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midterm Flashcards

1
Q

• is an essential part of a 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

• It subsequently supports the quality, and its uniformity, 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.

A

Documentation (OPPI Guideline)

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3
Q

COVERAGE
Good documentation encompasses practically all the aspect of pharmaceutical production :

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

maintenance
installation
cleaning
validation

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5
Q
  1. Equipment :
A

maintenance
installation ,
cleaning
calibration
, validation , ,

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6
Q
  1. Personnel :
A

Training, hygiene etc

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7
Q
  1. Materials:
A

ware-housing,
use,
rejection/disposal.
testing,
specification,

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8
Q

: individual steps in the process of manufacturing including controls thereof.

  1. Finished goods:
A
  1. Processing

specifications,
storage
testing,
distribution,
rejection/disposal.

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9
Q

coverage
• Complaints:

A

investigation, actions (including recall, if necessary). (OPPI Guidelines)

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10
Q

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

A

Have a clear title.
Have an identification number.
Be approved by authorized person.
Have the date of issue Have a due date of revision.
List to whom it has been issued.

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11
Q

•Where the documents carry instructions _______
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.

A

e.g. batch processing)

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12
Q

should provide for a periodic review, and revision, if necessary, of any document, or part thereof.

A

Documentation system

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13
Q

shall also be approved by the authorized persons.

A

revised versions

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14
Q

shall also be superseding the previous edition, and the document shall clearly indicate this.

A

Updated/revised versions

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15
Q

shall be immediately removed from active use, and copy retained only for reference.

A

Outdate/superseded document

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16
Q

If documentation is through_______ (computerized system) there shall be adequate, reliable systems in place:

A

electronic data processing system

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17
Q

For implementing efficient documentation practices, which meet, full GLP/GMP/ISO and FDA requirements. Here is a hint from the “documents” model, which lists out the areas required for GMP document implementation:

A

D= Design, development, deviations, dossiers and Drug Master Files for regulated markets, distribution records
O= Operational procedures/techniques/methods, Out of specifications (OOS), Out of trend (OOT) C= Cleaning, calibration, controls, complaints, containers and closures, contamination and change
control
U= User requirement specifications, utilities like water systems, HVAC, AHU etc.
M= Man, materials, machines, methods, maintenance, manufacturing operations and controls,
monitoring, master formula, manuals (quality, safety and environment), medical records
E= Engineering control and practices, Environment control, Equipment qualification documents N= Non-routine activities, New products and substances
T = Technology transfer, training, testing, Trend analysis, Technical dossiers
S= SOPs, safety practices, sanitation, storage, self-inspection, standardization, supplier qualification, specifications and standard test procedures and site master file. (Quality Assurance)

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18
Q

is 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

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19
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

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20
Q

• is 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

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21
Q

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

A

• The Standard operating procedure

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22
Q
  • the inspector has to know what operation come before and after his inspection
A
  1. When to inspect
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23
Q

– He should know what to look for during inspection

A
  1. What to inspect
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24
Q

– what is acceptable and what is unacceptable for each
characteristics inspected

A
  1. Inspection standards
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25
Q

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

A
  1. Inspection method
26
Q

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

A
  1. How to report data
27
Q

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

A
  1. Material handling
28
Q

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

A
  1. Administrative procedures
29
Q

Overview: Guidelines forManufacturers and Traders

A

Implementationo of
Administrative Order No. 2019-0007

30
Q

❑ 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

A

OBJECTIVES of Implementation of
Administrative Order No. 2019-0007

31
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

32
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

33
Q

The same process can apply for traders, with the exemption of the production process that is subcontracted to a manufacturer.
The coverage of the contract between a trader and a manufacturer vary, depending on the agreement between the two establishments.

A

Manufacturing process

34
Q

These are the key areas that a manufacturer needs to establish and maintain for its operation.
The FDA shall be issuing a detailed guideline for all areas and shall be discussed during the

A

Operational Requirements

QPIRA Seminar

35
Q

Quality System

A

Quality Control
Personnel
Premise
Equipment
Documentation
Sanitation and Hygiene Production

36
Q

Quality System

A

Quality Control
Personnel
Premise
Equipment
Documentation
Sanitation and Hygiene Production

37
Q

❑ A comprehensively designed and correctly implemented to system ensure the attainment the ocofmpany’s
objectives
❑ A company’s quality system must
be appropriate for its current activity
❑ The company must at least eitstabqliusahlity manual, organizational structure, procedures, controls, work instructions, forms, and other records.

