Topic 1 Flashcards
The manufacture, propagation, preparation, processing of a drug in a large scale (mass production)
Manufacturing
prescription order; specific for a particular patient; small scale
Extemporaneous Compounding
Producing small quantities of product for sensory, chemical, microbiological evaluations, clinical testing, limited market testing or furnishing samples to potential customers, shelf-life and storage stability studies
Pilot Plant
Providing data that can be used in making a decision on whether or not to proceed to a full-scale production process; and in the case of a positive decision, designing and constructing a full-size plant or modifying an existing plant
Pilot Plant
the making by physical, chemical, biological, or any other procedure of any article that meets the definition of drugs.
Manufacturing
• the manipulation, sampling, testing, or control procedures applied to the final product or any 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.
Manufacturing
large scale production of drug products
Manufacturing
Stages of Manufacturing
Dispensing of Raw Materials
Processing of Dosage Forms
Filling
Packaging and Repacking
The manufacture of raw materials
Primary Manufacturing
The manufacturing of dosage forms
Secondary Manufacturing
Packaging, Labeling, or Repacking of bulk finished products
Tertiary Manufacturing
An arrangement whereby a competent company manufactures the products for another company
Toll Manufacturing
Any organization or company involved in the manufacture, importation, repacking and/or distribution of drug or medicines
Drug Establishment
Revised Regulations for the Licensing of Drug Establishments and Outlets
AO 56 s. 1989
Rules and Regulations on the Licensing of Establishments Engaged in the Manufacture, Conduct of Clinical Trial, Distribution, Importation, Exportation, and Retailing of Drug Products, and Issuance of Other Related Authorizations
AO 2014-0034
Involved in production of drug products
(preparatory processing, compounding,
formulating. filling, packaging, repackaging. altering, ornamenting, finishing, labeling)
Drug Manufacturer
Involved in packaging of bulk drug product to its immediate container
Drug Manufacturer - Packer
Involved in repackaging of finished product into smaller quantities in a separate container and/or secondary packaging
Drug Manufacturer - Repacker
Registered owner of drug product and formulation but subcontracts manufacturing
- procures RM and PM
- provides monographs and QC protocols
Drug Manufacturer - Trader
Imports RM, API, and/or finished products for wholesale distribution to other licensed establishments
Drug Distributor - Importer
Exports RM, API, and/or finished products for wholesale distribution to establishments outside the country
Drug Distributor - Exporter
Procures RM, API, and/or finished products from a local licensed establishment for local distribution in wholesale basis
Drug Distributor - Wholesaler
• any establishment engaged in operations involved in the production of drugs, including propagation, processing, compounding, finishing, filling, packing, repacking, altering, or ornamenting with the end in view of storage, distribution or sale of the product
• does not include the compounding and filling of prescriptions in drugstores and hospital pharmacies
Drug Manufacturer
Types of Drug Manufacturer:
A. Ethical/Prescription Drug Manufacturer
B. Proprietary/Generic Manufacturers
C. Biologicals Manufacturer
Antitoxins, Antivenins, blood and blood derivatives, Immune serums,
immunologic diagnostic aids, toxoids, vaccines
Biological Manufacturer
Protein products using rDNA techniques, monoclonal antibodies
Pharmaceutical biotechnology products
Pharmaceutical biotechnology products:
▪ Veterinary Products Manufacturers
▪ Medicinal Chemicals Manufacturers
▪ Toll or Contract Manufacturers
Any establishment that imports/exports raw materials, active ingredients, and/or finished products for its own distribution or for wholesale distribution to other establishments or outlets.
Drug Importer/Exporter
Any establishment which is a registered owner of the drug product, procures the materials and packaging components and provides the production monographs, quality control standards and procedures, but subcontracts the manufacture of such products to a licensed manufacturer
- also engaged in the distribution and/or marketing of its products.
Drug Trader
Procures raw materials, active ingredients and/or finished products from a local establishment for local distribution on wholesale basis
Drug Distributor / Wholesaler
Includes manufacturers, importers and traders of drugs
Drug Supplier
• formulates new products
• involved in process development and scale-up
• prepares the master formula
Research and Development Dept