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GMP Process Validation is then a documented evidence that the process, oper\u00adated within established parameters, can perform effectively and reproducibly to produce an inter\u00admediate, drug substance or drug product meeting its predeter\u00admined specifications and quality attributes.<\/p>\n\n\n\n
STAGE 1: GMP PROCESS KNOWLEDGE AND DESIGN<\/h3>\n\n\n\n
The commercial process is defined during this stage based on knowledge gained through process development activities. Key deliverables are:<\/p>\n\n\n\n
- \n
- Risk Assessment<\/li>\n\n\n\n
- Design of Experiment<\/li>\n\n\n\n
- Control Strategy<\/li>\n\n\n\n
- Quality Target Product Profile<\/li>\n\n\n\n
- Process Description<\/li>\n<\/ul>\n<\/div>\n\n\n\n\n
STAGE 2: GMP PROCESS QUALIFICATION<\/h3>\n\n\n\n
The process design is confirmed as being capable of reproducible commercial manufacturing, including qualification of the facility, utilities and equipment. Key deliverables are:<\/p>\n\n\n\n
- \n
- Facility, Utilities, Systems and equipment, qualification<\/li>\n\n\n\n
- Process Knowledge & risk assessment<\/li>\n\n\n\n
- Process Performance Qualification<\/li>\n<\/ul>\n<\/div>\n\n\n\n\n
STAGE 3: GMP CONTINUED PROCESS VERIFICATION<\/h3>\n\n\n\n
The main objective of process continued verification is to ensure that the process remains in a validated state during commercial manufacturing. Key deliverables are:<\/p>\n\n\n\n
- \n
- Process Knowledge Documentation<\/li>\n\n\n\n
- Risk Assessment<\/li>\n\n\n\n
- Process Control Plan<\/li>\n\n\n\n
- Continued Process Verification Plan<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
MIVADO GP offers all the necessary support for a complete c<\/strong>ompliance of your facility , processes and products with respect to regulations (GHTF, PIC\u2019S, WHO, TPD, FDA and EMEA). Our experienced team of consultants assist you by completing projects in the following:<\/p>\n\n\n\n
\n\n- \n
- Pharmacovigilance and Clinical Platform<\/li>\n\n\n\n
- Medical devices<\/li>\n<\/ul>\n<\/div>\n\n\n\n\n
- \n
- In-vitro Diagnosis<\/li>\n\n\n\n
- Regulatory Affairs<\/li>\n\n\n\n
- Quality System<\/li>\n<\/ul>\n<\/div>\n\n\n\n\n
- \n
- Utilities and Plants<\/li>\n\n\n\n
- Foods Supplements<\/li>\n\n\n\n
- Cannabis Industries<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
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.<\/p>\n\n\n\n
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