Prof. Raymond C. Jagessar obtained his BSc (Distinction) in Chemistry/Biology from the University of Guyana (1992) and his PhD from the UK (1995). He held three Post Doctoral Research Fellowships at the University of South Carolina (USA), Wichita State University (USA) and the University of the West Indies (1996-1999). He has also won several international awards, amongst them are Chartered Chemist, CChem and Fellow of the Royal Society of Chemistry, FRSC, UK. His research interests are broad, covering the spectrum of Pure and Applied Chemistry, Chemical Biology, Pharmaceutical and Medicinal Chemistry. He has published over seventy (70) research articles, five book chapters and presented at several international conferences. He is currently Professor in Chemistry at the University of Guyana (South America)

Diabetes mellitus also is a group of metabolic diseases in which a person blood sugar level is higher above the threshold limit. This may result from the inability of the pancreas to secrete insulin or the body cells are resistant to insulin. Diabetes results in a wide range of ailments in humans that can ultimately lead to death. These include: heart diseases and stroke, nerve damage, diabetic neuropathy, erectile dysfunction, retinopathy, slow healing of cuts, burns and wounds, high blood pressure and cholesterol, diabetic nephropathy, nerve damage, leading to nausea, constipation or diarrhea. Thus, diabetes is a serious disease worldwide. The status of diabetes (diabetic mortality and diabetic morbidity) in Guyana was investigated over a period of time 2003 to 2008.There was a general increase in the diabetic mortality number from 2003 to 2008. This may have been

due to the eating habits and lifestyle of the populace in that region. Over the period 2003 to 2008, the average mortality of

403.5±29.30 was observed. A variance value of 162, 812.25 was computed. The confidence at the 95% level was calculated to be

403.5±9.57. Morbidity is the state of being diseased. This was recorded over the period 2003 to 2009. For the years 2003 to 2008, a mean morbidity of 9,506.71±496.86 was recorded. The confidence interval was found to 9,506.71±139.12. In general, there was an increase in morbidity from 8,920 in 2003 to 15,727 in 2009. The highest entry of 15, 727 were obtained in 2009. Diabetes can be controlled by both synthetic and herbal treatments. Synthetic treatments include the use of Insulin Secretagogues (Sulfonylureas), biguanides, Thiazolidinediones, α- Glucosidase, Glucagon etc. Herbal treatments include plant parts from Momordica charantia, Phyllanthus niruri, Cajanus cajan, Desmodium barbatum, Tinospora cordifolia, Azadirachta indica, Abrus precatorius, Catharanthus roseus, Centella asiatica, Curcuma longa, Phyllanthus emblica, Piper betle and Sphaeranthus indicus.

Muhammad Naeem has 19 plus years diversified experience in Quality Operations, Regulatory Affairs, Research and development and Operational Excellence. He is RAC-Global certified. He is an active member of ISPE, PDA and RAPS, USA. He has an extensive knowledge of ICH, USP, BP, and HACCP. He has lead several Investigational/Developmental and Technical/Analytical Projects at CMOs in USA, Europe and Pakistan. Some of the major pharmaceuticals he served are Pfizer & Takeda (USA), CCL Pharmaceuticals and Indus Pharma (Pakistan). He has strong scientific, analytical, planning, managerial and training skills. He has attended many national and international conferences as a speaker on Quality Risk Management, Data integrity, Pharmacovigilance, QMS elements, Validation, cGMP Guidelines, etc.

Introduction: The use of multiproduct facilities for the production of pharmaceutical products is need of time to allow products to be brought to patients in a timely and cost-effective manner. Doing this safely requires an understanding of the products, the facilities, the processes, and the equipment and the risks posed by this combination. The major risk of concern within shared facilities is the risk of cross-contamination. New GMP guidance for the EU came into effect in 2015 that requires a risk management process to determine if products can be safely manufactured in shared facilities. This new GMP requirement left industry unsure how to perform and document these risk assessments. User must understand the relationship of hazard, exposure, and risk. If done properly, the stakeholders should be able to demonstrate a full understanding of the processes being evaluated. A consistent approach across the hazard continuum is integral in this approach so that the regulators can be confident that a well thought out plan to reduce risk to an acceptable level has been established. Professionals in the pharmaceutical industry should move forward with a consistent approach on setting acceptable limits to assess the potential of cross-contamination causing an undue risk to patient safety. This approach is intended to enable manufacturers to implement appropriate controls to facilitate safe and affordable drug product manufacturing without complicating the engineering solutions

Recommendations: it has become clear that in the pharmaceutical sector, an adequate risk management system is not only required by regulatory stakeholders but may also result in a competitive advantage when appropriately implemented. Hence, to be prepared for future challenges, more predictive and proactive strategies towards product and process development, quality assurance and quality control, product life-cycle management and business operations in general are required. Risk management can be seen of one major aspect of these approaches with the goal to facilitate innovation and continuous

improvement. The chosen system in quality management represent major aspects of the pharmaceutical quality assurance system and their enhancement with regard to risk management can be well used as primer for further integration activities.

