gmp's of mcc

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includes gmp's gudelines of medicine control council

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GMP’S - MCC By: T.PRAVALLIKA 11031S0406 M.PHARM – P.A & Q.A

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CONTENTS INTRODUCTION QUALITY MANAGEMENT PERSONEL PREMISES AND EQUIPMENT DOCUMENTATION PRODUCTION QUALITY CONTROL SELF INSPECTION

MCC:

WHAT IS MCC MCC

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MEDICINE CONTROL COUNCIL

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The Medicines Control Council is a statutory body to over see the regulation of medicines in South Africa. This body has 2 parts Good manufacturing practices for manufacturing of medicinal products. Good manufacturing practices for active substances used as starting materials.

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Its main purpose is to safeguard and protect the public by making sure that all medicines that are sold and used in South Africa are safe. therapeutically effective and consistently meet acceptable standards of quality. Purpose of MCC

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STRUCTURE OF MCC

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UALITY MANAGEMENT Quality assurance GMP Quality control Quality risk management

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QUALITY ASSURANCE It is the sum total of the organized arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use.

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The system of Quality Assurance for the manufacture of medicinal products should ensure that: Medicinal products are designed and developed according the requirements of Good Manufacturing Practice Production and control operations are clearly specified and Good Manufacturing Practice adopted All necessary controls on intermediate products, and any other in-process controls and validations are carried out The finished product is correctly processed and checked, according to the defined procedures Ensure that the medicinal products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life There should be self-inspection and/or quality audit which regularly appraises the effectiveness and applicability of the quality assurance system.

GOOD MANUFACTURING PRACTICES:

GOOD MANUFACTURING PRACTICES Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the medicine registration or product specification.

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all manufacturing processes are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their specifications. critical steps of manufacturing processes and significant changes to the process are validated. all necessary facilities for GMP are provided including: appropriately qualified and trained personnel adequate premises and space suitable equipment and services correct materials, containers and labels approved procedures and instructions suitable storage and transport; GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS :

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Instructions and procedures are written in an instructional form in clear and unambiguous language. Operators are trained to carry out procedures correctly. Records are made, manually and/or by recording instruments, during manufacture which demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product was as expected. Any significant deviations are fully recorded and investigated

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QUALITY CONTROL

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Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organization, documentation and release procedures, which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.

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A dequate facilities, trained personnel and approved procedures are available for sampling, inspecting and testing starting materials packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP purposes. Samples of starting materials, packaging materials, intermediate products, bulk products and finished products are taken by personnel and by methods approved by Quality Control Test methods are validated The finished products contain active ingredients complying with the qualitative and quantitative composition of the medicine registration, are of the purity required, and are enclosed within their proper containers and correctly labeled Sufficient reference samples of starting materials and products are retained to permit future examination of the product

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Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively. The quality risk management system should ensure that: The evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient. T he level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk

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PERSONEL Eligibility Personel hygiene Training

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The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of medicinal products relies upon people The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs The manufacturer must have an organisation chart

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KEY PERSONNEL Key Personnel include the head of Production, the head of Quality Control, and if at least one of these persons is not responsible for the release of products the authorized person(s) designated for the purpose The head of the Production Department generally has the following responsibilities: To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. To approve the instructions relating to production operations and to ensure their strict implementation. To ensure that the production records are evaluated and signed by an authorised person before they are sent to the Quality Control Department. To check the maintenance of his department, premises and equipment. To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.

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The head of the Quality Control Department generally has the following responsibilities: to approve or reject, as he sees fit, starting materials, packaging materials, and intermediate, bulk and finished products. to evaluate batch records. to ensure that all necessary testing is carried out. to approve specifications, sampling instructions, test methods and other Quality Control procedures. to approve and monitor any contract analysts. to check the maintenance of his department, premises and equipment. to ensure that the appropriate validations are done.

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Personel hygiene

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PERSONEL HYGIENE They should include procedures relating to the health, hygiene practices and clothing of personnel These procedures should be understood and followed in a very strict way by every person whose duties take him into the production and control areas All personnel should receive medical examination upon recruitment Steps should be taken to ensure as far as is practicable that no person affected by an infectious disease or having open lesions on the exposed surface of the body is engaged in the manufacture of medicinal products. Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or personal medication in the production and storage areas should be prohibited Direct contact should be avoided between the operator's hands and the exposed product as well as with any part of the equipment that comes into contact with the products. Personnel should be instructed to use the hand-washing facilities

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TRAINING Personels should be provided with training in accordance with a written Programme whose duties are in production area or control laboratories including Technical, maintenance and cleaning personel .

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PREMISES AND EQUIPMENT

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Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build up of dust or dirt and, in general, any adverse effect on the quality of products. PREMISES Premises should preferably be laid out in such a way as to allow the production to take place in areas connected in a logical order corresponding to the sequence of the operations and to the requisite cleanliness levels. The adequacy of the working and in-process storage space should permit the orderly and logical positioning of equipment and materials so as to minimise the risk of confusion between different medicinal products or their components, to avoid cross-contamination and to minimise the risk of omission or wrong application of any of the manufacturing or control steps

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Production Area Pipe work, light fittings, ventilation points and other services should be designed and sited to avoid the creation of recesses which are difficult to clean. Drains should be of adequate size, and have trapped gullies. Open channels should be avoided where possible, but if necessary, they should be shallow to facilitate cleaning and disinfection. Production areas should be effectively ventilated, with air control facilities (including temperature and, where necessary, humidity and filtration) appropriate both to the products handled, to the operations undertaken within them and to the external environment. Premises for the packaging of medicinal products should be specifically designed and laid out so as to avoid mix-ups or cross-contamination.

