PST05207 Quality Assurance of Pharmaceutical Products

NTA Level 5 • Semester 2 • PST05207 Procedures for Quality Testing of Pharmaceutical Products Quality Assurance of Pharmaceutical Products • Source Session/Topic 11 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 11: Procedures for Quality Testing of Pharmaceutical Products Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • List methods commonly used for quality testing of pharmaceutical products from monographs • Explain procedures for carrying out physical quality tests for solid pharmaceutical dosage forms (Hardness, smell, colour, texture, thickness, diameter, friability, disintegration etc.) • Explain procedures for carrying out physical quality tests for liquid pharmaceutical dosage forms (pH, smell, colour, conductivity, osmolarity etc.) • Explain procedures for carrying out microbiological quality tests for pharmaceutical products (sterility tests, etc.) • Explain procedures for carrying out chemical qualitative tests (volumetric analysis, colour reaction, dissolution test etc.) • Explain procedures for carrying out chromatographic quality tests (TLC, etc.) Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer 79 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 15 minutes Methods Commonly Used for Quality Presentation 2 Testing of Pharmaceutical Products from Buzzing Monographs 20 minutes Procedures for Carrying Out Physical Presentation and 3 Quality Tests for Solid Pharmaceutical Brainstorming Dosage Forms Procedures for Carrying Out Physical 4 20 minutes Presentation Quality Tests for Liquid Pharmaceutical Dosage Forms 15 minutes Procedures for Carrying Out 5 Presentation Microbiological Quality Tests for Pharmaceutical Products 15 minutes Presentation Procedures for Carrying Out Chemical 6 Qualitative Tests 20 minutes Presentation Procedures for Carrying Out 7 Chromatographic Quality Tests 8 05 minutes Presentation Key Points 9 05 minutes Presentation Evaluation 80 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 objectives and clarify ASK students if they have any questions before continuing. STEP 2: Methods Commonly Used for Quality Testing of Pharmaceutical Products from Monographs (15 minutes) Activity: Buzzing (5minutes) ASK students to pair up and buzz on the following questions for 2 minutes • What are various tests in quality testing of pharmaceutical products? ALLOW few pairs to respond and let other pairs add on points not mentioned WRITE their response on the flip chart/board CLARIFY and SUMMARIZE by using the content below • There are various tests involve in quality testing of pharmaceutical products, these includes • Physical quality tests for solid pharmaceutical dosage forms includes; o Hardness, o Smell, o Colour, o Texture, o Thickness, o Diameter, o Friability test, o Disintegration test • Chromatographic quality tests includes o Thin layer chromatography method-TLC o High-performance liquid chromatography (HPLC o Gas chromatography (GC) o Paper chromatography • Physical quality tests for liquid pharmaceutical dosage forms includes o pH, o Smell, o Colour, o Conductivity, o Osmolarity • Microbiological quality test include 81 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 o Sterility tests for pharmaceutical products o Chemical qualitative tests includes Volumetric analysis o Colour reaction, Dissolution test STEP 3: Procedures for Carrying out Physical Quality Tests for Solid Pharmaceutical Dosage Forms (20 minutes) Activity: Brainstorming (5 minutes) Ask students to brainstorm on the following question: • What is disintegration? ALLOW few students to respond WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • Disintegration is the process where pharmaceutical solid dosage forms separate into parts or lose intactness or solidness and break up into particle or constituent under specified conditions • Disintegration time is the time required for a dosage form to break up in to granules of specified size (or smaller) under carefully specified conditions. • Disintegration Test- This test determines whether dosage forms such as tablets, capsules, pessaries and suppositories disintegrate within a prescribed time when placed in a liquid medium under the prescribed experimental conditions. For the purpose of this test, disintegration does not imply complete solution of the dosage unit or even of its active constituent. • Disintegration Apparatus consists of o A basket-rack assembly, o A 1-litre beaker, o A thermostatic arrangement for heating the fluid o Mechanical device for raising and lowering the basket in the immersion fluid at a constant frequency rate • Disintegration test procedures o 6 tablets from each batch are taken and subjected to the disintegration test. o One tablet is placed in the mesh screen at the bottom end of each of the 6 glass tubes, o Tap water is used as disintegration medium. Simulated gastric fluid. o The apparatus is maintained at a temperature of 37 ± 2°C. o Glass tube maintains up and down movement in and out of the basket containing 1000mls distilled water. the basket move through a distance of 5-6cm at a frequency of 28 to 32 cycles per minutes as specified by U.S.P 82 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 o Disintegration time of the each tablet is noted by means of a stopwatch and recorded. o Disintegration time does differ depending on the nature of the tablets e.g. uncoated, coated. Uncoated USP tablets have disintegration time as low as 5 minutes but majority have maximum disintegration time of 30 minutes. Disintegration test we start with 6 tablets if one or two tablets failed to disintegrate completely test should be repeated for additional 12 tablets the requirement met if not less than 16 of the total 18 are disintegrated. • Factors affecting the disintegration time o Content-especially the quality and quantity of the Disintergrants and lubricant. o Hardness .amount of binder, compression force. o Design of granulation procedure which will affect

