Equipment Qualification in the Pharmaceutical Industry

Steven Ostrove

• Éditeur: Academic Press
• Année: 2019
• ISBN:
  9780128175699
• Sujet: Medicine
• Sous-sujet: Pharmacology

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems.

Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.

• Incorporates good manufacturing processes into a compliant qualification program
• Provides examples of protocol layout
• Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements

Chapter One

Introduction

Abstract

This summary outlines the discussions found in this book. It lays the ground work as to why equipment qualification is done and some of the key questions leading to a successful qualification program.

Keywords

Compliance; Qualification; Validation; Prospective qualification; Retrospective qualification; Concurrent qualifications

There are several aspects to performing a good equipment qualification program. This book presents many of the ideas and possible solutions collected over many years in the industry.

As we begin the process of understanding how to perform an equipment qualification, several questions come to mind:

• • Why do we need to qualify the equipment?
• • Who can or who does the qualification?
• • What needs to be qualified?
• • What is qualification?
• • How much is it going to cost?
• • How long will it take?

In answer to the first question, qualification is needed for two major purposes. The first purpose is to demonstrate that the equipment is what was ordered and that it will function as needed for its intended use. In fact, if you think about it, everyone performs a qualification every time they purchase a new item: a new car, a new toaster, or a new house. The same steps are followed in determining that the unit is the one you want and that it works as you expect it to work. The big difference is that for the personal items the requirements and results are not being recorded. The second purpose is it is the law as specified in the Code of Federal Regulations (CFR) Title 21.^a

In answer to the second question, qualification usually falls at least in part on the engineering group but can be done by the validation group or any other person or group that is qualified and knowledgeable on the use and operation of the equipment and that has the training and experience to perform the tasks required.^b

In answer to the third question, read on. According to interpretation of the CFR Title 21,^c all equipment used in the manufacturing of a pharmaceutical (Aseptic, OTC, Tablet, device, etc.) and all equipment used in the laboratory for in-process testing or release and/or any unit used for the production of a device (classes I–III) needs to be qualified to be sure that they will work as intended and that the results of the testing are accurate and true results.

As to the fourth through sixth questions, often asked by management, this depends on the scope of the project, that is, number of units to be qualified, and the expertise of those doing the qualification (i.e., time it takes to write and execute the protocols). In short, qualification demonstrates that the equipment meets the requirements of the users, was received on-site in working order (or fixable), and will function as the users expect it to work for their product. Expense is not a valid consideration in determining how the program will be performed since it is required by the Food and Drug Administration (FDA) to be able to sell your product in the United States. That is what this book is all about.

In answer to the fifth and sixth questions, it depends. It depends on the number and complexity of the equipment to be qualified. It depends on the experience of the qualification team. It depends on previous experience and availability of protocols for similar units. And it depends on the risk analysis for each unit as it pertains not only to production but also to patient safety.

To further our understanding of the qualification process, three basic terms need to be defined and understood prior to taking on a Food and Drug Administration (FDA) qualification project. These are the following:

• • Compliance
• • Qualification
• • Validation

Compliance

According to the web dictionary^d:

• • “…the action or fact of complying with a wish or command”
• • “… the state or fact of according with or meeting rules or standards”

Qualification

According to the web dictionary^e:

• • “a condition or standard that must be complied with”^f

Validate/validation

According to the web dictionary^g,h:

• • to make legally
• • to support or corroborate on a sound or authoritative basis
• • to give legal force to; legalize
• • to give official sanction, confirmation, or approval to, as elected officials, election procedures, documents, etc.

The obvious first reason heard for qualifying process equipment is because the Food and Drug Administration (FDA) of the United States requires all pharmaceutical companies who manufacture, hold, or distribute a drug product or substance (virtual or other) to be compliant with the rules set out in the Federal Food, Drug, and Cosmetic (FD&C) Act as promulgated in the Code of Federal Regulations (CFR). But, qualification is employed for another very important (business) reason: “Did you receive what you ordered, and does it work as you need it to work?” As in the opening paragraph, qualification is performed every time a new purchase is made:

• For example, you purchase a new toaster. First the box is inspected, intact, and not damaged. Then the unit is removed from the box and placed on the counter. Question, is it what you expected the unit to be? Does it have two slots or four? The unit is then plugged in, and a piece of bread is inserted into one of the slots. The toast level is set, and the bread plunger is depressed. When it pops out, you check it for the level of darkness you like. Repeat as necessary (commissioning) until it is correct.

This example just followed all of the qualification steps that will be followed in manufacturing except it was not written down.

To acco...