Pharmaceutical manufacturing overview

Question 1

The entire manufacturing process is governed by

Answer 1

Good Manufacturing Practices (GMP)

Question 2

catastrophic for products

Answer 2

cross-contamination, adulteration, and

mislabeling

Question 3

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

Answer 3

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

Question 4

COMPONENTS OF GOOD MANUFACTURING PRACTICE

Answer 4

5 P’s

PEOPLE
PRODUCT
PROCESSES
PROCEDURES 
PREMISES

Question 5

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

Answer 5

ACTIVE PHARMACEUTICAL INGREDIENT (API)

Question 6

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.

Answer 6

AIRLOCK

Question 7

designed for people or goods and equipment use

Answer 7

AIRLOCK

Question 8

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

Answer 8

AUTHORIZED PERSON

Question 9

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

Answer 9

BATCH (OR LOT)

Question 10

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

Answer 10

BATCH NUMBER (OR LOT NUMBER)

Question 11

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.

Answer 11

BATCH RECORDS

Question 12

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

Answer 12

BULK PRODUCT

Question 13

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

Answer 13

CALIBRATION

Question 14

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.

Answer 14

CLEAN AREA

Question 15

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

Answer 15

CONSIGNMENT (OR DELIVERY

Question 16

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

Answer 16

CONTAMINATION

Question 17

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

Answer 17

CRITICAL OPERATION.

Question 18

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

Answer 18

CROSS-CONTAMINATION

Question 19

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

Answer 19

FINISHED PRODUCT

Question 20

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

Answer 20

IN-PROCESS CONTROL

Question 21

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

Answer 21

INTERMEDIATE PRODUCT

Question 22

Sterile solutions are intended for parenteral

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

Answer 22

LARGE-VOLUME PARENTERAL

Question 23

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

Answer 23

MANUFACTURE

Question 24

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

Answer 24

MANUFACTURER

Question 25

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.

Answer 25

MARKETING AUTHORIZATION

Question 26

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.

Answer 26

MASTER FORMULA

Question 27

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

Answer 27

MASTER RECORD

Question 28

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

Answer 28

PACKAGING

Question 29

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

Answer 29

PACKAGING MATERIAL

Question 30

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

Answer 30

PHARMACEUTICAL PRODUCT

Question 31

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

Answer 31

PRODUCTION

Question 32

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

Answer 32

QUALIFICATION.

Question 33

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.

Answer 33

QUALITY UNIT(S)

Question 34

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.

Answer 34

QUARANTINE.

Question 35

A comparison between the theoretical quantity and the actual quantity

Answer 35

RECONCILIATION

Question 36

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

Answer 36

RECOVERY

Question 37

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

Answer 37

REPROCESSING

Question 38

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

Answer 38

REWORKING

Question 39

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

Answer 39

REWORKING

Question 40

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.

Answer 40

SELF-CONTAINED AREA

Question 41

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

Answer 41

SELF-CONTAINED AREA

Question 42

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.

Answer 42

SPECIFICATION

Question 43

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)

Answer 43

STANDARD OPERATING PROCEDURE (SOP)

Question 44

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

Answer 44

STARTING MATERIAL

Question 45

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

Answer 45

VALIDATION

Question 46

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

Answer 46

QUALITY ASSURANCE

Question 47

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

Answer 47

QUALITY CONTROL

Question 48

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

Answer 48

Quality Risk Management

Question 49

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

Answer 49

Risk Identification

Question 50

The estimation of the risk associated with the | identified hazards

Answer 50

Risk Analysis

Question 51

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

Answer 51

Risk Evaluation

Question 52

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

Answer 52

Risk Control

Question 53

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

Answer 53

Risk Communication

Question 54

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

Answer 54

Diagram Analysis

Question 55

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

Answer 55

Risk Ranking and Filtering

Question 56

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

Answer 56

Risk Ranking and Filtering

Question 57

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

Answer 57

Fault-tree Analysis

Question 58

QRM Process

Answer 58

Initiation of QRM Risk Assessment Common Risk Management Tools

Question 59

Common Risk Management Tools

Answer 59

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