DP & QA.
Chairman: Benjamin Kwame BOTWE, B. Pharm, MSc, MPA, FGCPharm, FPCPharm, MRPS, FPSGH
Lead Consultant/ CEO
BB Associates Ltd Medicines Regulatory and Quality Assurance Consultants
Zion Plaza, 19 GICEL High Street, Accra, Ghana
Phone: +233 244318126
Email: benbotwe@gmail.com.
Vice chairman: Prof Oluwatoyin Odeku, B. Pharm. M. Sc. PhD, FAS, FPCPharm, FNAPharm, FPSN.
Professor of Pharmaceutics, University of Ibadan, Nigeria. Phone:+234 8057320466: email: pejuodeku@yahoo.com.
Faculty Secretary
Kamaldeen ABU-SAEED, B.Pharm; Pharm.D; M.Sc; MPH; FPCPharm; FIPMA
Consultant, Drug Production and Quality Assurance
Superintendent Pharmacist/ Manager,
Peace Standard Pharm. Ind. Ltd.
Ilorin, Kwara State. Nigeria.
Phone: +234 803 389 8351
Email: kamal.abusaeed@yahoo.com;
kamal.abusaeed@peacestandardpharma.com

Vice chairman: Prof Oluwatoyin Odeku, B. Pharm. M. Sc. PhD Kamaldeen ABU-SAEED, B.Pharm; Pharm.D
FACULTY OF DRUG PRODUCTION & QUALITY ASSURANCE CURRICULUM
PART ONE
S/N
|
CODE
|
TITLE
|
CONTENT
|
UNITS
|
|
1
|
PCP
101
|
Pharmaceutical Care I
|
Data collection and evaluation, drug therapy problems, Development, Implementation and Monitoring of care plans.
|
2
|
|
2
|
PCP
102
|
Pharmacy Management
|
Functions of management, human resources management, Financial and time management, Leadership, Management tools and their application to pharmacy
|
6
|
|
3
|
PCP
103
|
Inferential Biostatistics
|
Hypothesis testing, exploring differences between groups, t-test paired and unpaired, ANOVA, and their non parametric equivalents (Mann Whitney test, Kruskal Wallis etc), student t-test, exploring relationships: Pearson’s correlation, Chi squared test. Making predictions: regression; factor analysis. Biocomputation and use of statistical packages.
|
6
|
|
4
|
PCP
104
|
Research Methodology I
|
Conceiving (characteristic and development) research, literature search, study design, systematic reviews and meta analysis. project/research management, referencing, proposal writing.
|
6
|
|
5
|
PCP
105
|
Advanced Communication Skills
|
Cross cultural communications; Emphatic listening; Assertiveness; Perception and its role in communication; Conflict management; Interview techniques and Skills; Negotiation skills; Advocacy skills and practices; Public education techniques and skills; Public speaking; Writing skills; Communication strategies across diverse audiences; Communication program models; Evaluation techniques for communication programs in health and pharmacy.
|
4
|
6
|
PCP
131
|
Formulation and Delivery of Medicines
|
Formulation techniques, Drug delivery systems-modified-release, rate-controlled delivery systems and Drug Targeting,
Polymorphism in the pharmaceutical industry (formulation, stability, bioavailability).
|
4
|
7
|
PCP
132
|
Pediatric and Geriatric Formulations
|
Study of peculiarity of paediatric and geriatric patients; pharmaceutical calculations for doses in children and elderly; formulation and formulation factors, specific storage conditions; stability of these products.
|
2
|
8
|
PCP
231
|
Ethnopharmacy and Complementary Therapy
|
Natural Sources of Medicines: Design, Formulation, Standardization and Evaluation of Herbal Medicines and nutraceuticals, Herbal Medicines and nutraceuticals in Current Use, Clinical Application of Herbal Medicine, Interactions with food and preparations, Alternative/Complementary Therapies. Microbial contamination and Preservation.
