MODULE 5

• Manufacturing Pharmacy Plant Departments

  • Manufacturing
  • Research and Development
  • Production Line Department
  • Warehouse Department
  • Quality Assurance Department
  • Quality Control Department
  • Marketing Department
  • Regulatory Department
  • Engineering Department
  • Medical Department
• Manufacturing


  Mass production, large scale, manufacture, preparation, propagation of Drug products in large scale, biological, physicochemical means of production, sampling assaying, testing of control procedures, involves packaging, repacking, labeling, changing containers or wrappers, anything involved with the purchase, weighing, and everything else

  
• Extemporaneous


  Small scale, patient/medication specific, narrow therapeutic index (e.g. Digoxin, Theophylline, Warfarin)
• Drug Establishments


  • Drug Manufacturer
  • Drug Trader
  • Drug Distributor/Importer/Exporter
  • Drug Distributor/Wholesaler
• Drug Manufacturer


  Manufactures, sells, markets and/or distributes Prescription Drugs to pharmacies and other Persons that sell or dispense such drugs to the consuming public, all tasks, "biggest establishment" (e.g. Abbott, GSK, Hizon Lab, LLI)
• Drug Manufacturer Types


  • Ethical (Prescription or legendary drugs)
  • Generic/Branded (Manufacturer's generic/ branded drugs)
  • Biological (Sources plants and animals, e.g. vaccines/toxoids/ immune sera/Ig/antitoxins)
  • Veterinary (Drugs for animals, e.g. Leonie Agri Corp. Farm, Nueva Ecija)
  • Medicinal/chemical (Manufacturer's additives/excipients, Reagents, Raw materials)
  • Toll/ Contractual (Not registered owner of Drugs, with equipment, e.g. LLI, Hizon, La Croseus, Toll: Right Med; Trader: Unilab)
• Drug Importer


  Imports Raw material, AI, FP for its local distribution (e.g. Novartis, Aspen, Natrapharm)
• Drug Exporter


  Exports Raw Material, AI, FP to other countries (e.g. Abbott, Boehringer Ingelheim)
• Drug Traders (Registered Owner of Drugs)


  Subcontracts toll manufacturers, involved in toll manufacturing (AO 56 s 1989 and IRR of RA 9711)
• Drug Distributor/Wholesaler


  AKA Middlemen, exports Raw Material, AI, FP to local establishments in a wholesale basis
• Drug Supplier


  Drug Manufacturer + Drug Traders +Drug Importer, has a lot of sources (e.g. Mercury, Zuellig, P&G, Unilab, Colgate-Palmolive)
• Terminologies


  • Monograph
  • Certificate of Analysis
  • Formula
  • Batch formula
  • Raw Material Specification
  • Standard Operating Procedure
  • Finished Product Specification
  • Sample
• Monograph


  Document that specifies all the tests to be conducted on a product and/or appropriate references containing details of procedure and expected result
• Certificate of Analysis


  Document with the results of all tests conducted on material to show compliance or noncompliance with the standard specifications, needed for raw materials → Finished products
• Formula


  Concise and precise statement of the ingredients that comprise the product, together with the percentage and/or weight of each
• Batch formula


  Raw Material Specification that enumerates the characteristics of all the materials that go into the product and the permissible range of purity of each ingredient, according to monograph
• Standard Operating Procedure


  Step by step method on how to go about a job, according to FDA
• Finished Product Specification


  Covers all characteristics that affect the proper performance, purity, safety and stability of the Product, according to FDA
• Sample


  Finite number of objects selected from a batch
• Manufacturing Pharmacy Plant Departments

  • Manufacturing
  • Research and Development
  • Production Line Department
  • Warehouse Department
  • Quality Assurance Department
  • Quality Control Department
  • Marketing Department
  • Regulatory Department
  • Engineering Department
  • Medical Department
• Manufacturing Department


  Responsible for large scale production of Drug products
• Stages of Manufacturing


  • Dispensing of Raw Materials
  • Processing of DF
  • Filling
  • Packaging & Repacking
• Primary Manufacturing


  Manufacturing of APIs & excipients
• Secondary Manufacturing


  Manufacturing of Dosage Forms (e.g. Semi-Solids, Solids, Liquid, Aerosols)
• Tertiary Manufacturing


  Packaging, labeling, or repacking of bulk finished products
• Toll Manufacturing


  An arrangement whereby a competent company manufactures the products for another company
• Research and Development Department


  Formulates & develops new innovative products, serves as a pilot in manufacturing
• Stages of Drug and Development

  • Drug Discovery & Dev't
  • Preclinical Research (Animals)
  • Clinical Research (1st 3 Phases)
  • FDA review
  • Post-market surveillance
• Production Line Department Stages

  • BMR/MBR (Batch Manufacturing Record/Master batch record)
  • MO (Manufacturing Order)
  • Batch
  • Lot
  • Batch/ Lot. No
• Batch Manufacturing Record/ Master Batch Record

  Charts that ensure batches were properly made
• Manufacturing Order


  Gives instructions to manufacturing a product, signed by the Pharmacist or Chemical Engineer in charge
• Batch


  A specific quantity of product having uniform character and quality produced during a single manufacturing process, products made within the day
• Lot


  Portion of a batch, required by community pharmacist
• Batch/ Lot. No


  Alphanumeric code for identification & traceability, communication from industrial RPh towards the community RPh
• Warehouse Department


  Stores materials & finished products, holds incoming components in the quarantine area, involved in purchasing & logistics, temporary holding for QC testing
• Quality Assurance Department


  Assures operations meet the required standards of safety & efficacy, conducts quality audit & monitoring, prepares SOPs (step by step instructions for performing an operational task/ activity), main focus: Personnel
• Quality Control Department


  Tests compliance of materials & finished products to specifications, conducts sampling of materials, performs in-process testing, main focus: Process
• Marketing Department


  Studies current market trends, consumer behavior, & patent status in the market, advertisement & promotion (e.g. Medreps)
• Regulatory Department


  Ensures compliance with all pertinent regulations and laws about drugs and their marketing
• Engineering Department


  Installs, maintains & repairs equipment & premises, ensures safety, conducts validation (proving & documenting that a process, procedure/ method actually & consistently leads to the expected results) & qualification (a part of validation which focuses on premises, systems or equipment)