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Storage Areas Storage areas should be of sufficient capacity to allow orderly storage of the various categories of materials and products: starting and packaging materials, intermediate, bulk and finished products, products in quarantine, released, rejected, returned or recalled They should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored Highly active materials or products should be stored in safe and secure areas Printed packaging materials are considered critical to the conformity of the medicinal products and special attention should be paid to the safe and secure storage of these materials

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Quality Control Areas This is particularly important for laboratories for the control of biologicals , microbiologicals and radioisotopes, which should also be separated from each other Sufficient space should be given to avoid mix-ups and cross-contamination. There should be adequate suitable storage space for samples and records Separate rooms may be necessary to protect sensitive instruments from vibration, electrical interference, humidity, etc . Special requirements are needed in laboratories handling particular substances, such as biological or radioactive samples

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EQIUPMENT Manufacturing equipment should be designed, located and maintained to suit its intended purpose Repair and maintenance operations should not present any hazard to the quality of the products Manufacturing equipment should be designed so that it can be easily and thoroughly cleaned It should be cleaned according to detailed and written procedures and stored only in a clean and dry condition. Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods Balances and measuring equipment of an appropriate range and precision should be available for production and control operations

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DOCUMENTATION

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Good documentation constitutes an essential part of the quality assurance system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history. Specifications, Manufacturing formulations and instructions, procedures, and records must be free from errors and available in writing.

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There should be appropriately authorized and dated specifications for starting and packaging materials, and finished products; where appropriate, they should be also available for intermediate or bulk products. Specifications for active or inactive starting material : tests & limits for identity, purity, physical and chemical characteristics, microbiological standards and assay Specifications for packaging material : description of nature, dimensions, designated name with a code Specifications for intermediate and bulk products : similar to starting material or finished product Specifications starting materials or for finished products : name of the product with code, names of active ingrediants , formula, details of dosage and packaage , test limits for identity, purity, physical and chemical characteristics. Specifications

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Two types of records: Master records Master manufatcuring instructions Master processing instructions Batch record Batch record for manufacturing Batch record for packaging

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PRODUCTION

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Principle Prevention of cross contamination Validation Starting material Intermediate and bulk products Packaging materials and operations Finished products Recited, recovered, and returned materials

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Production operation must follow clearly defined procedures They must comply with principles of gmp in order to obtain products of requisite quality and be in accordance with the relevant manufacturing and medicine registrations All handling of materials and products, such as receipt and quarantine, sampling, storage, labelling , dispensing, processing, packaging and distribution should be done in accordance with written procedures or instructions and, where necessary, recorded All incoming materials should be checked to ensure that the consignment corresponds to the order Incoming materials and finished products should be physically or administratively quarantined All materials and products should be stored under the appropriate conditions established by the manufacturer and in an orderly fashion to permit batch segregation and stock rotation.

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providing appropriate air-locks and air extraction minimizing the risk of contamination caused by recirculation or re-entry of untreated or insufficiently treated air keeping protective clothing inside areas where products with special risk of cross-contamination are processed using cleaning and decontamination procedures of known effectiveness, as ineffective cleaning of equipment is a common source of cross-contamination Measures to prevent cross-contamination and their effectiveness should be checked periodically according to set procedures Prevention of cross contamination

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VALIDATION Validation studies should reinforce Good Manufacturing Practice and be conducted in accordance with defined procedures. Results and conclusions should be recorded. STARTING MATERIALS all aspects of the production and control of the starting material in question, including handling, labelling and packaging requirements, as well as complaints and rejection procedures are discussed with the manufacturer and the supplier. INTERMEDIATE AND BULK PRODUCTS Intermediate and bulk products should be kept under appropriate conditions. Critical processes should be validated .

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PACKAGING MATERIALS and OPERATIONS The purchase, handling and control of primary and printed packaging materials shall be accorded attention similar to that given to starting materials. Particular attention should be paid to printed materials. They should be stored in adequately secure conditions such as to exclude unauthorized access All products and packaging materials to be used should be checked on delivery to the packaging department for quantity, identity and conformity with the Packaging Instructions. Containers for filling should be clean before filling. Attention should be given to avoiding and removing any contaminants such as glass fragments and metal particles Special care should be taken when using cut-labels and when over-printing is carried out off-line. Roll-feed labels are normally preferable to cut-labels, in helping to avoid mix-ups.

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FINISHED PRODUCTS The evaluation of finished products and documentation which is necessary before release of product for sale should be done REJECTED, RECOVERED AND RETURNED MATERIALS Rejected materials and products should be clearly marked as such and stored separately in restricted areas The reprocessing of rejected products should be done exceptional Products returned from the market and which have left the control of the manufacturer should be destroyed unless without doubt their quality is satisfactory

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SELF INSPECTION

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Self-inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures Personnel matters, premises, equipment, documentation, production, quality control, distribution of the medicinal products, arrangements for dealing with complaints and recalls, and self-inspection, should be examined at intervals following a pre-arranged programme in order to verify their conformity with the principles of Quality Assurance Self-inspections should be conducted in an independent and detailed way by designated competent person(s) from the company All self-inspections should be recorded Reports should contain all the observations made during the inspections and, where applicable, proposals for corrective measures

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references Current good manufacturing practices for pharmaceuticals Manohar A Potdar INTERNET- wikipedia www.mccza.com

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THANK YOU

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