ICH Q7 – PROCESS EQUIPMENT

[Audio] ICH Q7 – PROCESS EQUIPMENT PREPARED AND PRESENTED BY: CHOW KOK FONG TPP DEPARTMENT.

[Audio] CONTENT OF PROCESS EQUIPMENT DESIGN AND CONSTRUCTION EQUIPMENT MAINTENANCE AND CLEANING CALIBRATION COMPUTERIZED SYSTEM.

[Audio] DESIGN AND CONSTRUCTION Appropriate design, size, suitably for use, cleaning, sanitation and maintenance. Equipment should be used within qualified operating range only. Major equipment and permanent installed processing lines should be identified properly. Food grade lubricants and oils should be used. Deviations should be evaluated. Closed or contained equipment should be used to avoid contamination. A set of current drawing of equipment should be maintained. Any substances associated with equipment operation ( E.g. Lubricants) should not contact the APIs. Equipment surface that contact with APIs should not alter the quality of APIs..

[Audio] EQUIPMENT MAINTENANCE AND CLEANING Schedules and procedures should be established for PM of equipment. Written procedures for cleaning equipment and its subsequent release for use should be prepared. Cleaning procedures should contain sufficient details. Equipment should be cleaned, stored, sanitized or sterilized to prevent contamination. Equipment in continuous production should be cleaned at appropriate intervals. Acceptance criteria for residues, cleaning procedures and cleaning agents should be defined..

[Audio] CALIBRATION Equipment should be calibrated according to written procedures and established schedule to ensure quality of APIs. Calibration should be performed with standards traceable to certified standards and records should be maintained. Current calibration status of critical equipment should be known and verifiable. Deviations from approved standards of calibration should be investigated. INSTRUMENTS THAT DO NOT MEET CALIBRATION CRITERIA SHOULD NOT BE USED!!!.

[Audio] COMPUTERIZED SYSTEM All GMP-related computerized systems should be validated. Sufficient controls required to prevent unauthorized access or changes to data and prevent omissions in data. Any changes, previous entry, who made the changes and when it is changed for the data should be recorded. Written procedures for operation and maintenance of computerized systems should be available. Additional check on data accuracy required for critical data that entered manually. Incidents should be recorded and investigated. Changes to computerized systems should be made according to change procedure. All changes should be records and system should be maintained in validated state. Back-up system should be provided..