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Alarm Management
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Facilities for the storage of materials under controlled temperature and humidity conditions are not sufficiently monitored Taenaka Kogyo Co., Ltd. |
12 Apr 2024 | Normal | Justification: Observation shows that alarms are not effectively managed, risking unaddressed temperature excursions. Excerpt: The alarm systems installed on such units throughout your facilities are configured to send email notifications to your Quality Control (QC) Manager, QC Test Manager, and Analytical Equipment Manager in the event one or more of the chambers experiences a temperature excursion. View Details |
| Ventilation systems, including equipment for control of air pressure, are not adequately designed and constructed to minimize risks of contamination. Taenaka Kogyo Co., Ltd. |
12 Apr 2024 | Normal | Justification: Alarm systems are critical for timely alerting personnel to address pressure excursions and prevent contamination. Excerpt: The monitoring devices used to ensure the differential pressure between the production suites and the neighboring outside environment are not equipped with alarm systems to alert personnel to pressure excursions. View Details |
| The responsibilities and procedures applicable to the quality control unit are not fully followed. Cipla Limited |
04 Apr 2024 | Normal | Justification: Alarm Management is linked to this observation since the issues stem from the failure to follow established protocols for handling the alarms, as indicated by the lack of evidence showing required actions were taken. Excerpt: The procedures 1035-G-0196 "Categorization and Handling of Alarms" and MT291 "Operation of (b)(4) System" are not adequately followed in case an alarm occurs for high (b) (4) (b)(4) value. View Details |
| Written records are not always made of investigations into unexplained discrepancies NATCO Pharma Limited |
18 Oct 2023 | Normal | Justification: Equipment used in Parenteral Manufacturing Unit lacks necessary features to manage and document alarms, a crucial aspect of alarm management. Excerpt: Major production equipment used in the sterile manufacturing of (b)(4) (b) (4) and other injectable drugs do not have the capability to store and print alarms. View Details |
| Written records are not always made of investigations into unexplained discrepancies NATCO Pharma Limited |
18 Oct 2023 | Normal | Justification: Equipment used in Parenteral Manufacturing Unit lacks necessary features to manage and document alarms, a crucial aspect of alarm management. Excerpt: Major production equipment used in the sterile manufacturing of (b)(4) (b) (4) and other injectable drugs do not have the capability to store and print alarms. View Details |
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