Validation is the documented act of demonstrating that any procedure, process, and activity will consistently lead to the expected results. It Includes testing methods, cleaning and transportation validation as well as the qualification of IT Systems, Utilities and Equipment.
GMP Process Validation is then a documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an intermediate, drug substance or drug product meeting its predetermined specifications and quality attributes.
STAGE 1: GMP PROCESS KNOWLEDGE AND DESIGN
The commercial process is defined during this stage based on knowledge gained through process development activities. Key deliverables are:
- Risk Assessment
- Design of Experiment
- Control Strategy
- Quality Target Product Profile
- Process Description
STAGE 2: GMP PROCESS QUALIFICATION
The process design is confirmed as being capable of reproducible commercial manufacturing, including qualification of the facility, utilities and equipment. Key deliverables are:
- Facility, Utilities, Systems and equipment, qualification
- Process Knowledge & risk assessment
- Process Performance Qualification
STAGE 3: GMP CONTINUED PROCESS VERIFICATION
The main objective of process continued verification is to ensure that the process remains in a validated state during commercial manufacturing. Key deliverables are:
- Process Knowledge Documentation
- Risk Assessment
- Process Control Plan
- Continued Process Verification Plan
MIVADO GP offers all the necessary support for a complete compliance of your facility , processes and products with respect to regulations (GHTF, PIC’S, WHO, TPD, FDA and EMEA). Our experienced team of consultants assist you by completing projects in the following:
- Pharmacovigilance and Clinical Platform
- Medical devices
- In-vitro Diagnosis
- Regulatory Affairs
- Quality System
- Utilities and Plants
- Foods Supplements
- Cannabis Industries
MIVADO GP provides support during the project design and development phases. We provide all necessary support and help to achieve validation, utilities and systems compliance with GMP.
