Thursday, 11 July 2019

Qualification in pharma

Qualification in pharma
Purpose
To lay down the procedure to prepare, review, approve and execution of equipment/ instrument/utility qualification protocol and report.
Responsibility
Head/Designee of concern department Preparation of URS for the respective equipment/Instrument/utility.
Preparation of FAT and SAT documents (protocols and reports).
To execute the FAT activity for the respective equipment/instrument/utility at vendor site.
To execute the SAT activity for the respective equipment/instrument/utility at manufacturing site.
Preparation of Operational Qualification protocol and report of respective equipment / instrument / utility in coordination with QA and engineering department.
Review of URS, DQ, FAT, SAT, IQ, OQ, PQ and RQ documents (protocol and report).
Head/Designee-ENG: Assistance in qualification of equipment/instrument/ utility.
Preparation of design specification sheet and installation qualification protocol and report of respective equipment / instrument / utility in coordination with vendor and concern departments.
To execute the FAT activity for the respective equipment/instrument/utility at vendor site with concern department.
To execute the SAT activity with concern department at manufacturing site.
Review of URS, DQ, FAT, SAT, IQ, OQ, PQ and RQ documents.
To provide necessary support and utility to execute qualification activity.
Executive/Designee- QA: Preparation of Performance qualification protocol and report of respective equipment / instrument / utility in coordination with concern departments.
To execute the FAT activity for the respective equipment/instrument/utility at vendor site with concern department.
To execute all qualification activity for the respective equipment/instrument/utility at manufacturing site with concern department.
Review of URS, DQ, FAT, SAT, IQ, OQ, PQ, RQ Protocols and reports of respective equipment/instrument/ utility.
Preparation of qualification schedule of equipment/ instrument/utility.
Head/Designee- EHS: Review of URS and other documents wherever applicable.
Head/Designee- QAD: Review and approval of URS, DQ, FAT, SAT, IQ, OQ, PQ, RQ Protocols and reports of respective equipment/instrument/utility.
Procedure:
Definition
Qualification: Qualification is the act of planning, executing and recording of tests on equipment and instrument, which form part of the validated process, to demonstrate that it works correctly and leads to the expected results.
User Requirement Specification (URS): A requirement specification that describes what the equipment or system is supposed to do, thus containing at least a set of criteria or conditions that have to be met. URS comprises a broad set of requirements or “wish list” that could be met in order to satisfy equipment or a utility need.
Design Qualification (DQ): The initial phase of qualification in which specifications and requirements are developed and established. Design qualification is documented evidence that the proposed design of the equipment and instrument are suitable for intended purpose. The compliance of the design with various standards like cGMP, safety, etc., shall be demonstrated and documented.
Factory Acceptance Test (FAT): Pre-delivery equipment testing designed to establish confidence that the equipment and ancillary systems will meet functional requirements, and is capable of consistent operation. FAT is performed at the supplier site, and the results are used to release the equipment for shipment.
Installation Qualification (IQ): Installation qualification is a documented verification that the equipment and instrument as installed or modified, comply with the approved design and manufacturer’s recommendation. Documented verification that determines whether all necessary equipment components were delivered and correctly connected, and installed in an environment suitable for required operation based on the manufacturer’s requirements (e.g., voltage, frequency, temperature, humidity, space, etc.)
Operational Qualification (OQ): Operational qualification is a functional testing to ensure that each component of a system perform as intended within the representative/ anticipated operating range according to functional specification. Documented verification which determines that equipment performs as expected throughout its entire operating range.
Performance Qualification (PQ): Performance qualification confirms that the system is capable and performing/ controlling activities of the process as intended according to URS in a reproducible manner while working in specified operating environment.
Re-qualification (RQ): Equipment, utilities and instrument should be evaluated at an appropriate frequency to confirm that they remain in a state of control.
Preventative Maintenance: A maintenance system designed to detect and prevent problems before they occur.
Qualification protocol: A written procedure that states how qualification testing will be conducted, including test parameters and acceptance criteria.
