Quality Management - Assignment

QA QC Pharma

Table of Contents
SECTION A.....................................................................................................................................1
1) ................................................................................................................................................1
2).................................................................................................................................................1
3).................................................................................................................................................1
4).................................................................................................................................................1
5).................................................................................................................................................1
6).................................................................................................................................................2
7).................................................................................................................................................2
SECTION B ....................................................................................................................................2
REFERENCES ...............................................................................................................................3

SECTION A
1)
Quality control is procedure by which companies revaluation quality of all factors
included in production. On other side, quality assurance is way of keep mistake and fault in
production of goods and neglect issues while delivery services to consumers(Gereffi, 2017).
Both are the part of quality management that directs on fulfilled quality requirements and
providing confidence.
2)
Quality management is the action of overseeing all task required to maintain desired level
of excellence. There are four main elements such as quality control, assurance, improvement and
planning. It is also means total quality management(TQM). It is beneficial for expressing the
requirements of new market and reducing cost for increasing profitability. The advantage of
TQM is to increase customer satisfaction.
3)
Validation is the procedure of launching written material information determining
process, and activities carried out in testing(Hilfiker and von Raumer, 2019). Validation protocol
is written plan including production equipment. There are many protocols such as Design,
installation etc. Design qualification is the check procedure on design to meet specific needs
relating to production quality.
4)
Documentation is set of writing given on paper, online and Analog media. It is distributed
through websites, software goods and online applications. Good documentation practices is term
used in pharmaceutical industries to determine standards of created documents. It includes
documentation creation, approval, handwritten entries, maintenance, modification and copies of
documents.
5)
Good clinical practice(GCP) is global quality standards that determines set of standards.
GCP involves all aspects of clinical trail. It is planned and carried out until result is reported to
trail. Phase 0 is to learn process of drug in body(Lardy-Fontan and et.al., 2016). Phase 1 is to
find the best dose of new drug with few side effects.
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6)
Good laboratory practices(GLP) is the set of values deliberate to assure quality and
integrity on non-clinical laboratory researches. GLP guidelines in OECD includes organization
and personnel, quality assurance program, equipment, reagents and material, test system,
performance of study. GLP means to quality system of management controls for research
laboratories.
7)
Good manufacturing practices(GMP) are the activities needed in relation to conform and
control authorization and licensing of manufacture and sale of pharmaceutical goods. Batch
processing records(BPR) is derived from Master Production Records that utilize to document
particular information for every batch(Steenbeke, Brunelli and Szucs, 2016). It includes cover
page, bill of material, equipment list, process testing, manufacturing instruction and review of
BPR.
8)
The handling of complaints is also sectioned of good manufacturing practices. GMP is
the system which handling complaints by some steps such as receiving complaints, technical
investigation, corrective measures. In the first step, open channels with regulator and customers
to receive information about position of product in market(Lardy-Fontan and et.al., 2016). Then,
technical investigation and measures in corrective way.
SECTION B
1. Schedule –M discuss about premises, quality control system and quality control laboratories
of pharmaceutical products.
2. Record in GMP should be maintain using schedule documentation and records.
3. A written statement of proof is call as a written evidence.
4. Written procedure for all laboratory programme in known as laboratory quality standards.
5. OECP stands for organization for energy conservation and planning.
6. GCP is defined as Good Clinical Practices.
7. ICH stands for International Conference on Harmonization.
8. The four phases of clinical trials include Phase 0, Phase 1, Phase 2, Phase 3.
9. Adverse drug reaction monitoring is called as Pharmacovigilance.
10.Clinical trial Data management is using clinical trials to manage the data of a clinical trial.
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REFERENCES
Books and Journals
Gereffi, G., 2017. The pharmaceutical industry and dependency in the Third World (Vol. 4964).
Princeton University Press.
Hilfiker, R. and von Raumer, M., 2019. Polymorphism in the Pharmaceutical Industry: Solid
Form and Drug Development. Wiley-Vch.
Lardy-Fontan, S. and et.al., 2016. For more reliable measurements of pharmaceuticals in the
environment: Overall measurement uncertainty estimation, QA/QC implementation and
metrological considerations. A case study on the Seine River. TrAC Trends in Analytical
Chemistry. 77. pp.76-86.
Steenbeke, P. S. G. V. M., Brunelli, F. D. K. S. C. and Szucs, R., 2016. On-Line Two-
Dimensional Liquid Chromatography (2D-LC) for the Analysis of Pharmaceuticals.
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