Leadership in regulation and quality affairs associated with ISPE core concerns and priorities
ISPE strives to facilitate industry wide clarity of new applicable regulations, advising on impacts and resolving towards solutions, seeking harmonization of regulatory expectations where desired and possible.
ISPE engages with all levels of regulators in the development and presentation of our education, training, document development, and interpretation to ensure that our offerings are cutting-edge and focused on clarifying issues and solving problems of importance to industry.
CALL FOR COMMENTS
WHO “Production of Water for Injection by Means Other Than Distillation”
This document provides guidance for the production of Water for Injection (WFI) by means other than distillation. The principles may be applied to other qualities of water produced, meeting other specifications.
Deadline: March 18
FDA draft Guidance “Principles of Premarket Pathways for Combination Products”
This draft guidance presents FDA's current thinking on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate.
Deadline: March 27
EMA “Guideline on the Quality of Water for Pharmaceutical Use”
The guideline addresses development, manufacturing and quality control, featuring sections on quality documentation (including parts on the active substance and the investigational medicinal product), non-clinical documentation and clinical documentation.
Deadline: April 3
FDA draft Guidance “Quality Considerations for Continuous Manufacturing”
This draft guidance provides information regarding FDA's current thinking on the quality considerations for continuous manufacturing of small molecule, solid oral drug products that are regulated by the Center for Drug Evaluation and Research (CDER).
Deadline: April 3Comment Now
Multi-Faceted Project Teams
ISPE’s Multi-Faceted Project Teams are working groups addressing the following topics:
PQLI is ISPE’s initiative for a practical approach to implementation of International Conference on Harmonization (ICH) guidances Q8 (R2), Pharmaceutical Development; Q9, Quality Risk Management; Q10, Pharmaceutical Quality System; and Q11, Development and Manufacture of Drug Substances.
PQLI Technical Teams are working groups addressing broad cutting-edge regulatory and compliance issues that affect industry across dosage forms and in small and large molecules.
- Blend Uniformity/Content Uniformity
- Breakthrough Therapies
- Continuous Manufacturing
- Knowledge Management
- Process Capability
- Process Validation
Regulatory Quality Harmonization Committee (RQHC)
The Regulatory Quality Harmonization Committee builds effective partnerships with regulators and agencies globally and ensures ISPE Members have access to the latest regulatory developments and expectations. The work of the Regulatory Quality Harmonization Committee is carried out by its four Regional Focus Groups in:
- Europe-Middle East-Africa (EMEA)
- Latin America
- North America
Good Manufacturing Practice GMP
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.
ISPE in Europe
The goal of ISPE European Operations is to promote the development and sharing of scientific, technical and regulatory understanding with specific focus on the needs of ISPE's European members and stakeholders. Through publications, seminars, conferences and discussion meetings, etc., ISPE will engage European Members and inform them of the latest developments and products that can help support the pharmaceutical industry in ensuring the reliable supply of quality medicines to patients.
For more information, contact RegulatoryAffairs@ispe.org