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:

EMA: Q&A Paper on Measures to Prevent Microbial Contamination of Non-Sterile Medicinal Products

EMA: Q&A Paper on Measures to Prevent Microbial Contamination of Non-Sterile Medicinal Products

The EMA has published a new Q&A paper on technical and organisational measures to prevent microbial contamination of non-sterile medicinal products.
Read more
When APS Fail and First Air is at Risk

When APS Fail and First Air is at Risk

At the PDA Good Aseptic Manufacturing Conference 2026, Alberto Gonzales (Takeda) discussed challenges and practical solutions related to aseptic process simulations (APS). Anna Campanella (Takeda) and Hussein Bachir (Franz Ziel) explored how first air protection in aseptic processing can be compromised by equipment design, glove interventions, and operator activities.
Read more
Why is import authorisation necessary for medicinal products entering the EU?

Why is import authorisation necessary for medicinal products entering the EU?

Read more
FDA: Updated Compliance Program for Preapproval Inspections

FDA: Updated Compliance Program for Preapproval Inspections

The FDA has revised its Compliance Program 7346.832, “Preapproval Inspections”. The updated program describes the planning, conduct and evaluation of preapproval inspections (PAIs) for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
Read more
EMA: Revised Q&A MRA EU-USA

EMA: Revised Q&A MRA EU-USA

The EMA has updated its Questions and Answers on the EU-US Mutual Recognition Agreement (MRA). The update follows the completion of the FDA's assessment of all EU authorities responsible for GMP inspections of veterinary medicinal products on 29 May 2026.
Read more
WHO: Draft on Regulatory Ovesight of Disposal of Medical Products

WHO: Draft on Regulatory Ovesight of Disposal of Medical Products

WHO published a draft consultation document on regulatory oversight of disposal of medical products throughout the lifecycle.
Read more
Previous
Next