1Laboratory and QC controls
Qualified personnel did not adequately supervise the fabrication, packaging, labelling, testing, and/or storage of drugs. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The duties of the individual in charge of the manufacturing department were delegated to an unqualified individual. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
2Other quality system
The recorded information or details were inadequate.
3Laboratory and QC controls
There was no evidence of a functioning and/or independent quality control department.
4Laboratory and QC controls
The specifications were not in writing and/or approved by the person in charge of the quality control department or the designated alternative. Lots or batches of finished product were not examined or tested against the specifications before they were fabricated or sold.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate.
6Equipment and facility
The design of the drug stability study was inadequate and/or not justified with a documented rationale. "The maintenance of records was inadequate.
7Other quality system
The written procedures and records for retaining samples were inadequate.
8Laboratory and QC controls
The quality control department's selection of a laboratory for testing and/or examination was inadequate.
9Laboratory and QC controls
The quality control department did not approve the specifications for packaging materials. The quality control department's release of packaging materials for use in packaging or labelling was inadequate.
10Laboratory and QC controls
The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation was inadequate. The master production documents were inadequate.
11Laboratory and QC controls
The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation was inadequate. The system for reviewing, revising, and approving standard operating procedures was inadequate. The procedure was inadequate for documenting quality control decisions by the person in charge of the quality control department.
12Contamination control
The drug was fabricated, packaged, labelled, and/or stored in premises that were not designed, constructed, and/or maintained to allow for effective cleaning, sanitary conditions, and/or the prevention of drug contamination.
13Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
14Validation and qualification
Critical production processes were not validated. Validation studies were not conducted in keeping with the predefined protocols.
15Material and supplier control
The drug fabricator's specifications for raw materials were inadequate. The raw materials used to fabricate a drug were not tested against the specifications, did not comply with the specifications, and/or were expired.
16Equipment and facility
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions. The establishment and/or the maintenance of a data governance plan was inadequate.