NTA Level 5 • Semester 2 • PST05207 Quality Assurance of Pharmaceutical Products – Complete Full Notes Complete educational source text in one page Completeness safeguard: this page keeps the complete educational module/source wording in one place so learning material is not lost when browsing topic by topic. Presenter/tutor metadata is intentionally excluded. UNITED REPUBLIC OF TANZANIA Ministry of Health, Community Development, Gender, Elderly and Children PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 Facilitator Guide March 2019 Copyright © Ministry of Health, Community Development, Gender, Elderly and Children – 2019 Table of Contents Background ………………………………………………………………………………………………………………. iv Introduction ……………………………………………………………………………………………………………..viii Abbreviations/Acronyms …………………………………………………………………………………………….. x Session 1: Introduction to Good Manufacturing Practices: ………………………………………………. 1 Session 2: Components of GMP …………………………………………………………………………………… 7 Session 3: GMP -Personnel requirements……………………………………………………………………. 13 Session 4: GMP Requirements on Raw Materials …………………………………………………………. 20 Session 5: GMP Documentations Requirements …………………………………………………………… 31 Session 6: GMP Equipments Requirements …………………………………………………………………. 38 Session 7: Quality Control and Assurance in Relation to Preparation of Pharmaceutical Products…………………………………………………………………………………………………………………… 45 Session 8: The Operating Principles of Equipments and Machines …………………………………. 56 Session 9: Standard Operating Procedures for Equipments and Machines ……………………….. 67 Session 10: Preventive Maintenance Procedures for Equipments and Machines……………….. 72 Session 11: Procedures for Quality Testing of Pharmaceutical Products ………………………….. 79 iii PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 Background There is currently an ever-increasing demand for pharmaceutical personnel in Tanzania. This is due to expanding investment in public and private pharmaceutical sector. Shortage of trained pharmaceutical human resource contributes to poor quality of pharmaceutical services and low access to medicines in the country (GIZ, 2012). Through Public-Private-Partnership (PPP) the Pharmacy Council (PC) together with Development Partners (DPs) in Germany and Pharmaceutical Training Institutions (PTIs) worked together to address the shortage of human resource for pharmacy by designing a project named “Supporting Training Institutions for Improved Pharmaceutical Services in Tanzania” in order to improve quality and capacity of PTIs in training. CSSC prepared a Multi-actor Partnership (MAP) project proposal on how to sustain and strengthen health care in Tanzania through improvement of pharmaceutical training and an inter-institutional coordination of actors. This will harmonize and improve access to quality pharmaceutical service in Tanzania. The project has a various key stakeholders like; CSSC, NACTE, PC, TCU, CEDHA and Pharmaceutical Training Institutions (PTIs). Through this project, few PTIs will receive infrastructural improvements to increase the quantitative and qualitative capacities (CUHAS, RUCU and KSP). Furthermore this project will train Pharmaceutical tutors from different PTIs on teaching and assessment methods in Tanzania and thus improved health delivery through increased qualified human resource. It was also observed that in the previous stakeholder‟s meetings there was a need for the development of training manuals and assessment plans for NTA Level 5 & 6, in order to support the establishment and implementation of the curriculum in PTIs. During MAP kick- off workshop done in February 2018, Stakeholders agreed that there was a need for development of the said manuals and it was among the highest priority in Pharmacy education in Tanzania. Therefore this project aims at developing facilitator‟s guide and assessment plans for NTA Level 5 & 6. Pharmacy Council, CSSC and action medeor developed the Terms of Reference and selected a qualified service provider with experience in material development to develop the mentioned training manuals and assessment plan. Centre for Educational Development in Health Arusha (CEDHA) was selected and offered a contract to develop Facilitators guide for NTA level 5 & 6 and assessment plan. Centre for Educational Development in Health Arusha (CEDHA) was offered a leading role with the instructions to include experts who have developed teaching materials for NTA Level 4. These experts are primarily experienced pharmaceutical and non-pharmaceutical tutors. The mode of operation used by CEDHA to develop facilitators guide and assessment plan was participatory approach which included a number of activities through various workshops such as planning, and orientation of material development. After these preliminary workshops, experts developed materials individually and in-groups. Thereafter, developed iv PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 draft materials were reviewed, edited and formatted and draft one was finalized and shared to stakeholders for inputs. Finally, CEDHA submitted the finalized Facilitator‟s guides and assessment plans for NTA level 5 and 6 to CSSC for endorsement, printing, dissemination and sharing with relevant authorities. There are 11 modules for NTA level 5 making 11 facilitator guides including one practicum guide. v PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 Acknowledgment The development of standardized training materials of a competence-based curriculum for pharmaceutical sciences has been accomplished through involvement of different stakeholders. Special thanks go to the Pharmacy Council for spearheading the harmonization of training materials in the pharmacy after noticing that training institutions in Tanzania were using different curricula and train their students differently. I would also like to extend my gratitude to Christian Social Service Commission (CSSC) for their tireless efforts to mobilize funds from development partners (German Ministry of Industry and action medeor). It is through the implementation of the Multi-Actors Partnership (MAP) project, CSSC has been able to provide the financial and technical support needed during the development of this training material. Many thanks go to the Centre for Educational Development in Health Arusha (CEDHA) experts on health material development and training who coordinated the development of these module sessions particularly Ms. Diana H. Gamuya for her commitment in coordinating and facilitating the planning and development to its completion. Particular acknowledgements are sent to Mr. Dickson Mtalitinya and Members from the secretariat of National Council for Technical Education (NACTE) for facilitating and providing their expertise to the success of this work. It will be unfair if I will not recognize the efforts and contributions of all CEDHA supportive staff that made this process a success; accountant, secretary, drivers and printers Finally, I very much appreciate the contributions of the tutors and content experts representing PTIs, hospitals, and other health training institutions. Their participation in meetings