GMP certification of pharmaceutical lyophilizer
GMP certification of pharmaceutical vacuum freeze dryer generally includes the following parts
1. Confirm user requirements / technical parameters
Define the detailed and measurable requirements / technical parameters that users expect to achieve for the lyophilizer.
All requirements / technical parameters will be used to determine the design standard of freeze dryer.
The stage of requirement or technical parameter definition is mainly to provide user requirement description.
The user's requirements or technical parameters shall be formulated by the user and supplier's experts to specify the requirements and performance indexes of the freeze dryer.
2. Confirm project plan
QPP is the project plan for quality assurance of the customer's freeze dryer, and describes the important confirmation plan at each stage.
The confirmation document must ensure that the freeze-drying machine is consistent with the terms in the contract, and also meet the requirements of customers and GMP.
In this plan, the confirmation documents provided in each stage of the life cycle of the project are listed to ensure the quality assurance in each stage.
3. Quality plan
The quality plan is based on the standard of scheme management in ISO9001 quality assurance system.
The purpose of the program is to achieve good communication, timely delivery and quality assurance
4. Design specification
The purpose of this document is to describe the technical specifications of the freeze dryer designed for the customer.
This design specification is carried out according to the urs or technical parameters and GMP of customers, and is used to guide engineers to define and design mechanical characteristics, process definition, work management, control system and human-machine interface.
5. Design validation
DQ confirmed that the design of the freeze-drying equipment fully meets the GMP standards of the pharmaceutical industry and the user's requirements or technical parameters.
Document that the design of the lyophilizer is suitable for a certain purpose
The document provides the following information: mechanical characteristics, process description, data management, control system and human-machine interface definition
6. Installation confirmation
The IQ inspection has the function of ensuring the complete installation, which fully conforms to the design specifications
The document confirms that the lyophilizer is installed according to the approved data specification
7. Operation confirmation
The operation of OQ confirmation and recording system meets the manufacturer's specifications and customer requirements. This operation check will confirm the operation of the lyophilizer system.
Confirm in writing that the lyophilizer operates within the specified range according to the approved data and specifications
8. Challenging test
"Challenging test" - the test behavior of identifying the capability limit of a certain element in the manufacturing process.
Capacity limit does not mean that the test must be carried out until the elements are destroyed, but refers to some limits of variables.
Within the standard operating procedures, a condition or a series of conditions surrounding the operating limits (limits) and environment above or below the performance of the equipment, and in comparison with the ideal conditions, assume the maximum possible situation that will lead to the failure of production or operation.
There is no need to cause the failure of production or operation. Sometimes called the worst case of operation.
An example of challenging test of freeze dryer.
For the condenser, the required limit temperature is ≤ - 75 ℃, so we carry out a series of tests at the limit temperature of - 75 ℃, which can be called challenging tests.
9. Performance validation
Simulate the production and confirm that the equipment meets the process requirements in the production process
● PQ will perform and verify that the freeze-drying process of the lyophilizer is effective and repeatable.
It is proved that the freeze-drying performance of the freeze-drying machine can meet the requirements of the successful operation of the customer when it is loaded with water.
● PQ documents
10. Factory acceptance test (fat)
Factory acceptance test is the factory test of the equipment in the presence of customers before delivery. The purpose of the test is to ensure that the equipment has been assembled and debugged in strict accordance with the contract requirements and subsequent modifications. After factory acceptance test, the indicators meet the customer acceptance requirements, and the equipment can be delivered.
11. Customer site acceptance test (SAT)
The customer site acceptance test is a test made by the customer. The purpose of this test is to ensure that the equipment has been assembled and debugged in strict accordance with the requirements of the contract and amendments. After the customer acceptance test, the indicators meet the customer requirements, the equipment can be delivered for operation.
12. Other equipment documents
Operation manual
Maintenance manual
Main parts list
List of spare parts
Operation instruction
The user manual is to guide the specific operation of the freeze dryer.
The operation software of the lyophilizer is described in detail. The user can operate the lyophilizer step by step according to the manual.
Maintenance manual
The purpose of technical maintenance plan is to guide all parts in the equipment that need to be maintained.
The maintenance plan is composed of a series of adjustments and actions, some of which need to be done every day and some only need to be done every two years. And every time you need to make records, which is very useful for future maintenance operations.
Main parts list
List the PID reference code, name, model and brand of the main parts of the freeze dryer.
The main function of this document is that customers can consult the parameters of the main components in the PID diagram, provide the main reference for customers to maintain and replace the components, and help customers understand the overall structure of the freeze-drying machine.
Spare parts list
According to the list of spare parts approved by customers, list the name, model, brand and quantity of spare parts provided to customers in detail.
The purpose of this document is to provide reference for customers to accept spare parts, and to provide preparation for future maintenance of freeze dryer.
13. SOP - standard operating procedure
Production quality management in the process of manufacturing freeze dryer
The basis for guiding operators to make products correctly
It is necessary to ensure the accuracy and reliability of the test results
It is the basis for guiding inspectors to conduct correct inspection
14. SOP for manufacturing and inspection of freeze dryer
SOP for box manufacturing and inspection
SOP for condenser manufacturing and inspection
SOP for plate manufacturing and inspection
SOP for pipeline manufacturing and inspection
Coil manufacturing and inspection SOP
SOP for door manufacturing and inspection
SOP for frame manufacturing and inspection
SOP for manufacturing and inspection of refrigeration system
SOP for manufacturing and inspection of vacuum system
SOP for manufacturing and inspection of circulation system
SOP for manufacturing and inspection of hydraulic system
SOP for pneumatic manufacturing and inspection
SOP for manufacturing and inspection of electrical system
