Q388 · How should we calibrate our critical…

Q388 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)

Equipment calibration is fundamental to ensuring that measurement data is accurate and reliable, and is a prerequisite for data integrity. You must establish a calibration programme for all critical equipment that affects the quality of medicines. The programme should include: 1. Equipment list: list all equipment requiring calibration. 2. Calibration frequency: set a reasonable calibration interval according to the importance and stability of the equipment (for example, calibrate temperature probes annually and electronic balances quarterly). 3. Calibration method: specify the standards and procedures used for calibration. Calibration must be traceable; the standards used for calibration must themselves be traceable to higher-level national or international standards. 4. Implementation and records: calibration may be carried out by competent internal personnel or outsourced to a qualified external organisation (such as a HOKLAS-accredited laboratory). Each calibration must be documented in detail in a calibration certificate, including readings before and after calibration, whether the equipment passed, and the name of the person performing it and the date. All calibrated equipment should be labelled with the date of the latest calibration and the date of the next calibration.

📘 Regulatory basis

Both GMP and GDP guidelines expressly require key equipment used for measurement, weighing, recording and control to be calibrated and checked regularly, with relevant records retained.

📗 Drew Tang's recommendations

We recommend that clients centrally manage calibration plans and records for all critical equipment, using a simple spreadsheet or specialist equipment management software to track due dates and prevent anything being overlooked. If calibration shows that equipment is outside tolerance, a deviation investigation must be initiated to assess the validity of all measurement data affected by the equipment since its last satisfactory calibration, and determine whether product quality was affected.

📕 Risk notice

Data generated using equipment that has not been calibrated or is overdue for calibration is invalid. For example, if the temperature records in your warehouse were generated by a probe that reads 2°C below the true temperature, all your “compliant” temperature records are false, and the medicines may already have been exposed to temperatures outside the permitted range. During an inspection, checking the calibration labels and certificates of critical equipment is a standard requirement; any omission will be recorded as a deficiency.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

How should we calibrate our critical measuring equipment, such as warehouse temperature probes and laboratory electronic balances?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang