13-04-2023 Validation - Bioreactor

Current Good Manufacturing Practices (cGMP) come strongly into play when participating in ------------validation activities

• pharmaceutical process

• physical process

• Chemical process

• None of these

The main objectives is to -------------------- the drug manufacturing process

• design

•  create,

•  maintain

• All the above

To produce pharmaceuticals that meet the critical attributes of

• Quality &

  Purity

• Identity &

  Strength

• Potency

• All the above

All samples must be representative of the batch under analysis, must 

• adhere to rules of quality

• adhere to rules of qualification

• adhere to rules of statistical confidence

• None of these

Which section mandates that information related to product quality and manufacturing practices ?

• Section 211.188

• Section 211.185

• Section 211.170

• Section 211.180

cGMP mandates that drug-manufacturing facilities and equipment be of --------------- to meet required needs

• acceptable size

•  construction, and location

•  location

• All the above

The FDA recommends a team-based approach to process validation

• True

• False

• Aplicable

• Not Aplicable

Process design experiments should be conducted under guidelines of sound scientific principles.

• Stage-I

• Stage-II

• Stage-III

• None of these

The FDA expects that process controls include

• examination of material

•  equipment monitoring

• A and B

• None of these

cGMP requirements include an ongoing program 

• to collect and analyze data relating to product quality

• to review and analyze data

• to discuss the error data

• All the above