Firm's quality unit (QU) failed to ensure adequate document control over paper and electronic records.
For example, investigators observed numerous logbooks, forms, and partially completed “Sample Request For Analysis (Other Than SAP)” in an uncontrolled temporary storage room.
Investigators also observed in firm's document center, a document shredder labeled for “emergency use” containing shredded documents.
Firm's document control personnel were unable to identify the documents in the shredder that were observed to contain information for relative humidity, temperature, and data recorded in writing.
Firm also failed to have adequate controls for your computerized systems.
Multiple usernames and passwords for software login of several users’ information were handwritten in an uncontrolled notebook.
Firm's response indicates you plan to revise multiple standard operating procedures and intend to centralize document control by forming a new document control center and document control team.
Firm's response also indicates that senior executive had an administrator role in the “ICDAS” software and they were subsequently reassigned to an operator role. But the response does not provide a detailed plan to ensure the future paper and electronic record and documentation practices comply with CGMP.
The response is also inadequate because it does not include a comprehensive retrospective risk assessment of the impact and scope for the inadequate document control at the facility, and it does not fully address tiered user access and controls to ensure access is appropriate to each users’ role and administrative roles are adequately controlled.
Firm failed to adequately investigate and determine the root cause of black particles in two batches of API. For example, the investigation report for (b)(4) batch (b)(4) stated the black particles were non-metallic charred product residue. The firm's report further indicated that the sample was observed by analysis to “dissolve in solution.” However, during the inspection, firm was unable to provide the investigator the data to support the conclusion.
Firm's response indicates they installed (b)(4) to limit the presence of metal particles in the API. However, firm's investigation remains inadequate because it did not provide the data to support the proposed root cause or identify an adequate CAPA.
For example, firm's CAPA does not address non-metallic sources of contamination, such as charred product residue or inadequate cleaning or fully address metallic sources of contamination, such as reactive, additive, or absorptive product contact surfaces.
Check on your site whether similar non-compliances are there on your site?
Make a plan of action to remove them as per the guidance & standard operating procedures.