Pharmaceutical Facility Management – New Book Released

Pharmaceutical Facility Management – New Book Released

New Delhi, India, February 9, 2005 – In a running pharmaceutical plant, the plant manager often has to manage a wide range of activities including production, machine maintenance, building maintenance, training of personnel, validation programs, environmental monitoring and last but not the least – managing regulatory inspections. This wide spectrum of activities entails the involvement of people from production, quality control, engineering, quality assurance, housekeeping etc. thus demanding a lot of time and efforts from the plant manager to effectively synchronize all these activities. Additionally, all work must be undertaken assuring minimal impact to all facility and plant operations while in compliance with cGMP (where required), regulations and policies, SOP’s, and federal codes. Expectedly, plant managers of most pharmaceutical companies are always on their toes and have to be in a constant state of readiness to meet any eventuality. An unexpected visit by a local regulatory inspector or a fire officer or even of the company CEO, can often be a cause for concern. Facility management if practiced on a continuous basis helps the plant manager to be on top in almost any situation and this results in tangible savings for the company.

In his new handbook aimed at the plant managers, the book PHARMACEUTICAL FACILITY MANAGEMENT – The Plant Manager’s Handbook (Business Horizons, $180 , ISBN 81-900788-6-0) is a welcome resource book providing practical solutions to everyday challenges facing a plant manager in a typical pharmaceutical facility.

It begins by providing possible solutions to common issues faced in the production department of tablets, capsules, liquid orals, topical preparations and the pharmaceutical water systems. Next, while providing a backdrop of the necessity of a computerized asset management system, delves into the typical structure of such systems and how a company should go about implementing it in their system in a practical and down to earth manner. Of special value in this part are the sections providing guidelines for small companies and the pros and cons of a preventive maintenance system. Practical advice for setting up and running a machine shop in a pharmaceutical factory is included in this chapter and also issues related to the safety and maintenance of such a workshop. Lastly regulatory and compliance issues are explained with respect to maintenance activities.

Chapter 3 goes deep into the issues involved with maintenance of various machines encountered in a pharmaceutical facility. Beginning with a detailed overview of company-wide calibration program and maintenance and repair of electric motors and pumps (which form a part of most machines), procedure for cleaning and maintenance of each machine is provided individually with a hands-on approach. This is followed by a very detailed and practical approach to running, maintaining and repairing common utilities like compressed air system, boiler system, HVAC/R and pharmaceutical water system. Detailed procedures are explained like cleaning and maintenance of ducts, AHU, chillers/condensers, cooling towers and clean room monitoring. Safety tips are especially mentioned for HVAC/R maintenance activities. For the water system, cleaning, passivation and sanitization procedures and options are explained in great detail. This chapter is very heavy in the field of pharmaceutical engineering.

Chapter 4 explores the issues involved with work environment and safety. It begins by detailing the commonly adopted procedures for housekeeping in various departments (tablets, capsules, liquids etc.) individually and goes on to the procedures for pest control and building maintenance, especially with respect to managing older buildings, roofing and indoor air quality. Procedures for creating a disaster management system for a facility are also explained. Next comes workplace safety, which is explained not only with the view of good engineering practices but also special features encountered only in pharmaceutical facilities and associated hazards are explained. Guidelines for a safety audit are also provided. Looking to the importance of electrical safety, a separate section has been provided in this chapter that includes electrical safety program, hazards encountered, work procedures and tools and first aid procedures specific to electrical accidents.

Chapter 5 enumerates the training programs of technical staff at a pharmaceutical manufacturing facility. It provides guidelines for writing a training program, structure of training programs and conducting and evaluating training sessions along with providing tips for becoming a better trainer. Some sample training programs have also been provided as examples. Chapter 6 provides validation program guidance and an extensive collection of sample formats for various validation documents required in a manufacturing facility. Environmental monitoring is covered in chapter 8 which has not really been covered in any such text observed for the pharmaceutical industry. It is interesting in that, it provides examples of companies having adopted greener technologies and having saved money in the process.

Lastly, chapter 9 is devoted entirely to regulatory inspections. Beginning with an in-depth study of worldwide trends in regulatory inspection, it gives practical guidance for the plant staff to prepare for and manage a regulatory inspection. It gives numerous scenarios where the factory staff are guided on what to say, and more importantly, what not to say to an inspector. There is a fine line that needs to be balanced between what information to provide and what to withhold from a regulatory inspector – all without offending anyone’s ego (professional or otherwise). The highlight of this book however is that it goes beyond the management aspect and delves deep into what inspectors are looking for when they come calling in various sections like tablet granulation, liquid packing etc. Most of the commonly encountered sections are dealt with individually and in a practical and down to earth manner.

J. P. S. Kohli is a pharmacy graduate from University of Delhi followed by Diploma in Management of Technology Transfer, Patents and Information Systems and has been involved in pharmaceutical engineering activities for last 18 years. He has wide ranging experience in the pharmaceutical industry, having worked in a pharmaceutical engineering company where the job responsibilities included overseeing the planning of plant layouts and supervision of installation of machines, followed by working in a pharmaceutical manufacturing facility as Manager-Projects and Exports.

Contact:
J. P. S. KOHLI
Business Horizons
http://www.businesshorizons.com