Qualification Approach:
The SOP is applicable to qualify the following:
Major manufacturing process equipment.
Analytical equipment/instrument.
Major supporting utilities.
Qualification shall normally be done in following stages/phases (but not limited to):
URS
Design Qualification (DQ).
Factory Acceptance Test (FAT).
Site acceptance Test (SAT).
Installation Qualification (IQ).
Operational Qualification (OQ).
Performance Qualification (PQ).
Re-qualification (RQ)/Re-validation, as applicable.
User Requirement Specification (URS): User requirement specification comprises a broad set of requirements or “wish list” that could be met in order to satisfy equipment or a utility need.
URS includes the following wherever applicable, but not limited to,
Desired operational requirement
Process controls
Technical specification of major components
Instrument and controls.
Safety features
MOC
Documents requirements.
URS shall be prepared. Content of URS shall be as per format but not limited to and can be added or updated as per requirement.
After the approval of the URS the engineering department shall prepare design specification sheet for respective equipment or instrument.
Engineering department shall ensure safety requirements during procurement and during qualification of the equipment.
Identification and selection of suppliers/ manufacturer/ vendor of the equipment/instruments by engineering or purchase department.
Purchase Indent shall be raised by user department which shall be approved by Head-concern department followed by Head/Designee-QAD.
Purchase order shall be prepared by purchase department.
After approval of Purchase order, a change control system is in place to ensure that any proposed change is reviewed, before implementation to assess their impact on validated systems.
Design Qualification:
The “next element is DQ” which serve to ensure the compliance of the design with GMP and should be “demonstrated and documented”. It also states the “requirements of the URS should also be verified during the design qualification”.
Equipment especially if incorporating novel or complex technology, may be evaluated, if applicable, at vendor site prior to delivery.
Design qualification shall be prepared by the engineering department on the basis of vendor / supplier documents and recommendation for protocol and for report but content is not limited to and can be added or updated as per the requirement.
DQ shall be further reviewed by Engineering, User department and Quality assurance and approved by Head/Designee-QAD.
DQ includes the following, wherever applicable, but not limited to:
Basic design
Critical component
MOC
Safety features
Requalification criteria
Deficiency and corrective action
Change Control
Document requirement
Factory Acceptance Test (FAT): FAT wherever applicable shall be done ABC Limited representative at vendor site.
For FAT, Engineering/QA/User department personal shall visit vendor site for Factory Acceptance Test to confirm that the equipment/instrument and fabrication as per design specification.
In case of any deficiency found during FAT, the same shall be recorded in the FAT report with corrective action.
After approval of FAT report, equipment/instrument/utility shall be transferred to ABC Limited site.
Site Acceptance Test (SAT):
Once the equipment/ instrument/Utility shall deliver at the ABC Limited premises, then the Engineering/QA/User department personnel shall perform SAT for verification of design specification at the site and any damage to the equipment/instrument/utility during transport. Checklist can be updated as per
the requirement.
In case of deficiency during SAT shall be recorded in the SAT report with corrective action as per format.
Installation Qualification (IQ):
Installation qualification is defined as documented verification that the equipment/instrument/utility, as installed or modified, comply with the approved design, manufacturer’s recommendations and or user requirements.
IQ shall be prepared by engineering department but the contents shall not be limited to this and can be added or updated as per the requirement.
A typical equipment/instrument/utility protocol and report for Installation Qualification shall be under the following heads as described (but not limited to):
Purpose: Give a clear and concise statement of the objectives of the qualification study.
Scope: The scope of the protocol shall be mentioned here.
Responsibility: Mention the individual responsible for executing the installation as per protocol.
Equipment Description: This section gives a brief description of the instrument/equipment. The details related to the identification of the instrument/equipment shall also be provided.
Supporting Documentation: This section provides a list of drawing, manuals including the list of spare parts for the equipment etc.
Material of Construction: This section identifies and provides the material of construction used for the contact as well as non-contact parts. The verification of the MOC used is based on the test certificates and manufacturer’s specifications, wherever available.
