Services purpose:
Foshan RuiTong Consulting Co.,Ltd. provides specialized technical and regulatory services during new/expanding establishment or improved establishment of drug plants according to the basic requirements and flow chart of 3C managements (Construction, Commissioning, Compliance), ensures that drug plant could finish the relevant projects with high efficiencies and high quality as planned, and also avoids that drug plant maybe goes in trouble and delay the project.
Services contents:
■ Project Management
▷ According to services contents, a reasonable project schedule will be prepared, and a reasonable project team will be oppointed together with customer.
▷ Establish basic responsibilities of the whole project team and communication methods （e.g.: project meeting each two weeks).
▷ Based on project schedule, follow up project progress, execute project meetings, support to solve project problems.
■ Support to establish the documentation system
▷ During preliminary stage of project, basic documents will be prepared to ensure that the document format and basic quality tools could be applied through the project, and avoid documents and quality management forms with different format.
▷ During the middle and later stage of project, we will support our customer to review their existing documents or provide some templates, finally the complete GMP documentation which complies with GMP requirements and customer’s actual manufacturing process, will be prepared.
■ Qualification and Validation
▷ Preparation of qualification and validation management procedures
◆ Prepare management and execution procedures related to qualification and validation.
◆ Prepare product and process URS and organize to do the process risk assessment.
◆ Implement system impact assessment based on product process flow chart and equipment list and prepare Validation Master Plan (VMP) based on the assessment results.
▷ Preparing URS of equipment and facilities and vendors selection
◆ Support to prepare URSs of equipment and facilities, execute risk assessments for critical equipment and facilities, measures for reducing risk will be defined in the URSs.
◆ Review and support to select qualified vendors.
▷ Design Qualification(DQ)
◆ Support to prepare DQ protocol.
◆ Review technical documents and drawings from suppliers and execute DQ.
◆ Support to prepare DQ reports
▷ Guide to prepare Factory acceptance tests (FAT) protocols and Site acceptance tests (SAT) protocols for critical equipment and facilities. If necessary, participate in executing the FAT and SAT, and review FAT and SAT reports.
▷ Installation Qualification(IQ), Operational Qualification(OQ) and Performance Qualification(PQ)
◆ Guide to prepare Installation qualification (IQ), Operational qualification (OQ), Performance qualification (PQ) protocols.
◆ On-site guidance and supervision on execution of IQ, OQ, and PQ.
◆ Review reports of IQ, OQ, PQ
◆ Participate in investigation of any deviation happened during IQ, OQ, PQ.
▷ Methods Validation
◆ Guide to prepare process and methods validation protocols (e.g.: analytical methods validation, process validation, cleaning validation)
◆ Guide to execute risk assessments for relevant process and methods validation
◆ Guide to execute process and methods validation
◆ Review process and methods validation reports.
■ Training
Provide specialized training and practices and discussion based on training contents and critical technical and regulatory knowledge required by customer.