Conclusion & Significance: It is important to have an escalation process that allows management to be informed of areas that have risk that is unacceptable or near unacceptable. The holistic approach that is described in this course is predicated on the fact that all of those involved have received appropriate education or training and have ready access to supporting risk assessment and management documentation.

Jacob Adegboyega Kolawole has completed his PhD from the Ahmadu Bello University, Zaria and The Robert Gordon University, Aberdeen, UK (1996). He is the Dean, Faculty of Pharmaceutical Sciences, University of Jos and Consultant at West African Health Organization on development of guidelines and training manuals for pharmaceutical finished products, pharmaceutical raw materials, standard operating procedures for laboratories and bioavailability/bioequivalent. He has more than 40 publications in international journals.

The manufacturing, distribution and use of drug (medicinal) products involve some level of risk. Quality risk management is a valuable component of an effective quality control system in the pharmaceutical industry. Built in product quality should be maintained throughout the product lifecycle such that the attributes those are important to the quality of the drug (medicinal) product remain consistent with those used in the clinical studies and production and assured by quality control mechanisms and tools. An effective quality risk management approach can further ensure the high quality of the drug (medicinal) product to the patient by providing a proactive means to identify and control potential quality issues during development, manufacturing and distribution. Additionally, the use of quality risk management tools can improve decision making in quality management systems as a whole for best quality products and not only when quality problem arises. Effective application of quality risk management principles can facilitate better and more informed decisions and provide regulators with greater assurance of a company’s ability to deal with potential risks and regulatory compliance.

Raymond C. Jagessar obtained his BSc (Distinction) in Chemistry/Biology from the University of Guyana (1992) and his PhD from the UK (1995). He held three Post Doctoral Research Fellowships at the University of South Carolina (USA), Wichita State University (USA) and the University of the West Indies (1996-1999). He has also won several international awards, amongst them are Chartered Chemist, CChem and Fellow of the Royal Society of Chemistry, FRSC, UK. His research interests are broad, covering the spectrum of Pure and Applied Chemistry, Chemical Biology, Pharmaceutical and Medicinal Chemistry. He has published over seventy (70) research articles, five book chapters and presented at several international conferences. He is currently Professor in Chemistry at the University of Guyana (South America)

The search for alternative complementary natural medicines to replace synthetic antibiotics is on the increase, considering the side effects produced by synthetic drugs, some of which are irreversible. The aqueous extract of leaves of Phyllanthus acidus, Sphagneticola trilobata and Doliocarpus dentatus’s bark, uncombined and combined in the absence and presence of Zn2+ were tested against selective pathogenic microorganism such as S. aureus, E.coli., K. pneumoniae, P. aeruginosa and C. albicans using the Disc Diffusion Assay. The area of zone of inhibition, Azoi was taken as an indicator of the plant extract’s

antimicrobial potency. The highest Azoi of 165.05 mm2 was induced by P. acidus extract against E. coli. In the absence of Zn2+, zero Azoi was observed for the combined extract of P. acidus + S. Trilobata, S. trilobata + D. dentatus and P. acidus + D. dentatus against S. aureus and K. pneumoniae. The combined plant extract, without Zn2+, seems to induce a higher Azoi against E. coli, K, pneumoniae, C. albicans and P. aeruginosa in comparison with the individual plant extract. As an example, the combined plant extract of S. trilobata and D. dentatus induces Azoi of 122.66 mm2, whereas S. trilobata induces AzoI of 117.79 mm2. For the combined plant extract with Zn2+, a lower Azoi was induced, compared with the individual plant extract. Selective

antimicrobial activity was observed for the uncombined and combined extracts, with and without Zn2+ against some of the pathogens. For example, P. acidus aqueous extract showed Azoi of 165.1 mm2 against E. coli, whereas S. trilobata showed Azoi of 67.17 mm2 against E. coli i.e., a selectivity ratio of 2.5 vs. E.coli with respect to the above two extracts 

James R Bruno has over 40 years of industrial experience working in the manufacturing and development of API’s. After many years of working in lab through senior positions in the pharmaceutical manufacturing sector, he has began consulting in 2002 working with emerging pharmaceutical company to help to develop their API’s and dosage. In addition, he has continued to consult in the area of new technology including continuous chemistry, chromatography and various other chemical transformations’. His objective has been to bring new technologies into the commercial work to safely and economically produce API’s. He has obtained his Master’s in Chemistry from St. Joseph’s University in Philadelphia and MBA Degree from Rider University located in Lawrenceville, NJ. He is also served on the Scientific Advisory Board. He has published numerous papers in many of the pharmaceutical journals.

