Product Design & Development
AS a leading Validation & Compliance Services Provider across Globe ,GAMP Group is dedicated to help pharmaceutical, biotechnology, medical device & Food to navigate the complex project, compliance ,Validation & regulatory landscape.
Our Detailed Knowledge And Understanding Of USFDA, EU GMP, EUMDR, WHO, PICS, TGA, ISPE And ISO Standards Across Multiple Industries Is The Result Of Our Experience As Production/QA Personnel Or As Auditors Working Within Production And Qc/QA Environments.
Validation
Validation is best described as the process of “establishing documented evidence” which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. Simply put, it is the act, process, or instance to substantiate something on reliable basis.
Our Validation Portfolio includes :
- GMP Facility Documentation & Validation
- GMP Utilities Documentation & Validation
- GMP Equipment - Systems Documentation & Validation
- Computer System Validation
- Data Integrity Policy, Procedure, Training & Implementation
- IT Infrastructure and Cloud Validation
- CQV -Commissioning, Qualification and Greenfield, Brown Field or Upgradation Project Documentation & Validation
- Thermal Validation System with Kaye AVS Systems
- Smoke Study Projects-Protocol to Review & Report
Our Compliance Portfolio includes :
GMP & GDP Services
- Gap Analysis, Review and Remediation for Facility, Equipment, Utilities and Systems as per EUGMP .EUMDR, USFDA, PICS, WHO,TGA or ISO Regulation.
- Risk & Impact Assessment & Risk Management
- Audit Readiness Inspections & Remediation
- QMS Development, Review and Remediation
- QA, Regulatory & Engineering documentation Review
- Smoke Study Review
- CSV & DI Documentation Review & Audit
- DIRA & Data Governance Programs
- Thermal Equipment Cycle Development
- Quality by Design (QbD) systems & approaches
- HACCP Quality Plans
- Operational Excellence & Process Criticality Analysis
- FMEAs, CAPA Investigations, Investigation Training
- Change Control, Assessment of Change Request (ACR),Deviations and Non-Conformance ,Investigation Reports
- CAPA – root cause investigation and implementation of corrective & preventative actions
- Vendor Quality Agreements review
- Customer Complaints Documentation review
- Stability Reports
- Regulatory Documentation & Inspection
- Staff Training Assessment
- Review of CQ & Validation Documents
- Internal & External audits
- Vendor audit & responses
- Audit Reports including different levels (Critical, Major, Minor, or Observation)
- GMP Training
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