|
6
|
9
|
PCP
232
|
Good Manufacturing Practice
|
Current Good Manufacturing Practice (cGMP), Personnel, Qualification, Experience, Responsibility, Premises and Equipment, Suitability of site/ventilation/nature of construction and finishes, Documentation and
Records (Master Formula, Batch manufacturing records, starting material specifications, Intermediate bulk and finished product specification and test records) Packaging material specification, Distribution, Quarantine/Detention/Release procedure, Complaints, Development and Utilization of Standard Operating Procedures, (SOPs). Process Validation, Packaging and Pharmaceutical Containers/Closures, Labelling, Stability Studies (ICH Recommended Evaluation), Shelf-Life Calculation/Predictions.
|
4
|
10
|
PCP
233
|
Quality Management Systems
|
TQM System Review (Validation and the Cost of Quality, Assuring Product Quality, Total Quality Culture, Quality Management Relationships).
Overview of Management Procedures of ISO 17025:2017 IEC.
Quality Management System (QMS)Overview of QMS (Context of the Organization, Leadership, Performance Management, Continual Improvement, Product Realization etc.),Process Performance and Product Quality Monitoring System, Relationship between ICHQ10 and ISO 9000 family.
Quality Audits and Inspections –Benefits of Audits and Inspections, Attributes of a Good Audit/Inspector, Six Systems Approach to GMP Inspections/Audits, Introduction to Quality System Inspection Techniques (QSIT), Overview of Audit Process (Planning/Scheduling, Audit Execution).
Preparing Quality Manuals.
|
8
|
11
|
PCP
234
|
Bioavailability and Bioequivalence
|
General concepts and definition, Bioavailability (Principles and Methods) Therapeutic Equivalent Evaluations: Clinical relevance, Methods for determining Bioequivalence, Minimizing the need for Bioequivalence testing, Bioequivalence Testing: Evaluation of Bioequivalence Data, Bioequivalence Assessment, Criteria for Bioequivalence, Study Design (Case Studies), Drug Product Selection, Waivers for Bioequivalence Testing/and product registration.
Biopharmaceutics (Principle, Biopharmaceutical Classification System / Drug Absorption / In Vitro, In Vivo Comparison (IVIVC).
|
4
|
12
|
PCP
235
|
Production and Quality Assurance of Herbal Medicines
|
Introduction and Definitions, Assessment of quality, Crude plant material, plant preparations, finished products, stability, Assessment of safety, Toxicological studies, Documentation, Assessment of efficacy,
Activity, Evidence to support indications, combination products, Intended Use, Product information for the consumer, Promotion and packaging.
|
4
|
|
13
|
PCP
200
|
Seminar
|
Presentation on selected topics.
|
4
|
|
14
|
PCP
201
|
Residency I
|
Experiential Learning
|
4*
|
|
Total
|
64
|
|
|
|
|
|
|
|
*1 unit is equivalent to 8 hours
of experiential learning
PART TWO
S/N
|
CODE
|
TITLE
|
CONTENT
|
UNITS
|
1
|
PCP 301
|
Research Methodology II
|
Measurements, Experimental/Questionnaire design, sample size, methods and techniques, data analysis, result presentation, discussion and conclusion. Report writing, grantsmanship
|
4
|
2
|
PCP
331
|
Inventory Management
|
The context of Inventory Management System, Standard Reports and Records, Inventory Control Models and Re-order, Mathematical Models for Reordering,
Identifying and Controlling Costs, Assessment Guide.
|
4
|
3
|
PCP
332
|
Drug and Food Regulation and Control
|
Pharmaceutical Production Policy-Levels, types and policies of Local Production (Market factors, Regulatory and Legal Provisions, Investment and Industrial development issues, physical infrastructure and human resources) National Regulatory Requirement in Drug Production,
Food production, Comparative studies; Dossier preparation, Allopathic Drugs, Herbal medicines and others, Clinical investigations, Clinical Trials, The New Drug Application/License, Post-Approval Activities- Safety Monitoring and Post-Marketing Surveillance, Patents and Patents Rights.
|
4
|
4
|
PCP
333
|
Logistics Management Information System (LMIS)
|
Terms and Definitions relating to LMIS, Decision-making based on LMIS
|
4
|
5
|
PCP
334
|
Management Information System (MIS)
|
Importance of a Drug Management Information System (functions, Information System, Data and Information, The Information system pyramid), Typical components of a Drug MIS, Designing or revising a Drug MIS, Implementing a Drug MIS, From information to action (processing data, presenting information, interpreting, information and taking action)
Computers in Drug MIS-Uses of Computers, Specialized software for Drug Management and Control, Building a Drug Master file in a database.