A

Control system

38
Q

❑ A comprehensively designed and correctly implemented to system ensure the attainment the company’s objectives
❑ A company’s quality system must
be appropriate for its current activity
❑ The company must at least eitstabqliusahlity manual, organizational structure, procedures, controls, work instructions, forms, and other records.

A

Quality system

39
Q

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

A

Site Master File

40
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

41
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

42
Q

Written instructions of the performance of specific activities.

A

Standard Operating Procedures

43
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

44
Q

Documentation
SITE MASTER FILE

A

I. Table of Contents
II. Company Overview
III. Personnel
V. Documentation
VI. Contract Manufacturing and Analysis
VII. Internal Quality Audit and FDA Reporting and Inspection

45
Q

SOP

A

• Training of personnel
• Handling of Raw Materials
• Handling of Raw Materials
• Production Procedure
• Batch Numbering System
• Handling of Finished Products
• Storage
• Distribution of Finished Products
• Handling of Complaints
• Product Recall
• Laboratory Analysis of Finished Products
• Records Keeping

46
Q

SOP

A

• Training of personnel
• Handling of Raw Materials
• Handling of Raw Materials
• Production Procedure
• Batch Numbering System
• Handling of Finished Products
• Storage
• Distribution of Finished Products
• Handling of Complaints
• Product Recall
• Laboratory Analysis of Finished Products
• Records Keeping

47
Q

PERSONNEL
General Requirements:

A
  1. Organizational chart showing the hierarchy of responsibilities
  2. Personnel File
48
Q

PERSONNEL
General Requirements:

A
  1. Organizational chart showing the hierarchy of responsibilities
  2. Personnel File
49
Q
  1. Organizational chart showing the hierarchy of responsibilities
A

General Manager / President
Head of Admin and Sales
Admin
Sales
Production Manager
Warehouse
Processing
Quality Assurance Manager
Quality Control

50
Q
  1. Personnel File
A

• Qualifications and background
• Job description
• Duties and responsibilities
• Training records
• Medical records

51
Q
  1. Personnel File
A

• Qualifications and background
• Job description
• Duties and responsibilities
• Training records
• Medical records

52
Q
  1. Personnel File
A

• Qualifications and background
• Job description
• Duties and responsibilities
• Training records
• Medical records

53
Q

shall mean any material, including printed material, employed in the packaging of product, excluding any outer packaging used for transportation or shipment, that is in direct contact with the electronic cigarette refill solution

A

Primary packaging

54
Q

Develop and establish SOPs in production
Ensure proper implementation of SOPs within the production area at all times
Ensure production personnel are capacitated prior to deployment in the production area
Ensure all areas of the production facility are well maintained

A

PRODUCTION MANAGER

55
Q

• Must be an Allied Health Science Professional (e.g. PRC registered pharmacist, chemist, chemical engineer, nurse, med tech, etc.)
• Establish standard operating procedures for inspection, testing and clearance of starting materials, packaging materials, intermediate, bulk and finished products;
• Ensure all starting materials, packaging materials, intermediate, and finished products are of quality and within current standards
• Ensure all critical processes of the company are followed accordingly based on written procedures and policies
• Keep and maintain all documents and records of the company
• Approve and monitor 3rd party testing laboratories
• Lead the conduct of internal quality audits and investigations.

A

QUALITY ASSUARANCE MANAGER

56
Q

Ensure that all operations of the company are in accordance with current national standards and regulations
Ensure that all the necessary marketing authorizations are secured and up-to-date prior to operation and/or distribution of products
Shall act as the point person of the company in relation to FDA- related processes

A

QUALIFIED PERSON

57
Q

can also serve as the Qualified Person

A

The Quality Assurance Manager

58
Q

can also serve as the Qualified Person

A

The Quality Assurance Manager

59
Q

shall mean any material, including printed material, employed in the packaging of product, excluding any outer packaging used for transportation or shipment, that is in direct contact with the electronic cigarette refill solution

A

Primary packaging

60
Q

shall mean any material, including printed material, employed in the packaging of product, excluding any outer packaging used for transportation or shipment, that is not in direct contact with the electronic cigarette refill solution (e.g. product inserts, tags,
etc.)

A

Secondary packaging

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