ICH

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Nathh Dipankarr

EXCLUSIVELY FOR BPHARM VI SEM FOR THE SUBJECT QA

Health & Medicine

TOPIC: ICH PART -I
BY
Mr.DIPANKAR NATH.
M.PHARM(PHARM.CHEMISTRY),GATE(2009),GPAT(2011)
ASSISTANT PROFESSOR.
DEPARTAMENT OF PHARMACEUTICAL ANALYSIS .
HIMALAYAN PHARMACY INSTITUTE,MAJHITAR,EAST SIKKIM.

 Since its inception in 1990 ,ICH has gradually evolved to respond to the increasing global
face of drug development.
 The International Council for Harmonization(ICH) formerly the International conference on
Harmonization(ICH) held the inaugural assembly meeting on 23rd October 2015
establishing ICH as an international association a legal entity under Swiss law.
2

CATEGORIES OF ICH TOPICS:
ICH topics are divided in to four categories:
Q-Quality Guidelines (Stability, Impurities Testing, GMP)
S-Safety Guidelines (Carcinogenicity,Genotoxicity,Reprotoxicity)
E-Efficacy Guidelines (Clinical trials, Pharmacogenomics)
M-Multidisciplinary Guidelines(MedDRA, CTD, ESTRI)
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The International Classification of Diseases (ICD) is a globally recognized system for classifying and coding diseases, health conditions, and related factors. It is maintained and updated by the World Health Organization (WHO) and serves several critical functions in healthcare and epidemiology. To describe the ICD comprehensively within 3000 characters, we'll cover its history, purpose, structure, and significance. **History:** The roots of the ICD can be traced back to the mid-19th century when various countries began documenting statistics on causes of death. The need for a standardized classification system became evident as different nations used their own systems, hindering international comparisons. The ICD was officially established in its modern form in 1948, with subsequent revisions and updates. **Purpose:** The primary purposes of the ICD are as follows: 1. **Disease Classification:** The ICD provides a systematic way to categorize diseases and health conditions. Each condition is assigned a unique code, which simplifies data collection and reporting. 2. **Clinical Diagnosis:** Healthcare professionals use the ICD to document and communicate diagnoses. This aids in patient care, medical billing, and insurance claims processing. 3. **Epidemiology:** The ICD is crucial for monitoring and analyzing disease patterns on a global scale. It helps identify emerging health threats, allocate resources, and develop public health policies. 4. **Health Statistics:** Governments and health organizations use the ICD to compile health statistics, such as causes of death and disease prevalence. This information guides healthcare planning and resource allocation. **Structure:** The ICD is organized into chapters, sections, and codes. The current version, ICD-10, is divided into 22 chapters, covering a wide range of health-related topics. Here's an overview of some key chapters: - **Chapter I:** Certain infectious and parasitic diseases - **Chapter II:** Neoplasms (cancers) - **Chapter III:** Diseases of the blood and blood-forming organs - **Chapter IV:** Endocrine, nutritional, and metabolic diseases - **Chapter V:** Mental and behavioral disorders - **Chapter VI:** Diseases of the nervous system - **Chapter VII:** Diseases of the eye and adnexa - **Chapter VIII:** Diseases of the ear and mastoid process - **Chapter IX:** Diseases of the circulatory system - **Chapter X:** Diseases of the respiratory system - **Chapter XI:** Diseases of the digestive system - **Chapter XII:** Diseases of the skin and subcutaneous tissue - **Chapter XIII:** Diseases of the musculoskeletal system and connective tissue - **Chapter XIV:** Diseases of the genitourinary system - **Chapter XV:** Pregnancy, childbirth, and the puerperium - **Chapter XVI:** Certain conditions originating in the perinatal period - **Chapter XVII:** Congenital malformations, deformations, and chromosomal abnormalities - **Chapter XVIII:** Symptoms, signs, and abnormal clinical and labor

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intertnational council for harmonization The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects Details of the ICH guidelines for pharmaceutical quality from Q1 to Q12 including stability analysis, evaluation of impurities and quality risk management. ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical guidelines for industries.

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