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Pharm Manufacturing > Pharmaceutical manufacturing overview > Flashcards

Pharmaceutical manufacturing overview Flashcards

1
Q

The entire manufacturing process is governed by

A

Good Manufacturing Practices (GMP)

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2
Q

catastrophic for products

A

cross-contamination, adulteration, and

mislabeling

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3
Q

Some areas that can influence the safety and quality of products that GMP guidelines and regulations address are the following

A
  1. Quality management
  2. Sanitation and hygiene
  3. Building and facilities
  4. Equipment
  5. Raw materials
  6. Personnel
  7. Validation and qualification
  8. Complaints
  9. Documentation and recordkeeping
  10. Inspections & quality audits
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4
Q

COMPONENTS OF GOOD MANUFACTURING PRACTICE

A

5 P’s

PEOPLE
PRODUCT
PROCESSES
PROCEDURES 
PREMISES
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5
Q

Such substances are intended to furnish pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body

A

ACTIVE PHARMACEUTICAL INGREDIENT (API)

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6
Q

An enclosed space with two or more doors interposed between two or more rooms, e.g. of differing classes of cleanliness, controls the airflow between those rooms when they need to be entered.

A

AIRLOCK

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7
Q

designed for people or goods and equipment use

A

AIRLOCK

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8
Q

The person recognized by the national regulatory authority as responsible for ensuring that each batch of the finished product has been manufactured, tested and approved for release in compliance with the laws and regulations in force in that country

A

AUTHORIZED PERSON

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9
Q

A defined quantity of starting material, packaging material, or product processed in a single process or series of processes so that it is expected to be homogeneous

A

BATCH (OR LOT)

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10
Q

A distinctive combination of numbers and letters uniquely identifies a batch on the labels, its batch records and corresponding certificates of analysis, etc.

A

BATCH NUMBER (OR LOT NUMBER)

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11
Q

All documents are associated with manufacturing a batch of bulk or finished products. They provide a history of each batch of products and all circumstances pertinent to the quality of the final product.

A

BATCH RECORDS

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12
Q

Any product that has completed all processing stages up to, but not including, final packaging.

A

BULK PRODUCT

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13
Q

Under specified conditions, the set of operations establishes the relationship between values indicated by an instrument or system for measuring (especially weighing), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard.
Limits for acceptance of the results of measuring should be established

A

CALIBRATION

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14
Q

An area with defined environmental control of particulate and microbial contamination is constructed and used in such a way as to reduce the introduction, generation, and retention of contaminants within the area.

A

CLEAN AREA

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15
Q

The number of pharmaceuticals made by one manufacturer and supplied at once in response to a particular request or order. may comprise one or more packages or containers and may include material belonging to more than one batch

A

CONSIGNMENT (OR DELIVERY

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16
Q

The undesired introduction of impurities of a chemical or microbiological nature, or foreign matter, into or onto a starting material or intermediate during production, sampling, packaging or repackaging, storage or transport

A

CONTAMINATION

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17
Q

An operation in the manufacturing process may cause variation in the quality of the pharmaceutical product

A

CRITICAL OPERATION.

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18
Q

Contamination of a starting material, intermediate product or finished product with another starting material or product during production.

A

CROSS-CONTAMINATION

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19
Q

A finished dosage form has undergone all stages of manufacture, including the packaging in its final container and labelling

A

FINISHED PRODUCT

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20
Q

Checks are performed during production to monitor and, if necessary, adjust the process to ensure that the product conforms to its specifications

  • control of the environment or equipment
A

IN-PROCESS CONTROL

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21
Q

The partly processed product must undergo further manufacturing before it becomes a bulk product

A

INTERMEDIATE PRODUCT

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22
Q

Sterile solutions are intended for parenteral

application with 100 ml or more volume in one container of the finished dosage form

A

LARGE-VOLUME PARENTERAL

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23
Q

All operations of purchase of materials and products, production, quality control (QC), release, storage and distribution of pharmaceutical products, and the related controls.

A

MANUFACTURE

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24
Q

A company that carries out operations such as production, packaging, repackaging, labelling and relabelling of pharmaceuticals

A

MANUFACTURER

25
Q

A legal document issued by the competent medicines regulatory authority establishes the
detailed composition and formulation of the product and the pharmacopoeial or other recognized specifications of its ingredients and the final product itself. It includes details of packaging, labelling and shelf-life.

A

MARKETING AUTHORIZATION

26
Q

A document or set of documents specifying the starting materials with their quantities and the packaging materials, with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls.

A

MASTER FORMULA

27
Q

A document or set of documents serves as a basis for batch documentation (a blank batch record).

