GMP/QA

Question 1

what is cGMP?

Answer 1

current Good Manufacturing Practices
–A series of minimum standards to which pharmaceutical companies must comply.
– These standards ensure that the products produced are PURE, SAFE and EFFECTIVE.

Question 2

what are the basic rules of cGMP?

Answer 2

free from contamination
contain the correct dose - e.g. all batches
have not deteriorated - e.g. during storage/transport
provide the required therapeutic benefit

Question 3

describe the process of cGMP

Answer 3

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

Question 4

what is quality assurance/QA?

Answer 4

Has overall responsibility for the quality of the product encompassing all aspects of GMP (testing, personnel, training, validation, documentation, etc.), ensuring that quality is built into the process

Question 5

what is quality control/QC?

Answer 5

Has the responsibility of sampling and testing raw materials (APIs, excipients, packaging), intermediate products (powder mixes, emulsions) and final products (before release of product and during stability)

Question 6

what must you do for quality control?

Answer 6

• Adequate facilities
• Trained personnel
• Approved procedures and testing methods
• Maintenance of QC records&failure investigation records
• Ingredients comply with regulatory specification (grade, composition, strength)
• Review and evaluation of production documentation
• Assessment of process deviations
• Release of batches by authorized person(QP)
• Sufficient reference samples of starting materials and finished products

Question 7

what is quality assurance?

Answer 7

That production and control operations are clearly specified and GMP is adopted
– Managerial responsibilities are clearly defined and specified
– All raw materials are suitable for use
– Ensure that finished products are correctly processed &
checked before release
– Provide satisfactory arrangement to ensure products
are stored, distributed & handled appropriatel
– Put in place a mechanism for regular self inspection / internal quality audit

Question 8

what is GLP?

Answer 8

Good Laboratory Practice may be defined as:
– A set of principles that provides a framework within which lab studies are conducted
– These studies are undertaken to generate data & then assess the hazards & risks to users, consumers & 3rd parties
– Helps assure regulatory authorities that data submitted are a true reflection of the results obtained during the study & can therefore be relied upon

Question 9

what are the objectives of GLP?

Answer 9

1. Promote the quality & validity of data generated in the testing of pharmaceutical products, raw materials, manufacturing intermediates
2. Facilitate the recognition of pharmaceutical products
3. Protection of human health & the environment
4. Time & resource efficiency
5. Avoidance of non-tariff barriers to trade