INTRODUCTION TO PHARMACEUTICAL MANUFACTURING

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Master Batch Record

is a document showing the formulation, procedure, specifications, packaging, and labelling instructions to guarantee proper manufacture of products.

Manufacturing

is from the dispensing of materials to the release for distribution of the finished products.

Manufacturing Pharmacy

is one of the major fields of the pharmaceutical profession.

Manufacturing Pharmacy

is primarily engaged in the development and production of medicines, foods, cosmetics, nutraceuticals, and other pharmaceutical preparation.

Medicinal-Chemical Manufacturers

manufacturers of active ingredients and excipients

Veterinary Product Manufacturer

manufacturers of animal drugs

Proprietary/Generic Manufacturer

manufacturers of branded and generic products

Biological Manufacturer

manufacturers of vaccines, toxoids, anti-sera, and biotechnology products

Toll/Contract Manufacturers

manufactures for other companies

WAREHOUSE

responsible for storing materials and items

Sales and Marketing Department

responsible for the design of the package, container, and input on the DF design as preferred by customers

Medical Department

responsible for treatment of all sick employees

PURCHASING DEPARTMENT

select reliable suppliers

Quality Control Department

make sure that SARS is done effectively and efficiently for product quality.

PURCHASING DEPARTMENT

responsible for checking of all incoming materials

Sales and Marketing Department

responsible for consumption of finished products (c/o med reps, sales reps)

WAREHOUSE

responsible for delivery of stocks

WAREHOUSE

responsible for documentation (stock cards, stickers, personnel, delivery forms, acquisition forms)

Ethical Manufacturer

specializes in prescription products

RESEARCH DEPARTMENT

undertake investigational work in various fields of pharmaceutical interest

Warehouse

uses color coded stickers properly segregate materials:

GREEN STICKER

for approved materials

Procurement/Acquisition area

area of receiving of materials, chemicals, finished products for packaging.

ENGINEERING DEPARTMENT

assist other departments

Environmental hazard elimination

elimination of anything that will compromise the entire manufacturing process

Purchasing Department

ensures that stuffs arrive on time and with the right quality.

RED STICKER

for rejected materials

Manufacturing Pharmacy

includes the research and development of newly-drugs, new dosage forms.

Manufacturing

involves all the steps and procedures employed from the acquisition of the materials, processing and final distribution.

YELLOW STICKER

materials under quarantine/ materials that are still to be tested for quality before they are used in the production

Administrative Order 56 series of 1989

order that defined drug establishment

Administrative Order 43 series of 1999

order that defined manufacturing

PRODUCTION DEPARTMENT

produce the right amount of products at the right time, at the right conditions

Medical and Regulatory Affairs

publish the company's newsletters.

Packaging

puts on the finishing touches to complete the finished product.

Drug Establishment

refers to any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs or medicines.

Manufacturing

refers to the complete set of activities to produce a drug that comprise production and quality control.

Warehouse

Holding area for properly segregated, identifies, and labelled materials

WAREHOUSE

reporting for items which reached "replenish level"

PURCHASING DEPARTMENT

responsible for accounting and general inventory

QUALITY CONTROL DEPARTMENT

responsible for assessment of process deviations

ENGINEERING DEPARTMENT

responsible for environmental hazard elimination

QUALITY CONTROL DEPARTMENT

responsible for environmental monitoring

ENGINEERING DEPARTMENT

responsible for ground setting and maintenance; calibration/standardization; internal and external services

ENGINEERING DEPARTMENT

responsible for location, installation, and maintenance of equipment, machines, electrical devices, and other apparatus (regular cleaning, standardization, and tuning/calibration)

QUALITY CONTROL DEPARTMENT

responsible for maintenance of QC records and failure investigation records

Medical Department

responsible for medical examination of all employees and applicants

WAREHOUSE

responsible for monitoring stock levels

PRODUCTION DEPARTMENT

responsible for packaging and shipping

PRODUCTION DEPARTMENT

responsible for procurement/acquisition area

Sales and Marketing Department

responsible for promotion (advertisements, drug/pdt launch, exhibits)

PURCHASING DEPARTMENT

responsible for public relations with suppliers

Medical Department

responsible for publications

WAREHOUSE

responsible for receiving procured materials and items

Medical Department

responsible for researches (epidemiologic, post-marketing surveillance, etc)

QUALITY CONTROL DEPARTMENT

responsible for sampling, specification and testing

PURCHASING DEPARTMENT

responsible for sourcing and buying of all materials, supplies, and equipment

Shipping

transports materials from warehouse to different recipient.

