Medicine Control Council (MCC) ppt

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medicine control council (MCC South Africa)

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Medicines Control Council (MCC): South Africa :

Presented By: MINHAJ UDDIN M.Pharm III rd Sem (Pharmaceutics) SBCOP Aurangabad. Medicines Control Council (MCC): South Africa

CONTENTS::

CONTENTS: What is MCC History Purpose and Operated by The structure of Council and its committees Guidelines Pharmaceutical & Analytical MCC Reference September 26, 2011 2

What is MCC? :

What is MCC? Medicines Control Council(MCC) is a statutory body that was established in terms of the Medicines and Related Substances Control Act, 101 of 1965, to oversee the regulation of medicines in South Africa Over the last 30 years South Africa has developed MCC with International recognized standing. Past five years it has transformed to regulatory Process. September 26, 2011 3

History ::

History : More than 20,000 medicines approved. More than 220 meetings held to decide on the registration of medicines. Applications for more than 11,800 complementary medicines submitted for evaluation by the Complementary Medicines Committee. SAPC licensed 300 wholesalers and distributors. These must still be licensed by the Medicines Control Council in terms of the Medicines Act. MCC approves more than 280 clinical trials annually September 26, 2011 4

Purpose :  :

Purpose : Medicines used in South Africa are safe, therapeutically effective consistently meet acceptable standards of quality. MCC applies standards laid down by the Medicines and Related Substances Control Act, (Act 101 of 1965) which governs the manufacture, distribution, sale, and marketing of medicines. The prescribing and dispensing of medicines is controlled through the determination of schedules for various medicines and substances. September 26, 2011 5

Operated by: :

Operated by : External experts-members of Council Committee structures. Registrar Provides administrative and technical support to Council. Registrar is CDMRA ,within Dept of Health. Registrar is executive secretary to Council. Four Directorates--co-ordination and execution of various activities. Deputy Registrar who performs functions as determined by the Registrar. Council has 11 Technical committees, With 146 members from Various institute in the Country. September 26, 2011 6

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MCC Structure September 26, 2011 7

Pharmaceutical & Analytical MCC:

Pharmaceutical & Analytical MCC PART 2A Pharmaceutical & Biological Availability. PART 3A API Biological Medicine Primary Production. PART 3B Formulation. PART 3C Specification & Control procedure for PI. PART 3D Containers & Packaging Material. PART 3E Manufacturing Procedure. PART 3F Final Product Specification & Control. PART 3G Stability data of Finished Pharmaceutical product. PART 3H Pharmaceutical Development. PART 3I Expertise & Premises used for the manufacture of biological Medicine. September 26, 2011 8

PART 2A: Pharmaceutical & Biological Availability :

PART 2A: Pharmaceutical & Biological Availability If efficacy & Safety are intended to established by Clinical data. Bioequivalence In vitro Dissolution Disintegration Acid Neutralizing Capacity Microbial Growth inhibition Zones Particle size distribution Blanching Test September 26, 2011 9

PART 3A: Active Pharmaceutical Ingredient (API):

PART 3A: Active Pharmaceutical Ingredient (API) Approved-name, INN, Chemical description, Structural Formula, Molecular F, Empirical Formula. Solubility of each API Storage requirement of API Name & Physical address of each Manufacturer September 26, 2011 10

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Active Pharmaceutical Ingredient File (APIF)/ Open Part of DMF should be submitted in Dossier Name & Physical Address of Manufacturer Approved Name (INN) of API Chemical Structure of API Flow Chart / Pathway of synthesis Occurrence of Isomer, Polymorphism Impurities Valid Certificate of Analysis (COAs) Reference Standard Stability Data September 26, 2011 11

PART 3B: Formulation:

PART 3B: Formulation Formulation Show- INN, API, IPI Name & qty of API per dosage unit corresponds to final product specification If product contain more than one API the product does not decrease the safety, Stability, Efficacy of Product IPI Should be use multi purpose should be indicated Any overages for the API should be stated separately Permitted Flavoring & Coloring agent (Foodstuffs, Cosmetics and Disinfectant Act, Act54 of 1972) The use of dyes, Printing ink, Coating material Subject to safety & Quality apply to medicinal Substances. September 26, 2011 12

PART 3C: Specification & Control Procedure For Pharmaceutical Ingredients:

