Quality Assurance and Control in Pharmaceutical Manufacturing
Added on 2020-10-04
16 Pages3912 Words83 Views
|
|
|
QUALITY ASSURANCEAND GOODMANUFACTURINGPRACTICES
Table of ContentsSECTION A.....................................................................................................................................1SECTION B.....................................................................................................................................1SECTION C.....................................................................................................................................4SECTION A.....................................................................................................................................5SECTION B.....................................................................................................................................5SECTION C.....................................................................................................................................9REFERENCES..............................................................................................................................12
SECTION A1- C) Reactive and proactive process.2- A) Quality control.3- A) C, A, D, B4- D) All of these.5- B) Recorded in writing and such written procedures to be followed.SECTION B1- Quality Assurance (QA) is the method which protect any problem or issue in the qualityof product and service. It helps the company to properly manage quality of all their products. Itensures that products and services will get delivered to customers without any defect andproblem. It is needed because customers mostly get satisfied by the quality of things and qualityassurance manages it very well by solving every problem and issue regarding the quality ofproducts and services (Abou-El-Enein and et.al., 2013). 2- Quality Control (QC) and quality assurance both are different terms. QC sees that actualproducts and services are made with excellence and finds out the defect in it. On the other hand,QA handles the activities or quality which are made for improving the products and services. QC is the process of reactive whereas quality assurance in the process of proactivequality. QC deals with the finished products; on the other hand, QA deals with process of makingthe products and services.QC uses tools to solve the defect in quality but QA works in the direction of makingbetter system of quality management. 3- GMP is the Good Manufacturing Practice. It is a system which ensures that every processis followed which will make the products and services of quality. It checks that goods areproduced in accordance with the standards of quality. GMP is important because it lowers thelevel of all the risks which arises while ensuring the quality of things. The issues which cannotbe removed can be minimised by using this process (Alli, 2016). This practice controls the1
quality of products and services at all the levels. It is important in every process by which goodis manufactured. 4- Safe medical devices act is formed for regulating the use devices in the health and carecentre. It came into action when some patient faced serious problem because of the medicaldevices. This act ensures that every device is made with proper quality which will not cause anyharm to the health of any person. This act was made in the year 1990. Safe Medical Devices Act1990 was an improved version of the Medical Device Amendments 1976. It ensures that everypatient should not face any problem or issue regarding the medical devices.5- There are many GMP regulatory agencies which works in the direction of checkingproper quality of the products and services. Medicines and Healthcare Products RegulatoryAgency is situated at UK. In addition to this, Medicines Control Council works in South Africa.These are some regulatory agencies and their headquarters. 6- ICH means International Conference Harmonisation which works in the direction ofdeveloping innovative drugs in the world. There are many countries which are non-ICH but areaffected by working of this. By this effect, it is ensured that people within these countries willalso get benefits (Borowitzka, 2013). ICH is global so, it will definitely provide some benefits topatients of non-ICH countries. These countries will also get developed by the effect ofinternational conference harmonisation. 7- PIC's is pharmaceutical inspection convention. It checks that same procedure ofinspection should be followed in every country. It sets the common standards for all. This is verybeneficial for the GMP standards development worldwide. PIC sets guideline which is same forall over the world. It ensures that every standard of GMP is followed by the manufacturingcompany. By this, it ensures the development of standards of good manufacturing productsworldwide (He and et.al., 2015)..8- TGA is Therapeutic Goods Administration. There are many products which are includedin this department. It works for the government of Australia. Every therapeutic product who2
End of preview
Want to access all the pages? Upload your documents or become a member.
Related Documents