Quality in the pharmaceutical industry

By Hegazovich

This book discusses all related to quality in the pharmaceutical industry including validarion, calibration, qualification, quality, effecacy, safety, ISO and so on.

• Language: English
• Publisher: Hegazovich
• Release date: Jun 27, 2023
• ISBN: 9798223245490

Hegazovich

Holding the bachelor degree of pharmacy from 6th October university Hospital and community pharmacist Reviewer for pharmaceutical journals Researcher in medical and pharmaceutical sciences 

Book preview

Thank you Letter to

Prof- Muhammed Ashraf

––––––––

Dear Prof. Muhammed Ashraf,

I realize that teaching is often a thankless job, but I saw how you poured your heart and soul into daily lessons. Your passion for your students is inspiring to us as students.

Just because you don’t hear the words ‘thank you’ every day, do not think that I am not grateful for your effort.

Thank you for believing in my dreams.

You have provided me with all the means I need to plan my future and to make my dreams possible.

Only a special person, such as you, could have given this gift. Thank you so much.

Yours faithfully,

Your student Ahmed Abd El-Moniem Amer

Introduction

Quality definition:

✓  Fitness for intended purpose

✓  The intrinsic characters of the product which satisfy the users’ needs.

Criteria of quality:

✓  Safety

✓  Efficacy

✓  Reliability

❖  Safety and efficacy are not separate from quality but are a part of it.

Brief history:

Quality and safety control mechanisms were introduced by US regulatory authorities in response to health disasters:

›  Elixir sulfanilamide:

✓  A toxic cough syrup that killed 107 people in the US

✓  The US introduced the first safety standards for pharmaceuticals in 1938.

›  Thalidomide disaster:

✓  A sleeping pill and prescribed to pregnant women to treat morning sickness.

✓  Although safe for adults, it was toxic to fetuses.

✓  After the thalidomide tragedy, the US introduced even more stringent approval procedures requiring proof of efficacy in addition to safety before marketing pharmaceutical products.

❖  1st GMP guidelines for manufacturing, processing, packing, or holding finished pharmaceuticals introduced by US FDA (Food and Drug Administration).

❖  Many countries developed their own GMP guidelines which are based on the WHO guidelines.

The Egyptian Guide GMP for medicinal Products consists of 9 chapters covering the following Items:

✓  CHAPTER 1- QUALITY MANAGEMENT SYSTEM (QMS)

✓  CHAPTER 2- PERSONNEL

✓  CHAPTER 3- PREMESIS AND EQUIPMENT

✓  CHAPTER 4- DOCUMNETATION

✓  CHAPTER 5- PRODUCTION

✓  CHAPTER 6-