German API manufacturer hit with six-item 483 for unvalidated computer systems: BASF Aktiengesellshaft, Ludwigshafen, Germany, Rockville, MD.BASF BASF Bar Association of San Francisco (since 1872; San Francisco, California)
BASF Badische Anilin und Soda Fabrik (German chemical products company)
BASF Builders Association of South Florida Aktiengesellshaft, Ludwigshafen, Germany, was slapped with a six-item 483 for computer labeling systems that were not properly validated.
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 audit records, compiled by investigator Michele Perry-Williams and chemist (jargon) chemist - (Cambridge) Someone who wastes computer time on number crunching when you'd far rather the computer were working out anagrams of your name or printing Snoopy calendars or running life patterns. May or may not refer to someone who actually studies chemistry. Luella Rossi, "the labeling systems...used to generate labels for all GMP-API products distributed to the U.S. have not been validated." The company stated that it attempted to validate the systems but had several problems and discontinued dis·con·tin·ue
v. dis·con·tin·ued, dis·con·tin·u·ing, dis·con·tin·ues
1. To stop doing or providing (something); end or abandon: these validation efforts.
According to the 483, the computer system had been used for the past five years and is the computer system they are currently validating for the generation of labels for GMP-API products only.
Further, the company did not establish written procedures for the review and approval of labeling material to determine compliance with an accurate reproduction of the master label before use during packaging for the GMP-API product.
"Management agreed with this observation and stated procedures were not currently in place for all areas of the company that generates labels for use on 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. products distributed in the U.S.," the FDAer stated. She observed different packaging and labeling operations in the firm's different buildings.
"Management stated this would be corrected immediately and provided documentation showing one of their departments that generates and applies labels to GMP-API products does have the appropriate procedures in place. They stated that they would use this procedure as a guide for all areas where label review procedures and adequate documentation are not in place."
In a related observation, the 483 stated that there were no label specimens located in the master packaging record. "I reviewed the master records and found they do not have a specimen of the labels used during packaging."
Next, "actual and theoretical yield information is not recorded in the API batch records for all U.S. GMP-API products," she stated. The FDAer stated that because of time constraints In law, time constraints are placed on certain actions and filings in the interest of speedy justice, and additionally to prevent the evasion of the ends of justice by waiting until a matter is moot. , she only reviewed the master processing and DMF (Distribution Media Format) A floppy disk format from Microsoft that was used to distribute its software. DMF floppies compressed more data (1.7MB) onto the 3.5" diskette, and the files could not be copied with normal DOS and Windows commands. A DMF utility had to be used. records for one undisclosed product. "I found both DMFs contained theoretical yields in these records. I reviewed the master production records, and did not see a range of acceptance for actual yields and theoretical yields included in this documentation," she stated.
The FDAer also noted in a verbal observation the following: "The current [undisclosed] methods used for analysis gives the impression that there are no system suitability requirements. The SOPs for use of the equipment, however, require that the standards analyzed an·a·lyze
tr.v. an·a·lyzed, an·a·lyz·ing, an·a·lyz·es
1. To examine methodically by separating into parts and studying their interrelations.
2. Chemistry To make a chemical analysis of.
3. with each method be run at least [undisclosed] and that they be reproducible. I explained that if these methods were to be transferred to another laboratory as written, they would be deficient de·fi·cient
1. Lacking an essential quality or element.
2. Inadequate in amount or degree; insufficient.
a state of being in deficit. in this aspect. The requirement for suitability should be with each method."
BASF Aktiengesellshaft, Ludwigshafen, Germany, 1/12-15/04, Doc. 110019M, $8 plus retrieval.