Qualification of Systems and Equipment in Pharmaceuticals

1. Principle

1.1 Systems and equipment should be appropriately designed, located, installed, operated and maintained to suit their intended purpose.

1.2 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.

1.3 The continued suitable performance of equipment is important to ensure batch-to-batch consistency. Critical equipment should, therefore, be qualified.

2. Scope

2.1 These guidelines describe the general aspects of qualification for systems and equipment.

2.2 Normally qualification would be applicable to critical systems and equipment whose performance may have an impact on the quality of the product.

3. General

3.1 The manufacturer should have a qualification policy for systems and equipment.

3.2 Equipment (including instruments) used in production and quality control should be included in the qualification policy and programme.

3.3 New systems and equipment should pass through all stages of qualification including design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) as appropriate (Fig. 1).

3.4 In some cases, not all stages of qualification may be required.

3.5 Systems should be qualified before equipment.

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

3.7 Systems and equipment should undergo periodic requalification, as well as requalification after the change.

3.8 Certain stages of the equipment qualification may be done by the supplier or a third party.

3.9 The relevant documentation associated with qualification including standard operating procedures (SOPs), specifications and acceptance criteria, certificates and manuals should be maintained.

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

3.11 The extent of the qualification should be based on the criticality of a system or equipment (e.g. blenders, autoclaves or computerized systems).

Related: Vendor Audits and Checklist for Pharmaceuticals

4. Design Qualification of Equipment

Note: see also “Supplementary guidelines on good manufacturing practices (GMP): validation”.

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

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

5. Installation Qualification of Equipment

Note: see also “Supplementary guidelines on good manufacturing practices (GMP): validation”.

5.1 Systems and equipment should be correctly installed in accordance with an installation plan and installation qualification protocol.

5.2 Requirements for calibration, maintenance and cleaning should be drawn up during installation.

5.3 Installation qualification should include identification and verification of all system elements, parts, services, controls, gauges and other components.

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

5.5 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.

6. Operational Qualification of Equipment

Note: see also “Supplementary guidelines on good manufacturing practices (GMP): validation”.

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

6.2 Critical operating parameters should be identified. Studies on the critical variables should include conditions encompassing upper and lower operating limits and circumstances (also referred to as “worst case conditions”).

6.3 Operational qualification should include verification of operation of all system elements, parts, services, controls, gauges and other components.

6.4 There should be documented records for the verification of operation (operational qualification report) to indicate the satisfactory operation.

6.5 Standard operating procedures for the operation should be finalized and approved.

6.6 Training of operators for the systems and equipment should be provided, and training records maintained.

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

7. Performance Qualification of Equipment

Note: see also “Supplementary guidelines on good manufacturing practices (GMP): validation”.

7.1 Systems and equipment should consistently perform in accordance with design specifications. The performance should be verified in accordance with a performance qualification protocol.

7.2 There should be documented records for the verification of performance (performance qualification report) to indicate the satisfactory performance over a period of time. Manufacturers should justify the selected period over which performance qualification is done.

8. Requalification

Note: see also “Supplementary guidelines on good manufacturing practices (GMP): validation”.

8.1 Requalification of systems and equipment should be done in accordance with a defined schedule. The frequency of requalification may be determined on the basis of factors such as the analysis of results relating to calibration, verification and maintenance.

8.2 There should be periodic requalification.

8.3 There should be requalification after changes. The extent of requalification after the change should be justified based on a risk-assessment of the change. Requalification after change should be considered as part of the change control procedure.

9. Qualification of “in-use” systems and equipment

9.1 There should be data to support and verify the suitable operation and performance of systems and equipment that have been “in use” for a period of time, and which had not been subjected to installation and or operational qualification.

9.2 These should include operating parameters and limits for critical variables, calibration, maintenance and preventive maintenance, standard operating procedures (SOPs) and records.

Get editable documentsView List