QP Duties

Question 1

What must be completed to support certification related to the batch?

Answer 1

Investigations pertaining to the batch (including OOS/OOT)

OOS stands for Out of Specification, and OOT stands for Out of Trend.

Question 2

What is the compliance requirement for T (TSE) status?

Answer 2

T (TSE) status must be compliant with MA (where relevant)

MA refers to Marketing Authorization.

Question 3

What compliance must sites of manufacture/analysis & certification meet?

Answer 3

Sites must be compliant with MA

MA refers to Marketing Authorization.

Question 4

What does finished product QC testing need to comply with?

Answer 4

Specification as per MA

MA refers to Marketing Authorization.

Question 5

What activities must be consistent with those described in the MA?

Answer 5

Manufacturing & Testing activities

MA refers to Marketing Authorization.

Question 6

What is required regarding the validation state of manufacture and testing?

Answer 6

All manufacture & testing must be in validated state and personnel must be qualified

Validation ensures processes are consistently producing results.

Question 7

According to 2001/83, how must API be manufactured and distributed?

Answer 7

Manufactured in accordance with GMP & distributed in accordance with GDP

GMP stands for Good Manufacturing Practice, and GDP stands for Good Distribution Practice.

Question 8

What must be active and current as part of the inspection requirements?

Answer 8

Si programme

Si likely refers to a specific inspection program.

Question 9

What arrangements must be in place for distribution and shipping?

Answer 9

Appropriate arrangements

This ensures compliance with regulations during distribution.

Question 10

How must excipients be manufactured according to 2001/83?

Answer 10

Manufactured in accordance with GMP article 46 (f)

Excipients are inactive substances used as a carrier for the active ingredients.

Question 11

What records must be complete and endorsed by appropriate personnel?

Answer 11

All records and all in-process control checks

This ensures accountability and traceability.

Question 12

What must the supply chain documentation include?

Answer 12

API & product supply chain mapped up to certification, including sites for starting & packaging materials

This documentation is crucial for quality assurance.

Question 13

What must be addressed regarding marketing post-commitments?

Answer 13

Post marketing commitments must be addressed and ongoing stability supports certification

This is essential for maintaining product safety and efficacy.

Question 14

What is required for audit testing and manufacturing sites?

Answer 14

Testing & manufacturing sites (product and API) must be completed and available to OP

OP likely refers to the appropriate authority or oversight personnel.

Question 15

What must all activities associated with manufacture and testing comply with?

Answer 15

GMP

GMP stands for Good Manufacturing Practice.

Question 16

What must the importation of API for human medicine comply with?

Answer 16

Article 46(b) of 2001/83/EC

This regulation pertains to the importation standards for active substances.

Question 17

What must be assessed regarding changes to product manufacture?

Answer 17

Impact assessed, additional checks and tests are complete

This ensures that changes do not negatively affect product quality.

Question 18

What must be true about ongoing complaints, investigations, or recalls?

Answer 18

They must not negate batch certification conditions

This is critical for maintaining product integrity.

Question 19

What type of agreements must be in place?

Answer 19

Technical agreements

These agreements outline the responsibilities and expectations between parties.

Question 20

What safety features must be complied with according to EU regulations?

Answer 20

EU safety features ant 54

This likely refers to specific safety requirements for pharmaceuticals in the EU.

Question 21

What must the source and specification of starting and packaging components comply with?

Answer 21

Compliance with MA and supplier QMS

QMS stands for Quality Management System, ensuring quality materials are supplied.