Structure Lists

Question 1

What words to write down for a deviation

Answer 1

1. Deviation
2. Boundary
3. Hold & Stop
4. Impact assess & Classify
5. Stock location / shelf life
6. Ref samples / BD
7. Root cause
8. Committee
9. Capa
10. Capa effictiveness

Question 2

What words to write down for a lab investigation

Answer 2

1. LIR
2. Obvious error
3. Supervisor – checklist
4. Hypothesis
5. Manufacturing investigation
6. No assignable cause then consider retest
7. If reject then any tests can be performed

Question 3

What words to write down for a customer complaint

Answer 3

1. Number
2. Sample / photo
3. Ref sample
4. Other complaints?
   4.5 Warehouse
5. BD
6. Falsified?
7. Substantiate
8. Committee

Question 4

What words to write down for Contamination event

Answer 4

1. Deviation
2. Ring-fence - hold & stop
3. Identify
4. Contra-indications
5. Rogue?
6. patient impact - better to take bad for continuity?
7. Quantity
8. MACO
9. LIC

Question 5

What words to write down for stability failure

Answer 5

1. Why on stability
2. Other tests / conditions / batches on test
3. Bracket / matrix
4. Shelf life
5. Stock location
6. Manufacturing investigation
7. LIC
8. Competent authority

Question 6

What words to write down for API

Answer 6

1. Solvents
2. Metals
3. Genotox
4. Polymorph
5. Nitrosamines
6. Supply chain map
7. QP Dec
8. Side reaction
   9 stereo
9. CEP

Question 7

What words to write down – process sim failure

Answer 7

1. Why on test
2. What did the vials look like
3. What was the organism
4. CCTV
5. Operator – what else they done
6. Deviation
7. LIC
8. Recall

Question 8

Change Control

Answer 8

1. Impact assess
2. Prod qual
3. Reg
4. Val
5. GMP / QA agreement
6. Stability
7. Supplier audit
8. Testing
9. Approve to implement