Biozyme Labs receives 3-item 483 for process deviation investigations: Biozyme Laboratories, Blaenavon, South Wales, U.K., Rockville, MD.Biozyme Laboratories, Blaenavon, South Wales South Wales south n → sud m du Pays de Galles , U.K., received a three-item 483 because its investigations into the production of 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. validation See validate.
validation - The stage in the software life-cycle at the end of the development process where software is evaluated to ensure that it complies with the requirements. batches were not complete.
The audit of the manufacturer of active biopharmaceutical intermediates was conducted by CDER CDER Center for Drug Evaluation and Research (US FDA)
CDER Centre de Développement des Energies Renouvelables (French)
CDER Client Development and Evaluation Report investigator Daniel Grabicki.
"The acceptability of the [undisclosed] lot used in the manufacture of the validation batches and the compatibility of the newly modified [undisclosed] were not investigated," Grabicki wrote.
The investigations into the process deviations concluded there was no adverse impact on product quality. The specific activity and yield of the undisclosed material for each batch were within the acceptance criteria. The FDAer reviewed historical data pertaining per·tain
intr.v. per·tained, per·tain·ing, per·tains
1. To have reference; relate: evidence that pertains to the accident.
2. to the specific yield and activity of the undisclosed material from validation, pre-validation and development batches. No significant variability was observed.
"During the inspection, I explained to the firm that the investigations were not complete to determine the cause and establish appropriate corrective action A corrective action is a change implemented to address a weakness identified in a management system. Normally corrective actions are instigated in response to a customer complaint, abnormal levels if internal nonconformity, nonconformities identified during an internal audit or . The firm stated the investigation needed to be expanded to try and determine the cause of the process deviations."
Next, the company's manufacturing batch records for an undisclosed intermediate did not contain certain undisclosed specifications. The firm stated in its response that the specifications were inadvertently omitted and would be established.
Further, the firm's production operators lacked training to determine abnormalities in the appearance of the undisclosed intermediate and a certain API at the completion of one of the steps of the manufacturing process.
"Visual examples of the above referenced abnormalities were not contained in the procedure nor were they shown to operators during training.
Biozyme stated in its written reply that it would develop training aids Any item developed or procured with the primary intent that it shall assist in training and the process of learning. based on recent experience and library pictures of artificially produced abnormalities. The training aids and modified SOP and all relevant staff have been trained in the new procedures."
Biozyme Laboratories, Blaenavon, South Wales, U.K., 2/13-17/04, Doc. 110018M, $4.50 plus retrieval.