The PIC/S Committee met on 24-25 September 2018, in Chicago. The meeting was attended by 38 Participating Authorities as well as by a number of Applicants, Pre-Applicants and Associated Partner Organisations. The event was hosted by the US FDA which symbolised the effort to strengthen inspectional approaches and assessments worldwide and to further share and discuss respective regulatory decisions and information. The keyword “harmonisation” and the impact of PIC/S on this matter had been especially highlighted by the FDA.
Here are the headlines and developments for the area of GM(D)P:
- New PIC/S guidance on classification of GMP deficiencies (PI 040-1)
The adoption is scheduled to enter into force on 1 January 2019. The guideline is considered a tool to support the risk based classification of GMP deficiencies from inspections which ensures greater consistency amongst inspectorates. It will enable industry to be informed of the principles used to classify GMP deficiencies and also provide examples of the classification of different types of deficiencies. Its scope shall be further extended also to Good Distribution Practice (GDP) deficiencies in future.
- The stakeholder consultation on the revision of Annex 1 (Sterile Manufacturing) ended with more than 6.300 comments being received. These are currently assessed by the responsible Working Group.
- The revision of Annex 2 (Manufacture of Biological Medicinal Substances and Products for Human Use) of the PIC/S GMP Guide is progressing. The PIC/S Working Group on the revision of Annex 2 is focusing first on the development of a new Annex which is currently being proposed to be Annex 2A for Advanced Therapy Medicinal Products (ATMP) with Annex 2B being the modified version of the existing Annex 2 for Biologics. This approach aims to harmonise, where possible, the the EC’s guidelines on ATMPs.
- PIC/S is represented in the EMA drafting groups of Chapter 1 (PQS), Chapter 4 (Documentation), Annex 11 (Computerized Systems) and Annex 13 (IMPs).
- A PIC/S version of Annex 16 (Certification by a QP and Batch Release) is currently under development, as well as a PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 3)). This draft will be launched shortly and includes a a new implementation trail period.
- Drafts on PE 005-3 (Blood Establishments) and PE 008-3 (Plasma Establishments and -Warehouses) are also worked on.
- A revision of the PIC/S Recommendations on Validation Master Plan; Installation and Operational Qualification; Non-Sterile Process Validation; and Cleaning Validation (PI 006-3) is still underway.
- PI 011-3 on Good Practices for Computerised Systems is under revision.
- The PIC/S Inspectorates’ Academy (PIA) has launched its website and with this launched step 1 of the PIA project. Currently stages 2 and 3 are in development and will encompass a fully integrated learning management system extending the current training resources, on the basis of a harmonised training curriculum.
- The 2019 work plan was adopted and will be published on the page “Publications” prior to the start of 2019.
News around PIC/S Memberships:
- The Bulgarian Drug Agency (BDA) applied for PIC/S membership.
- The Jordan Food and Drug Administration (JFDA) applied for PIC/S pre-accession.
- India’s CDSCO attended the meeting due to interest in joining PIC/S.
- China’s National Medical Products Administration, NMPA (formerly CFDA) plans a PIC/S application in future and took part in a bilateral meeting.
PIC/S: Press Release