Concept of Validation
According to Gmp definition Validation is "Establishing documented evidence which provides a high degree of assurance that a specific process will consistently yield a goods meeting its pre-determined specifications and potential attributes."
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Appropriate and unblemished documentation is recognized as being crucial to the validation effort. Accepted Operating Procedures (Sops), manufacturing formulae, detailed batch documentation, turn operate systems, investigational reporting systems, analytical documentation, improvement reports, validation protocols and reports are integral components of the validation philosophy. The validation documentation provides a source of data for the ongoing operation of the premise and is a reserved supply that is used in subsequent process improvement or modification activities.
All validation activities will couple a level of Impact appraisal to ensure that systems, services and products directly influenced by the testing have been identified.
A revalidation program should be implemented based on habit equipment revalidation requirements and on the turn operate Policy.
Types of Validation
Prospective validation
Establishing documented evidence that a piece of equipment/process or law will do what it purports to do, based upon a pre-planned series of scientific tests as defined in the Validation Plan.
Concurrent validation
Is employed when an existing process can be shown to be in a state of operate by applying tests on samples at strategic points throughout a process; and at the end of the process. All data is collected concurrently with the implementation of the process until adequate data is ready to demonstrate process reproducibility.
Retrospective validation
Establishing documented evidence that a process does what it purports to do, based on spin and diagnosis of historical data.
Design Qualification (Dq)
The intent of the Dq is met while the establish and commissioning process by a whole of mechanisms, which include:
- Generation of User Requirement Specifications
- Verification that establish meets relevant user requirement specifications.
- victualer appraisal /Audits
- Challenge of the establish by Gmp spin audits
- goods potential Impact Assessment
- Specifying Validation documentation requirements from equipment suppliers
- bargain with suppliers on the operation objectives
- premise Acceptance Testing (Fat), Site Acceptance Testing (Sat) & commissioning procedures
- Defining construction and premise documentation to help with premise Qualification (Iq).
Installation Qualification (Iq)
Iq provides documented evidence that the equipment or law has been developed, supplied and installed in accordance with establish drawings, the supplier's recommendations and In-house requirements. Furthermore, Iq ensures that a record of the significant features of the equipment or system, as installed, is ready and that it is supported by adequate adequate documentation to enable satisfactory operation, maintenance and turn operate to be implemented.
Operational Qualification (Oq)
Oq provides documented evidence that the equipment operates as intended throughout the specified design, operational or beloved acceptance range of the equipment, as applicable. In cases where process steps are tested, a suitable placebo batch will be used to demonstrate equipment functionality.
All new equipment should be fully commissioned prior to commencing Oq to ensure that as a minimum the equipment is safe to operate, all mechanical assembly and pre-qualification checks have been completed, that the equipment is fully functional and that documentation is complete.
Performance Qualification (Pq)
The purpose of Pq is to provide documented evidence that the equipment can consistently perform and utter its operation specifications over a continued operating duration at a defined operating point to yield a goods of pre-determined quality. The operation specification will reference process parameters, in-process and goods specifications. Pq requires three goods batches to meet all acceptance criteria for in-process and goods testing. For utility systems, Pq requires the utility medium to meet all specifications over a continued sampling period.
The Pq documentation should reference Accepted manufacturing procedures and batch records and spin the methodology of sampling and testing to be used.
What Gets Validated
General
All process steps, production equipment, systems and environment, directly used for the establish of sterile and non sterile products must be formally validated.
All major packaging equipment and processes should be validated. This validation is less comprehensive.
All ancillary systems that do not directly impact on goods potential should be qualified by means of a technical documentation of the extent of the law and how it operates.
Facility
- Manufacturing Area Design.
- Personnel and material flow etc.
Process and equipment Design
Process steps and equipment description. I.e. Dispensing, Formulating, Packaging, equipment washing
and cleaning. Etc
Utility Systems Design
Raw/purified steam, Purified water, Compressed Air, Air conditioning system, Vacuum, Power supply, Lighting, Cooling water, Waste etc
Computerized Systems Design
Information system, Laboratory self-acting equipments, Manufacturing self-acting equipments, Electronic records etc
Cleaning Validation (Cv)
Cv provides documented evidence that a cleaning policy is effective in reducing to pre-defined maximum allowable limits, all chemical and microbiological contamination from an item of equipment or a manufacturing area following processing. The means of evaluating the effectiveness of cleaning involves sampling cleaned and sanitized surfaces and verifying the level of goods residues, cleaning residues and bacterial contamination.
The term Cv is to be used to spin the analytical investigation of a cleaning policy or cycle. The validation protocols should reference background documentation relating to the rationale for "worst case" testing, where this is proposed. It should also explain the improvement of the acceptance criteria, including chemical and microbial specifications, limits of detection and the choice of sampling methods.
Method Validation (Mv)
Mv provides documented evidence that internally developed test methods are accurate, robust, effective, reproducible and repeatable. The validation protocols should reference background documentation relating to the rationale for the estimation of limits of detection and formula sensitivity.
Computer Validation
Computer Validation provides documented evidence to assure systems will consistently function according to their pre-determined specifications and potential attributes, throughout their lifecycle. Leading aspects of this validation advent are the formal supervision of establish (through a specification process); system-quality (through systematic spin and testing); risk (through identification and appraisal of novelty and significant functionality) and lifecycle (through sustained turn control).
Where equipment is controlled by embedded computer systems, elements of computer validation may be performed as part of the equipment Iq and Oq protocols.
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