Topic 1 Flashcards by Marianne Nadeen Aini Tupay

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

Manufacturing

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prescription order; specific for a particular patient; small scale

Extemporaneous Compounding

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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

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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

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

Manufacturing

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• 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

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large scale production of drug products

Manufacturing

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Stages of Manufacturing

Dispensing of Raw Materials
Processing of Dosage Forms
Filling
Packaging and Repacking

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The manufacture of raw materials

Primary Manufacturing

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The manufacturing of dosage forms

Secondary Manufacturing

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Packaging, Labeling, or Repacking of bulk finished products

Tertiary Manufacturing

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An arrangement whereby a competent company manufactures the products for another company

Toll Manufacturing

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

Drug Establishment

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Revised Regulations for the Licensing of Drug Establishments and Outlets

AO 56 s. 1989

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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

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

Drug Manufacturer

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Involved in packaging of bulk drug product to its immediate container

Drug Manufacturer - Packer

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

Drug Manufacturer - Repacker

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Registered owner of drug product and formulation but subcontracts manufacturing
- procures RM and PM
- provides monographs and QC protocols

Drug Manufacturer - Trader

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

Drug Distributor - Importer

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

Drug Distributor - Exporter

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Procures RM, API, and/or finished products from a local licensed establishment for local distribution in wholesale basis

Drug Distributor - Wholesaler

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• 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

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Types of Drug Manufacturer:

A. Ethical/Prescription Drug Manufacturer
B. Proprietary/Generic Manufacturers
C. Biologicals Manufacturer

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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

Stages of Drug Development

Discovery and Development Preclinical Research Clinical Research FDA Review Post-Market Surveillance

Contains the formulation, specifications, manufacturing procedures, QA requirements, and labeling of a finished product

Master Formula

• justifies any overages in the formula • improves existing products

Research and Development Dept

Addition of an excess amount of API in an unstable preparation

Overage

• deals with all stages of mfg batches of finished drug products • plans the production according to MO • accomplishes the BMR to ensure that batches were properly made and tests were conducted

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

Document containing the details of the manufacture of each batch

Batch Manufacturing Record (BMR)

Gives instructions to manufacture a product

Manufacturing Order

• stores materials & finished products • holds incoming components in the quarantine area • involved in purchasing & logistics

Warehouse Dept

Status of materials which are isolated physically while a decision is awaited on their release, rejection, or reprocessing

Quarantine

• assures all operations meet the required standards of safety and efficacy (cGMP) • conducts quality audit & monitoring • prepares SOPs

Quality Assurance Dept

Step-by-step instructions for performing operational tasks or activities

Standard Operating Procedure (SOP)

• Test compliance of materials and finished products to specifications • Conducts sampling of materials • Performs IPQC and environmental testing

Quality Control Dept

• studies current market trends, consumer behavior, and product status in the market • advertisement and promotion

Marketing Dept

• ensures compliance with all pertinent regulations and laws about drugs and their marketing

Regulatory Dept

• installs, maintains and repairs equipment and premises • conducts validation and qualification • ensures safety

Engineering Dept

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

• concerned with the physical exam and medical tx of employees • performs clinical studies • publishes house organ/paper

Medical Dept

• purchases, receives and makes inventories of supplies

Purchasing Dept

It refers to the pharmaceutical research and manufacturing companies providing pharmacist with medicines in pre-fabricated or ready to take forms.

Industrial Pharmacy

It is a mechanism for determining and assigning duties to people, in order to work effectively.

Organization

It is a combination of manpower, money, machines and methods so coordinated that they can fulfill an economic objective.

Business Organization

Responsibility must be delegated. The company objectives must be determined and the organizational plan must be consulted with the aim of achieving them. The types of work must be identified and group logically on related problems.

Division of Responsibility (Obligation of duty)

Authority must be defined and delegated to avoid negligence of duty.

Delegation of Authority

• The power or right to give commands • Enforcement of obedience • Ability to make final decision

Authority

The first basic tool of Organization. It is interpreted as chart.

Organizational Planning

1. An organizational chart lists all important positions and functions of each division or department. 2. An organizational chart is a means of quickly showing the shape or structure of the company to employees and other interested parties outside the company

Second basic tool of organization. This will clearly define the authority, duty or responsibility of the areas in the chart.

Positional Description

The third basic tool of organization. This is also referred to as the “Management Guide” which combines the chart and position descriptions, with description materials about the organization to provide all levels of management a clear understanding of the organizational plan, top management , philosophy and objectives of the company

Organizational Manual

Usually consist of the Board of Trustees or Board of Directors. The functions are: 1. To protect and make the most effectiveness use of the asset of the company. 2. Establishes objectives and determines the basic policies and general course of the business. 3. Represents and safeguards the interest of the stockholders.

Level I

Consists of the President, the function being general, management or administrative. This includes active planning, direction, coordination and control of the business within 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. It embraces the topmost level of executives concerned with a particular division of the company rather than the enterprise as a whole.

Level III

It constitutes the framework for the organizational structure.

Line

Are those that have direct responsibility to accomplish the objectives of the enterprise. Only these have the power or authority to initiate and carry through other primary activities necessary to reach the stated goals of the company.

Line Functions

It 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

Production Control consists of 3 sections:

Purchasing Inventory Control Planning and Scheduling

Watches and monitors closely. Records all materials used in the production: • Controls the stocks of both raw materials • Packaging materials • Finished products • This section, therefore is in charge of checking stocks periodically.

Inventory Control

It coordinates with then marketing department on what products are required for supply, and then plans and schedules the manufacture of the product. Then, through a manufacturing order (MO). • The production department manufactures the quantity scheduled at the time limit allowed.

Planning and Scheduling

Raw materials: consist of three subdivisions:

a. Quarantine area b. Approved for use area c. Rejected area

These 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

These are labeled with green coded labels with the bold letters “APPROVED FOR USE” 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 Area

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