QC / QA laboratories

Chemical testing

Assay, dissolution, particulate matter and physical tests.

Microbiological testing

Microbial enumeration, agar diffusion (antibiotic potency), bacterial endotoxin and sterility.

Instrument calibration

Monthly/annual calibration plan, internal and external.

Water systems

Daily PW, WFI and pure-steam checks per USP 39 (TOC, conductivity, total viable aerobic count, bacterial endotoxin).

Validation

Process validation (minimum 3 lots) · cleaning validation (visual, MACO, TOC, microbial) · analytical method validation.

Media fill

Aseptic process simulation with culture media; three consecutive runs for the first media fill.

Environmental monitoring

Settle plates, air sampling, contact plates and five-finger glove prints in clean rooms.

Stability

Long term 30 °C/75% RH (0–24 months) · accelerated 40 °C/75% RH (0–6 months) · on-going stability, at least one batch per year.

Release & post-market

Batch release with Certificate of Analysis · returns · recall · customer complaints · Product Quality Review.

• Ampoules, vials and cartridges; liquid or freeze-dried products
• Inspects for extraneous reflecting and non-reflecting particles, fibres, glass and correct fill level
• Designed to current GMP; software compliant with 21 CFR Part 11
• Can be integrated with a leak-test unit for container integrity