Halewood Laboratories Private Limited — EU GMP NCR (EudraGMDP) Findings

The inspection identified extensive critical and major deficiencies demonstrating a systemic failure to comply with EU GMP. Inadequate control of tablet manufacturing was identified. Manual loading of the compression equipment generated excessive dust and process interruptions, potentially compromising product quality. In addition, the primary packaging line could not be operated during the inspection. Inadequate control of liquid manufacturing was observed. There was inadequate control of the equipment used for bottle filling and sealing, with repeated stoppages and syrup spillages. Cleaning of affected areas and gloves was inadequate. No procedure was available describing the management of spillages or stoppages. Quality Control deficiencies were identified. Analyses were missing and Ph. Eur. reference standards were absent. An inappropriate reference to the Ph. Eur. was made for potable water testing. Inconsistencies were noted between system records and equipment status, including inconsistencies between computerised system records and the operational status of equipment. There was also a lack of clarity regarding the application of analytical methods for EU products (in-house versus Ph. Eur. methods). Validation deficiencies were observed. Validation testing was performed in other Indian laboratories for APIs and finished products. Process validation for EU products was incomplete, and no process validation was in place covering all stages of manufacture. Data integrity failures were identified. Inconsistencies were noted between records and the information declared by the entity. Cleaning activities and material traceability were inadequately documented. Logbooks were incomplete or inconsistent. Technical Agreement deficiencies were identified. Contracts did not clearly define responsibilities, scope of testing, or subcontracting conditions. The contract with the MAH was also incomplete regarding EU importation and PQR requirements. Inadequate contamination and cross-contamination controls were observed. Gowning practices were inadequate, including barefoot transitions between dirty and clean areas. Operators were observed handling product inappropriately. Segregation between clean and dirty areas was inadequate in some places and by some operators. Premature batch approval by Halewood was identified, as a batch was approval prior to approval of analytical results at Halewood. Deficiencies were also noted in finished goods storage, as no humidity records were available for EU finished products. Overall, the deficiencies represent a profound and systemic failure of GMP principles, compromising product quality, contamination control, data integrity and the reliability of operations. These failures collectively demonstrate that the site’s pharmaceutical quality system lacks the control, oversight and governance required to ensure compliant and reliable manufacturing operations. The extent and severity of the deficiencies show persistent weaknesses in risk management and an overall absence of effective quality oversight, resulting in a system that is not operating in a state of control. Action taken/proposed by the NCA: Prohibition of supply Given the deficiencies identified, an inspection report will be issued. The adequacy and effective implementation of the CAPA plan will be assessed during a follow-up inspection to determine whether compliance with Good Manufacturing Practice has been satisfactorily restored.