German API manufacturer hit with six-item 483 for unvalidated computer systems: BASF Aktiengesellshaft, Ludwigshafen, Germany, Rockville, MD.

BASF Aktiengesellshaft, Ludwigshafen, Germany, was slapped with a six-item 483 for computer labeling systems that were not properly validated.

According to the audit records, compiled by investigator Michele Perry-Williams and chemist 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 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 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, she only reviewed the master processing and DMF 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 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 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.