<div style="text-align: center;"><strong>Elective</strong></div>

are a compilation of various guidelines/guidance documents/directives
issued and elaborated by international organizations and institutions

are guidelines which govern the production, distribution and supply of a drug.

is an international organization with the propose of making recommendations
and implementing standards of the International Organization for Standardization (ISO) to achieve greater harmonization in the understanding and application of the guidelines and technical requirements for registration of pharmaceutical products.

It provides an activity and constructive cooperation in the field of GMP with several objectives such as the implementation, development and maintenance of harmonized GMP standard and quality inspectors systems in the field of drugs

aims to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of human and veterinary medicines.

a decentralized agency of the European Union (EU).
The Agency is responsible for the scientific evaluation of medicinal products
developed by pharmaceutical companies in the EU.

is an agency of the US Department of Health and Human Services, which is responsible for protecting the Public Health by assuring the appropriate regulation of medicinal products for human use, and through the
encouragement of product innovations.It provides the accurate and science-based information of the medicinal products to the public

This guideline describes a comprehensive model for an effectiveness quality system of medicinal products, based on the concepts of ISO quality and its implementation throughout all stages of the life cycle of the product

constitutes an essential part of the quality assurance system and it is the key
to operate in compliance with GMP requirements.

concerned with sampling, specifications and testing
as well as the organization, documentation and release procedures
which ensure that the required 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 satisfactory.

It must be designed to detect any deficiency in the implementation of GMP and to recommed corrective procedures

evaluation and supervision of compliance of the manufacturer with GMP in all aspects of production and quality control.

an operation where a small fraction of the batch is removed integrating operations to select a portion of a pharmaceutical product for a specific purpose, in accordance with an appropriate procedure

In these requirements, manufacturers identify what validation work needed to prove control of the critical aspects of their particular operations

a system of release that provides assurance that the product is of the intended
quality based on information collected during the manufacturing process and in accordance with specific GMP requirements, annexes and related guidelines

GMP is a necessary condition for marketing authorization (MA)

True

False

PIC\s facilitating cooperation and networking for national regulatory authorities and international organisations.

True

False

EMA is responsible for emphasizing the development of guidelines, setting standards and contribution to international cooperation activities with authorities outside the EU

True

False

The objectives of the system of documentation must be to establish, monitor and record all activities with impact on all aspects of the quality of medicinal products

True

False

Production operations must clearly follow the procedures. They must comply with the principles of GMP in order to obtain quality products and be in accordance with the relevant manufacturing and MA.

True

False

Quality control is not confined to laboratory operations, but must be
involved in all decisions that may concern the quality of the product.

True

False

The independence of quality control from production is considered
fundamental to the satisfactory operation of quality control

True

False

This type of manufacture must strictly follow methods and preparation processes, carefully established and validated, since the quality assurance, is of particular importance

manufactured through methods that involve biological processes and materials, such as cultivation cells or extraction of material from living organisms.

according to the GMP guidelines of the EC/EEA, requires a special consideration mainly due to the particular nature of these dosage forms.

A consistent quality assurance requires more detailed information on its agricultural production.

The manufacture of sterile products should occur in......... whose access must be achieved through airlocks for personnel and/or equipment and materials

Class room

Clean areas

مكان تاني

مكان تالت

the agency that regulates the transport of radiopharmaceuticals and the requirements for protection against radiation

The International Atomic Energy Agency

Food and drug administration

اختيار غلط

اختيار غلط برضو

Procedures need to be flexible as the process increases, and it should be appropriate to the stage of development of the product.

True

False

It is noted that an increase in complexity in manufacturing operations requires a highly effective quality system

True

False

The requirements for the collection, testing and quality control of
medicinal products derived from human blood or plasma are
defined by a system of quality assurance

True

False

The guidelines of the EC/EEA are a guide of GMP to holders of medicinal products with MA or for export.

True

False

refers only to part of parametric release that deals with the routine release of finished products without carrying out a sterility test

EU guidelines

The PIC/S guidelines

Food and Drug Administration

seek covers a wide scope that includes a reduction or elimination of finished
products routine testing.

EU guidelines

The PIC/S guidelines

Food and Drug Administration

provides recommendations to applicants on the information to be
included as support of parametric release for sterile products terminally subjected to sterilization by moist heat, at the time of submission of a new medicinal product.

EU guidelines

The PIC/S guidelines

Food and Drug Administration

The PIC/S guidelines are not intended to be a barrier to technical innovation.

True

False

Parametric release does not mean that all tests specified should be executed in the finished product before release

True

False

According to EU guidelines, the implementation of parametric release is in line with the European Pharmacopoeia.

True

False

Samples are divided into categories:

Reference and retention

Reference only

Retention only

Non

Quality risk management can be applied not only in the manufacturing environment, but also in connection with the pharmaceutical development and preparation of quality part of the dossier for MA.

True

False

parenteral products require additionally tests for volume in container, sterility, pyrogens, clarity and particulate analysis and glass-seal ampoules, leaker tasting.

True

False

Sterility Testing include all except

Direct transfer to test media

Membrane filtration technique

Limulus test

It is carried out by transferring aseptically the specified volume of the parenteral product from each test container to culture media (both aerobic
and anaerobic).

Direct transfer to test media

Membrane filtration technique

Limulus test

It is the method of choice for liquids and soluble powders especially those possessing bacteriostatic or fungistatic properties.

Direct transfer to test media

Membrane filtration technique

Limulus test

It is useful for oily solution, ointments, and creams that can be diluted with diluting fluids.

Direct transfer to test media

Membrane filtration technique

Limulus test

A membrane generally suitable for sterility testing has a porosity of 0.45 ± 0.02 u m.

True

False

Pyrogen Testing include all except

Rabbit test

Limulus test

Membrane filtration technique

A new method for pyrogen detection is known as

Rabbit test

Limulus test

Membrane filtration technique

According to USP the test is carried out by injecting in an ear vein of each ............... with 10 ml of the test solution per kg body weight, through 10 min

5 rabbits

4 rabbits

3 rabbits

2 rabbits

The solution is non- pyrogenic if no rabbit shows an individual rise in temperature of 0.6°C or the sum of the temperature rise of
the rabbits does not exceed 1.4°C

True

False

Limulus test: A test sample is incubated with ............. From the
blood of the horseshoe crab (Limulus polyphemus).

Lipase

Lysate

Ligase

Limulus test: A pyrogenic substance will cause a.......

Gel

Emulsion

Suspension

Ampoules which have been sealed by fusion must be tested to ensure that a tight seal was obtained.

True

False

The, leaker test is performed by

Immersing the ampoules in a dye solution, such as 1% methylene blue

Inspected against a black and sometimes a white background within a sort of light lamp.

Leaker Testing: Defective ampoules will contain blue solution.

True

False

............is defined as the state or quality of being clear or transparent to the eye.

Clarity

Sterility

Pyrogens

Clarity Testing: All products containing clear solutions should be inspected
against a black and sometimes a white background within a
sort of light lamp

True

False

The light source usually recommended is a .......... Luminescent lamp

100 w

150 w

200 w

50 w

B.P gave two limits for LVP not more than 100 particles of 5µm and larger/ml and not more than 1000 particles of 2µm and larger

True

False

Elective

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