Shweta kate
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This document provides an overview of Good Manufacturing Practices (cGMP) regulations for pharmaceutical manufacturing. It discusses several key points: 1) cGMP regulations ensure identity, strength, quality and purity of drug products and concern all aspects of production and quality control. 2) Objectives of cGMP include providing complete guidelines for facility requirements, equipment, production methods, testing and quality standards. 3) The document outlines policies for employee qualifications, training, and hygiene. It also describes requirements for building layout, lighting, ventilation, plumbing, sewage and sanitation. 4) Maintenance and cleaning of equipment is discussed to ensure suitability for intended use and prevent contamination of drug products.
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Helpful contains for al pharmacy students like diploma, degree and also masters of pharmacy students
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The document discusses quality assurance considerations related to plant design for pharmaceutical manufacturing. It covers topics like building construction, personnel flow, material flow patterns, effluent treatment, sterilization process control, temperature/humidity control via air handling units, air flow testing and validation of manufacturing equipment, water systems, and air handling units. Proper plant design is important to ensure consistent production of safe, effective pharmaceutical products and compliance with good manufacturing practices (GMP) regulations.
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2. Specific sections cover water treatment systems, warehousing, production area layout, quality control laboratory independence, personnel training, and inventory/raw material management. Equipment must be properly located, maintained and defective units removed.
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Shweta kate
- 1. GMP & Industrial Management Name: Shweta S. Kate Teacher’s Name: Ms. Vaishnavi Jagtap Subject Name: Modern Pharmaceutics Roll No: 10
- 3. 1 2 3 4 cGMP is defined as “it is the part of quality assurance which ensure that products are consistently produced & controlled to the quality standards appropriate for their intended use and the legal requirements”. cGMP is thus concerned with both production & quality control matters. cGMP provides complete guidelines on designing material & product specifications, testing methods and reproducing methods for same. The drug regulatory authorities all over world e.g. WHO, M.H.R.A(U.K), T.G.A(Australia), M.C.C(South Africa), U.S.F.D.A etc. provides guidelines based on their requirements. INTRODUCTION
- 4. cGMP regulations assures identity, strength, quality, & purity of drug products. Concerned with all aspects of production and quality control. Ensure that the products are consistently manufactured and controlled to the specific quality. It provides complete guidelines on requirements of facilities and equipment’s.. In the manufacturing of cosmetic products, overall control and monitoring. OBJECTIVE OF cGMP
- 5. The manufacturer should have an adequate no.of personal with the necessary qualification & practical experiences. 1 The qualification required for production : B.Pharm; M.Pharm; Ph.D. 2 Q.A/Q.C: B.Pharm; M.Pharm; Ph.D. Stores: P.G. in material management. 3 Peoples in organization are main resource & more imp than equipment's and materials. 4 Training improves human performance on job, working capacity. 5 Smoking, drinking, chewing, food material should not be permitted into manufacturing, production areas. 6 POLICIES OF cGMP
- 6. LAYOUT OF BUILDINGS Plant Layout Plant layout is coordinated effort to achieve the final objective to integrate machine, materials, and personnel for economic production. Involve location of different departments and arrangements of machinery in each department. A rticular process or ADVANTAGES e as a number of unit be performed ine as one B PLANT ecisions ion C
- 8. Lighting: Adequate lighting shall be provided in all areas. Ventilation and Air filtration: Adequate ventilation shall be provided. Air filtration systems, including prefilters and particulate matter air filters, shall be used appropriate on air supplies to production areas. Plumbing: Potable water shall be supplied under continuous positive pressure in plumbing system free of defects that could contribute contamination to any drug product. Potable water shall meet the standards as prescribed. Sewage and Refuse: Sewage, trash and other refuse from the building and premises shall be disposed of in a safe and sanitary manner. Sanitation: Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition, any such building shall be free of infestation by rodents, birds, insects, and other vermin Trash and organic waste matter shall be held and disposed of in timely and sanitary manner.
- 9. EQUIPMENTS & MAINTANENCE De Equipm suit the The equ any in-p absorb t Equipm product and thro adaption Equipm Equipm should b E c t b W w b o S a a a