USFDA 483 / Torrent, Indrad, India / FEI 3005029956 / Inspection 8-16 April 2019 / FDA Inspectors – Lata Mathew (USFDA investigator), Jogy George (USFDA Investigator), Zhao Wang (USFDA) / Observation 3

Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.

Qualification of Vision Inspection system of Tablet (redacted) Machine is deficient. Production operators purportedly trained on the operational aspects confirmed that they do not know how to set up the vision profile settings for the vision inspection system of the machine. The vision system ensure that the tablets confirm to inprocess specification limits. Consequently, during the process demonstration on April 12, 2019 several false rejects were found in the reject chute associated with the vision check cameras on the equipment thus providing no assurance of the optimum functionality of the vision system.

When sophisticated automated electronic equipment and systems are implemented, many times it happens that all features and functionalities are not adequately understood by the operations and engineering teams. The functionalities are not adequately qualified / calibrated; only minimum functionalities and features of the equipment are understood and utilized, others taken for granted. Even when the equipment installation and commissioning follow the classic equipment qualification model (URS, DQ, IQ, OQ, PQ), it is possible that several features of the equipment which are utilized during operation are missed out from qualifications / calibrations / operational SOPs. The operational SOPs of the equipment fail to address all the operations step by step. To avoid such pitfalls companies need to have a technically sound process for implementation of equipment and systems:

• When sophisticated, automated, electronic equipment are implemented, it shall follow a process of adequate technology absorption supported by the equipment supplier. The equipment manuals shall be thoroughly understood.
• If there are functionalities / features of the equipment which are not going to be used, it shall be clearly identified in qualification documents and operational SOPs. When such functionalities are enabled later, it shall follow a change control procedure which identifies the all actions that need to be performed while implementing the change (Operational SOP revision, qualification / requalification, training and qualification of personnel).
• Develop subject matter experts / equipment experts for such equipment who will train and qualify other operating personnel. Firms may maintain a list of such experts and have systems and processes to ensure that such knowledge is transferred to alternate personnel during employee movement.

Review the equipment / equipment features and equipment manual along with expert staff from the equipment supplier, perform a gap assessment. Identify gaps with respect to qualification, calibration, detailing of operational instructions in SOP and awareness of the operating and engineering personnel.

Revise the operational SOP with step by step operational instructions for all functionalities that is used in routine operations. Perform requalification of the equipment for all functionalities which were not adequately addressed during earlier qualifications at the time of equipment installation and commissioning, Ensure calibration of all the measurement and control systems as applicable and implement a schedule for periodic calibration.

Train the operations and engineering personnel in the equipment, equipment features, requalification and equipment operation.