Lesson8: Basis of Pharmaceutical Operation

Question 1

What’s GMP ?

Answer 1

Good Manufacturing Practice (GMP) is a quality system ensuring that products are consistently manufactured to a quality appropriate to their intended use.

Question 2

All necessary facilities/resources for GMP should be
provided ?

Answer 2

All necessary facilities/resources for GMP should be provided:
▪ Provide a high level assurance that drugs are manufacture in a way to ensure their safety, efficacy, and quality
▪ Design to minimize the risks involved in any pharmaceutical production that cannot be eliminated through

Question 3

How can Governments promote their countries export of pharmaceuticals ?

Answer 3

Governments seeking to promote their countries export of pharmaceuticals can do by making GMP mandatory for production and by training their inspectors in GMP requirements.

Question 4

Principle of GMP ?

Answer 4

1. Design and construct the facilities and equipment properly
2. Follow written procedures and Instructions
3. Document work
4. Validate work
5. Monitor facilities and equipment
6. Write step by step operating procedures and work on instructions
7. Design, develop and demonstrate job competence
8. Protect against contamination
9. Control components and product related processes
10. Conduct planned and periodic audits

Question 5

Regulation of cGMP ?

Answer 5

➢ Regulations of cGMP are included:
▪ Organization and Personnel
▪ Buildings and Facilities
▪ Equipment
▪ Control of Components, Containers, and Closures
▪ Production and Process Controls
▪ Packaging and Labeling Control
▪ Holding and Distribution
▪ Laboratory Controls
▪ Records and Reports
▪ Returned and Salvaged Drug Products

Question 6

What are the responsibility that organization and personnel deal with ?

Answer 6

▪ Quality control unit: authority and responsibility for all functions that may affect
product quality.
▪ Personal qualifications: e.g. supervisory positions
▪ Personal responsibilities: fulfill the assigned responsibility
▪ Consultants: advising on scientific and technical matters

Question 7

what are the regulation of building and facilities included ?

Answer 7

The regulations include the design, structural features, and functional aspects of buildings and facilities.