The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced this month that it has adopted new guidance on good manufacturing practice (GMP) inspections, outlining a process for “desk-top assessment” of overseas facilities to identify instances when an acceptable level of GMP compliance can be confirmed and assured without on-site inspections.
Based on a draft from the International Coalition of Medicines Regulatory Authorities (ICMRA), PIC/S said the guidance provides a tool and framework aiming to help competent authorities (CAs) prioritize resources for GMP inspections for human and veterinary medicines.
“The demand for inspecting pharmaceutical manufacturing facilities far exceeds what any one CA can accomplish and this framework will assist regulators in managing product quality risks posed by the increasingly complex pharmaceuticals global supply chain,” the group said.
The main feature of this new guidance, PIC/S said, “It is a non-binding (i.e. applicable on a voluntary basis) high-level guidance for ICMRA and PIC/S Participating Authorities (PA) alike, whose purpose is to facilitate this assessment process. It does not supersede country/regional guidance, procedures or legislation where they exist.”
The adoption by PIC/S of this new guidance highlights efforts undertaken by the group to improve sharing of inspection information between authorities, which for 2018, PIC/S said contains more than 900 scheduled inspections.
“The procedure should include the information that is needed to make an informed regulatory decision about site compliance, triggers and risk factors that would result in an inspection being required, and how the assessment and outcome should be recorded,” PIC/S said. “The aim in assessing the gathered information is to gain assurance that GMP compliance has been established by the hosting CA and that there are no other new evidence that would warrant an on-site inspection by the requesting CA.”
The group notes that two chapters in the guide have been revised to include requirements to prevent cross-contamination. A change in the qualification of suppliers has also been introduced by another revised chapter.
The revision was completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada/RORB
). PIC/S said the revised GMP Guide will enter into force on 1 July 2018 and will be published on the group’s website before it is published.
“All non-EU/EEA Participating Authorities of PIC/S (and Applicants) have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides,” the group said.
Other PIC/S Updates
PIC/S also said it has established with the World Health Organization a new working group led by Australia’s Therapeutic Goods Administration (TGA) on a revision of Annex 2 (biologicals) of the PIC/S GMP guide in order to review the European Commission’s (EC) guidelines on GMPs specific to Advanced Therapy Medicinal Products (ATMPs) in order to identify:
- “strengths and weaknesses;
- legitimate concerns by industry and regulators with respect to ATMPs;
- areas of GMP applicable to ATMP that may benefit from modernization to reflect the current status of the manufacturing processes and manufacturing settings. The objective is to advance a recommendation to the PIC/S Committee on a strategy to harmonize where possible with the EC guidelines while addressing the perceived concerns raised by PIC/S Participating Authorities which have led to international divergence in this field.”
The PIC/S Working Group on Data Integrity, co-led by Australia’s TGA and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), also has revised the draft PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments.
The purpose of this guidance is to outline the position an inspector would adopt during the inspection of GDP/GMP facilities and is designed to facilitate a harmonized approach to an inspection, including reporting in regards to data management and integrity.
PIC/S also said registrations for the 2018 PIC/S seminar on "Management of Risk through the Product Life-Cycle" (in Chicago from 26-28 September 2018) are now open.
The group said the seminar is for medicines regulatory authorities only.
PIC/S meetings in Geneva, Switzerland, 16-18 April 2018