Introduction to Pharmaceutical Production
Session 1: Introduction to Pharmaceutical Production
Total Session Time: 60 minutes
Pre-requisites
Learning Tasks
By the end of this session students are expected to be able to:
Resources Needed
SESSION OVERVIEW
|Step |Time |Activity/ |Content |
| | |Method | |
|1 |05 minutes |Presentation |Introduction, Learning Tasks |
|2 |25 minutes |Buzzing |Definitions |
| | |Presentation | |
|3 |10 minutes |Presentation |Requirements for Pharmaceutical |
| | | |Production |
|4 |10 minutes |Buzzing |Products in Pharmaceutical |
| | |Presentation |Productions |
|5 |05 minutes |Presentation |Key Points |
|6 |05 minutes |Presentation |Evaluation |
SESSION CONTENTS
STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)
READ or ASK students to read the learning tasks and clarify
ASK students if they have any questions before continuing
STEP 2: Definitions (25 minutes)
|Activity: Buzzing (5 minutes) |
| |
|ASK students to pair up and buzz on the following question for 2 |
|minutes |
| |
|Define Good Manufacturing Practices |
| |
|ALLOW few pairs to respond and let other pairs to add on points not |
|mentioned |
| |
|WRITE their response on the flip chart/board |
| |
|CLARIFY and SUMMARIZE by using the content below |
o This is the process of industrial (large) scale synthesis of
pharmaceutical drugs by pharmaceutical companies
o A batch is a quantity or consignment of pharmaceutical products
produced in a single manufacturing run
o The total number of items in one batch is the batch size
o Each batch is given a specific identification code called the batch
number
o This is a technique used in manufacturing, in which the object in
question is created stage by stage over a series of workstations, and
different batches of products are made
o A batch manufacturing record is a document designed to provide a
complete record of the manufacturing history of a batch of product
o BMR is also known as;
o A document or set of documents specifying the starting materials with
their quantities and the packaging materials, together with a
description of the procedures and precautions required to produce a
specified quantity of the product as well as the processing
instructions including the in-process controls
o There are must be a master formula record for each product and batch
size to be manufactured
form a mixture
o Weighing is a process of determining weight of ingredients (for
example by using a weighing balance)
o Measuring is the determination of volume of liquid ingredients by
using graduated measures such as measuring cylinders, pipettes etc.
o This is a process of compressing powders or granules to form tablets
o This is an equipment that is used for manufacturing of tablets
o This is a process of enclosing powders, tablets, pellets, granules or
liquids in shells commonly made up of gelatin to form capsules
o It is a wide ranging concept covering all matters that individually or
collectively influence the quality of a product
o GMP is a part of quality assurance (which sets out principles and
procedures) that ensures that products are consistently manufactured
and controlled to the quality standards appropriate to their intended
use
o It is part of GMP concerned with sampling, specifications and testing
and with the organization, documentation and release procedures which
ensure that the necessary the necessary and relevant tests are carried
out and the materials are neither released for use nor products are
used for sale or supply until their quality has been satisfactory
o An ingredient which gives a drug its chief therapeutic value; i.e.
responsible for pharmacological action. OR
o Any substance or mixture of substances intended to be used in the
manufacture of a pharmaceutical dosage form and that, when used in
production of a drug, becomes an active ingredient of that drug.
o Any chemical compound used on or administered to humans or animals as
an aid in the diagnosis, treatment or prevention of disease or other
abnormal condition, for the relief of pain or suffering, or to control
or improve any physiologic or pathologic state. OR
o Medicine, pharmaceutical substance which when absorbed into a living
organism may modify one or more of its functions.
o A unique combination of drug(s), strength and dosage form in which a
drug is administered.
o A medicinal product/dosage form which has undergone all stages of
manufacture or production, including packaging in its final container
and labeling.