Installation verification of support Utilities: This section shall list the specifications of the utilities installed. Utility hook-up and the requirement of utilities of the equipment shall also be verified.
Safety Features: This section shall list and verify all safety features and alarms installed.
Identification of SOPs: This section shall identify and list all the standard operating procedures(SOPs)/Preventive Maintenance Plan associated with the equipment/instrument.
Installation Acceptance Criteria: This section shall provide an overview of all pertinent information and data required to qualify the installation of the equipment/instrument as acceptable and ready for installation qualification.
Deviation and corrective actions: This section shall also list the deviations and corrective actions taken if any to accept the equipment.
Summary and conclusion: This section shall provide the overview of the summarized data and observed results during qualification and to verify with acceptance criteria. As summarized qualification report the conclusion and recommendation shall be given.
Approval: After complete execution and compilation of the protocol, report approval sheet shall be reviewed and approved.
Installation certification: All the concerned department personnel shall certify and sign off for qualifying the installation.
Operational Qualification:
Operational qualification is defined as documented verification that the equipment or each component of the system, as installed or modified, performs as intended throughout the anticipated operating ranges.
OQ shall be prepared by user department. The contents of the OQ protocol and report shall not be limited to format and can be added or updated as per the requirement.
A typical protocol and report for OQ shall be under various heads as described below:
Objective: The objective of preparing the protocol shall be mentioned in brief in sub head.
Scope: The scope of the protocol shall be mentioned here.
Responsibility: mention the persons responsible for executing the protocol.
Equipment Description: This section gives a brief description of the instrument/equipment.
Pre-requisite of Operation Qualification: Availability of required documents like identified draft SOPs and calibration status shall be verified prior to OQ.
Training of personnel: After approval of the protocol, training shall be provided on protocol for execution to all concern personnel and oral assessment shall be done.
Operational and functional test: This section shall provide purpose, scope, equipment used, procedure, documentation and acceptance criteria of the individual tests to be performed. The data sheets and test results shall be attached to the Validation document.
Safety Features testing: This section shall verify that all safety features and alarms installed functions when the required conditions are simulated.
Operation acceptance criteria: This section shall provide an overview of all pertinent information and data required to qualify the operation of the equipment/instrument and data required to qualify the operation of the equipment/instrument as acceptable. This section shall also list the deviations and corrective actions taken, if any, to accept the equipment.
Deficiency and correction action: This section shall also list the deviations and corrective actions taken if any to accept the equipment.
Summary and conclusion: This section shall provide the overview of the summarized data and observed results during qualification and to verify with acceptance criteria. As summarized qualification report the conclusion and recommendation shall be given.
Approval: after complete execution and compilation of the protocol, report approval sheet shall review and approved.
Certification: All the concerned department personnel certify and sign off for qualifying the operation.
Performance Qualification (PQ):
PQ is defined as the documented verification that the equipment/instrument/utility and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and meet the pre-established specifications.
PQ of the equipment shall be done after the successful completion of OQ.
PQ can also be performed during the process validation batches or taking dummy trial batches or commercial batches.
If PQ is performed using dummy batch the composition of the dummy batch record shall be part of the PQ protocol.
A separate batch record shall be maintained for the dummy batch and shall be attached with the qualification document of the equipment/instrument. Quality attributes related to product, affected by equipment performance shall be monitored.
PQ shall be prepared. The content of the PQ protocol and report shall not be limited to format and can
be added or updated as per requirement.
Quality of the product shall meet the acceptance criteria of approved product specification.
After completion of PQ, equipment/instrument shall be certified as qualified and handover to user department for routine use.
A typical equipment/instrument/utility protocol and report for Performance qualification shall be under various heads as described below:
Purpose: The purpose of preparing the protocol shall be mentioned in brief in this sub head. This is to document the initial performance of equipment for defined process parameters.
Scope: the scope of the protocol shall be mentioned here.
