Study Set Content:
Organizational structure of Pharmaceutical Industrial Quality Control Department, First department
Material Inspection Department
Organizational structure of Pharmaceutical Industrial Quality Control Department, under Material Inspection Department
Analytical Laboratory Department
Organizational structure of Pharmaceutical Industrial Quality Control Department, under Analytical Laboratory Department
Specifications and analytical development
Organizational structure of Pharmaceutical Industrial Quality Control Department, under Specifications and analytical development
Quality Coordination Office
Organizational structure of Pharmaceutical Industrial Quality Control Department, under Quality Coordination Office
Biological Testing Laboratory Department
Scope of responsibilities: 1. To sample and examine all raw materials received. 2. To sample and conduct physical tests on: a. all shipments of packaging materials b. all manufacturing, filling and packaging operations.3. To maintain periodic examination on the quality of inventories throughout all phases of storage, shipping, and distribution. 4. To perform an audit which is independent of the work done by production personnel
Materials Inspection Department
Scope of responsibility: 1. Performs physical and chemical analysis checking whether these parameters conforms to the standards.
Analytical Laboratory Department
Scope of responsibilities: 1. To perform and evaluate microbiological and pharmacological assays, as well as sterility, pyrogen tests and acute toxicity tests. 2. To conduct environmental monitoring and assessment.
Biological Testing Laboratory Department
1. Coordinates with research, product development, production, sales and management towards improvement of a product. 2. Establish specifications for raw and packaging materials. 3. Validates existing and tentative procedures for testing. 4. Establish specifications based on validated procedures. 5. Develops new assay methods for in-house use. 6. Develops and improves specifications for quality characteristics of the final product being manufactured.
Specifications and analytical Development
Scope of responsibilities Specifications and analytical development
1. Coordinates with research, product development, production, sales and management towards improvement of a product. 2. Establish specifications for raw and packaging materials. 3. Validates existing and tentative procedures for testing. 4. Establish specifications based on validated procedures. 5. Develops new assay methods for in-house use. 6. Develops and improves specifications for quality characteristics of the final product being manufactured.
Scope of Responsibilites 1. This department is responsible in storing and maintaining records of a certain batch from start to finish.2. They provide data that aids in analyzing the product’s performance in the market 3. They usually relates to the customers regarding complaints, and product inquiry these data will be reported to the technical sales committee. 4. They also coordinate with the development group for product improvement. 5. Helps develop Standard Operating Procedures (SOP)6. Helps to provide data that gives scientific and legal status.
Quality Coordination Office
responsible in discovering and developing new pharmaceutical compounds “Candidates” bioactive molecule compounds suspected to possess pharmacological activity are being selected using computerized tool and are being tested by its pharmacokinetics and pharmacodynamics property and its interaction with a desired pathology.
Research and Development
advertising the products, product promotion, customer service, and even sales
Marketing and Sales Department
Scope of responsibilities: 1. Sales goal setting 2. Pricing and distribution planning of the product3. Customer service and sales 4. Product promotions and marketing
Marketing and Sales Department
backbone of an organization• headed by an administrator • ensures the smooth flow of information from one part to another
Administrative Department
is a process or procedure of comparing the actual performance with the set standards of the company
Control
This control function plays an important role in conducting tests and assays on raw materials, packaging materials, bulk or volume product and packaging of product prior to release.
Analytical functions
does not depend solely to a certain personnel responsibility.
Monitor functions
This test includes determining microbial content in the air and determining whether the levels of these particulates are within limits.
Monitor functions
This function covers the carefully review of batch records for a certain period of time of production.
Record, Review, and Release Functions
