GMP Process Validation

Validation is the documented act of demonstrating that any procedure, process, and activity will consistently lead to the expected results. Its Includes testing methods, cleaning and transportation validation as well as the qualification of IT Systems, utilities and equipment.

GMP PROCESS VALIDATION

GMP Process Validation is then a the 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: Process Knowledge and Design

The commercial process is defined during this stage based on knowledge gained through process development activities:

  • Risk Assessment
  • Design of Experiment
  • Control Strategy
  • Quality Target Product Profile
  • Process Description

Stage 2: Process Qualification

The process design is confirmed as being capable of reproducible commercial manufacturing. Including qualification of the facility, utilities and equipment:

  • Facility, Utilities, Systems and equipment, qualification
  • Process risk assessment
  • Process Performance Qualification

Stage 3: Continued Process Verification

The main objective of process continued verification is the process remain in a validated state during commercial manufactur:

  • 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 help you achieve validation, utilities and systems compliance with GMP. Contact us today!


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