Equipment assembly and validation.

1.0 OBJECTIVE

To lay down a procedure for equipment assembly and validation.  

2.0 SCOPE

This procedure is applicable for equipment assembly and validation at XXX, Company. 

3.0 RESPONSIBILITY

3.1 Executive- Maintenance and utilities

3.2 Head-Maintenance and utilities

3.3 Head-Quality Assurance

3.4 Heads of the concerned departments 

4.0 PROCEDURE

4.1 New systems and equipment shall pass through all the stages of qualification including design qualification (DQ), installation qualification(IQ), Operational Qualification(OQ) and performance Qualification(PQ). 

4.2 In some cases, not all the stages of t qualification may be required. 

4.3 Systems shall be qualified before use. 

4.4 Equipment shall be qualified prior to being brought into routine use to provide documented evidence that the equipment is fit for its intended purpose. 

4.5 Systems and equipment shall undergo periodic requalification including standard operating procedures, specifications and acceptance criteria, certificates and manuals shall be maintained. 

4.6 Qualification shall be done in accordance with predetermined and approved qualification protocols. The results of the qualification shall be recorded and reflected in qualification reports.

4.7 The extent of qualification shall be based on the criticality of a system or equipment ( eg. Blender, autoclaves etc.) 

4.8 Design Qualification 

4.8.1 User requirements shall be considered when deciding on the specific design of a system or equipment. 

4.8.2 A suitable supplier shall be selected for the appropriate system or equipment (approved vendor).

4.9 Installation qualification

4.9.1 Systems and equipment shall be correctly installed in accordance with an installation plan and installation qualification protocol. 

4.9.2 Requirements for calibration, maintenance and cleaning shall be drawn up during installation. 

4.9.3 Installation qualifications shall include identification, verification of all the system elements, parts, services, controls, gauges and other components. 

4.9.4 Measuring, control and indicating devices shall be calibrated against appropriate national or international standards, which are traceable. 

4.9.5 There shall be documented records for the installation (Installation qualification report) to indicate the satisfactoriness of the installation, which shall include the details of the supplier, manufacturer, system or equipment, model and serial number and date of installation, spare parts, relevant procedures and certificates.   

4.10 Operational qualification 

4.10.1 Systems and equipment shall operate correctly and their operation shall be verified in accordance with an operational qualification protocol. 

4.10.2 Critical operating parameters shall be identified. Studies on the critical variables shall include conditions encompassing upper and lower operating limits and circumstances. 

4.10.3 Operational qualification shall include verification of all system elements, parts, services, controls, gauges, and other components. 

4.10.4 There shall be documented records for the verification of operation   (Operational qualification report) to indicate the satisfactory operation. 

4.10.5 Standard operating procedures for operation shall be finalized and approved. 

4.10.6 Training of operators for the systems and equipment shall be provided and training records shall be maintained.  

4.10.7 Systems and equipment shall be released for routine use after completion of operational qualification, provided that all calibration, cleaning, maintenance, training and related tests and results were found to be acceptable. 

4.11 Performance qualification 

4.11.1 Systems and equipment shall consistently perform in accordance with design specifications. The performance shall verify in accordance with a performance qualification protocol. 

4.11.2 There shall be documented records for the verification of performance (Performance qualification report) to indicate the satisfactory performance over a period of time.  

4.12 Revalidation  

4.12.1 The revalidation process is intended to ensure that validated systems continue to perform in accordance with the parameters defined during the original validation. 

4.12.2 All systems or equipment shall be re validated with in a pre-specified period of time. The revalidation frequency will be determined upon completion of the initial validation of a system. 

4.12.3 Revalidation are of two types : 

4.12.3.1 Revalidation after the changes to equipment or system and periodic revalidation.  

4.12.3.1.1 Revalidation after change is done in the following circumstances

• Major change in equipment, design, construction and its material of fabrication. 

• Major change in area and support system. e.g. AHU, water system etc.  

4.12.4 Periodic revalidation at scheduled intervals. 

4.12.4.1 Periodic Revalidation is done to evaluate the consistency in operations, equipment wear and tear, processing steps, IPQC standards and the overall product quality.  

4.12.4.2 Periodic Revalidation is done for unit process such as mixing, drying, compression, coating, homogeneity etc.. for systems, computers(software), utilities e.g. compressed air and steam.

5.0 ABBREVIATIONS

Not applicable  

6.0 ANNEXURE

Not applicable

7.0  CHANGE HISTORY