Bulk Drug Manufacture Flashcards
What are all the parts of bulk drug manufacture answer
1) Bulk compound
2) Control systems
a) Manufacturing process control
b) Quality control
c) Budgetary control
3) requirements for manufacturing
a) Material requirement
b) Manufacturing capacity
c) Manufacturing facilities
d) Manufacturing staff
e) Manufacturing costs
f) Maintenance of manufacturing equipments
4) Sterile manufacturing
a) Facilities and requirements
b) Precautions
What is a bulk drug
A bulk drug also called a active pharmaceutical ingredient API is the chemical molecule in a pharmaceutical product that gives the product the claimed therapeutic effect
What are the types of control systems
1) manufacturing control systems
2) Quality control systems
3) Budgetary control systems
Explain manufacturing process control
It is the responsibility of hospital pharmacist to make a product with high pharmaceutical standards
Adequate controls over manufacturing eventuate into the products in identify, strength, purity and quality
The good manufacturing practices regulations provide minimum requirements for the preparation of drug products for administration to humans with respect to the premise and environment
Explain quality control
Quality of product is its degree of possession of the characteristics which contributes to the performance of an intended function when used
Quality control of raw material
Quality control of instruments
Quality control of environment
Quality control of the finished product
Explain budgetary control
Budgetary control is employed to regulate economic aspects of hospital pharmacy manufacturing program
The feasibility of a manufacturing program depends on the budgetary control
Explain manufacturing requirements
The manufacturing requirements can be estimated in terms of rate of production volume batch quantity
The manufacturing requirements of any item depends on its expected consumption rate
Explain Material requirement
Materials for which the planning is done include raw materials, containers labels ancillary
The estimated manufacturing requirements provide the basis of prediction of material requirement for the manufacturing program
Explain manufacturing capacity
It is the type and size of manufacturing equipments required for manufacturing program
Explain manufacturing facility
Manufacturing facilities include maximum degree of cleanliness is aseptic filling rooms . For construction it requires best material and design
Explain manufacturing staff
Number of manufacturing staff constitutes pharmacist as a supervisor and the ancillary personnel
The number of Manufacturing staff is also a very critical factor for economics of a bulk compounding program
Explain operating costs
Operating costs includes both direct and indirect costs
The direct cost is price spent on materials and labour involved in manufacturing
Indirect cost is cost such as housekeeping, maintenance etc
Explain maintenance of manufacturing equipments
Maintenance of manufacturing equipments is actually a control over equipment operation
A high investment on pharmaceutical manufacturing equipment and expenses associated with frequent repairs necessitate an equipment maintenance program to ensure maximum performance with the lowest possible repair cost