Quality Control Department

Referred to as a heart and soul of drug manufacture

Pharmaceutical Manufacturing Extemporaneous Manufacturing

TYPES OF MANUFACTURING

WAREHOUSE

A holding area for properly segregated, identified, and labeled materials

ENGINEERING DEPARTMENT

Maintain and upgrade physical plant structure of facilities and equipment used

DRUG TRADER

Also engaged in distribution and/or marketing of its products

Research and Development Department Production Department Quality Control Department Purchasing Department Sales and Marketing Department Engineering Department Medical and Regulatory Affairs Warehouse Department

DEPARTMENTS/UNITS IN A DRUG ESTABLISHMENT

DRUG MANUFACTURER

Engaged in the operation and involved in the production of a drug.

QUALITY CONTROL DEPARTMENT

Ensures that no materials or products will be released for sale or supply until their

PURCHASING DEPARTMENT

Ensures that stocks arrive on time and to the right quality

Interphil Laboratories in Laguna Hizon Laboratories in Antipolo

Examples of Drug Establishment

Pharmaceutical Research Chemical Research Physical Research Pharmacological Research Biological Research Clinical Research Radioactive Research Epidemiological Research

Fields of pharmaceutical interest

DRUG DISTRIBUTOR/IMPORTER/EXPORTER

Imports or exports materials, active ingredients and/or finished products for its own use for wholesale distribution to other establishments or outlets.

Engineering Department

In charge of installation, repair and maintenance of equipment to warrant plant and personnel safety.

Production Department

In charge of the manufacture of drug products along with controlling the procedures and personnel to ensure smooth flow of work.

Pharmaceutical Manufacturing

Involves the manufacture, preparation, and propagation of processing large scale.

Extemporaneous Manufacturing

Involves the small-scale preparations of drug products.

United Laboratories (Unilab) Pfizer Glaxo-Smith Kline Sanofi Aventis Novartis Johnsons & Johnsons Natrapharm

KEY PLAYERS IN THE PHILIPPINES

Sales and Marketing Department

Maximize or increase the turnover of drug products

Regulatory Affairs

Monitor legislations and regulations affecting the company and its products

Medical and Regulatory Affairs

Prepares product inserts and literatures.

Regulatory Affairs

Presents data of drug products to FDA for registration

Regulatory Affairs

Presents the company's views to professional groups

DRUG DISTRIBUTOR/WHOLESALER

Process raw materials, active ingredients and/or finished products from a local establishment for local distribution on wholesale basis.

PURCHASING DEPARTMENT

Provide raw materials, components, and equipment

Regulatory Affairs

Recommends actions that the company can take on particular cases

DRUG TRADER

Registered owner of the drug product but subcontracts toll manufacturers to produce their products

ENGINEERING DEPARTMENT

Renders services necessary for plant operations (ie: water, air, steam, air conditioning, temperature control, humidity control)

PURCHASING DEPARTMENT

Requires "on-site inspections" of supplier facilities

Medical and Regulatory Affairs

Responsible for physical and medical examination of employees and applicants.

Sales and Marketing Department

Responsible for product promotion with the intention to maximize or increase the turn-over of drug products.

Purchasing Department

Responsible for the acquisition, receipt, and inventory of supplies.

Research and Development Department

Responsible in creating or improving new or existing products.

Sampling, Assay, Recording, Systematically

SARS

Research and Development Department

Undertakes investigational work in various fields of pharmaceutical interests like pharmaceutical research, chemical research, clinical research, and others.

Production Department

Uses and keeps in place the Master Batch Record

Medical Department

Work with R&D on clinical trials

DRUG MANUFACTURER DRUG TRADER DRUG DISTRIBUTOR/IMPORTER/EXPORTER DRUG DISTRIBUTOR/WHOLESALER

TYPES OF DRUG ESTABLISHMENT

Ethical Manufacturer Proprietary/Generic Manufacturer Biological Manufacturer Veterinary Product Manufacturer Medicinal-Chemical Manufacturers Toll/Contract Manufacturers

TYPES OF DRUG MANUFACTURER

PRODUCTION DEPARTMENT

Take inputs and turn them into outputs for customer use through a series of production processes

Storage Area

area of holding of materials


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