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Review
. 2024 Sep 9;16(9):e69043.
doi: 10.7759/cureus.69043. eCollection 2024 Sep.

Pharmaceutical Inspection Co-operation Scheme: An Overview

Prasanna Gayathri B  1 , Kamaraj R  1
Affiliations
Review

Pharmaceutical Inspection Co-operation Scheme: An Overview

Prasanna Gayathri B et al. Cureus. .

Abstract

To address the challenges posed by the globalization of regulatory agencies, it is essential to harmonize regulatory requirements, assess Good Manufacturing Practice (GMP) compliance, license production facilities, manage product recalls, and improve information exchange. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) provides a robust framework for tackling these global issues. Through the PIC/S GMP Forum, PIC/S facilitates informal interactions among non-member authorities, professionals, and various organizations with the Committee, fostering networking and collaboration. Furthermore, PIC/S has developed a comprehensive guide on GMP requirements for inspectorates and organizations, ensuring consistent standards across borders. The scheme collaborates with other organizations to enhance and complement collective efforts. With 56 countries involved in PIC/S, whether as members or through the Accession and Pre-Accession Process, the exchange of inspection reports among authorities verifies compliance with PIC/S standards, leading to fewer and more targeted inspections and reducing redundancy. This study's purpose is to establish uniform GMP standards by providing extensive training for inspectors and promoting collaboration and networking among regional and international bodies, regulatory authorities, and other relevant organizations. This approach seeks to build trust in inspections, optimize resource use, and foster a more efficient regulatory environment. Through these efforts, PIC/S continues to play a pivotal role in advancing global pharmaceutical regulatory practices.

Keywords: accession; gmp compliance; gmp requirements; information exchange; inspectorates; international cooperation; networking; pharmaceutical inspection co-operation scheme (pic/s); pic/s gmp forum; pre-accession..

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Conflict of interest statement

Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

Figures

Figure 1
Figure 1. PIC/S countries and participating authorities
This is an original illustration [5].
Figure 2
Figure 2. Arrangement of the sub-committees
This is an original illustration [8].
Figure 3
Figure 3. Seven sub-committees
This is an original illustration [9].
Figure 4
Figure 4. Accession procedure step-by-step
This is an original illustration [13].
See this image and copyright information in PMC

References

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    1. PIC/S [Pharmaceutical inspection convention and pharmaceutical inspection scheme] [ Jun; 2024 ]. 2024. https://pharmastate.academy/pic-s-pharmaceutical-inspection-convention-a... https://pharmastate.academy/pic-s-pharmaceutical-inspection-convention-a...
    1. Mission, vision and values. [ Jun; 2024 ]. 2024. https://picscheme.org/en/mission-vision-and-values https://picscheme.org/en/mission-vision-and-values
    1. Members: list of PIC/S participating authorities. [ Jun; 2024 ]. 2024. https://picscheme.org/en/members https://picscheme.org/en/members

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