Responsibility: mention the responsibility of individual responsible for executing the protocol.
Pre-requisite of PQ: Availability of required documents like identified Sops, OQ report etc. shall be verified prior to performance qualification.
Acceptance criteria: Product parameters shall meet the desired specification. Equipment shall show the correlation between physical and chemical parameters of product and equipment performance at identified processing steps.
Deviation and corrective action: This section shall also list the deviations and corrective actions taken if any to accept the equipment. If a test fails or if it becomes necessary to modify the test procedure or acceptance criteria during testing, the deviation shall be investigated, justified and documented.
Summary and conclusion: This section shall provide the overview of the summarized data and observed results during qualification and to verify with acceptance criteria. As summarized qualification report the conclusion and recommendation shall be given.
Approval: after complete execution and compilation of the protocol, report approval sheet shall be reviewed and approved.
Certification: All the concerned department personnel certify and sign off for qualifying the performance after reviewing the results and other supporting documentation. The performance qualification for the equipment shall be considered acceptable.
Re-Qualification/Re-validation (RQ):
Equipment/instruments shall be qualify / evaluated as per below mentioned table:
Sr. No.           Re-Qualification/Re-Validation   Re-Validation Period         Frequency
1.                     QC/Micro/ARD Equipment/Instruments    One year        ±15 days
2.                     PLC/HMI        Five years      ±30 days
3.                     Major Equipment      Five years      ±30 days
HVAC shall be evaluated as per below mentioned table:
Sr. No.           Test Parameter       Re-Validation Period         Frequency
1.                     Integrity test for HEPA filter            Yearly             ±30 days
2.                     Air flow pattern         Yearly ±30 days
3.                     Velocity and air changes    Six months    ±15 days
4.                     Non-viable particulate count          Six months    ±15 days
5.                     Recovery test (non-viable particle count) Yearly ±30 days
Equipment shall be re-qualified under following conditions:
After major breakdown
Major modification of equipment
Design changes of spares that have impact on performance of the equipment.
After re-location of critical equipment involving various utilities.
As per scheduled re-qualification.
Situations arising out of unusual occurrences of system/process.
Situations arising out of annual review of machine history.
Change control procedure shall be followed for re-qualification activities except scheduled qualification.
Re-qualification/re-validation shall be done to evaluate the impact of changes on equipment/instrument/utilities, intentionally or un-intentionally. The process is intended to ensure that the qualified equipment/instrument continue to perform in accordance with the parameters defined during the initial qualification.
PLC/HMI shall be verifying in every five years for their input/output check.
Re-qualification/Re-validation shall not be done under following conditions:
Routine preventative maintenance.
Repair/replacement with identical parts but not impacting the product quality directly or indirectly.
Re-calibration
Adjustments within calibrated parameters
RQ shall be prepared. The content of the RQ protocol and report shall not be limited to format and can be added or updated as per requirement.
A typical equipment/instrument protocol and report for re-qualification/Re-validation shall be under various heads as described below but not limited to:
Purpose.
Scope.
Responsibilities.
System Description
Pre-requisite of Performance re-qualification/re-verification.
Performance re-qualification procedure
Acceptance criteria
Deviation and corrective action report
Summary and conclusion
Approval
Qualification and Re- qualification Schedule:
Qualification and Re- qualification Schedule shall be prepared QA equipment/instruments and for HVAC.
Qualification Documentation:
A written protocol shall be established to specify how to conduct the qualification activity.
The first page contains the table defining necessary details of the equipment/instrument and company logo and address below the table.
The Header part contain the document name, Protocol No., effective date and page number and its common for all pages.
DQ, IQ and OQ Protocol/Report received from the vendor shall be considered for the qualification purpose.
System generated documents (protocols and reports) shall not contain the effective date, prepared by, checked by and approved by at the bottom.



Rahul Kashyap is the executive in a Leading Pharma Company, he author in-depth guide that teach pharma industry owner and workers way to follow, manage and grow the quality work in this Field.

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