o Is the form in which drugs are formulated and ready for delivery to
the patients. E.g. solution, mixture, emulsion, suspension,
injectable, tablets, capsules etc
o A chemical substance/additive with no pharmacological action, used in
the formulation of dosage forms. Vehicle for the drug.
o A substance, other than the active ingredient, which has been
appropriately evaluated for safety and is included in a drug delivery
system to:
manufacture,
patient acceptability,
effectiveness of the drug during storage or use.
o All operations involved in the preparation of a medicinal product,
from receipt of materials, through processing and packaging, to its
completion as a finished product.
o It involves both small and large industrial scale synthesis of
pharmaceutical drugs by pharmaceutical companies2
o The process whereby a drug or drugs (active ingredient/s) are combined
with other substances (pharmaceutical adjutants or excipients or
additives) to produce a dosage form (or formulation) suitable for
administration to a patient.
o It is the provision of accurate, specific and definite description of
the procedures to be employed from receipt of raw materials to release
of finished product by carrying out tests at critical stages of the
production process to ensure batch uniformity and integrity of a drug
product
STEP 3: Requirements for Pharmaceutical Production (10 minutes)
such as milling, drying, compression, coating etc.
competent authority to produce medicines by using validated equipment and
methods.
o Premises
o Processes
o Equipment and machines
o Human resource
o Raw materials
o Packaging materials
head of production (production manager) and head of quality control.
STEP 4: Products in Pharmaceutical Productions (10 minutes)
|Activity: Buzzing (5 minutes) |
| |
|ASK students to pair up and buzz on the following question for 2 |
|minutes |
| |
|What are the forms of drugs produced in pharmaceutical manufacturing |
|processes? |
| |
|ALLOW few pairs to respond and let other pairs to add on points not |
|mentioned |
| |
|WRITE their response on the flip chart/board |
| |
|CLARIFY and SUMMARIZE by using the content below |
drugs delivery systems)
formulations
o Tablets
o Capsules
o Powders
o Granules
o Convenience of administration
o Convenient to carry (light and compact)
o Accuracy of dosing
o Increased stability
o Easy of mass production
STEP 5: Key Points (5 minutes)
synthesis of pharmaceutical drugs by pharmaceutical companies
which ensures that products are consistently manufactured and controlled
to the quality standards appropriate to their intended use
such as milling, mixing, drying, compression and coating
STEP 6: Evaluation (5 minutes)
References
Aulton, M.E, & Kevin, M.G., Eds: (2013) Pharmaceutics: The design and
manufacture of medicines, (4th ed.) Churchill Livingstone.
Hugo and Russell (2011), Pharmaceutical Microbiology (8th ed.) Willey-
Blackwel publications.
Gennaro, R. A, et al. (Eds) 1995 Remington: The Science and Practice of
Pharmacy, Volume I & II, (19th ed.): Mack Publishing Company, Easton,
Pennsylvania 18042
Liebsch, B et al. (1988): Tanzania Pharmaceutical Handbook, Dar es Salaam
University Press.
Lund, W. Editor (1994). The Pharmaceutical Codex, Principles and Practice
of Pharmaceutics (12th ed.): The Pharmaceutical Press, London
Polderman, J. (1990). Introduction to Pharmaceutical Production: Novib, The
Hague
Rawlins E.A, Editor: (1977) Bentley’s Textbook of Pharmaceutics, (8th ed.)
Baillie're Tindall. London Kamm, G. and Kohler, B. Editors: (1995)
Manual for Decentralized Infusion Production, Infusion Unit Project
Tanzania
Schmidt, O. (ed) (2000) Pharmaceutical Quality systems, Interpharm Press,
Colorado.
Shayne C et al (2008), Pharmaceutical Manufacturing Handbook: Production
and processes, John Wiley & Sons
Watson, D. G. (1999) Pharmaceutical Analysis: A Textbook for Pharmacy
Students and Pharmaceutical Chemists: Churchill Livingstone,
Edinburgh.
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