1 - Introduction to Manufacturing Pharmacy

Proverbs 16:3

b. Manufacturing

Large-scale production of drug products' preparation, processing, packaging, labeling, repacking, changing wrapper, label or container of any drug products
a. Compounding
b. Manufacturing
c. Formulation
d. Dispensing

Dispensing of Raw Materials

↓

Processing of Dosage Forms

↓

Filling

↓

Packaging & Repacking

Stages of Manufacturing [4]

d. Primary Manufacturing

[Manufacturing Activities]

Manufacture of raw material (APIs and Excipients)
a. Tertiary Manufacturing
b. Secondary Manufacturing
c. Toll Manufacturing
d. Primary Manufacturing

a. Secondary Manufacturing

[Manufacturing Activities]

Manufacture of finished dosage form
a. Secondary Manufacturing
b. Primary Manufacturing
c. Tertiary Manufacturing
d. Toll Manufacturing

c. Tertiary Manufacturing

[Manufacturing Activities]

Packaging, labeling, and repacking of bulk finished product
a. Toll Manufacturing
b. Primary Manufacturing
c. Tertiary Manufacturing
d. Secondary Manufacturing

b. Toll Manufacturing

[Manufacturing Activities]

An arrangement whereby a competent company manufactures products for another company
a. Secondary Manufacturing
b. Toll Manufacturing
c. Tertiary Manufacturing
d. Primary Manufacturing

b. AO 56 s.1989

[Administrative Order]

Revised Regulations for the Licensing of Drug Establishments and outlets
a. AO 2014-0034
b. AO 56 s.1989
c. AO 43 s.1992
d. AO 153 s.2004

b. AO 2014-0034

[Administrative Order]

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 Authorization
a. AO 56 s.1989
b. AO 2014-0034
c. AO 2016-0003
d. AO 2018-0014

Drug Establishments (AO 56 s. 1989):

Drug Establishments (AO 2014-0034)":

c. Manufacturer

[Types of Drug Establishments - Drug Manufacturer]

Involved in production of drugs products (preparatory processing, compounding, formulating, filling, packaging, repackaging, altering, ornamenting, finishing, labeling)
a. Repacker
b. Trader
c. Manufacturer
d. Packer

b. Packer

[Types of Drug Establishments - Drug Manufacturer]

Involved in packaging of bulk drug product to its immediate container
a. Manufacturer
b. Packer
c. Repacker
d. Importer

d. Repacker

[Types of Drug Establishments - Drug Manufacturer]

Involved in repackaging of finished product into smaller quantities in a separate container and/or secondary packaging
a. Wholesaler
b. Packer
c. Manufacturer
d. Repacker

b. Trader

[Types of Drug Establishments - Drug Manufacturer]

Registered owner of drug product and formulation but subcontracts manufacturing

• Procures RM and PM,

• Provides monographs and QC protocols

a. Exporter
b. Trader
c. Importer
d. Wholesaler

d. Importer

[Types of Drug Establishments - Drug Distributor]

Imports RM, API, and/or finished products for wholesale distribution to other licensed established
a. Wholesaler
b. Trader
c. Exporter
d. Importer

a. Exporter

[Types of Drug Establishments - Drug Distributor]

Exports RM, API, and/or finished products for wholesale distribution to establishments outside the country
a. Exporter
b. Importer
c. Wholesaler
d. Repacker

c. Wholesaler

[Types of Drug Establishments - Drug Distributor]

Procures RM, API, and/or finished products from a local licensed establishment for local distribution in wholesale basis
a. Importer
b. Trader
c. Wholesaler
d. Exporter

c. Research and Development Department

[Departments in Manufacturing Company]

Department that formulates new products
a. Production Department
b. Quality Control Department
c. Research and Development Department
d. Quality Assurance Department

c. Research and Development Department

[Departments in Manufacturing Company]

Department involved in process development and scale-up
a. Production Department
b. Quality Control Department
c. Research and Development Department
d. Quality Assurance Department

c. Research and Development Department

[Departments in Manufacturing Company]

Department involved in preparing Master formula

a. Production Department
b. Quality Control Department
c. Research and Development Department
d. Quality Assurance Department

c. Research and Development Department

[Departments in Manufacturing Company]

Department that justifies the overages in the formula and improves the existing products

a. Production Department
b. Quality Control Department
c. Research and Development Department
d. Quality Assurance Department

Discovery and Development

↓

Preclinical Research

↓

Clinical Research

↓

FDA Review

↓

Post-market Surveillance

[Departments in Manufacturing Company]

Stages of Drug Development [5]

c. Master formula

[Departments in Manufacturing Company]

Contains the formulation, specifications, manufacturing procedures, QA requirements, and labeling of a finished product
a. Batch Manufacturing Record
b. Manufacturing Order
c. Master formula
d. Standard Operating Procedure

a. Overages

[Departments in Manufacturing Company]

Addition of an excess amount of API in an unstable preparation
a. Overages
b. Batch
c. Lot
d. Master formula

d. Production Department

[Departments in Manufacturing Company]

Department that deals with all stages of manufacturing batches of finished drug products
a. Research and Development Department
b. Quality Control Department
c. Quality Assurance Department
d. Production Department

b. Production Department

[Departments in Manufacturing Company]

Department that plans the production according to MO
a. Quality Control Department
b. Research and Development Department
c. Production Department
d. Quality Assurance Department

b. Production Department

[Departments in Manufacturing Company]

Department that accomplishes the BMR to ensure that batches were properly made and tests were conducted
a. Quality Assurance Department
b. Production Department
c. Research and Development Department
d. Quality Control Department

c. Batch

[Departments in Manufacturing Company]

