Regulatory

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

Revised Draft PIC/S Guidance on Good Practices for Data Management and Integrity

The purpose of the 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 the inspection, including reporting in regard to data management and integrity.

Deadline: 28 Feb

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Multi-Faceted Project Teams

ISPE’s Multi-Faceted Project Teams are working groups addressing the following topics:


Product Quality Lifecycle Implementation ® (PQLI)

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

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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:

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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.

GMP Resources


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.

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For more information, contact RegulatoryAffairs@ispe.org