Validation

Question 1

Where would you find guidance on qualification and Validation

Answer 1

Eudralex volume 4 Annex 15

Question 2

Identify the main steps of qualification

Answer 2

URS
DQ
FAT
IQ
OQ
PQ

Question 3

Outline the requirements for URS

Answer 3

The specification for equipment, facilities, utilities or systems should be defined, the essential elements of quality need to be built in and GMP risks mitigated to an acceptable level

Question 4

Outline what is required in DQ

Answer 4

Compliance of the design with GMP should be demonstrated and documented, the requirements of URS should be verified during DQ

Question 5

Outline the requirements of FAT

Answer 5

Equipment can be evaluated at the vendor prior to delivery, prior to installation equipment should be confirmed to comply with the URS

Question 6

Outline the requirements of IQ

Answer 6

IQ should include

Verification of correct installation against engineering drawings and specs

Collection of supplier operating and working instructions and maintenance requirements

Calibration of instrumentation

Verification of the materials of construction

Question 8

Which two steps of qualification may be combined

Answer 8

IQ/OQ

Question 9

Outline the requirements of OQ

Answer 9

Tests developed from process knowledge

Tests to confirm upper and lower operating limits and worst case conditions

Successful completion of OQ should allow the finalisation of SOPs, operator training and preventive maintenance procedures

Question 10

Outline the requirements of PQ

Answer 10

Should include tests using production materials or qualified substitutes, the frequency of sampling to confirm process control should be justified

Tests should cover the operating range of the intended process unless documented evidence from the development phases is available

Question 11

Which intended market strengths should be covered by process validation?

Answer 11

All intended market strengths. Bracketing may be applied based on extensive process knowledge from the development stage in conjunction with an ongoing verification program

Question 12

Why is cleaning validation performed?

Answer 12

To confirm the effectiveness of any cleaning procedure for all contact equipment

Question 13

How should limits for carryover of product residues be established?

Answer 13

These should be based on a toxicological evaluation

Question 14

How would you identify a worst case product residues?

Answer 14

Solubility, Cleanability, toxicity and potency.