Contract Acceptor definition
Examples of Contract Acceptor in a sentence
X D8 If the Contract Acceptor are audited by a regulatory body or competent authority and any issues arise relating to Service provided by The Contract Acceptor, The Contract Acceptor will inform Save the Children International within 5 working days and if reasonably requested will provide Save the Children International with a copy of that inspection report and any review undertaken by it.
X D12 The Contract Acceptor has an annual internal audit schedule which is based on their own risk assessments as agreed by their senior management.
X G2 The overall responsibility for carrying out route risk assessment will by Save the Children International, however it is expected that the Contract Acceptor will input into this process by making available their own route risk assessments to Save the Children International.
X D1 A designated individual within the Contract Acceptor organisation is identified and responsible for and oversees compliance arrangements in respect of quality management X D2 All changes that have GDP impact will be handled by a change control process.
X D6 The Contract Acceptor will provide Save the Children International with a written response to the observations within 30 calendar days after receipt of the written report from Save the Children International.
The Contract Acceptor operate and maintain a quality management system which shall demonstrate active participation of the management and individuals of the different Services involved and must cover all documentation generated during the transportation, transport conditions and engagement of sub-contractors.
Written procedures will be available from The Contract Acceptor upon reasonable request by Save the Children International.
The Contract Acceptor will, as far as is reasonable, rectify any agreed deficiencies noted as observations during the inspection by Save the Children International and to the extent that any remedial action requires investment.
X D13 The Contract Acceptor are responsible for ensuring that any sub-contractors are comprehensively assessed for their suitability for purpose and meet requirements of Save the Children International.
BDU Biotherapeutics Development Unit CA Contract Acceptor CG Contract Giver GMP Good Manufacturing Practice EU European Union EU GMP European Union current Good Manufacturing Practice as defined in directive 2003/94/EC IMP Investigational Medicinal Product = drug product (unless otherwise stated IMP means manufactured to EU cGMP or its equivalent) MCB [***] QP Qualified Person Retention A sample of a packaged unit from a batch of finished sample product for each packaging run/trial period.