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Pharmaceutical Manufacturing Lec > AO no. 43 S. 1999 Part 1: General Provisions > Flashcards

AO no. 43 S. 1999 Part 1: General Provisions Flashcards

1
Q

is addressed TO:

A

ALL DRUG AND DEVICES MANUFACTURERS, TRADERS AND PARTIES CONCERNED

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2
Q

SUBJECT:

A

CURRENT GOOD MANUFACTURING PRACTICE GUIDELINES FOR
DRUGS.

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3
Q

The _________ hereby adopts the 1st edition of Current Good Manufacturing Practice Guidelines and the specific GMP guidelines hereunder prescribed.

A

Bureau of Food and Drugs

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4
Q

The Bureau of Food and Drugs hereby adopts the ____ edition of Current Good Manufacturing Practice Guidelines and the specific GMP guidelines hereunder prescribed.

A

1st

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5
Q

Part 1 involves _________

A

general provisions

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6
Q

Part 1 Section 1

A

Authority

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7
Q

Section 1 Authority

This order is issued under the authority conferred upon the ________ by virtue of section 26(a) of RA 3720 as amended.

A

Secretary of Health

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8
Q

Section 1 Authority

This order is issued under the authority conferred upon the Secretary of Health by virtue of _________ as amended.

A

section 26(a) of RA 3720

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9
Q

Part 1 Section 2

A

Statement of policies

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10
Q

Section 2 Statement of Policies

2.1 Drugs shall be manufactured using _______, ________ & ________ adequate to preserve their identity, strength, quality and purity.

A

methods, facilities and control procedures

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11
Q

Section 2 Statement of Policies

2.1 Drugs shall be manufactured using methods, facilities and control procedures adequate to preserve their ______, ______, ______ & _______.

A

identity, strength, quality and purity.

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12
Q

Section 2 Statement of Policies

2.2 _____________ shall be issued only upon compliance with Current Good Manufacturing Practice guidelines.

A

License to manufacture drugs

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13
Q

Section 2 Statement of Policies

2.2 License to manufacture drugs shall be issued only upon compliance with _____________ guidelines.

A

Current Good Manufacturing Practice

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14
Q

Section 2 Statement of Policies

2.3 ___________ is essential to ensure the manufacture of drugs conforming officially recognized standards of quality, efficacy and safety.

A

Overall control

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15
Q

Section 2 Statement of Policies

2.3 Overall control is essential to ensure the manufacture of drugs conforming __________ of quality, efficacy and safety.

A

officially recognized standards

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16
Q

Section 2 Statement of Policies

2.4 The __________ depend on the starting materials, production, quality control processes, building, equipment, and personnel involved and testing protocols.

A

qualities of drug products

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17
Q

Part 1 Section 3

A

Statement of Objectives

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18
Q

Section 3 Statement of Objectives

3.1 _____________ in the manufacture of drug products
3.2 Ensure that no person or establishment shall manufacture drugs under ____________.

A

3.1 Prescribe standard guidelines

3.2 substandard conditions

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19
Q

Part 1 Section 4

A

Definition of Terms

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20
Q

The nearest value obtained during measurement or analysis to the true value.

A

Accuracy

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21
Q

The quantity that is actually produced at any phase of production of a particular
drug product based on the initial input.

A

Actual Yield

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22
Q

An enclosed space with two or more doors, which is interposed between two or more rooms e.g. of different standard of cleanliness for the purpose of controlling the air flow between those rooms when they need to be entered. An airlock may be designed for and used by either people or materials; in the latter case it can be termed a “pass through hatch”. An airlock can also be the “anteroom” to a clean room in which sterile goods are handled.

A

Airlock

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23
Q

airlock designed for materials

A

pass through hatch

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24
Q

A supplier of all components of finished products generally approved for use by the trade and accredited by the manufacturer based on a vendor rating which include but not limited to conformance to the company or compendium material specifications.

A

Approved Supplier

25
Q

A designation in numbers or letters or combination thereof that identifies the batch, and permits the tracing of the complete history of a batch, including all stages of its production, control and distribution.

A

Batch Number

25
Q

A quantity of drug product/device that is homogenous in character and quality produced during a given cycle of manufacture and from a specific manufacturing order.

