INTRODUCTION TO PHARMACEUTICAL MANUFACTURING
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
