Pharmaceutical Quality Control

An in-plant training report, submitted to the Apex Pharma Limited, in partial fulfillment of

the requirement of the In-plant Training Certificate.

Submitted by

A. K. M. Radowan Ahmad

Ashrafi Karim

Zarin Tasneem

Submitted to

Apex Pharma Limited (Factory)

Shafipur, Gazipur.

Bangladesh.

Declaration by the In-plant Training Candidates

We, A. K. M. Radowan Ahmad, Ashrafi Karim and Zarin Tasneem, hereby declare that

the dissertation entitled “Pharmaceutical Quality Control”, is submitted by us to the Apex

Pharma Limited (Factory), Shafipur, Gazipur, Bangladesh, in partial fulfillment of the

requirement of the In-plant Training Certificate and is a bonafide record of original in-

plant training carried out by us (A. K. M. Radowan Ahmad, Ashrafi Karim and Zarin

Tasneem) from 15 January, 2014 to 11 February, 2014 at Apex Pharma Limited under the

supervision of Md. Mehedi Hasan, Senior executive, Apex Pharma Limited and it has not

formed the basis for the award of any other Degree/Diploma/Certificate or other similar

title to any other candidates.

Signature of the Candidates

A. K. M. Radowan Ahmad

Ashrafi Karim

Zarin Tasneem

Certificate

This is to certify that the report entitled “Pharmaceutical Quality Control” submitted to the

Apex Pharma Limited (Factory), Shafipur, Gazipur, Bangladesh, in partial fulfillment of

the requirement of the In-plant Training Certificate was carried out by A. K. M. Radowan

Ahmad, Ashrafi Karim and Zarin Tasneem under my supervision and that no part of the

thesis has been submitted for any other degree or certificate.

……………………………………

Md. Mehedi Hasan

Senior Executive

Apex Pharma Limited

Acknowledgement

First, all praise and glory are to Allah for the bounties granted to me and only with His

guidance, mercy and help this achievement has become possible.

We would like to specially thank Mr. Syed Manzur Elahi (Chairman of Apex Group of

Industry) and M. A. Khashru (GM Apex Pharma Limited) for making this training

possible for us.

We wish to express our thanks and gratitude towards our supervisor Md. Mehedi Hasan,

Senior Executive, for his constant encouragement, helpful discussion and guidance

throughout the training period. And would like to thanks Mr. Rokonuzzaman Rony, Mr.

Shohidul, Mr. Nazmul, Mr. Ruhul Amin for their precious help. Without their knowledge

and guidance we would have never been able to develop such a crystal clear concept about

the quality aspects of a pharmaceutical industry.

With that a special thanks to Mr. Salekin, Mr. Khaled, Tanvir Ahamed Talukder, Mr.

Shohag, Mr. Hedaiyat, Mr. Jahir for their endless support and sharing of knowledge

throughout the training period which was very helpful for us to understand the activities

proceed in a pharmaceutical company.

Moreover, we would like to articulate our earnest appreciation to the executive team for

giving us the prospect to perform our In-plant Training at Apex Pharma Limited. Our In-

plant Training at Apex Pharma Limited was the first step towards our professional life as

Pharmacists and it would have never been possible without the endless support by the

Apex management.

So our grateful thank to each and every individual starting from the managers, officers and

all the employees helped us in every way they could and cooperated with their utmost

levels which enabled us to develop a vivid concept of the maxims that form the pillars of a

truly quality compliant pharmaceutical company. Our training program helped convert

theoretical knowledge learned at our university into practical aspects and principles.

Finally in the training period, we must convey that, everyone is to be thanked for helping

us in making this experience become successful. If we lacked in any aspect, the fault is

absolutely ours, but we promise to improvise in the steps we take into our professional

life.

Introduction

The word “QUALITY” has its origin in a Latin word “Qualitas” means ‘general exllence’

or ‘a distinctive feature’. Oxford Reference Dictionary defines quality as- “A standard of

how good something is as measured against other similar things.” From this definition we

come across some key words, which are:

Standard

Measurement

Goodness and

Comparison

Means we are trying to measure some thing (quality attributes) with a standard (may be a

reference standard or a set of specifications) to know where the object in a question stands

in the continuum of the expectation of its quality attributes being assured or measured