document compiled, checked, authorized and approved by an experienced personnel as necessary and appropriate. As with any other documentation master formula record shall also be open for review. If there are changes, it should be approved by designated staff responsible for production and quality control.

A

Master Formula Record

31
Q

Master formula record shall:

A
  • Give patent/proprietary name of the product, and its strength.
  • Give pharmacopoeia/generic name of the product, and its strength.
  • Give dosage form (e.g. tablet, ampoule) and physical characteristics of the product.
  • Give sufficient, detailed information of product pack and primary packaging materials.
  • Give identity, quality and quantity of every ingredient, including overages/assay value based quantities, if any, irrespective of whether, or not, the material
32
Q

Master Formula Record

A
  • Is an active drug substance in the formulation/product,
  • Is used as a pharmaceutical aid (excipient).
  • Appears, or is detected/tested in the final product.
  • Briefly describe all the raw materials
  • Give broad outlines of the process of manufacture (as a flow-chart, for example).
  • Give brief description of equipment/ machinery used for manufacturing the product
33
Q

One of the function of quality control. This function is performed by alert individual who have understood the written instructions is provide in the SOP on how to inspect certain quality
characteristics

A

Inspection

34
Q

The ___ is a step by step method on how to go about a specific job. The ___ in inspection should include one of those of the basic types of information needed by an inspector

A

Standard Operating Procedure (SOP)

35
Q

The inspector has to know what operation come before and after his inspection

A

When to inspect

36
Q

He should know what to look for during inspection

A

What to inspect

37
Q

what is acceptable and what is unacceptable for each characteristics inspected

A

Inspecting standards

38
Q

The procedures that will results in the most effective inspection and that will permit reliable interpretation of the results of inspection

A

Inspection method

39
Q

The inspector has to know the data recording and reporting
procedures so that the information he provides can be truly reliable

A

How to report data

40
Q

He has to know the appropriate actions to take with the materials he handles

A

Material handling

41
Q

The inspector has to know the rules and procedures which govern his conduct on the job

A

Administrative procedures

42
Q

Guidelines for Manufacturers and Traders

A

Implementation of Administrative Order No. 2019-2017

43
Q

Objectives of the AO

A
  • To provide stakeholders engaged in the manufacturing processes for ENDS/ENNDS products a general overview of FDA’s regulation for manufacturers and traders
  • To ensure that all concerned stakeholders understand the process for the application of a license to operate and the regulatory requirements during operations
44
Q

Means an establishment engaged in any and all operations involved in the production of health products including preparation, processing, compounding, formulating, filling, packing, repacking, altering, ornamenting, finishing and labeling with the end in view of its storage, sale or distribution. A trader shall be categorized a manufacturer.

A

Manufacturer

45
Q

Means any establishment which is a registered owner of a health product and procures the raw materials and packing components and provides the production monographs, quality control standards and procedures, but subcontract the manufacture of such product to a
licensed manufacturer. In addition, a trader may also engage in the distribution and/or marketing of its products.

A

Trader

46
Q

The same process can apply for
traders, with the exemption of the production process that is
subcontracted to a manufacturer.

A

Manufacturing Process

47
Q

Manufacturing Process

The coverage of the ___ between a trader and a manufacturer vary, depending on the agreement between the two establishments.

A

contract

48
Q

Manufacturing Process (6)

A
  1. Formulation
  2. Procurement and Preparation of Raw Materials
  3. Production Process
  4. Testing and Inspection
  5. Storage/Warehousing
  6. Delivery/Distribution
49
Q

These are the key areas that a
manufacturer needs to establish
and maintain for its operation.

A

Operational Requirements

50
Q

The FDA shall be issuing a
detailed guideline for all areas
and shall be discussed during
the QPIRA Seminar

A

Operational Requirements

51
Q

Operational Requirements (6)

A
  • Quality System Documentation
  • Personnel
  • Premise
  • Equipment Sanitation Hygiene Production
  • Quality Control
52
Q

A comprehensively correctly implemented system ensure
the attainment of designed and to the company’s objectives

A

Quality System

53
Q

A company’s quality system must be appropriate for its current activity. The company must at least establish its ___ , ___ , ___ , ___ , ___ , ___ , and other ___ .

A

quality manual;
organizational structure;
procedures;
controls;
work instructions;
forms;
records

54
Q

A document providing a general overview of the structure and activities of the manufacturer.

A

Site Master File

55
Q

Describe in detail the requirements with which the materials used or obtained during manufacture have to conform. They serve as a basis
for quality evaluation.

A

Raw Material Specifications

56
Q

This contains all information about the manufacturing process for the product and the expected output. This document is kept and controlled by the QA personnel.

A

Master Formula, Procedures, and Standards

57
Q

Written instructions of the performance of specific activities.

A

Standard Operating Procedures

58
Q

Provide evidence of various actions taken to demonstrate compliance with instructions, e.g. activities, events, investigations, and in the case of manufactured batches a history of each batch of product, including its distribution. Records include the raw data which is used to generate other records. For electronic records regulated users should define which data are to be used as raw data. At least, all data on which quality decisions are based should be defined as raw data.

A

Records

59
Q

DOCUMENTATION

Site Master File (7)

A
  1. Table of Contents
  2. Company Overview
  3. Personnel
  4. Premise and Equipment
  5. Documentation
  6. Contract Manufacturing and Analysis
  7. Internal Quality Audit and FDA Reporting and Inspection
60
Q

DOCUMENTATION

Site Master File

II. Company Overview

A
  • General Information
  • Site Overview
  • Products Produced
61
Q

DOCUMENTATION

Site Master File

III. Personnel

A
  • Organizational Chart
  • Employees with Job Description
  • Training Requirements
  • Health and Hygiene
  • Requirements
62
Q

DOCUMENTATION

Site Master File

IV. Premise and Equipment

A
  • General Location of Site
  • Detailed Site Layout (with dimensions)
  • Personnel, Material, and Product Flow
  • List of Manufacturing Equipment
  • Maintenance and Calibration
63
Q

DOCUMENTATION

Site Master File

V. Documentation

A
  • SOPs and Forms
64
Q

DOCUMENTATION

Site Master File

VI. Contract Manufacturing and Analysis

A
  • Toll Manufactured Products
  • Analysis Contracted Out
65
Q

DOCUMENTATION

Site Master File

VII. Internal Quality Audit and FDA Reporting and Inspection

A
  • Inspections Conducted
  • Compliance History
66
Q

Standard Operating Procedures (11)

A
  1. Training of personnel
  2. Handling of Raw Materials
  3. Production Procedure
  4. Batch Numbering System
  5. Handling of Finished Products
  6. Storage
  7. Distribution of Finished Products
  8. Handling of Complaints
  9. Product Recall
  10. Laboratory Analysis of Finished Products
  11. Records Keeping

MANU (2 decks)

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