AI Homework HelpExpert HelpStudy Resources Manufacturing-Ph-Prelim-… Pages 67 Log in Join DOC PREVIEW Identi몭ed Q&As 70 Solutions available Total views 100+ Liceo de Cagayan University • BrigadierKnowledgeMonkey611 PHARMA • • 12/23/2020 0 PHARMA 1 • • 100% (2) 0 View full document Search this document PHARMACEUTICAL MANUFACTURING (WITH REGULATORY PHARMACY, QUALITY ASSURANCE AND CGMP) Pharmaceutics 2 Manufacturing (AO No. 43 s. 1999) – law of manufacturing pharmacy • The complete set of activities to produce a drug that comprise production and quality control from dispensing of materials to the release for distribution of the finished product. • This includes designing, testing, pre-formulation, formulation, quality control, preparation of raw materials and etc. • Drug – diagnose, mitigate, treat, and cure Pharmaceutical Manufacturing • The manufacture, propagation, preparation and processing of a drug product in a large scale. • The making by physical, chemical, biological or any other procedure of any article that meets the definition of drugs. • The manipulation, sampling, testing or control procedures applied to the final product or any other part of the process. • The packaging, repacking or changing the container, wrapper or label of any drug package in preparation for its distribution from the manufacturer to the final user. • Mass production of drug products. • • • • • Extemporaneous Compounding Small scale preparation of drug products Prescription order Specific for a particular patient. Done in community pharmacy and hospital pharmacy E.g: Paper tablets Types of Pharmaceutical Manufacturing • Primary manufacturing – produces API and excipients, produce raw materials • Secondary manufacturing – production of finished dosage form or drug product from API and excipients, receive and order from primary manufacturer. • Tertiary manufacturing – production of packaging, labelling, and repacking of bulk finished product, no direct contact with API and excepients • Toll manufacturing – an arrangement whereby a competent company processes raw materials, semifinished goods, and packages product for another company, used by facilities that cannot produce their own medicine by hiring another manufacturing firm o Advantages: time efficient, can save money and effort Drug Establishment • An organization or company involved in the manufacture, importation, repackaging and distributions of drugs and medicines. Any establishment engaged in operations involved in the production of drugs. a) Proprietary/generic manufacturer – Ritemed , Rhea, Unilab (Proprietary) b) Ethical manufacturer – Rx drugs/ prescribed drug Drug c) Biological manufacturer – vaccines, sputnik by Russian company Manufacturer d) Veterinary products manufacturer – animals e) Medicinal chemical manufacturer – reagents, alcohols, disinfectants f) Toll/Contract manufacturer • Imports or exports raw materials, active ingredients or finished products for its own use or for wholesale distribution on wholesale basis Drug Distributor • Drug distributor (wholesaler) • Produce raw materials, active ingredients and or finished product from local establishment or for local distribution on wholesale basis. • Registered owner of the drug product but subcontracts toll manufacturer of such Drug Trader products to a licensed manufacturer. • May also engage in distribution and or marketing of products. DEPARTMENT IN A DRUG ESTABLISHMENT 1. Research and development department 2. Production department • Formulates and develops new product, improves existing • Manufacture drug products according to products. schedule (Manufacturing order) • Does pharmaceutical, chemical and physiological • Warehousing, Inventory control, Storage researchers • • • • • • • • • • • 3 facilities: Library, Animal house, Pilot plant 3. Quality control and quality assurance department Ensure that all operations involved meet the standards of quality, purity, safety and efficacy. Assures the compliance to cGMP “Heart and Soul” of a drug manufacturer Sampling, testing and assaying of drugs 5. Engineering department Install maintains and repairs equipment’s and facilities. Ensure the safety of the plant and employees/personnel. 7. Medical department Does annual or quarter physical and medical examination of employees and applicants. Does the clinical studies. Prepares product inserts and literature. Publishes company’s newsletter/organ • • • • • 4. Marketing department Promotes maximum volume of sales of products (advertisement) Monitors product status, consumers behaviour and market trends. 6. Purchasing department Purchases, receives and inventories of supplies. 8. Regulatory affairs department Responsible for the processing of all regulatory processes. Responsible for product registration. General Design and Construction Features of Pharmaceutical Plant • • Premises The premises for manufacturing shall be suitable size, design, construction and location to facilitate proper operation, cleaning and maintenance. The individual working area shall be adequate so that any risk of confusion, cross contamination and other mistakes that will adversely affect the quality of drugs and devices will be avoided. Location, Construction, Design & Layout • Shall be located and protected against contamination from the environment • Shall be constructed and maintained to protect against weather, flood, ground seepage and the access and harboring of vermin, rodents, birds, insects or other animals. • In determining the design and layout of premises, consideration should be paid to: • Compatibility of other manufacturing operations that may carried out in the same or adjacent premises. • Allow production to take place in areas connected in logical order according to the sequence of the operations and to the requisite cleanliness level. • Adequacy of working space, which shall allow orderly and logical placement of equipment and materials to suit the operation, efficient flow of work, effective communication and supervision to avoid crowding and disorder. • Avoid the use of production areas as general traffic for personnel or materials or for storage other than the materials in process. The layout of rooms, corridors and spaces shall provide for logical movements of materials and personnel with minimal traffic for operations to be carried out in defined area and to avoid cross-contamination. The design and layout shall fulfill the following requirements: • Prevent risk of mix-up between different drugs or their components, cross- contamination and omission of any production step. • Penicillin’s shall be produced only in separate buildings, with separate air handling facilities. • Cephalosporins shall be produced in separate buildings with separate air handling facilities. End of preview Want to read all 67 pages? Upload your study docs or become a member. View full document Recently submitted questions See more There has been a substantial increase in recent years of the number of lawsuits over negligence. Do you think many of these truly… Q&A Question about currency Q&A The responsibilities of the Para legalism and ethics? 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