ACTIVITY ONE

Read the text below and summarize it in less than 200 words.

Quality cannot be adequately assured by in-process and finished inspections and testing but it should
be built in to the manufacturing process. These processes should be controlled in order that the
finished product meets all quality specifications Validation is one of the important steps in achieving
and maintaining the quality of the final product. If each step of production process is validated we can
assure that the final product is of the best quality. Validation of the individual steps of the processes is
called the process validation. Different dosage forms have different validation protocols. Quality is
always an imperative prerequisite when we consider any product. Therefore, drugs must be
manufactured to the highest quality levels. Process Validation is one of the important steps in
achieving and maintaining the quality of final product. It gives a higher degree of assurance.

TYPES OF VALIDATION

Prospective validation

The objective of the prospective validation is to prove or demonstrate that the process will work in
accordance with validation protocol prepared for the pilot production trials. Prospective validation
should normally be completed prior to the distribution and sale of the medicinal product. In
Prospective Validation, the validation protocol is executed before the process is put into commercial
use. During the product development phase the production process should be broken down into
individual steps. Each step should be evaluated on the basis of experience or theoretical considerations
to determine the critical parameters that may affect the quality of the finished product. A series of
experiments should be designed to determine the criticality of these factors. Each experiment should
be planned and documented fully in an authorized protocol

Concurrent validation
It is a process where current production batches are used to monitor processing parameters. It gives of
the present batch being studied, and offers limited assurance regarding consistency of quality from
batch to batch. Concurrent Validation means establishing documented evidence a process does what it
is supposed to base on data generated during actual implementation of the process. Concurrent
validation may be the practical approach under certain circumstances. It is important in these cases
when the systems and equipment to be used have been fully validated previously.

Retrospective validation

Conducted fir a product already being marked, and is based on extensive data accumulated over
several lots and over time. Retrospective Validation may be used for older products which were not
validated by the fabricator at the time that they were first marketed, and which is now to be validated
to confirm to the requirements of division 2, Part C of the Regulation to be Food and Drugs Act.
Retrospective Validation is only acceptable for well-established detailed processes and will be
Inappropriate where there have recent changes in the formulation of the products, operating
procedures, equipment and facility.

Revalidation
Re-validation is usually performed to the confirmation of initial validation for a Periodic review. Re-
validation provides the evidence that changes in a process and /or the process environment that are
introduced do not adversely affect process characteristics and product quality. Documentation
requirements will be the same as for the initial validation of the process. Revalidation becomes
necessary in certain situations.
PROCESS VALIDATION
Process Validation is “Establishing documented evidence which provides a high degree of assurance
that a specific process will consistently produce a product meeting its pre-determined specifications
and quality attributes. Process validation involves a series of activities taking place over the lifecycle
of the product and process. This guidance describes process validation activities in three stages.
Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based
on knowledge gained through development and scale-up activities.

Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the
process is capable of reproducible commercial manufacturing.

Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that
the process remains in a state of control. A successful validation program depends upon information
and knowledge from product and process development. This knowledge and understanding is the basis
for establishing an approach to control the manufacturing process that results in products with the
desired quality attributes.

ACTIVITY TWO

Translate this paragraph into French.

Regulatory affairs (RA) professionals play critical roles in a pharmaceutical industry because
it is concern about the healthcare product lifecycle, it provide strategic, tactical and
operational direction and support for working within regulations to expedite the development
and delivery of safe and effective healthcare products to individuals around the world. The
role of regulatory affairs is to develop and execute a regulatory strategy to ensure that the
collective efforts of the drug developmentteam results in a product that is approvable by
global regulators but is also differentiated from the
competition in some way and also is to ensure that the company’s activities, from non-clinical
researchthrough to advertising and promotion, are conducted in accordance with the
regulations and guidelines established by regulatory authorities. Regulatory Affairs is an
attractive career choice for graduate students from a scientific background who enjoy
communication and team work, are comfortable with multi-tasking and are eager to expand
their knowledge in the wide realms of the Pharmaceutical world. Regulatory Affairs is a
rewarding, intellectually stimulating and highly regarded profession within pharmaceutical
companies.

ACTIVITY THREE

Write an essay (150-200 words) about ONE of the topics bellow:

1. Young people are said to have lost many of the traditional values of the older
generation. This does not matter, because the old values have no relevance in the
modern world. We need to develop a whole new set of values.
Do you support this statement?

2. We live in a technological age. However, technology cannot solve all

ACTIVITY ONE
Quality assurance is important to the manufacturing process it ensure that the product meets all quality
specifications. To give a higher degree of assurance we contribute a process validation, instead of process
validation there are 4 more types of validation: Prospective validation, Concurrent validation, Retrospective
validation, and Revalidation.

The objective of the prospective validation is to prove or demonstrate that the process will work in
accordance with validation protocol prepared for the pilot production trials.

Concurrent Validation means establishing documented evidence a process does what it is supposed to base on
data generated during actual implementation of the process.

Conducted fir a product already being marked and is based on extensive data accumulated over several lots
and over time.

Re- validation provides the evidence that changes in a process and /or the process environment that are
introduced do not adversely affect process characteristics and product quality.

Finally, Process Validation is Establishing documented evidence which provides a high degree of assurance
that specific process will consistently produce a product meeting its pre-determined specifications and quality
attributes. There are three stages of process validation activities: Process design, Process qualification and
continued process verification.

ACTIVITY TWO

Les affaires réglementaires professionnels jouent un rôle critique dans l’industrie pharmaceutique, parce
qu’elles concernent la santé du produit durant son cycle de vie, ces derniers fournit des orientations stratégique
tactique opérationnelle et un soutien pour travailler avec réglementation dans le but de faciliter le
développement et la livraison d’un produit sécurisé et de bonne santé aux personnes du monde entier.

Le rôle des affaires réglementaires est de développer et d’exécuter une stratégie réglementaire pour assurer
que l’effort collectif de l’équipe du développement des médicaments se traduit par un produit approuvé par
tous les organismes réglementaires mais aussi différencié de la compétition d’une certain façon et aussi pour
assurer que les activités de l’entreprise, de la recherche non-clinique, de la publicité et de la promotion soient
effectué en accord avec les règlements et les instructions établis par les autorités réglementaires.

Les affaires réglementaires est un choix de carrière attractive pour les étudiants fraichement diplômé avec
une arrière-plan scientifique qui aiment la communication et le travail d’équipe, sont confortable avec le multi
taches et impatient d’élargir leurs connaissances dans le monde pharmaceutique.

Les affaires règlementaires sont une profession enrichissante, intellectuellement stimulante et hautement
appréciée dans les sociétés pharmaceutiques.

ACTIVITY THREE

2- We live in a technological age. However, technology cannot solve all the

Nowadays, we live in a world of technology that grows every day, we cannot deny that this
technology has made our living easier than before, but the use of this technology must be
chosen selectively to avoid damages.
Technological world have their advantages and damages, we can rely to it to solve our
problems, but we should employ it effectively and efficiency. Personally, I share this point
of view for several reasons.

First of all, technology have been a part of our lives due to computer, internet and also
smartphone. Human should control the use of technology especially teenagers because if
we lose control, we will become addicted and that could bring a psychological disease.

Moreover, by the growth of technology we became able to improve our health, cure any
disease, predict disasters faster and more good things that serves humanity, in other hand if
we use that technology for the bad side, we could destroy humanity in the ugliest ways, for
example the construction of powerful weapons.

To summarize, Technology comes for the good of humanity. I strongly believe that its
advantages clearly outweigh its disadvantages, and that it can contribute greatly to the
development of the world.