Adapting to the Future of GMP Compliance: Key Takeaways from the PIC/S Guidance on Remote Assessments

First let’s get familiar with the abbreviations that will be used in this blog post: 

• PIC/S: Pharmaceutical Inspection Convention / Pharmaceutical Inspection Co-operation Scheme 

• GMP: Good Manufacturing Practices  

• GxP: Good Practice (In the Life Science industry) 

The PIC/S Guidance on Remote Assessments (PI 056-1) is a significant step forward in formalizing remote GMP inspections as a legitimate and structured regulatory tool. Over the past few years, we have seen an accelerated shift toward digital compliance oversight, driven initially by necessity during the pandemic but now evolving into a more permanent and strategic inspection methodology. As seasoned GxP experts with extensive experience in pharmaceutical manufacturing, validation, auditing, and quality documentation, we see this guidance as both a necessary adaptation and a challenge for industry stakeholders who must now integrate remote assessments into their compliance frameworks. 

The Risk-Based Approach to Suitability 

First of mind as a key takeaway is the risk-based approach outlined in the guidance. PIC/S emphasizes that not all facilities or processes are suitable for remote assessment, and decisions should be risk-driven. From an auditor’s perspective, this is a crucial point. If a facility has a strong compliance history, minimal recent changes, and operates within a well-controlled GMP framework, a remote assessment may be appropriate. However, for aseptic operations, facilities with prior compliance concerns, or sites undergoing major operational changes, on-site inspections will likely remain the gold standard. We fully support this tiered approach as it ensures that regulatory oversight remains rigorous without being unnecessarily burdensome for facilities that have demonstrated a high level of compliance. 

Documentation, Transparency, and Long-Term Implications 

The logistics outlined in the guidance also reinforce a fundamental principle that we've seen demonstrated over and over again in years of auditing and project management - the success of an inspection is directly tied to preparation and transparency. The ability to provide clear, well-organized documentation in a remote format will separate companies that excel in compliance from those that struggle with ad-hoc regulatory interactions. Whether it’s a Corrective and Preventive Action (CAPA) plan, batch records, or supplier qualification documents, companies must ensure that their documentation structure supports efficient retrieval and review. Additionally, PIC/S makes it clear that GMP certificates and inspection reports will indicate whether an assessment was conducted remotely or as part of a hybrid inspection. This means that inspection transparency is non-negotiable, and any organization undergoing a remote assessment must be prepared for its outcomes to carry the same regulatory weight as an on-site inspection. 

From an industry-wide perspective, this guidance signals a long-term shift in GMP compliance strategies. While remote assessments were initially an emergency response to global restrictions, their efficiency, cost-effectiveness, and ability to optimize inspection resources have made them a valuable addition to regulatory oversight. However, companies must not make the mistake of treating remote assessments as a less rigorous alternative to on-site inspections. In fact, in many ways, remote assessments introduce new compliance challenges, particularly regarding data integrity, cybersecurity, and the effectiveness of virtual site walkthroughs. 

Moving Forward: Adaptability and Digital Transformation 

In our view, the key to success under this new model is adaptability and proactive compliance management. Organizations should invest in compliance-driven digital transformation, ensuring that they have the technology, documentation, processes, and personnel readiness to seamlessly handle remote inspections. Quality and validation teams must work closely with IT and operations to integrate digital compliance tools, enhance remote collaboration, and develop protocols for handling virtual audits. Moreover, vendor and supplier management will need to be adjusted -if a regulatory authority chooses to assess a third-party manufacturer remotely, organizations must ensure that their suppliers are equally prepared for virtual inspections. 

Looking ahead, we anticipate that hybrid inspections will become the industry standard, balancing the flexibility of remote assessments with the critical need for on-site verification in high-risk environments. As GxP experts, we see this as an opportunity for companies to redefine their approach to regulatory readiness. By embedding digital inspection preparedness into their quality management systems (QMS), organizations can position themselves as leaders in compliance excellence while ensuring they meet evolving regulatory expectations. 

Ultimately, the PIC/S Guidance on Remote Assessments is not just a regulatory update. It is a call to action for the industry to modernize its approach to GMP compliance. Those who embrace digital transformation, enhance transparency, and proactively align with these best practices will gain a competitive advantage in regulatory compliance, while those who resist change may find themselves struggling to keep up with the new reality of remote and hybrid inspections.