1 Flashcards by Jeehada Palinta

The manufacture, propagation, preparation, processing of drug in a large scale (mass production)

MANUFACTURING

How well did you know this?

Not at all

Perfectly

Prescription order; specific for a particular patient; small scale

EXTEMPORANEOUS COMPOUNDING

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

the making by physical, chemical, biological, or any other procedure of any article that meets the definition of drugs.

MANUFACTURING

How well did you know this?

Not at all

Perfectly

the manipulation, sampling, testing, or control procedures applied to the final product or any part of the process.

MANUFACTURING

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

large-scale production of a drug products

MANUFACTURING

How well did you know this?

Not at all

Perfectly

4 stages of manufacturing

• DISPENSING OF RAW MATERIALS
• PROCESSING OF DOSAGE FORMS
• FILLING
• PACKAGING AND REPACKING

How well did you know this?

Not at all

Perfectly

4 Mfg activities

• PRIMARY MFG
• SECONDARY MFG
• TERTIARY MFG
• TOLL MFG

How well did you know this?

Not at all

Perfectly

Manufacturing of raw materials

PRIMARY MFG

How well did you know this?

Not at all

Perfectly

Manufacturing of dosage forms

SECONDARY MFG

How well did you know this?

Not at all

Perfectly

Packaging, labeling or repacking of bulk finished products.

TERTIARY MFG

How well did you know this?

Not at all

Perfectly

An arrangement whereby a competent company manufacturers the product for another company.

TOLL MFG

How well did you know this?

Not at all

Perfectly

Any organization or company involved in the manufacture, importation, repacking and/ot distribution of drug or medicines.

DRUG ESTABLISHMENT

How well did you know this?

Not at all

Perfectly

Revised Regulations for the Licensing of Drug Establishments and Outlets

AO 56 s. 1989

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

Involved in production of drug products (preparatory processing, compounding, formulating, filling, packaging, repacking, altering, ornamenting, finishing, labeling)

DRUG MANUFACTURER

How well did you know this?

Not at all

Perfectly

Involved in packaging of bulk drug product to its immediate container.

DRUG MANUFACTURER- PACKER

How well did you know this?

Not at all

Perfectly

Involved in repacking of finished product into smaller quantities in a separate container and/or secondary packaging.

DRUG MANUFACTURER - REPACKER

How well did you know this?

Not at all

Perfectly

Registered owner of drug product and formulation but subcontracts manufacturing.

DRUG MANUFACTURER - TRADER

How well did you know this?

Not at all

Perfectly

Procures RM and PM
Provides monographs and QC protocols

DRUG MANUFACTURER- TRADER

How well did you know this?

Not at all

Perfectly

Imports RM, API, and/or finished products for wholesale distribution to other licensed establishments.

DRUG DISTRIBUTOR - IMPORTER

How well did you know this?

Not at all

Perfectly

Exports RM, APU, and/or finished products for wholesale distribution to establishments outside the country.

DRUG DISTRIBUTOR - EXPORTER

How well did you know this?

Not at all

Perfectly

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

1 Flashcards

(98 cards)