TOP 15 Countdown: "Question of the Week"

In this feature you now have the opportunity to view the most clicked questions in 2020. Could you answer them yourself? If not, you are not alone. Subscribers to the GMP Compliance Adviser just follow the additional link and get even more in-depth knowledge from the GMP Compliance Adviser.

15.

Which two factors are particularly important for a GMP-compliant process validation?

This is important for a GMP-compliant process validation:

• When drawing up a process validation, keep the objective of the process validation in mind.
• Ask yourself at any time: What do I want to prove and am I on the right track to get there?

Read more in the GMP Compliance Adviser: Chapter 21.C

14.

What does official calibration mean?

Official calibration describes any examination, evaluation and marking of a measuring instrument by or on behalf of an authority which is associated with permission to use the measuring instrument for a further verification period within the scope of the intended purpose and under the corresponding conditions of use.

Read more in the GMP Compliance Adviser: Chapter 4.F

13.

What are complexing agents and how do they work?

Complexing agents are organic compounds that bind the charged ions into their molecular structure. This creates large, stable and complex organic compounds. The concentration of free (unwanted) ions is dramatically reduced. As a result, unwanted reactions such as precipitation are prevented.

Read more in the GMP Compliance Adviser: Chapter 5.B

12.

What is a risk?

Definition of ICH Q9: The combination of the probability of occurrence of harm and the severity of that harm.

Read more in the GMP Compliance Adviser: Chapter 19.A

11.

How can medicinal products requiring cool transport conditions be transported?

For refrigerated transports it is necessary to utilize active cooling units in vehicles or containers or to use passive shipping containers, respectively.

Read more in the GMP Compliance Adviser: Chapter 16.I

10.

In which phases is the quality risk management process divided?

Quality risk management is understood as a systematic and continuous process that allows the assessment, management and control of product quality risks throughout the entire product life cycle.

The process model presented in ICH Q9 comprises 5 stages:

1. Initiating the process
2. Risk assessment
3. Risk management
4. Risk communication
5. Risk monitoring

Read more in the GMP Compliance Adviser: Chapter 19.B

9.

What is a residual risk?

Residual risk is the risk remaining after protective measures have been implemented.

Read more in the GMP Compliance Adviser: Chapter 19.A

8.

What is an alert limit, and what happens when it is exceeded?

Alert limit: A predetermined value somewhat outside the normally expected tolerance band. If exceeded, intensified supervision according to a pre-determined plan should be triggered.

Read more in the GMP Compliance Adviser: Chapter 3.K

7.

What is meant by active and passive temperature control?

Active cooling systems are understood to be cooling systems that provide temperature control on the basis of energy input (electricity/battery) from the outside. Passive systems on the other hand function autonomously without energy input from outside sources. The temperature control here is provided by cooling elements that contain different cooling media.

Read more in the GMP Compliance Adviser: Chapter 16.J

6.
What are the requirements for successful quality risk management (QRM)?

Important requirements for successful QRM are the support by the management, the reference to quality management and the regular review of the effectiveness and efficiency of QRM.

Read more in the GMP Compliance Adviser: Chapter 19.A

5.
For what purposes can drinking water be used in the pharmaceutical industry?

In addition to supplying the pharmaceutical water treatment system, drinking water is also used for pre-rinsing the equipment and containers during cleaning cycles. Drinking water can also be used during the initial stages of active substance manufacture.

Read more in the GMP Compliance Adviser: Chapter 5.A

4.
How do you ensure the traceability of the batch documentation?

To ensure the traceability of the batch documentation:

• Independent verification of traceability, e.g. in the context of self-inspections
• Check of consistency with other documents, including process validation, validation of holding times, media fills, clean and dirty hold times
• In particular, ensuring the traceability of the chronological order and reconciliation

Read more in the GMP Compliance Adviser: Chapter 21.C

3.
What role does quality risk management play in the quality management system?

An effective pharmaceutical quality management system (QMS) should ensure the systematic application of QRM. That is why the triggers of QRM activities must be carefully defined and the corresponding trigger mechanisms embedded in the core and supporting processes of the QMS.

Read more in the GMP Compliance Adviser: Chapter 19.B

2.
What data is monitored when monitoring a HVAC system?

In the pharma monitoring of a HVAC system, microbiological and physical measurands are recorded. The physical measurands include particle concentrations, pressure differences defined as critical, as well as process-relevant temperatures and air humidity.

Read more in the GMP Compliance Adviser: Chapter 3.K

1.
Where can you find concrete information regarding "transport and temperature?"

Specific information on the topic of "transport and temperature" can be found, for example, in the USP monograph <1079>.

Read more in the GMP Compliance Adviser: Chapter 16.H