1 Flashcards
The manufacture, propagation, preparation, processing of 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.
MANUFACTURING
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 a drug products
MANUFACTURING
4 stages of manufacturing
• DISPENSING OF RAW MATERIALS
• PROCESSING OF DOSAGE FORMS
• FILLING
• PACKAGING AND REPACKING
4 Mfg activities
• PRIMARY MFG
• SECONDARY MFG
• TERTIARY MFG
• TOLL MFG
Manufacturing of raw materials
PRIMARY MFG
Manufacturing of dosage forms
SECONDARY MFG
Packaging, labeling or repacking of bulk finished products.
TERTIARY MFG
An arrangement whereby a competent company manufacturers the product for another company.
TOLL MFG
Any organization or company involved in the manufacture, importation, repacking and/ot 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, Drugstore and Retailing of Drug Products, and Issuance of RONPD Other Related
Sponsor Authorizations
AO 2014-0034
Involved in production of drug products (preparatory processing, compounding, formulating, filling, packaging, repacking, altering, ornamenting, finishing, labeling)
DRUG MANUFACTURER
Involved in packaging of bulk drug product to its immediate container.
DRUG MANUFACTURER- PACKER
Involved in repacking 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.
DRUG MANUFACTURER - TRADER
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, APU, and/or finished products for wholesale distribution to establishments outside the country.
DRUG DISTRIBUTOR - EXPORTER
Procures RM, APU, and/or finished products from a local licensed establishment for local distribution in wholesale basis
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
DRUG MANUFACTURER
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
Included manufacturers, importerd and traders of drugs.
DRUG SUPPLIER
It formulates new products
RESEARCH AND DEVELOPMENT (R&D) DEPT.
- involved in process development and scale-up
- prepares the master formula
- justifies any overages in the formula
- improved existing products
RESEARCH AND DEVELOPMENT (R&D) DEPT.
It contains the formulation, sepcifications, manufacturing procedures, OA requirements, and labeling of a finished product
MASTER FORMULA
It deals with all stages of mfg batches of finished drug products
PRODUCTION DEPT
Specific quantity of product intended to have uniform character and quantity, produced during the same single cycle of manufacture
BATCH
Specific identified portion of a batch
LOT
-plans the production according to MO
- accomplished the BMR to ensure that batches were properly made and tests were conducted
PRODUCTION DEPT.
Stores materials and finished products
WAREHOUSE DEPT
Holds incoming components in the quarantine area
WAREHOUSE DEPT
Involved in purchasing and logistics
WAREHOUSE DEPT
Assures all operations meet the required standards of safety and efficacy (cGMP)
Conducts quality audit and monitoring
Prepares SOPs
QUALITY ASSURANCE (QA) DEPT.
Test compliance of materials and finished products to specifications
QUALITY CONTROL DEPT
Conducts sampling of materials
QUALITY CONTROL DEPT
Performs IPQC and environmental testing
QUALITY CONTROL DEPT
Studies current market trends, consumers, behavior, and product status in the market
MARKETING DEPT
Advertisement and promotion
MARKETING DEPT
Accomplished 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)
Document containing the details of the manufacture of each batch
BATCH MANUFACTURING RECORD (BMR)
Status if materials which are isolated physically while a decision us awaited on their release, rejection ir reprocessing.
QUARANTINE
Step-by-step instructions for performing operational tasks or activities
STANDARD OPERATING PROCEDURE (SOP)
Ensures compliance with all pertinent regulations and laws about drugs and their marketing
REGULATORY
Installs, maintains and repairs equipment and premises
ENGINEERING DEPT
Conducts validation and qualification
ENGINEERING DEPT
Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results
VALIDATION
LTO
License to Operate
CPR
Certificate of Product Registration
Action of proving that premises, systems or equipments work correctly and actually lead to expected results
QUALIFICATION
• Ensures safety
ENGINEERING DEPARTMENT
• concerned with the physical exam and medical tx of employees
MEDICAL
• performs clinical studies
MEDICAL
Publishes house organ/paper
MEDICAL DEPARTMENT
Purchases, receives and makes inventories of supplies
PURCHADING DEPARTMENT
10 Departments in a Manufacturing Company
• RESEARCH AND DEVELOPMENT DEPTARTMEMT
• PRODUCTION DEPARTMENT
• WAREHOUSE DEPARTMENT
• QUALITY ASSURANCE DEPARTMENT
• QUALITY CONTROL DEPARTMENT
• MARKETING DEPARTMENT
• REGULATORY DEPARTMENT
• ENGINEERING DEPARTMENT
• MEDICAL DEPARTMENT
• PURCHASING DEPARTMENT
Refers to the pharmaceutical research and manufacturing companies providing pharmacist with medicines in pre-fabricated or ready to take forms.