A

MASTER RECORD

28
Q

All operations include filling and labelling that a bulk product must undergo to become a finished product

A

PACKAGING

29
Q

Any material, including printed material, employed in the packaging of a pharmaceutical, but excluding any outer packaging used for transportation or shipment

A

PACKAGING MATERIAL

30
Q

Any material or product intended for human or
veterinary use presented in its finished dosage form or as a starting material for use in such a dosage form that is subject to control by pharmaceutical legislation in the exporting State and the importing State

A

PHARMACEUTICAL PRODUCT

31
Q

All operations involved in preparing a pharmaceutical product, from receipt of materials, through processing, packaging and repackaging, labelling and relabeling, to completion of the finished product

A

PRODUCTION

32
Q

The action of proving that any premises, systems and items of equipment work correctly and lead to the expected results.

A

QUALIFICATION.

33
Q

An organizational unit independent of production which fulfils both quality assurance (QA) and quality control (QC) responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.

A

QUALITY UNIT(S)

34
Q

The status of starting or packaging materials, intermediates, or bulk or finished products isolated physically or by other effective means. At the same time, a decision is awaited on their release, rejection or reprocessing.

A

QUARANTINE.

35
Q

A comparison between the theoretical quantity and the actual quantity

A

RECONCILIATION

36
Q

The introduction of all or part of previous batches (or of redistilled solvents and similar products) of the required quality into another batch at a defined stage of manufacture. It includes the removal of impurities from waste to obtain a pure substance or recovering used materials for different use

A

RECOVERY

37
Q

Subjecting all or part of a batch or lot of an in-process medicine, bulk process intermediate (final biological bulk intermediate) or bulk product of a single batch or lot to a previous step in the validated manufacturing process due to failure to meet predetermined specifications

A

REPROCESSING

38
Q

Subjecting an in-process or bulk process intermediate (final biological bulk intermediate) or final product of a single batch to an alternate manufacturing process due to a failure to meet predetermined specification

A

REWORKING

39
Q

REWORKING OR REPROCESSING

Which is not pre-approved as part of the market authorization

A

REWORKING

40
Q

Premises which provide complete and total separation of all aspects of an operation, including personnel and equipment movement, with well established procedures, controls and monitoring.

A

SELF-CONTAINED AREA

41
Q

This includes physical barriers and separate air-handling systems but does not necessarily imply two distinct and separate buildings.

A

SELF-CONTAINED AREA

42
Q

A list of detailed requirements for the products or materials used or obtained during manufacture must conform. They serve as a basis for quality evaluation.

A

SPECIFICATION

43
Q

An authorized written procedure gives instructions for performing operations not necessarily specific to a given product or material (e.g. equipment operation, maintenance and cleaning; validation; cleaning of premises and environmental control; sampling and inspection)

A

STANDARD OPERATING PROCEDURE (SOP)

44
Q

Any substance of a defined quality is used in producing a pharmaceutical product, excluding packaging materials

A

STARTING MATERIAL

45
Q

Under the principles of GMP, the action of proving that any procedure, process, equipment, material, activity or system leads to the expected results

A

VALIDATION

46
Q

It is the total of the organized arrangements made to ensure that medicinal products are of the quality required for their intended use.

A

QUALITY ASSURANCE

47
Q

part of Good Manufacturing Practice that is concerned with sampling, specifications, and testing, and with the organization, documentation, and release procedures which ensure that the necessary and relevant tests are carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory

A

QUALITY CONTROL

48
Q

A systematic process for assessing, controlling,
communicating and reviewing risks to the quality of the medicinal product. It can be applied both proactively and retrospectively

A

Quality Risk Management

49
Q

The systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description

A

Risk Identification

50
Q

The estimation of the risk associated with the

identified hazards

A

Risk Analysis

51
Q

The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk

A

Risk Evaluation

52
Q

The sharing of information about risk and risk
management between the decisionmaker and other stakeholders. It is a decision-making activity designed to reduce and accept risks

A

Risk Control

53
Q

The output and associated risk analysis justifying the approach taken should be documented and
communicated to key stakeholders

A

Risk Communication

54
Q

Simple techniques that are commonly used to gather and organize data, structure the risk management process, and facilitate decision-making

A

Diagram Analysis

55
Q

▪ Typically involves evaluating diverse quantitative and qualitative factors for each risk and weighing factors and risk scores.

A

Risk Ranking and Filtering

56
Q

▪ Useful for situations when the risk and underlying consequences are diverse and challenging to compare using a single tool

A

Risk Ranking and Filtering

57
Q

▪ The method used to identify all root causes of an assumed failure or problem
▪ Used to investigate product complaints

A

Fault-tree Analysis

58
Q

QRM Process

A

Initiation of QRM
Risk Assessment
Common Risk Management Tools

59
Q

Common Risk Management Tools

A

Diagram Analysis
Risk Ranking and Filtering
Fault-tree Analysis
Hazard Operability Analysis (HAZOP)

Pharm Manufacturing (2 decks)

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