The chemical industry has looked at the use of continuous reactions for many years. In fact, the only industry sector not involved in continuous chemistry has been the manufacturing of pharmaceutical ingredients. More recently, the manufacturing of API’s has seen a push into continuous chemistry and the FDA is helping to lead the charge. However, from a regulatory point of view, we may see a major switch in how we produce our products. The concept of a batch will change dramatically and the requirements for validation will need to be adaptive to a new manufacturing paradigm. In addition, the switch to continuous reactions could benefit the overall economic and safety of drug production. This presentation will look at the issues around manufacturing API’s and the regulatory changes required moving from batch to continuous. The presentation will focus on the definition of the batch and the critical parameters working in continuous reactions.

Rashid Mahmood has Master Degree in Analytical Chemistry and MS in Total Quality Management. He has 15 years of experience of Pharmaceutical Quality Operations and has participated in many international conferences as a keynote speaker. He has presented various talks in USA & China on Cleaning Validation, cGMP Guidelines, Quality Risk Management, Role of Mass Spectrometry in Pharmaceuticals and on new Drug Delivery Systems. Currently he is working as a Senior Executive Manager Quality Operations for Surge Lab.(Manufacturer of Microencapsulated APIs, Liquid & Dry Powder Parentrals) which is the best export oriented company of Pakistan.

Every product or process has associated risks. Zero risk reduction is not a realistic goal nevertheless protection of patient by managing this risk in the quality system and manufacturing process is being given prime importance in the pharmaceutical industry. Quality Risk Management (QRM), a systematic process that assesses risk to the quality of a drug product across the lifecycle. QRM gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients. One of the primary principles of QRM states, “the degree of rigor and formality of quality risk management should reflect available knowledge and be commensurate with the complexity and/or criticality of the issue to be addressed.” Therefore, a QRM framework can be applied to all levels of potential risk to the safety of a product, and it does not have to be done in a long, arduous process. With this in mind, quality risk management can and should be integrated into the daily operations of any company that wants to maintain a focus on product integrity and patient safety. Assessing, reviewing, and rating risks can then become a natural reaction to product and operation issues. ICH Q9 and FDA guidance document on quality risk management provides a detailed information for the use of risk management tools in pharmaceutical product development and manufacturing quality decision making. Effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a company’s ability to deal with potential risks, and might affect the extent and level of direct regulatory oversight.

Bernice Brempong holds a Bachelor degree in Pharmacy from University of Ghana, Legon. She has extensive experience in hospital practice, community practice and pharmaceutical production. She has worked in several pharmaceutical industries including Ernest Chemist in 2013 and Entrance Pharmaceuticals in 2016/2017 where she gathered practical experience and later assumed the Chief Executive Officer position in Makhealth Pharmaceuticals Limited. Makhealth Pharmaceuticals is currently putting up a WHO-GMP compliant facility in collaboration with international partners for the production of solid and liquid oral dosage forms and sterile products including dropper products, parenteral and vaccines. Makhealth intends to collaborate internationally in contract manufacturing and also to act as the state-of-the-art manufacturing industry in Sub-Saharan Africa.

Good Manufacturing Practice (GMP) is part of the quality management system which ensures that products are consistently produced and controlled to meet quality standards appropriate for their intended  se as required by the marketing

authorization, clinical trials authorization or product specification. Current Good Manufacturing practice (cGMP) is aimed at managing and minimizing the risks inherent in pharmaceutical manufacturing to ensure that the quality, safety and efficacy of products are reproducible. Such risks are essentially human errors which occur during the handling and processing of materials and machines. While most pharmaceutical industries from the industrialized world work tirelessly to comply with

cGMP requirements to produce in compliant facilities, industries in the developing countries have not been able to meet most of these requirements. Factors such as lack of skilled personnel with technical know-how, weak regulatory systems, lack of appropriate equipment, machinery and technology and high cost of manufacturing drugs thus modern equipment and technology among others have been identified as some of the major factors within the sector bringing about the differences we see today in developing countries. In conclusion, GMP guidelines provide the requirements that a manufacturer must meet to ensure that their products are consistently high in quality, from batch to batch, for their intended use in order to always prevent harm from occurring to the end user.