Confirmation: A series of activities to demonstrate that a plant, facility, or piece of equipment operates correctly and achieves a desired result.
Verification: a series of activities to demonstrate that any operating procedure (or method), production process or system can achieve the desired results.
Verification and validation are essentially the same concept, validation is usually used for plant, facilities, equipment, test instruments, while verification is used for production processes, operating procedures, test methods or systems.
Confirmation of plant, facilities and equipment includes design confirmation, installation confirmation, operation confirmation and performance confirmation, in this sense, confirmation is part of verification.
●Confirmation and validation are important parts of GMP.
●Enterprises should establish and maintain a validation master plan, clarify validation responsibilities, and define technical requirements to ensure consistency and reasonableness of validation methods.
●Enterprises should select systematic and reasonable confirmation and validation methods based on the process requirements, complexity, technical realizability and other factors of drug production to confirm and validate the implementation of facilities, equipment, processes, cleaning and sterilization methods, inspection methods, computerized systems, and to maintain documentation related to validation documents.
● Define processes and equipment through product system review, production process control, change control, and in validation management to maintain a continuous validation status.
Interpretation:
1) New concepts introduced by the new version of GMP: validation, validation status maintenance, validation master plan, etc.
2) Validation cycle: validation has been added to the new version of GMP.
3) The scope of validation and verification through risk assessment has been introduced. Validation should determine through risk analysis which steps and
specific operations are critical quality attributes that determine the product. The validation process should pay attention to these critical steps and operations and identify critical parameters through further
analysis.
4) Clearly propose to carry out process validation, cleaning validation (including cleaning methods)
●Propose the purpose of validation, clarify the principle of determining the scope and extent of validation, and put forward the concept of validation of state maintenance.
●In accordance with the division of the validation life cycle, it is stipulated that the content of validation includes five stages, including design confirmation, installation confirmation, operation confirmation, performance confirmation, and process validation.
●The timing of verification is stipulated in principle.
●The control of validation results is stipulated
1) The new version of GMP requires that the scope and extent of confirmation and validation be determined by risk assessment.
2) The scope of verification and validation has been expanded: from the 98th edition of GMP, which stipulates that "the production process and key facilities and equipment of the product", to "the enterprise's plant, facilities, equipment and testing instruments should be validated, and validated production processes, operating procedures and testing methods should be adopted for production, operation and testing. test methods for production, operation and inspection".
3) The new version of GMP puts forward the concept of validation status maintenance.
4) Validation should include plant facilities, air purification systems, process water systems, production processes and their changes, equipment cleaning, changes in the main raw and auxiliary materials. Validation of key equipment and sterile drugs should include sterilization equipment, drug filtration and filling (dispensing) system. Analytical methods and their testing equipment and instruments.
Confirmation and validation of the clear purpose: the enterprise in order to prove that the key elements of the operation can be effectively controlled.
Related operations: refers to the plant, facilities, equipment, testing instruments and systems, production processes, operating procedures, testing methods or systems that may affect product quality.
2, confirmation and verification of the scope: plant, facilities, equipment or process may directly or indirectly affect the quality of the product and its important changes in all factors should be confirmed and verified.
3, confirmation and verification of the scope and extent of the determination:
Confirmation or verification of the scope and extent should be determined after a risk assessment.
Example: (1) List the quality risks of injectables:
a. Microbial contamination
b. Contamination by pyrogens
c. Insoluble particles
d. Purity of raw materials
e. Other risks: safety (irritation of tissues, toxic reactions
reaction), osmolality, PH.
(2) Perform risk assessment
1. Deep understanding of the manufacturing process;
2. Identify, evaluate the quality factors such as sterility, pyrogen, particulates, etc., and the degree of their influence at each process step;
3. Adopt effective means of control in the process to address the quality risks of the injectable;
4. Validate the validity of these means.
(3) determine the scope and extent of validation
Example: the validation of aseptic lyophilized powder injection process:
From the beginning of the liquid dispensing to the end of the rolled cap, the scope of validation includes:
Liquid dispensing process, filtration process, liquid storage process, washing process, filling process, lyophilized process, rolled cap process, sterilized process, aseptic process.
General equipment need to design confirmation, installation confirmation, commissioning confirmation, test run confirmation, etc., and then verify its performance
I don't know if there is any help, *** with the discussion ha.