Consulting

Consultants for Good Manufacturing Practices (GMP)

Our GMP consultants support clients in fully complying with good manufacturing practice (GMP) rules and setting up the necessary guidelines to meet the industry standards.

We deliver a skilled GMP consultations which help plasmapheresis centers with quality assurance and compliance.

Our services include:

Needs/requirement analysis and GMP consulting

Documentation: SOPs review, Validation Reports, Manuals

Audits and audit coordination’s

Assistance with inspections performed by competent authorities

Planning and carrying inspections

Delivery of quality management systems

Support in efficiently taking corrective and preventive actions (CAPA)

SOP’s Delivery

We have already performed Standard Operating Procedure (SOP’s) delivery for numerous plasmapheresis centers to ensure their process compliance with several of major fractionators.

Our standard delivery includes:

Customization and consulting to match the specific country and center setup needs

SOP’s custom country set, or SOP’s default EU set