Process validation in Pharm Ind

What is the primary goal of process validation in pharmaceutical manufacturing?

• To ensure compliance with SOPs

• To identify critical quality attributes of raw materials

• To demonstrate that a process consistently produces a product meeting its pre-determined specifications and critical quality attributes

• To perform risk assessment on all equipment used in the process

Which of the following is the first stage of process validation in process validation life cycle?

• • Performance Qualification (PQ)

• Process Design

• Process Qualification

• Continued Process Verification

Which types of PV using real-time analysis techniques for determination of CQA?

• Prospective Validation

• Alternative Approach (Continuous PV)

• Retrospective Validation

• Concurrent Validation

Which types of PV using analysis of CQA for 3 lots consecutively before product launch into the market?

• Prospective Validation

• Alternative Approach (Continuous PV)

• Retrospective Validation

• Concurrent Validation

Which regulatory guideline is commonly referred to for guidance on process validation?

• USP <61>

• ICH Q10

• PICS/GMP

• ISO 9001

"Blending Uniformity" is suitable to be a ...... for process validation of premixing step.

• CQA

• CPP

• CMA

• RCA

What are the acceptance criteria for blending uniformity in PV of premixing step?

• Mean +- 10%

• SD <= 3.8 (n=10)

• Both of them

• None of them

"Standard Deviation Prediction Interval (SDPI)" is used to calculate the SD value for analysis PV result of .... in tablets.

• Blending uniformity

• Dissolution

• Moisture content

• Content uniformity

If these changes have been applied in the process, the process re-validation is needed or not?

Groups:

(a) Yes, it needed.

,

(b) No, it do not need.

• Mixing order

• Excipient From sucrose to sorbitol

• Production pharmacist

• New mixing baffle (same geometry)

• Batch size

• Water producing machine

• Mixing chamber size

• HPMC to MC