Manufacturing Pharmacy: Introduction

manufacturing

large scale production of drugs

manufacturing

preparation, processing, packaging, repacking or changing the container, wrapper or label of any drug

primary manufacturing

manufacture of API, raw materials, excipients

secondary manufacturing

manufacture of finished dosage forms

tertiary manufacturing

packaging, repacking and labelling of bulk final products

toll manufacturing

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

drug manufacturer

any establishment engaged in the operations involved in the production of a drug

proprietary

ethical

biological

veterinary

medicinal/chemical

toll

** for familiarization

types of manufacturer

drug trader

registered owner of the drug product; subcontracts to a toll manufacturer

drug importer

drug exporter

drug wholesaler

types of drug distributor

drug importer

drug distributor who imports products from other countries for distribution to local outlets

drug exporter

drug distributor who exports products to be distributed to other countries

drug wholesaler

drug distributor who acquires products from local establishments distributed to local outlets on a wholesale basis

research & development (R&D) department

DEPARTMENTS IN A MANUFACTURING COMPANY

• formulates new products

• improves or develops existing products

• does chemical, pharmaceutical, and physiological research the prepares the master formula

• prepares master formula

• justifies overages or overaging

formulation

evaluation of the drug for uniformity, stability, and other factors; followed by the development of an appropriate drug delivery system

master formula

contains all the information about the manufacturing process in a pharmaceutical product

manufacturing overages or overaging

addition of an active in an unstable preparation

production department

DEPARTMENTS IN A MANUFACTURING COMPANY

• deals with all stages of manufacturing batches or lots of finished drug products according to an MO

• accomplishes BMR

batch

specific quantity of product having uniform character and quality, produced during tha same single manufacturing cycle

lot

a specific identified portion of a batch

manufacturing order (MO)

gives instructions to the production department to produce a product

batch manufacturing record (BMR)

ensures that batches were properly made and QC tests were performed

warehouse 

DEPARTMENTS IN A MANUFACTURING COMPANY

• stores materials and finished products

• holds incoming components in a quarantine area

• involved in purchasing and logistics (involved in inventory)

quarantine area

area that is marked, designated or set aside for the holding of incoming components prior to acceptance testing and qualification for use

identification test ????

1st QC test perfomed ????

Quality assurance department

DEPARTMENTS IN A MANUFACTURING COMPANY

• assures all operations meet the required standards of safety and efficacy (cGMP)

• conducts quality audit and monitoring

• prepares SOPs

AO 220 s. 1974 (WHO)

old basis of cGMP

AO 2012-0008 (PICS/cGMP)

current basis of cGMP

standard operating procedures (SOPs)

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

quality control (QC) department

DEPARTMENTS IN A MANUFACTURING COMPANY

• conducts sampling, inspection and testing of RM, PM, and FP

• conducts in-process testing

• performs environmental monitoring

• tests product complaint samples and on-going stability

marketing department

DEPARTMENTS IN A MANUFACTURING COMPANY

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

• advertisement and promotion

regulatory department

DEPARTMENTS IN A MANUFACTURING COMPANY

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

Dr. Teodoro "Ted" J. Herbosa

DOH secretary

engineering department

DEPARTMENTS IN A MANUFACTURING COMPANY

• installs, maintains and repairs equipment and premises (e.g. HVAC system)

Heating, Ventilation and Air Conditioning (HVAC)

system that helps maintain good indoor air quality through adequate ventilation with filtration and provides thermal comfort

validation

action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results

medical department

DEPARTMENTS IN A MANUFACTURING COMPANY

• concerned with physical examination and medical treatment of employees

• performs clinical studies

• publishes house organ/paper