Installation Qualification (IQ) Protocol and Report in Pharmaceuticals  

Installation Qualification (IQ) Protocol and Report in Pharmaceuticals.

 

Installation Qualification:- Systems and equipment should be correctly installed in accordance with an installation plan and installation qualification protocol. Requirements for calibration, maintenance and cleaning should be drawn up during installation. Installation qualification should include identification and verification of all system elements, parts, services, controls, gauges and other components. Measuring, control and indicating devices should be calibrated against appropriate national or international standards, which are traceable.

There should be documented records for the installation (installation qualification report) to indicate the satisfactoriness of the installation, which should include the details of the supplier and manufacturer, system or equipment name, model and serial number, date of installation, spare parts, relevant procedures and certificates. Systems and equipment should be appropriately designed, located, installed, operated and maintained to suit their intended purpose.

Critical systems, i.e. those whose consistent performance may have an impact on the quality of products, should be qualified. These may include,where appropriate, water purification systems, air-handling systems, compressed air systems and steam systems.

Validation Protocol_______ Installation Qualification ________Page_____ Of_____

Title:__________________ Name and address of site :_____________________________

 

Validation Protocol :_____________________ IQ Protocol Number________________

Title:__________________________________________________________________________

Protocol Written By:__________________________________________________________

Protocol Approved By:_______________________________     Date:________________

QA Approval :_______________________________________      Date:________________

 

Objective:-

To ensure that ________ (System/Equipment) installed conforms to the purchase specifications and the manufacturer details and literature, and to documents the information that  ____________________ (System/Equipment) meets its specifications.

Equipment Inventory Number: ____________________________________________________

 

Scope:-

To  perform installation qualification as described in this IQ Protocol at the time of installation , Modification and Relocation.

 

Responsibility:-

____________________ ( Post/Person ) overseeing the installation will perform the qualification and record results.

____________________ ( Post/Person ) will verify results and write the report.

Quality Assurance will review and approve the IQ protocol and Report.

 

System/Equipment: _______________________________ Code No:_________________

A. Description of the System/equipment being installed: general description of the function and the main components.




 

B. List of the main Components:-

1.

2.

3.

4.

 

C. Description of supporting utilities (e.g. piping, connections, water supply) :-

1.

2.

3.

4.

Procedure:-

  1. prepare a checklist of all components and parts, including spare parts according to the purchase order and manufacture’s specifications.
  2. 2.Record the information for each actual part, component, item of auxiliary equipment, supporting facilities, and compare with the manufacturer’s specifications.
  3. Record any Deviations to the System/Equipment.
  4. Prepare a deviation report including justification of acceptance and impact on the function.
  5. Prepare an IQ Report.
  6. Submit the report to QA for review and approval.

Note:- As a Minimum, the IQ report should Include the date of installation of the study, date completed, observations made, problems encountered, completeness of information collected, summary of deviation reports, result of any tests, sample data, location of original data, other information relevant to the study , and the conclusion on the validity of the installation.

 

Checklist for component No:_________________________________

Name: _____________________________________ Code No: ____________________________

Component Function : ___________________________________________________________

 

Sr. No. Components Require/order Actual Deviations
1. Serial No.
2. Specification
3. Manua
4. Drawing
5. Writing/Cabing
6. Power, Fusing
7. SOP (Operation)
8. SOP (Maintenance)
9. SOP(Calibration)
10. Input/Output Control
11. Environment
12. Test Equipment Or Instruments
13. Utilities and Service
14. Spare parts list, Part Number and Suppler
15. Other
 

Performed By:- ________________________________________  Date:- __________________

Deviations:- __________________________________________   Date:- __________________

Verified By:- __________________________________________   Date:- __________________

 

 

Deviation Report:-

Deviations:- ________________________________________________________________________________________


 

Justification For Acceptance :- ________________________________________________________________________________________


Impact On Operation:-



Report Written By :___________________________________ Date: ________________________

 

Installation Qualification Report :-

Results:- ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Conclusions:-



Report written by:- ____________________________ Date:- _______________________________

QA Approved By :- ____________________________ Date:- ________________________________

Reference :-

WHO – Quality Assurance Pharma Vol2.

 

 

Qualification Stages For Equipment, Facilities, Utilities And System.

Qualification  Steps For Equipment, Facilities, Utilities And System.

Qualification activities should consider all stages from initial development of the user requirements specification through to the end of use of the equipment, facility, utility or system. The main stages and some suggested criteria (although this depends on individual project circumstances and may be different) which could be included in each stage are indicated below:
User Requirements Specification (URS):-
The specification for equipment, facilities, utilities or systems should be defined in a URS and/or a functional specification. The essential elements of quality need to be built in at this stage and any GMP risks mitigated to an acceptable level. The URS should be a point of reference throughout the validation life cycle.
Design Qualification (DQ):- 
The next element in the qualification of equipment, facilities, utilities, or systems is DQ where the compliance of the design with GMP should be demonstrated and documented. The requirements of the user requirements specification should be verified during the design qualification.
Factory Acceptance Testing (FAT) /Site Acceptance Testing (SAT):-

  • Equipment, especially if incorporating novel or complex technology, may be evaluated, if applicable, at the vendor prior to delivery.
  • Prior to installation, equipment should be confirmed to comply with the URS/ functional specification at the vendor site, if applicable.
  • Where appropriate and justified, documentation review and some tests could be performed at the FAT or other stages without the need to repeat on site at IQ/OQ if it can be shown that the functionality is not affected by the transport and installation.
  • FAT may be supplemented by the execution of a SAT following the receipt of equipment at the manufacturing site.

Installation Qualification (IQ):-

IQ should be performed on equipment, facilities, utilities, or systems. IQ should include, but is not limited to the following:
i. Verification of the correct installation of components, instrumentation, equipment, pipe work and services against the engineering drawings and specifications;
ii. Verification of the correct installation against Pre-defined criteria;
iii. Collection and collation of supplier operating and working instructions and maintenance requirements;
iv. Calibration of instrumentation;
v. Verification of the materials of construction.
Operational Qualification (OQ):-
OQ normally follows IQ but depending on the complexity of the equipment, it may be performed as a combined Installation/Operation Qualification (IOQ).
OQ should include but is not limited to the following:
i. Tests that have been developed from the knowledge of processes, systems and equipment to ensure the system is operating as designed;
ii. Tests to confirm upper and lower operating limits, and /or “worst case” conditions. The completion of a successful OQ should allow the finalisation of standard operating and cleaning procedures, operator training and preventative maintenance requirements.
Performance Qualification (PQ):-

PQ should normally follow the successful completion of IQ and OQ. However, it may in some cases be appropriate to perform it in conjunction with OQ or Process Validation.

PQ should include, but is not limited to the following:
i. Tests, using production materials, qualified substitutes or simulated product proven to have equivalent behaviour under normal operating conditions with worst case batch sizes. The frequency of sampling used to confirm process control should be justified;
ii. Tests should cover the operating range of the intended process, unless documented evidence from the development phases confirming the operational ranges is available.

RE-QUALIFICATION:-

Equipment, facilities, utilities and systems should be evaluated at an appropriate frequency to confirm that they remain in a state of control.
Where re-qualification is necessary and performed at a specific time period, the period should be justified and the criteria for evaluation defined. Furthermore, the possibility of small changes over time should be assessed.

Reference :-

 Quality assurance of Pharmaceuticals (Volume 2)