A

Batch

26
Q

for identification and history of batch

A

Batch Number

27
Q

A contained system, such as a fermenter, into which biological agents are introduced together with other materials in order to effect their multiplication or their production of other substances by reaction with other materials.

A

Biogenerator

28
Q

are generally equipped with devices for regulation, control connection, material addition and material withdrawal.

A

Biogenerators

29
Q

include genetically engineered microorganisms, cell
cultures, as well as endoparasites, whether pathogenic or not.

A

Microbiological Agents

30
Q

collected from a single donor and processed either for transfusion
or further manufacturing.

A

Blood/Whole blood

31
Q

Any processed material which has to undergo another process including
packaging operation to become a finished product.

A

Bulk Product

32
Q

for any machine that provides numerical value

A

Calibration

33
Q

The operations carried out to determine the accuracy of measuring instruments, of “material measures” such as masses or gauges and of measurement standards.

A

Calibration

34
Q

Calibration should be done _________

A

quarterly

35
Q

A system whereby successive batches of a product manufactured by culture in cells derived from the same master cell bank

A

Cell Bank System

36
Q

The cell bank system is validated for a passage level or number of population doubling beyond that which was achieved during routine production.

A

Cell Bank System

37
Q

The in-vitro growing of cells isolated from multicellular organisms.

A

Cell Culture

38
Q

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

A

Clean Area

39
Q

The in-vitro serological tests performed on donor and recipient blood samples to establish the serological matching of a donor’s blood or blood components with that of a potential recipient.

A

Compatibility Testing

40
Q

Any material intended to be used for the manufacture of a product whether raw
or packaging materials.

A

Component

41
Q

An area constructed, operated and equipped with air-handling and filtration system in order to prevent contamination of the external environment by biological agents from within the area.

A

Contained Area

42
Q

Anything that cause contamination to the product.

A

Contaminants

43
Q

An area constructed and operated to control the introduction of potential contamination (an air supply approximately class III may be appropriate), and the consequences of accidental release of living organisms. The level of control exercise shall reflect the nature of the organism employed in the process. The area shall be maintained at a pressure negative to the immediate external environment and allow for the efficient removal of small quantities of airborne contaminants.

A

Controlled Area

44
Q

Contaminations of a starting, intermediate product or finished product.

A

Cross Contamination

45
Q

A container designed to store liquefied gas at extremely low temperature.

A

Cryogenic Vessel

46
Q

A container designed to store gas at a high pressure.

A

Cylinder

47
Q

The date indicating the start of processing of every batch.

A

Date of Manufacture

48
Q

The activity of weighing, counting or measuring and checking of starting materials and issuing these to the appropriate production personnel; details of the activity being duly and properly documented.

A

Dispensing

49
Q

Written recording of all procedures, instructions and processes involved in the manufacture of drug products.

A

Documentation

50
Q

Any substance or mixture of substances in finished dosage forms that is manufactured, offered for sale, or presented for use in (1) the treatment, mitigation, cure, prevention, or diagnosis of disease, abnormal physical state, or the symptoms thereof in man or animal; or (2) the restoration, correction or modification of organic functions in man or animal; regardless of whether it is in package form.

A

Drug Product

51
Q

Instrument, apparatus, or contrivances, including their components, parts and accessories, intended (1) for use in the diagnosis, cure, mitigation, or prevention of disease in man and animals; or (2) to affect the structure or any function of the body of man or animal.

A

Device

52
Q

A date fixed for each individual batch on or before which the batch is expected to meet the standard specifications for quality, safety and efficacy.

A

Expiration Date

53
Q

Any area used for the collection, processing, compatibility
testing, storage or distribution of blood and blood components.

A

Facilities For Blood Products

54
Q

This refers to the building, premises and equipment necessary in the manufacture of drugs.

A

Facilities For Other Products (drugs, medical devices, bulk chemical material and others)

55
Q

A product which has undergone all stages of manufacturing operations.

A

Finished Product

56
Q

It is the system of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate for their intended use. It is thus concerned with both manufacturing and quality control processes and procedures.

A

Good Manufacturing Practice (GMP)

57
Q
A

Pharmaceutical Manufacturing Lec (3 decks)

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