4. Failure to establish an adequate quality control unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. (21 CFR 211.22(a) and 211.22(d)).
Your quality unit (QU) failed to ensure that you have adequate procedures and did not provide adequate oversight of your manufacturing activities. For example: ·
- You lack adequate control over the issuance, use, and reconciliation of manufacturing batch records and equipment maintenance sheets. Uncontrolled copies of manufacturing batch records and in-process control forms were pre-printed and kept in a room with unrestricted access.
- Several test reports of your drug product assay were reviewed and the raw data for the standard curve could not be located. It was noted that scrap pieces of paper were used to record data which was later entered to calculate the [redacted] concentration for the assay test.
- Your firm failed to establish and follow procedures for calculating production yields.
In your response, you stated" ... starting July 2019, relevant personnel will be handed just enough blank forms on a [redacted] basis and they must account for the whereabouts of all blank forms at the [redacted]." You stated that all documents will be archived and procedures will be drafted and/or updated to meet CGMP requirements.