Dr Girish Pai K, Faculty – Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences gives details of an upcoming book which has documented several product defects/complaints with suitable illustrations to guide the readers in developing skills involved in identifying the root cause of complaints that occur in real-life situations
Quality is an important parameter that makes any consumer happy. Whether it is an electronic item, packed foods, FMCG products or any other marketed products, product complaints are a matter of concern. But when there is a Quality problem in a pharma product, it becomes a ‘serious’ matter of concern as it affects the health of already suffering patients and its implications are dangerous and life-threatening. Zero defect is the aim of a pharma manufacturer. But, complex processes, various challenges, market competition, regulatory hurdles and associated factors may lead to the escape of a defective product from a Quality system and reach the consumer, which, in turn, will spoil the goodwill and reputation of the company.
Subsequently, due to lack of awareness, the end-user unknowingly consumes these defective products which may lead to serious complications. Additionally, it is not only lack of awareness, but also the poor sense of observation of the personnel involved in the pharma field (across areas comprising from the design of the product to dispensing to a patient). Poor sense of observation or casual approach by personnel across areas like manufacturing, pharmacy outlets and hospital setups are importantly responsible for this error to occur.
Looking at the seriousness of the issue and with a commitment to creating awareness in the pharma field, a unique idea was initiated with an intention to educate both the academia and industry. The target group is faculty and students in academics and technical staff in the pharma industry.
Thus, this book titled “Pharmaceutical Consumer Complaints: A Guide to Academia and Pharmaceutical Industry” will be a useful guideline serving the pharma community. The purpose of the book is to ensure that ailing patients get Quality medicines. This manual or guide is a unique rare collection (live examples masking important information on the product pack like brand name, manufacturer, manufacturing license number, company logo etc) of product defects with information like dosage form, description of defects/complaints, probable root causes, preventive measures, remediation and clinical significance.
Till date, no attempt has been made so far to systematically document these complaints, to facilitate the training of students, pharma research scientists and production chemists. These complaints have been presented along with illustrations and an in-depth evaluation of the probable root causes, a general discussion, and possible remediation approaches to prevent its reoccurrence and a discussion on the clinical significance of the complaint. This section on the possible remediation approaches based on the invaluable experience of dealing with international auditors will ensure that the reader cultivates a comprehension approach to remediation resulting in successful rectification of the cause of the complaint.
Root Cause Analysis is an excellent tool to guide the decision process involved in identifying the cause of a complaint. While many books have dealt with the topic of root cause analysis, the presentation of possible root causes for the complaints illustrated in this book will guide the readers and help them to develop the skills involved in identifying the root cause of other complaints that the reader may come across in real-life situations. The contribution from various other well-experienced professionals from the industry is another great bonus for the reader of this book. This book will be a reference handbook for students and industrial process chemists and R&D chemists.
The book comprises of 50 unique real-life case studies and three relevant chapters matching the case studies in this book. This is first of its kind in pharma space and mainly prepared with an intention to impart knowledge to the outgoing pharma UG and PG students so that they are aware of such complaints beforehand and be industry ready to avoid such recurrences in their professional career. This is going to make a “serious difference” in the pharma manufacturing sector and pharmacy academia.
It is an ‘Encyclopedia of defects – Creating awareness for better Quality