Introduction
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international collaborative framework between regulatory authorities, aimed at harmonizing Good Manufacturing Practice (GMP) standards for medicinal products for both human and veterinary use.
Originally, these guidelines faced resistance in Belgium due to the significant costs associated with implementation. However, this changed with the publication of a royal decree in September 2020, making compliance mandatory. In response, hospital pharmacies and healthcare groups requested an extended transition period that was set to expire in 2023. Authorities extended this grace period to the beginning of 2026.
This article explores the key challenges posed by these new guidelines and their implications for healthcare institutions.
Summary of PIC/S Guidelines
- Harmonization of GMP Standards: PIC/S aims to standardize GMP requirements across different regulatory authorities.
- Controlled Environment for Medicine Preparation: Requires cleanroom facilities meeting strict regulatory standards.
- Enhanced Quality Management Systems: Implementation of updated or new quality systems to ensure compliance.
- Increased Staffing Requirements: Additional personnel and extensive training to meet new standards.
- Regulatory Compliance Measures: Close collaboration with governmental agencies to maintain adherence to evolving regulations.
- Significant Financial Investment: Institutions must allocate substantial resources to upgrade infrastructure and systems before the 2026 deadline.
Key Challenges
The updated PIC/S guidelines introduce significant operational and financial challenges, particularly in four critical areas: infrastructure, quality systems, staffing, and regulatory compliance.
1. Infrastructure
The guidelines mandate that medicinal product preparation must take place in a controlled environment, potentially necessitating the construction of new cleanrooms for institutions that do not yet have one. These cleanrooms must meet stringent regulatory standards and undergo thorough validation before becoming operational.
2. Quality Systems
Existing quality management systems must either be upgraded or completely replaced to align with the new regulatory requirements. This process involves a comprehensive overhaul of procedures and systems, requiring meticulous validation before deployment.
3. Staffing
Compliance with the new guidelines may necessitate a 30% increase in pharmacy personnel. Both new and existing staff will require specialized training, leading to further resource demands. Additionally, securing experienced trainers to ensure proper education and adherence to the guidelines adds another layer of complexity.
4. Regulatory Compliance
To achieve full compliance, healthcare institutions must collaborate closely with regulatory bodies such as the Federal Agency for Medicines and Health Products (AFMPS/FAGG). This will involve rigorous audits, documentation, and ongoing assessments to maintain regulatory alignment.
Healthcare institutions must address these challenges with the required financial investment. Depending on the size of the institution, commitments could reach several million euros in preparation for 2026.
Who Else Can Benefit from Our Support?
While hospital pharmacies are at the forefront of compliance with the new PIC/S guidelines, other organizations facing regulatory challenges in GMP compliance can also benefit from Avertim’s expertise, including:
- Compounding Pharmacies: Ensuring compliance with updated GMP standards for customized medication preparation.
- Healthcare Groups & Networks: Assisting multiple institutions in streamlining compliance efforts and resource allocation.
- Government & Regulatory Bodies: Offering strategic consulting and audits to ensure national healthcare institutions meet evolving international GMP standards.
Avertim’s Role in Supporting Compliance
Avertim is committed to guiding healthcare institutions through this regulatory transition by offering expertise in four key areas:
1. Infrastructure
Our technical teams provide expertise in cleanroom design, construction, and validation to ensure full compliance and operational readiness.
2. Quality Systems
Our quality experts conduct gap analyses to identify deficiencies in existing quality systems and implement tailored solutions to achieve compliance efficiently.
3. Staffing
Our Lead Auditors & Trainors deliver comprehensive training programs and workforce assessments to optimize staffing levels while ensuring all personnel meet the new regulatory requirements.
4. Regulatory Compliance
Our Lead Auditors conduct audits to assess compliance readiness, mitigate regulatory risks, and ensure a smooth transition to the new guidelines.
Are You Ready for 2026?
The new PIC/S guidelines represent a paradigm shift for hospital pharmacies, requiring significant investment in infrastructure, processes, and personnel. Compliance is not merely an obligation—it is an opportunity to future-proof operations and enhance efficiency.
