Concept of validation
GMP-definition is the validation of "establishing documented evidence that establishes a high degree of certainty that a particular process will consistently a product that provides the previously established specifications and quality attributes are available."
Appropriate and complete documentation is recognized as crucial for the validation. Standard Operating Procedures (SOPs), production formulas, detailed documentation batch changeControl, experimental reporting systems, analytical documents, reports development, validation protocols and reports are an integral part of validation philosophy. The validation of the documentation provides a source of information for the ongoing operation of the plant and is a resource that is used in the subsequent process of development or modification activities.
All test activities will take a level of impact assessment to ensure that systems, services andProducts were determined directly affected by the test.
A revalidation program should be implemented on a permanent equipment on the revalidation requirements and change control.
Types of Validation
Establishing documented evidence that a device / process or system to do what they do, on a pre-planned series of scientific investigations within the meaning of validation sets basedPlan.
Is used when an existing process can be shown to be in a state of control by use of tests on samples taken at strategic points in a process, and at the end of the process. All data are collected simultaneously with the implementation of the process, to demonstrate sufficient information to process reproducibility.
Establishing documented evidence that a process does notwhat it purports to do, based on review and analysis of historical data.
Design Qualification (DQ)
The intent of the DQ is in the planning and commissioning process met with a number of mechanisms, including:
- Generation of User Requirement Specifications
- Verification of this type corresponding user requirement specifications.
- Supplier Evaluation / Audit
- Check the Challenge of the design by GMP audits
- Product Quality ImpactAssessment
- Specifying Validation documentation requirements of suppliers
- Agreements with the suppliers about the performance targets
- Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and commissioning procedures
- Definition of construction and installation documentation) to assist with Installation Qualification (IQ.
Installation Qualification (IQ)
IQ is a proof that the equipment or system has been documented in developeddelivered and installed in accordance with design drawings, vendor recommendations and in-house requirements. Moreover, IQ, that a record of the main features of the equipment or system is installed, how available and ensure that they are supported by sufficient and appropriate documentation to implement satisfactory operation, maintenance and control of changes.
Operational Qualification (OQ)
OQ is documented proof that operates the facilityas provided in the above design, operation or approved acceptance range of equipment, as applicable. In cases where process steps are considered an appropriate placebo batch is used to demonstrate device functionality.
All new devices should be fully taken into service before the start of OQ to ensure that at least be sure to use the device, complete with all mechanical assembly and pre-qualification checks are that the device is fully functional and thatDocumentation is complete.
Performance Qualification (PQ)
The goal of PQ is documented proof that the equipment can always be achieved while producing the specifications for a longer period at a defined operating point, a product of the specified quality. The specification will make reference to process parameters, in-process and product specifications. PQ requires three product batches available for all acceptanceCriteria for in-process and product testing. For supply PQ requires the benefits of medium to fulfill all the data over a longer period of sampling.
The PQ documentation should be on standard manufacturing procedures and batch records and describe the methodology of sampling and testing to be.
What is Validated
All process steps, production equipment, systems and environment, directly relevant to the production ofsterile and non-sterile products must be formally confirmed.
All major packaging equipment and processes should be validated. This validation is less comprehensive.
All ancillary systems, which should have no direct effect on product quality to be qualified by a technical documentation on the extent of the system and how it works.
- Manufacturing Area Design.
- Personnel and material flow, etc.
Process Equipment andDesign
Process steps and equipment description. Ie dosing, formulation, packaging, washing equipment
and cleaning. etc
Utility Systems Design
Raw / steam cleaned, purified water, compressed air, air conditioning, vacuum, power, lighting, cooling water, wastewater, etc.
Computerized Systems Design
Information system, automated laboratory equipment, automated manufacturing equipment, electronic recordsetc
Cleaning validation (CV)
CV provides evidence documenting that a cleaning procedure for the reduction of effective pre-defined maximum allowable limits, all chemical and microbiological contamination by one piece of equipment or a production area for processing. The means for evaluating the effectiveness of cleaning includes cleaning and disinfecting surfaces, sampling and inspection of product residues, cleaning residues and bacteriaContamination.
The term CV is used to describe the analytical investigation of a cleaning or by bicycle. The validation protocol should be based on background documentation on the reasons for the "worst case" test, where it is proposed. It should also develop the criteria for acceptance, including chemical and microbiological specifications, limits of detection and the selection of sampling.
Method Validation (MV)
MVprovides documented evidence that the internally-developed test methods are accurate, robust, efficient, reproducible and repeatable. The validation protocol should be based on background documentation on the reasons for determining the method detection limit and sensitivity.
Computer Validation is a proof to ensure systems are consistently documented in accordance with the predetermined specifications and quality functionAttributes throughout their lifecycle. Important aspects of this approach are) the validation of formal management design (through a specification process), system quality (through systematic review and testing, risk (through the identification and evaluation of new and critical functions) and lifecycle (through sustainable change Control).
If the equipment in embedded computer systems, the elements of the validation of computer controlled, can be carried out as part of the equipment IQ and OQProtocols.