Introduction to Good Manufacturing Practices
Session 1: Introduction to Good Manufacturing Practices:
Total Session Time: 120 minutes
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Manufacturing
Resources Needed:
SESSION OVERVIEW
Activity/
Step Time Content
Method
1 05 minutes Presentation Introduction, Learning Tasks
2 10 minutes Presentation Overview of Good Manufacturing Practice
3 05 minutes Presentation Definition of GMP
30 minutes Brainstorming
4 Principles of GMP
Presentation
60 minutes Importance of GMP in pharmaceutical
5 Presentation Manufacturing
05 minutes Presentation Key points
6
05 minutes Presentation
7 Evaluation
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
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: Overview of Good Manufacturing Practice (10 minutes)
(GMP) was prepared in 1967 by a group of consultants at the request of the Twentieth
World Health Assembly.
Certification Scheme on the Quality of Pharmaceutical Products Moving in International
Commerce, it accepted at the same time the GMP text as an integral part of the Scheme.
one of the elements of the WHO Certification Scheme on the Quality of Pharmaceutical
Products Moving in International Commerce, through the assessment of applications for
manufacturing authorizations and as a basis for the inspection of manufacturing facilities.
production, quality control and quality assurance personnel in the industry.
STEP 3: Definition of Good Manufacturing Practices (5 minutes)
o Good Manufacturing Practice is that part of Quality Assurance which ensures that
pharmaceutical products are consistently produced and controlled to the quality
standards appropriate to their intended use and as required by the marketing
authorization or product specification.
QUALITY ASSURANCE
Good Manufacturing Practices QUALITY CONTROL
(GMP)
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
STEP 4: Principles of GMP (30 minutes)
Activity: Brainstorming (5 minutes)
ASK students to brainstorm on the following question
ALLOW few students to respond
WRITE their responses on the flip chart/ board
CLARIFY and SUMMARISE by using the content below
with both production and quality control. The basic principles /essential elements are:
o Quality assurance
o Good manufacturing practices for pharmaceutical products
o Sanitation and hygiene
o Qualification and validation
o Complaints
o Product recalls
o Contract production and analysis
o Self-inspection and quality audits
o Personnel
o Training
o Personal hygiene
o Premises
o Equipment
o Materials
o Documentation
o Good practices in production
o Good practices in quality control
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
STEP 5: Importance of GMP in pharmaceutical manufacturing
(60minutes)
Activity: Buzzing (10 minutes)
ASK students to pair up and buzz on the following question for 2 minutes
•What are the importances of GMP in pharmaceutical manufacturing?
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
production, quality control, release, storage, shipment of finished products and the related
controls. Such operations need to be carried out according to Good Manufacturing
Practices (GMP) that forms an important part of a comprehensive system of quality
assurance. Adherence to GMP ensures that pharmaceutical products are manufactured to
meet quality standards required for their intended use.
are consistently produced and controlled to the quality standards appropriate to their
intended use and as required by the marketing authorization.
production.
contaminants) and mix-ups (confusion) caused by, for example, false labels being put on
containers. It is required that:
o All manufacturing processes are clearly defined, systematically reviewed in the light
of experience, and shown to be capable of consistently manufacturing pharmaceutical
products of the required quality that comply with their specifications;
o Qualification and validation are performed.
o All necessary resources are provided, including ,
Appropriately qualified and trained personnel.
Adequate premises and space.
Suitable equipment and services.
Appropriate materials, containers and labels
Approved procedures and instructions.
Suitable storage and transport.
Adequate personnel, laboratories and equipment for in- process
o Instructions and procedures are written in clear and unambiguous language
specifically applicable to the facilities provided.
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
o Operators are trained to carry out procedures correctly.
o Records covering manufacture and distribution, which enable the complete history of
a batch to be traced, are retained in a comprehensible and accessible form.
o The proper storage and distribution of the products minimizes any risk to their
quality.
o A system is available to recall any batch of product from sale or supply.
o Complaints about marketed products are examined; the causes of quality defects
investigated, and appropriate measures taken in respect of the defective products
to prevent recurrence.
o Poor quality medicines are not only a health hazard, but a waste of money for both
governments and individual consumers.
o Poor quality medicines can damage health
o A poor quality medicine may contain toxic substances that have been unintentionally
added.
o A medicine that contains little or none of the claimed ingredient will not have the
intended therapeutic effect.
o GMP helps boost pharmaceutical export opportunities:
o Most countries will only accept import and sale of medicines that have been
manufactured to internationally recognized GMP.
o Governments seeking to promote their countries' export of pharmaceuticals can do so
by making GMP mandatory for all pharmaceutical production and by training their
inspectors in GMP requirement
STEP 6: Key Points (5 minutes)
manufacturing.
(in particular of unexpected contaminants) and mix-ups (confusion) caused by, for
example, false labels being put on containers.
STEP 7: Evaluation (5 minutes)
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
References
Signore, A. A., & Jacobs, T. (2017). Good design practices for GMP pharmaceutical
facilities. Boca Raton, Fl.: CRC Press.
amm, G., hler, . . Manual for decentralized infusion production: Infusion Unit
Project, Tanzania. Erscheinungsort nicht ermittelbar: Verlag nicht ermittelbar.
Lund, W. (2009). The pharmaceutical codex: Principles and practice of pharmaceutics. New
Delhi: CBS.
Tanzania Foods and Drug Authority (2017). Guidelines for production of extemporaneous
formulations and Hospital based sterile preparations,
Aulton, M. E., & Taylor, K. (2018). Aulton s pharmaceutics: The design and manufacture of
medicines. Edinburgh: Elsevier.
Gad, S. C. (2008). Pharmaceutical manufacturing handbook production and processes.
Hoboken, NJ: Wiley-Interscience.
United States pharmacopoeia. (2004). Montvale, NJ: Medical Economics.
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
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