VAL-090 Equipment Validation Guideline

5.1 Equipment Validation Rationale

The qualification and validation process should establish and provide documentary evidence that:

5.1.1 The equipment and the processes have been designed in accordance with the requirements of GMP.  This normally constitutes Design Qualification or DQ.

5.1.2 The equipment has been built and installed in compliance with their design specifications.  This constitutes Installation Qualification or IQ.

5.1.3 The equipment operated in accordance with the design specifications.  This constitutes Operational Qualification or OQ.

5.1.4 A specific process will consistently produce a product meeting its predetermined specification and quality attributes.  This constitutes Process Validation.  The term Performance Qualification or PQ may also be used.

5.1.5 The extent of the validation should be based on risk assessment, such that critical aspects and other system components or functions are verified to be fit for intended use.  The risk assessment should be based on the impact to product quality and patient safety.  Additional items for consideration include the level of standardization, level of complexity, configuration, customisation, intended use, and vendor quality system assessment where applicable.

5.2 Equipment Validation Requirements

5.2.1 Protocols for each type of qualification will be written as per approved SOP.  (See all types of protocol templates from the site https://www.gmpsop.com).

Depending on the size of the system or item to be validated IQ and OQ may be combined into one protocol and one report.

5.2.1.1 Assessment of vendor quality system, as a component of the risk assessment, shall be considered to determine the extent of validation and potential leveraging of vendor documentation to support the validation effort.  The assessment method chosen shall be based on the criticality of the system, the complexity of the system, and previous experience with the vendor.

5.2.1.2 The validation team will make additions to the vendor documentation as necessary to meet Site Quality Standards. Vendor protocols must be pre approved by the validation committee to meet site requirement as outlines in this document.  A validation report will be issued for vendor protocols.

5.2.1.3 When there is more than one identical piece of equipment, each item has to be qualified, however identical protocols can be used.

5.2.2 Where operating manuals exist for equipment, protocols should reference these manuals.

5.2.3 Validation reports will be written for each protocol.  Protocols written for specific equipment must adequately describe the intended use of the equipment and the products, which are to be manufactured on it.

5.2.4 All test equipment used in the execution of the validation protocols for measuring purposes or assessing a process, equipment or product must be calibrated prior to use.  The calibration records shall be part of the site’s calibration documentation.

5.2.5 An EH&S risk assessment is considered as an essential part of any equipment qualification protocol.

5.2.6 The acceptance criteria for each item will be described and justified in the specific protocols for that item.  Generally the equipment must conform to GMP requirements, OHS standards, applicable country standards and process requirements.

5.2.7 Any deviations encountered during the validation study must be documented in the validation protocol / report and must be approved by Quality Assurance.

5.3 Validation Project Plan

For large scale projects a Validation Project Plan (VPP) should be written. VPPs represent dynamic, project specific master validation plans, often accompanied by several appendices that change as the project progresses.

5.4 Design Qualification

The first element of the validation of the new systems or equipment is Design Qualification (DQ).  The DQ documents that the design of equipment meets applicable regulatory, GMP, process user, EH&S requirements and is suitable for intended use.  The DQ process can be incorporated into the IQ.

5.5 Installation Qualification

5.5.1 Installation Qualification (IQ) provides evidence that the equipment has been installed in accordance with the design specifications, user requirements and manufacturer recommendations.

5.5.2 Furthermore, IQ ensures that a record of the principal features of the equipment or system, as installed, is available and that it is supported by sufficient and adequate documentation to enable satisfactory operation, maintenance and change control to be implemented.

5.5.3 Installation Qualification (IQ) should be performed on new or modified facilities and equipment.  IQ should include an appropriate, but not limited to the following:

5.5.3.1 Installation of equipment, piping, services and instrumentation checked to current engineering drawings and specification;

5.5.3.2 Collection and collation of supplier operating and working instructions and maintenance requirements;

5.5.3.3 Calibration requirements;

5.5.3.4 Verification of materials of construction;

5.5.3.5 Cleaning and passivation results;

5.5.3.6 Pressure testing / weld checks / pipe slope isometrics;

5.5.3.7 Safety requirements;

5.5.3.8 Training.

5.5.4 For complicated or large pieces of equipment a Factory Acceptance Test (FAT) should be performed at the suppliers. The FAT is not a substitute for the IQ however certain tests performed and documented in an approved FAT document may not have to be repeated on installation.

5.6 Operational Qualification

5.6.1 Operational Qualification (OQ) provides documented evidence that the equipment operates as intended throughout the specified design or anticipated operating ranges and complies with GMP, OHS legislation and other relevant standards.

5.6.2 The critical operating parameters for the equipment should be identified at the Operational Qualification stage.  The plans/protocols for the Operational Qualification should identify the studies to be undertaken on the critical variables, the sequence of those studies and the measuring equipment to be used and the acceptance criteria to be met.

5.6.3 Where applicable, simulated product may be used to conduct the Operational Qualification.  Studies on the critical variables should include worst case conditions.

5.6.4 All testing equipment should be identified in the protocol and calibrated before use.

5.6.5 All critical instruments on a item of equipment will be calibrated prior to Operational Qualification.

5.6.6 Where sampling is performed, the specific sampling site be trained under the supervision of the engineer responsible for the equipment.

5.6.7 Commissioning performed following installation is not a substitute for OQ, however if the commissioning is documented the witnessed/reviewed by a Site employee, the results may be used as part of the OQ.

5.6.8 The completion of satisfactory Installation Qualification and Operational Qualification exercises should permit a formal ‘release’ of the equipment/plant for the next stage in the validation exercise.  This release should be documented through completion of the validation exercise.

5.7 Qualification of Existing Equipment

For legacy equipments with critical aspects that are not validated, gaps in qualification activities in the existing documentation shall be identified.  If there are gaps, remediation activities shall be developed and implemented.

5.8 Qualification of Equipment with Computer Systems

Equipment containing Programmable Logic Controllers and or computer systems must also conform to the Site computer system guidelines.  Usually the computer system will be qualified as part of the equipment qualification.  Separate protocol and report are not required.

5.9 Re-Qualification

5.9.1 Modifications to, or relocation of, validated equipment must be authorised through the change control system.  Modification or relocation will require full or partial re- qualification.

5.9.2 Re-qualification is not required if mobile equipment is moved however procedures for operating of this equipment must contain extensive checks on the equipment prior to its operation and operation of any instrumentation must be verified prior to use.

5.10 Maintaining the Validated State

All processes and systems once validated will be maintained in a validated state through the life cycle of the process / system.  Maintaining the validated state will be achieved by the change control system, re-qualification, training, SOPs, calibration and engineering maintenance programmes.