GMP

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By: karale.mahesh (13 month(s) ago)

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Good Manufacturing Practices (GMPs ) is a universal concept with a dual purpose: to make pharmaceutical products both safe and consistent in their effectiveness. Remarkable changes are taking place in the basic approach to achieve these goals Scope a. The regulations in this part contain the minimum cGMP for preparation of drug products for administration to humans or animals. b. The cGMP regulations in this chapter as they pertain to drug products; in parts 600 through 680 in the FDA guidelines, as they pertain to drugs that are also biological products for human use.

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Pending consideration of a proposed exemption, published in the federal register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, and which products may also fall within the legal definition of drugs by virtue of their intended use.

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Though there are many common elements among the approach to GMP taken by the worldwide drug regulatory guidelines, there remains a major difference between the approvals awarded in the United States vis -a- vis Europe and the rest of the world. The U.S. Food and Drug Administration (FDA) inspection is triggered only when an application for marketing authorization has been submitted to the FDA. If the FDA chooses to inspect a facility—the so-called preapproval inspection (PAI)—the company is so advised and the approval of the pending New Drug Application (NDA) or abbreviated New Drug Application ( aNDA ) is delayed until the inspection is completed. The main focus of PAI is to establish if the applicant firm is capable of manufacturing a safe product, the issues relating to efficacy, dosing, and label copy being reviewed by the agency office in Washington, D.C. It is important to realize that all documents labeled cGMP

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as guidelines remain guidelines and the FDA inspectors are not bound by any specifications, requirements, or designs suggested in the current Good Manufacturing Practices (cGMP) documents. In almost all instances, the FDA inspector visiting a facility for the first time would take time to explain this to the technical team that receives the inspection team. “We are not bound by the CGMP guidelines because these meant to guide you and not bind us.”

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cGMP for Finished Pharmaceuticals Subpart A—General Provisions Scope Definitions Subpart B—Organization and Personnel Responsibilities of quality control unit Personnel qualifications Personnel responsibilities Consultants Subpart C—Buildings and Facilities Design and construction features Lighting Ventilation, air filtration, air heating and cooling Plumbing Sewage and refuse Washing and toilet facilities Sanitation Maintenance

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Subpart D—Equipment Equipment design, size, and location Equipment construction Equipment cleaning and maintenance Automatic, mechanical, and electronic equipment Filters Subpart E—Control of Components and Drug Product Containers and Closures General requirements Receipt and storage of untested components, drug product containers, and closures Testing and approval or rejection of components , drug product containers, and closures

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Use of approved components, drug product containers, and closures Retesting of approved components, drug product containers, and closures Rejected components, drug product containers, and closures Drug product containers and closures Subpart F—Production and Process Controls Written procedures; deviations Charge-in of components Calculation of yield Equipment identification Sampling and testing of in-process materials and drug products Time limitations on production Control of microbiological contamination Reprocessing

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Subpart G—Packaging and Labeling Control Materials examination and usage criteria Labeling issuance Packaging and labeling operations Tamper-evident packaging (TEP) requirements for OTC human drug products Drug product inspection Expiration dating Subpart H—Holding and Distribution Warehousing procedures Distribution procedures

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Subpart I—Laboratory Controls General requirements Testing and release for distribution Stability testing Special testing requirements Reserve samples Laboratory animals Penicillin contamination

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Subpart J—Records and Reports General requirements Equipment cleaning and use log Component, drug product container, closure, and labeling records Master production and control records Batch production and control records Production record review Laboratory records Distribution records Complaint files Subpart K—Returned and Salvaged Drug Products Returned drug products Drug product salvaging

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Responsibilities of quality control unit

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quality control unit that shall have the responsibility and authority to approve or reject all components. Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process Materials. The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product. The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.

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Personnel qualifications

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Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience. Training-employees remain familiar with cGMP requirements applicable to them. to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess. There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.

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Personnel responsibilities

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Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings Personnel shall practice good sanitation and health habits. Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products.

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Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.

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Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations. The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination. Operations shall be performed within specifically defined areas of adequate size. Receipt, identification, storage, and withholding from use of components, drug product containers, closures, and labeling, pending the appropriate sampling, testing, or examination by the quality control unit before release for manufacturing or packaging

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rejected components, drug product containers, closures, and labeling before disposition storage of released components, drug product containers, closures, and labeling; storage of in-process materials; manufacturing and processing operations; packaging and labeling operations; quarantine storage before release of drug products; storage of drug products after release; control and laboratory operations; aseptic processing:floors , walls, and ceilings of smooth, hard surfaces that are easily cleanable; temperature and humidity controls; an air supply filtered through high-efficiency particulate air filters under positive pressure,regardless of whether flow is laminar or nonlaminar

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Thank you