summary Flashcards
large-scale production of drug products’ preparation, processing, packaging, labeling, repacking, changing wrapper, label or container of any drug products
manufacturing
Stages of Manufacturing
- Dispensing of Raw Materials
- Processing of Dosage Forms
- Filling
- Packaging and Repacking
manufacture of raw material (APIs and
Excipients)
Primary Manufacturing
manufacture of finished dosage form
Secondary Manufacturing
packaging, labeling, and repacking of bulk finished product
Tertiary Manufacturing
an arrangement whereby a competent company manufactures products for another company
Toll Manufacturing
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 Authorization
AO 2014-0034
involved in production of drugs products (preparatory processing, compounding, formulating, filling, packaging, repackaging, altering, ornamenting, finishing, labeling)
Manufacturer
involved in packaging of bulk drug product to its immediate container
Packer
involved in repackaging of finished product into smaller quantities in a separate container and/ or secondary packaging
Repacker
Registered owner of drug product and formulation but subcontracts manufacturing
Trader
- Procures RM and PM
- Provides monographs and QC protocols
Trader
Drug Manufacturers:
Manufacturer
Packer
Repacker
Trader
imports RM, API, and/or finished products for wholesale distribution to other licensed established
Importer
exports RM, API, and/ or finished products for wholesale distribution to establishments outside the country
Exporter
procures RM, API, and/ or finished products from a local licensed establishment for local distribution in wholesale basis
Wholesaler
Drug Distributors
Importer
Exporter
Wholesaler
• formulates new products
• involved in process development and scale-up
• prepares Master formula
Research and Development Dept
Stages of Drug Development
1) Discovery and Development
2) Preclinical Research
3) Clinical Research
4) FDA Review
5) Post-market Surveillance
contains the formulation, specifications, manufacturing procedures, QA requirements, and labeling of a finished product
Master formula
addition of an excess amount of API in an unstable preparation
Overages
• prepares Master formula
• justifies overages in the formula
Research and Development Dept
• deals with all stages of manufacturing batches of finished drug products
• Plans the production according to MO
Production Dept
specific quantity of product intended to have uniform character and quality, produced during the same single cycle of manufacture
Batch
specific identified portion of a batch
Lot
gives instructions to manufacture a product
Manufacturing Order (MO)
• accomplish the BMR to ensure that batches were properly made and tests were conducted
Production Dept
document containing the details of the manufacture of each batch
Batch Manufacturing Record (BMR)
• stores materials and finished products
• holds incoming components in the quarantine area
• involved in purchasing and logistics
Warehouse Dept
status of materials which are isolated physically while a decision is awaited on their release, rejection, or reprocessing
Quarantine
• assures that all operations meet required standards for safety and efficacy, ensures compliance to cGMP
• conducts quality audit and monitoring
• prepares SOPs
Quality Assurance Dept
step-by- step instructions for performing operational tasks or activities
Standard Operating Procedures (SOP)
• tests compliance of raw materials, packaging materials, and finished products to specifications
• conducts sampling of materials to be tested
• performs IPQC and environmental testing
Quality Control Dept
• studies current market trends, consumer behavior and product status in market
• promote and advertisement
Marketing Department
ensures compliance of company and its products with all pertinent regulations and laws about drugs and their marketing
Regulatory Dept
• installs, maintains and repairs of equipment and premises
• conducts validation and qualification
• ensures safety
Engineering Department
action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results
Validation
action of proving that premises, systems or equipment work correctly and actually lead to expected results
Qualification
