Validation consultancy
Satisfying regulatory bodies (e.g. EMA, FDA, NMPA, etc) is a key requirement for the Life Science
Companies. Complying with various GXP (GCP, GDP, GLP, GMP as appropriate) and creating the
necessary validation documentation and hosting audits is a major challenge.
PharmaBioSolutions consultants with their extensive validation expertise provide cost effective assistance to meet your regulatory compliance and validation requirements. Validation of Automation system following GAMP is a key strength of the PharmaBioSolutions engineers.
Including:
• Assistance for preparation of validation documentation for new plants for regulatory bodies: FDA, EMA, NMPA, etc
• Validation audits for existing plants (Retrospective validation) for GMP & GLP
Our consultants can assist you in the followings:
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- Handover procedures
- Change Control Procedures
- Maintenance Procedures
- Standard Operating Procedures
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- Validation Reports
- Protocols (DQ, IQ, OQ, PQ)
- Test Protocols (FAT, SAT)
- Functional Requirement
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- Vendor audit guides
- Risk Assessment
- User Requirement Specification
- Validation Master plan
Assistance in execution and Implementation
• Vendor Audits
• Review of Vendor documents
• Execution of Test Plans
• Vendor FAT and SAT
• Execution of DQ, IQ, OQ, PQ
Assistance in maintaining compliance during operation
• Incidence management support
• Assistance in CAPA (Corrective and preventive Action)
• Periodic Review and Internal Audit Support
Validation of Automation Systems
• Life Cycle support according to GAMP
• Vendor audit
• Preparation of Validation master plan
• Assistance in creation of URS
• Review of supplier documents (Quality Plan, FDS, SDS, SMS,etc)
• Assistance for DQ and Code Review
• Support for FAT and SAT, IQ, and OQ
• Assistance in creation of validation report
Automation validation is a speciality of PharmaBioSolutions consultants. A number of the consultants are active members of GAMP forum. They have provided assistance in preparing validation documents following GAMP5. Evaluation of 21CFR Part 11 for Electronics Records and Electronic Signatures has been carried out for a number of clients around the world. Review and approval of validation documents and protocols supplied by equipment vendors is an important part of validation activities. It is important the documents & protocols are written following the relevant standards and guidelines and include sufficient detail. PharmaBio solutions consultants are available to review the documents and protocols on behalf of the clients and challenge their contents. PharmaBioSolutions consultants can provide valuable assistance during the protocol execution which includes supervision, and review of the results and generation of report. Having passed the inspection, maintenance of validated state is a key requirement. PharmaBioSolutions consultant with their extensive experience are available to provide support including:
• Periodic Reviews
• Internal Audits
• Incident Management
• Assistance in CAPA (Corrective And Preventive Action)
