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UK MEDICINES CONTROL AGENCY GUIDELINES :

Presented By Surya Narayana Parichha M Pharm 3 rd Semester ( P’ceutical Chemistry) Govt College Of Pharmacy, A’bad What you Need To Know UK MEDICINES CONTROL AGENCY GUIDELINES

Snapshot:

Abbreviation History Introduction Aims Corporate Governance Activities What MHRA Regulate UK Guidance on Manufacturing UK Legislation on Manufacturing How Does Licensing work Dealing with Faulty Medicine References Snapshot 9/21/2011 2

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Abbreviations UK : United kingdom. GMP: Good manufacturing practices. M P : Medicinal product. GDP: Good Distribution practices. 9/21/2011 3

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History 1960- Thalidomide Crisis 1963- Committee on Safety of Drug 1989- Medicines Control agency 2003- Medicines & Healthcare Product Regulatory Agency There are around 20,000 different medicines available in UK photo 9/21/2011 4

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Introduction UK: MHRA/ MCA MHRA is Medicines and Healthcare products Regulatory Agency. This agency is of United Kingdom (UK). This agency is responsible for MHRA audits through the world. The companies those complies their GMP regulations can export their pharmaceutical products to UK. The GMP guidelines of MHRA is known as Orange Guide. All the GMP regulation are given in this guide that are to be followed in pharmaceutics according to MHRA. 9/21/2011 5

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Cont… In the united kingdom the provision for the manufacturer & wholesale dealer implement-undertaking in regulations medicinal Act1968. The European community guide to GMP including its annexes provides detailed guidance which interpret & expand on the statutory principles & guidelines. The aim of the GDP & GMP – assure quality. 9/21/2011 6

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Cont… The great majority of reported defective medicinal products has resulted from human error or carelessness, not from failure technology. All the people involved with the activities which lead to a patient taking a medicine, should bear this constantly in mind when performing their duties. ( production , key personnel, inspection of regulatory authorities, quality control) 9/21/2011 7

Safe Guard Public Health :

Safe Guard Public Health Safe guard public health by effective regulation Ensure medicines sold of acceptable standard of Safety, Quality, Efficacy Construct principles for good manufacturing & distribution practice Influence International Regulation Aims 9/21/2011 8

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Corporate Governance 9/21/2011 9

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Activities 9/21/2011 10

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Activities : 9/21/2011 11

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Regulate Clinical trials 9/21/2011 12

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Activities : 9/21/2011 13

Monitors safety & quality Standard by :

Regular inspection of goods & safe practice Annual routine sampling of around 3000 marketed medicines at premises Publishing standards on ingredients & expected quality of medicine ( BP ) GPRD used to detect healthcare trends & monitoring marketed license Legally enforcing regulations on both licensed/unlicensed products Monitors safety & quality Standard by 9/21/2011 14

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Activities : 9/21/2011 15

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Quality Surveillance System Address quality defects Monitors safety & quality of imported unlicensed medicines Investigate internet sales of medicines quality photo Safety & Quality of Medicines 9/21/2011 16

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Activities : 9/21/2011 17

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Post Marketing Surveillance Reporting, investigating, monitoring adverse reaction to medicines Quality defect monitoring Sampling & testing Product recall 9/21/2011 18

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Activities : 9/21/2011 19

Around 5% of the UK population’s health record on GPRD database:

Around 5% of the UK population’s health record on GPRD database Internationally recognized database Contains records of patients register by doctors UK Govt. entrusts the MHRA to manage GPRD Use to research issues of licensed medicine & improve understanding of disease Nearly 500 studies published based on GPRD General Practice Research Database 9/21/2011 20

New Technologies Forum :

What MHRA Regulate ? New Technologies Forum Devices International Activities Clinical trials Blood Medicines Policy Therapy Nanotechnology 9/21/2011 21

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The MHRA carries around 1000 inspections on pharmaceutical manufacturers and wholesalers each year . Quality Management Manufacturing Documentation Personnel Premises & Equipment Self Inspection Guidance On Manufacture 9/21/2011 22

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UK Guidance on manufacture Manufacturer’s Obligations Qualified Persons Contract Manufacture General Principles 9/21/2011 23

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Manufacturer’s Obligations The License Holder Shall- Comply with principles of GMP Use active starting material which manufactured in accordance with GMP Maintain such staff, premises, equipment & facilities necessary to conduct the manufacturing as per requirement of license Inform licensing authority before making any alteration to premises or facilities Ensure that any arrangement made for the control, storage, distribution of relevant MP are adequate to maintain the Quality of product 9/21/2011 24

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Cont… License holder shall in relation to M P: i ) other than for human use. ii) for human use. i ) other than for human use: Provide & maintain accordance with relevant product license. Any test of M P that under his license, when animal used – suitably housed & managed. ii) for human use: Provide & maintain a designed QC department 9/21/2011 25

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Qualified person i ) All holders of manufactures & wholesale dealers licenses – Have QPs must be named on license. ii) Assessment of nominee’s eligibility made by : i . Joint assessment panel of the institute of biology. ii. Royal pharmaceutical society of great Britain. iii. Royal society of chemistry. iii) MCA assess only that QPs is not a member of any of these professional bodies. 9/21/2011 26

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Manufacture and importation of unlicensed medicines for human use In medicine Act contain certain exemption i.e. requirement to hold product license (marketing authorization). Two type of unlicense a) special unlicense . b) nonspecial unlicense . Medicines for human regulation 1994 (SI 1994 3144) requires that M P are licensed before marketed in UK. In certain condition special unlicense product applicable 9/21/2011 27

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UK Legislation on Manufacture The Medicines for Human Use Regulations 2005 Standard provisions which may be incorporated in a manufacturers license relating to Schedule 1 : Manufacture & assembly of relevant medicinal products Schedule 2 : Import of relevant medicinal products from a third party Schedule 3 : Vaccines ( Smallpox, BCG, Toxins & Sera ) 9/21/2011 28

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License referred as marketing Authorization Company apply for permission to test drugs by Clinical trials Assessment team satisfy license How Does Licensing Work ? 9/21/2011 29

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Around 5,000 licenses are granted to medicines, manufacturers each year Clinical Trails Manufacturers Medicine Importers Generics Blood Banks Traditional Herbal Medicines New Forms of Existing Medicines New Uses of Existing Medicines The MHRA Licenses 9/21/2011 30

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Class 1: Require immediate recall ( serious risk to health ) Class 2: Specifies recall within 48 hrs ( Harmful but not serious ) Class 3: Action to be taken within 5 days ( unlikely to harm ) Class 4: Advice caution to be exercised while using the product Dealing with faulty medicines Most recall fall into class 2/3 9/21/2011 31

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Rules and Guidance For Pharmaceutical Manufactures and Distributors 2007, Compiled by MHRA Forensic Pharmacy, Dr. B. S. Kuchekar , Mr. A. M. Khadatare , Mr. Sachin Itkar – 2006 Page no.-17.13,17.15 www.mhra.gov.in www.google.com References 9/21/2011 32

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THANK YOU ! 9/21/2011 33

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