Cambrex slapped with 7-item 483 for admin assistant validating results in computer system.Cambrex Profarmaco Milano, Paullo, Italy, netted a seven-item 483 because an unqualified administrative assistant was assigned as the site director in a computer system to validate analytical results and modify release specifications.
Only the 483 was available as this publication went to press. Investigators Alicia Mozzachio and chemist Luella Rossia from CDER CDER Center for Drug Evaluation and Research (US FDA)
CDER Centre de Développement des Energies Renouvelables (French)
CDER Client Development and Evaluation Report performed the inspection, according to according to
1. As stated or indicated by; on the authority of: according to historians.
2. In keeping with: according to instructions.
3. the documents.
The report stated that the administrative assistant's responsibilities in the computer system included controlling inventory of materials, status of materials (quarantined quar·an·tine
a. A period of time during which a vehicle, person, or material suspected of carrying a contagious disease is detained at a port of entry under enforced isolation to prevent disease from entering a country. , rejected, approved), maintaining master batch records and allowing the printing of batch records. This was beyond the scope of a person in an administrative position, FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. argued.
Further, the FDAers noted that "critical processing steps in batch production Batch production is a manufacturing process used to produce or process any product in batches, as opposed to a continuous production process, or a one-off production. The primary characeristic of batch production is that all components are completed at a workstation before they records are not reviewed and approved by the quality unit before an API (Application Programming Interface) A language and message format used by an application program to communicate with the operating system or some other control program such as a database management system (DBMS) or communications protocol. batch is released." Also, there were no written procedures for review and approval of batch records.
Next, the report stated there was not a documented procedure describing the recording of all laboratory raw data into laboratory notebooks, and laboratory control records were incomplete or inadequate. Specific examples cited included a notebook that did not reference the current test method used, and a notebook that did not include a reference to lots of standards used for analysis.
Another example noted in FDA documents was complaint samples. These did not follow the QC laboratory practices related to controlled documentation. "The data is recorded on uncontrolled paper and attached to the complaint. Information related to equipment/instruments used, methods followed and sample preparations were not recorded," the investigator wrote.
Next, FDA stated that the analytical technology transfer for stability studies was insufficient for the assay determination. "The analytical results were not compared to similar results determined by Cambrex, but to results determined by an [undisclosed] procedure, [which is] a different analytical technique An analytical technique is a method that is used to determine the concentration of a chemical compound or chemical element. There are a wide variety of techniques used for analysis, from simple weighing (gravimetric) to titrations (titrimetric)to very advanced techniques using ."
Cambrex Profarmaco Milano, Paullo, Italy, 2/23-3/3/05, Doc. 109936M, $3 plus retrieval.
* The Checklist--Cambrex
* Admin assistant validating computer results
* Critical processing steps not reviewed