Application: Laboratory Information Management Systems (Function, Decision, Information and Interpretation of Data).
|
4
|
6
|
PCP
335
|
Pharmaceutical Biotechnology
|
Biotechnology and Drugs, Milestones in Biotechnology, Biotechnology Drugs, Application of Biotechnology in Pharmaceutical Manufacturing, Pharmacogenomics, Modified-release Drug Therapy, Drug properties relevant to Extended Release formulation, Rate Controlled Delivery Systems, Targeted Delivery Systems, Delivery of Biotechnology Products, Novel Delivery Systems
|
4
|
Sub-specialties
|
|
|
7
|
PCP
431
|
Pharmaceutical Quality Systems
|
Quality Assurance/Quality Control, Definition of Terms: QC, QA, Concept of Quality by Design (QbD)-Quality Management; Drug Information/Research, Quality Control Lab-Release of Raw Materials, Products, Assay, etc., Environmental Control.
Overview of technical Procedures of ISO 17025:2017 IEC.
Quality Control within the Production Unit. Documentation.
Advances in Analytical Methods and techniques Non-instrumental Methods-Titrimetry, Gravimetry, Instrumental Methods-Spectrophotometry, Chromatography, HPLC, GC MS, NMR, Sampling, Sampling, Chemical and Microbiological, Detection of impurities and documentation, Self-Inspection, Composition of Team, Inspection Report, Follow up Action, Complaints and Product Recall.
Good Laboratory Practice (GLP).
Contract Manufacture and Analysis, GMP assessement, Assessment of the ability of the Contract Laboratory, Drug Registration, Counterfeit Medicines, Drug Donation, Orphan Drugs.
|
10
|
8
|
PCP
432
|
Production Management
|
Production Planning: Update, Manpower requirements for Pharmaceutical Services in the public and private sectors, Manufacturing Data Base: Sales forecast methods, Computation of man-hours, Computation of labour personnel, Capacity Utilisation on Equipment, Monitoring Efficiency: Labour, Material, Cost Improvement Projects, Faking and Counterfeiting of Drugs and counter-measures, Drug Production: Problems, Constraints and Prospects, Regulatory Control of Drug Production.
|
10
|
9
|
PCP
433
|
Pharmaceutical Sales and Marketing
|
Sales Forecast Methods, Setting Drug Sales Prices and Drug Sales Revenue, Medical Representatives (functions/responsibilities), Market Economics, Markets and competition, Economics of Scale, Ethics and business, Market surveillance (data collection on sales), Drug Promotion – Ethical guidelines. Product Launch-Definitions of Key Concepts-Product Launch, Product Re-Launch, Product Life Cycle, Life Cycle Management, Regulatory Requirements for Product Launch, Strategies for New Product Launch in the Pharma Industry, Applications of Social Media in Product Launch. Post Marketing Surveillance (PMS)-Definitions of Key Concepts- PMS, Pharmacovigilance, Drug Safety, Adverse Drug Reactions, Adverse Events, Product Recall , The Need for Post Marketing Surveillance, Challenges of Substandard, Spurious, Falsely labelled, Falsified & Counterfeit (SSFFC) Medical Products, Product Quality Surveillance/Combating SSFFC Medical Products, Post Marketing Changes & Variations.
|
10
|
|
10
|
PCP 400
|
Seminar
|
Presentation on selected topics
|
4
|
|
11
|
PCP 401
|
Residency II (Sub-specialty)
|
Experiential Learning
|
30*
|
|
12
|
PCP 402
|
Dissertation (Sub-specialty)
|
Research Work
|
12
|
|
Total
|
80
|
|
|
|
|
|
|
*1
unit is equivalent to 8 hours of experiential learning