Steri-Med Pharma Inc. — Health Canada Inspection Findings

Evaluation of production processes, equipment, and/or materials was inadequate.

The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

The qualification and/or verification of utilities and/or support systems was inadequate.

The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.

The aseptic process simulation study was not long enough to cover all routine manipulations, normal interventions, and worst case situations.

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range. The assessment to release finished products was inadequate.

The condition of the clean area used to produce sterile products was inadequate. In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.

The operators'aseptic practices were inadequate to maintain sterility.

The validation of aseptic processing was inadequate.

After equipment maintenance, the company did not adequately clean, disinfect, or sterilize the clean area. The operators'aseptic practices were inadequate to maintain sterility. Sterile disinfectants were not used in Grade A and B areas. The ongoing training of personnel was inadequate. In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.

The "Water for Injection" was not produced, stored or distributed to prevent microbial growth.

Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate.

The quarantine, sampling, testing, release of raw material, and/or the packaging materials prior to use were inadequate.

A reduced retesting program for raw materials was in place without the raw material vendor certification. The establishment of specifications was inadequate for packaging materials approved by the quality control department. The procedures to prevent mix-ups between irradiated and non-irradiated materials were inadequate. The company did not adequately validate how the sterilizer was loaded.

The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas. The company's investigations of microbial contamination in critical areas were inadequate.

The stability data did not demonstrate or justify the retention period of a reworked lot of a drug before it was marketed.