PART 3C: Specification & Control Procedure For Pharmaceutical Ingredients Specification of all Active & Inactive ingredient should be listed (BP, USP) Use of any other Pharmacopeia should be listed Control Procedure of all active & inactive Ingredient Control Procedure for Particle size of API Permitted Flavoring & Coloring agent Microbial limit & Control procedure of all organic ingredient Frequency of Testing of Water September 26, 2011 13

PART 3D: Containers & Packaging Material:

PART 3D: Containers & Packaging Material Full detail of Immediate container Specification - Title, Limit, Nature of Material, Dimensions Test Performed- Suppliers of Packaging Material Description-Outer Container Bulk Container-Type of Material Pack Size –described in Submission September 26, 2011 14

PART 3E: Manufacturing Procedure:

PART 3E: Manufacturing Procedure Flow Diagram - sites & Processes. Batch Manufacturing Formulation (BMF) & Batch Size. If More than one BS then BF of each batch BMR/BPR for a batch Should be send & available for inspection. All in-process Control test shown in Flow diagram. A Process Validation Protocol (VP)/ Report (VR) Should Submitted to SA Guide to GMP September 26, 2011 15

PART 3F: Final Product Specification & Control:

PART 3F: Final Product Specification & Control Specifications Physical & other Properties Assay Content Dissolution & Disintegration Preservative Efficacy Control Procedure Certificate of Analysis Validation Endotoxin Imported Product September 26, 2011 16

PART 3G: Stability Data of Finished Pharmaceutical product (FPP):

PART 3G: Stability Data of Finished Pharmaceutical product (FPP) Summary of data, Clearly indicating – Number Type/Size Packaging Material Storage Condition Storage Period All Applications for registration of a Medicine should be Submitted with stability Guidelines September 26, 2011 17

PART 3H: Pharmaceutical Development :

PART 3H: Pharmaceutical Development Any differences in the formulation during development must be indicated clearly. Pharmaceutical Development Report - API Formulation Manufacturing Procedure Stability Conclusion References used in compilation of Report September 26, 2011 18

Part 3I: Expertise & Premises Used For The Manufacture of A Biological Medicine :

Part 3I: Expertise & Premises Used For The Manufacture of A Biological Medicine Description & Address where Primary production, or Bulk batch is carried out should be given. A Floor Plan of Premises should be included. Details of Premises should be given. Condition under which the product stored should be described. September 26, 2011 19

Medicines and related substances control act 101 of 1965 ::

Medicines and related substances control act 101 of 1965 : Medicines and related substances control act 101 of 1965 Same like a D & C Act, India. To provide the all information related to the registration of medicines and related substances intended for human and for animal use. September 26, 2011 20

Fees payable to Registrar :  :

Fees payable to Registrar : Fees payable to registrar Mainly 3 category: Category A: Human medicines including biologicals (Ready to use) Category B: Human medicines including biologicals (Required manipulation) Category C: Veterinary medicines including biologicals September 26, 2011 21

Why needed? :

Why needed? Facilitate the removal of barriers to trade in medicinal products, to promote uniformity in licensing decisions and to ensure the maintaining of high standards of quality assurance in the development, manufacture and control of medicinal products. Medicines Control Council of South Africa accepts the European, British or United States Pharmacopoeia September 26, 2011 22

Conclusion: :

Conclusion: The aim of these Guidelines is to assist applicants in the preparation of documentation for the registration of medicines for human use. The types of medicine include A new medicine for a new chemical entity (NCE), A multisource (generic) product, A product line extension, and A biological medicine. September 26, 2011 23

Indian Pharma in African Market ::

Indian Pharma in African Market : Zydus Cadila Torrent Pharmaceuticals Dr. Reddy’s Labs Ranbaxy Pharmaceuticals Intas Pharmaceuticals Sun Pharmaceuticals September 26, 2011 24

MCC approved CRO’s in Ahmadabad :

MCC approved CRO’s in Ahmadabad Accutest BioArc Research Labs Zydus Research Center (ZRC) Torrent Research Center (TRC) Cadila Pharma Lambda Research Center Veeda Research Center Synchron Research Labs September 26, 2011 25

Reference: :

Reference: ICH Guidelines (Q1A, Q1B and Q1F) WHO Guidelines on Biological WHO Technical Report Series CPMP Notes for Guideline on Development Pharmaceutics Log on to : http://www.mccza.com 9/9/2011 September 26, 2011 26

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Thank you September 26, 2011 27

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