INDUSTRIAL PHARMACY
Is a mechanism for determining and assigning duties to people, in order to work effectively.
ORGANIZATION
A combination of manpower, money, machines and methods so coordinated that they can fulfill an economic objective
BUSINESS ORGANIZATION
Organizational Planning is Interpreted as a?
CHART
The first basic tool of an organization
ORGANIZATIONAL PLANNING
The second basic tool of an organization
POSITIONAL DESCRIPTION
This will clearly define the authority, duty or responsibility of the areas in the chart?
POSITIONAL DESCRIPTION
The third basic tool of an organization?
ORGANIZATION MANUAL
Organization Manual is also referred to as the?
MANAGEMENT GUIDE
This combines the chart and position descriptions, with description materials about the organization to provide all levels of management a clear understanding of the organization plan, top management, philosophy and objectives of the company
MANAGEMENT GUIDE
3 levels of Top Management
LEVEL I
LEVEL II
LEVEL III
This Usually consist of the Board if Trustees or Board of Directors?
LEVEL I
Consist of the President, the function being general, management or administrative .
LEVEL II
This level of management includes active planning, direction, coordination and control of the business with the scope of policies established and authorized by the level I management.
LEVEL II
Consist of the Vice- President, General Managers, and department Managers. The functions include management of the major departments of the company. They are fully responsible and accountable to the level II management for the success of their respective operations.
LEVEL III
embraces the topmost level of executives concerned with a particular division of the company rather than the enterprise as a whole.
LEVEL III
Consitutes the framework for the organizational structure
LINE
- Are those that have direct responsibility to accomplish the objectives of these enterprise.
- It has the power or authority to initiate and carry through other primary activities necessary to reach the stated goals of the company
LINE FUNCTIONS
the chain of command from the top to the bottom of the organization?
LINE FUNCTIONS
Constitutes the work functions or the organization components that are required to supply information and service to the “line” components.
STAFF
In charge of purchasing requisitioned material (both packaging materials and raw materials). Both from local and imported sources.
PURCHASING
3 production control:
PURCHASING
INVENTORY CONTROL
PLANNING AND SCHEDULING
Watches and monitors closely. Records all materials used in the production:
INVENTORY CONTROL
Coordinates with then marketing department on what products and required for supply, and then plans and schedules the manufacture of the product.
PLANNING AND SCHEDULING
3 subdivisions of Raw materials:
QUARANTINE AREA
APPROVED FOR USE AREA
REJECT AREA
Are labeled with yellow-coded labels bearing the word “QUARANTINE”. This implies that the materials are subject to test and assays by the quality control section and are not yet to be used.
QUARANTINE MATERIALS
Are labeled with green coded labels with the bold letters “APPROVED FOR USE”.
APPROVED FOR USE MATERIALS
The materials from the quarantine area found to conform to the standards and
specifications are transferred to the Approved for use area. Replacing the quarantine label with the Approved for use label.
APPROVED FOR USE MATERIALS
are those found to be substandard are transferred from the quarantine are to the rejected area. The quarantine stickers are replaced with the red-coded stickers bearing the bold letters “REJECTED” these materials are either returned to the supplier (for replacement) or disposed of properly
REJECTED MATERIALS
This section consist of product which have been bottled, stripped or packed, but not yet labeled or packed into boxes or cartons, because they still await the results of the quality control test and assays as well as the final disposition
IN-PROCESS
This area contains the products packaged and finished and are ready for distribution and sale.
FINISHED PRODUCTS/GOODS
In as much returns cannot be avoided, the products returned are stored in this section of the warehouse, pending disposition by the Quality Control.
RETURNED GOODS
Is an area in the warehouse where raw materials for use in the production are weighed and or/measured. The packaging materials are also counted upon issuance. A quality control checker should be present in this area, to avoid errors, the inspector also perform routine checking in all sections of the warehouse.
DISPENSING
Takes charge of the care, maintenance and repair of all machines and equipment used in the Plant Department, including electrical lines, water and sewerage aquatics, waste management, telecommunication lines, environment sanitation, etc.
ENGINEERING AND MAINTENANCE SECTION