Specific quantity of product intended to have uniform character and quality, produced during the same single cycle of manufacture
a. Lot
b. Master formula
c. Batch
d. Manufacturing Order (MO)

a. Lot

[Departments in Manufacturing Company]

Specific identified portion of a batch
a. Lot
b. Batch
c. Overages
d. Manufacturing Order (MO)

c. Manufacturing Order (MO)

[Departments in Manufacturing Company]

Gives instructions to manufacture a product
a. Batch Manufacturing Record (BMR)
b. Master formula
c. Manufacturing Order (MO)
d. Standard Operating Procedure

d. Batch Manufacturing Record (BMR)

[Departments in Manufacturing Company]

Document containing the details of the manufacture of each batch
a. Master formula
b. Manufacturing Order (MO)
c. Standard Operating Procedure
d. Batch Manufacturing Record (BMR)

c. Warehouse Department

[Departments in Manufacturing Company]

Department that stores materials and finished products
a. Production Department
b. Quality Control Department
c. Warehouse Department
d. Marketing Department

b. Warehouse Department

[Departments in Manufacturing Company]

Department that holds incoming components in the quarantine area
a. Quality Assurance Department
b. Warehouse Department
c. Production Department
d. Quality Control Department

b. Warehouse Department

[Departments in Manufacturing Company]

Department involved in purchasing and logistics
a. Marketing Department
b. Warehouse Department
c. Production Department
d. Quality Assurance Department

d. Quarantine

[Departments in Manufacturing Company]

Status of materials which are isolated physically while a decision is awaited on their release, rejection, or reprocessing
a. Segregation
b. Rejection
c. Hold
d. Quarantine

b. Warehouse Department

[Departments in Manufacturing Company]

Department involved in purchasing and logistics
a. Marketing Department
b. Warehouse Department
c. Production Department
d. Quality Assurance Department

c. Quality Assurance Department

[Departments in Manufacturing Company]

Department that assures that all operations meet required standards for safety and efficacy, ensures compliance to cGMP
a. Quality Control Department
b. Production Department
c. Quality Assurance Department
d. Warehouse Department

d. Quality Assurance Department

[Departments in Manufacturing Company]

Department that conducts quality audit and monitoring
a. Quality Control Department
b. Marketing Department
c. Production Department
d. Quality Assurance Department

b. Quality Assurance Department

[Departments in Manufacturing Company]

Department that prepares SOPs
a. Production Department
b. Quality Assurance Department
c. Quality Control Department
d. Warehouse Department

c. Standard Operating Procedures (SOP)

[Departments in Manufacturing Company]

Step-by-step instructions for performing operational tasks or activities
a. Batch Manufacturing Record
b. Master formula
c. Standard Operating Procedures (SOP)
d. Manufacturing Order

b. Quality Control Department

[Departments in Manufacturing Company]

Department that tests compliance of raw materials, packaging materials, and finished products to specifications
a. Quality Assurance Department
b. Quality Control Department
c. Warehouse Department
d. Production Department

c. Quality Control Department

[Departments in Manufacturing Company]

Department that conducts sampling of materials to be tested
a. Quality Assurance Department
b. Warehouse Department
c. Quality Control Department
d. Production Department

d. Quality Control Department

[Departments in Manufacturing Company]

Department that performs IPQC and environmental testing
a. Quality Assurance Department
b. Production Department
c. Warehouse Department
d. Quality Control Department

b. Marketing Department

[Departments in Manufacturing Company]

Department that studies current market trends, consumer behavior and product status in market
a. Quality Assurance Department
b. Marketing Department
c. Warehouse Department
d. Production Department

d. Marketing Department

[Departments in Manufacturing Company]

Department that promotes and advertises
a. Warehouse Department
b. Quality Control Department
c. Production Department
d. Marketing Department

b. Regulatory Department

[Departments in Manufacturing Company]

Department that ensures compliance of company and its products with all pertinent regulations and laws about drugs and their marketing
a. Quality Assurance Department
b. Regulatory Department
c. Medical Department
d. Engineering Department

d. Engineering Department

[Departments in Manufacturing Company]

Department that installs, maintains and repairs of equipment and premises
a. Regulatory Department
b. Production Department
c. Warehouse Department
d. Engineering Department

b. Engineering Department

[Departments in Manufacturing Company]

Department that conducts validation and qualification
a. Quality Control Department
b. Engineering Department
c. Regulatory Department
d. Quality Assurance Department

c. Engineering Department

[Departments in Manufacturing Company]

Department that ensures safety
a. Regulatory Department
b. Medical Department
c. Engineering Department
d. Quality Assurance Department

c. Validation

[Departments in Manufacturing Company]

Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results
a. Qualification
b. Verification
c. Validation
d. Certification

d. Qualification

[Departments in Manufacturing Company]

Action of proving that premises, systems or equipment work correctly and actually lead to expected results
a. Validation
b. Certification
c. Verification
d. Qualification

d. Medical Department

[Departments in Manufacturing Company]

Department concerned with physical examination and medical treatment of employees
a. Regulatory Department
b. Quality Assurance Department
c. Engineering Department
d. Medical Department

c. Medical Department

[Departments in Manufacturing Company]

Department that performs clinical studies
a. Regulatory Department
b. Research and Development Department
c. Medical Department
d. Quality Assurance Department

c. Medical Department

[Departments in Manufacturing Company]

Department that publishes house organ/paper
a. Marketing Department
b. Regulatory Department
c. Medical Department
d. Human Resources Department