Skip to main content Skip to search Skip to main navigation

PIC/S: Guidance on Risk Assesment of Routine on-Site Inspections with COVID 19

PIC/S published a new guidance COVID-19 Risk Assessment for Routine On-Site Inspections” (PI 055-1) which entered into force on 15 July 2021.

The guidance is addressed to inspectors and covers the actions to be taken during the planning phase of an inspection, in consultation with the site to be inspected.

Following, the site must confirm that the necessary measures identified in the risk assessment are implemented before inspection. The document lists all points to be considered for the risk assessment of an inspector while planning. This includes a risk rating into three categories from low to high risk (unacceptable).

If facing an inspection during COVID-19, check out the required measures.


Source:

PIC/S: PI 055-1

 

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be Interested in the Following Articles:

PIC/S: Jordan FDA Joins PIC/S

PIC/S: Jordan FDA Joins PIC/S

On 1 January 2026, the Jordan Food & Drug Administration (JFDA) became the 57th PIC/S Participating Authority.

Read more
Swissmedic: Scientific GMDP Meetings

Swissmedic: Scientific GMDP Meetings

Swissmedic offers companies holding or seeking a Swissmedic manufacturing or distribution license the opportunity to discuss project-specific GMP and GDP topics in Scientific GMDP Meetings.

Read more
Purified Water – The new Chinese Pharmacopoeias and What Happens Next? NEU

Purified Water – The new Chinese Pharmacopoeias and What Happens Next? NEU

A new Chinese Pharmacopoeia was published in 2025. This has some significant implications for the pharmaceutical water industry, which we will discuss in more detail in this article. Firstly, it is important to note that cold WFI systems are now permitted worldwide and can be used across the board.
Read more
What are the requirements for gas distribution systems?

What are the requirements for gas distribution systems?

You can view the answer here:
Read more
What are the quality requirements for pharmaceutical gases?

What are the quality requirements for pharmaceutical gases?

You can view the answer here:
Read more
EMA: Update on the Guideline “Stability Testing for Variations”

EMA: Update on the Guideline “Stability Testing for Variations”

The EMA has updated the guideline on stability testing for variations (Revision 3, applicable from 15 January 2026).
Read more
Previous
Next