12/9/2023 0 Comments Tsb media preparation![]() United States Pharmacopeia (USP) General Chapter Weights and Balances.21 CFR 211.160(b)(4): General requirements (Laboratory Controls).21 CFR 211.68: Automatic, mechanical, and electronic equipment.Additionally, the calibration of an auto-calibrator should be periodically verified-a common frequency is once a year-using National Institute of Standards and Technology (NIST)-traceable standards or NIST-accredited standards in use in other countries. Note that all batches of a product manufactured between two successive verifications would be affected should the check of the auto-calibrator reveal a problem. The frequency of performance checks depends on the frequency of use of the scale and the criticality and tolerance of the process or analytical step. For a scale with a built-in auto-calibrator, we recommend that external performance checks be performed on a periodic basis, but less frequently as compared to a scale without this feature. The auto-calibration feature of a balance may not be relied upon to the exclusion of an external performance check (21 CFR 211.68). Are such auto-calibration procedures acceptable instead of external performance checks? If not, then what should the schedule for calibration be? Many leading analytical balance manufacturers provide built-in "auto-calibration" features in their balances. Is testing rinse solution enough to support residue determinations for cleaning validation?ĭoes FDA prefer one type of material over another (e.g., polyvinylidene difluoride over stainless steel) for construction of recirculating loops in water for injection (WFI) systems?ġ. If a procedure’s ability to clean a piece of equipment made of a particular material, such as 316 stainless steel, is acceptable and validated, can that “material-specific” cleaning procedure be applied to other pieces of equipment and compounds without extensive validation? What is an acceptable level of detergent residue, and what is the basis for arriving at this level, if any? Should laboratory glassware be included in a firm's equipment cleaning validation program? How do I perform cleaning validation, including for homeopathic drug products?ĭoes equipment need to be clean enough to meet limits based on the most sensitive possible methods of residue detection or quantification?ĭo firms need to quantify the total amount of residue remaining on equipment surfaces after manufacturing a product (before cleaning) to support cleaning validation studies? What are the cleaning validation requirements for potent compounds (e.g., compounds that are cytotoxic, mutagenic, or have high pharmacologic activity), and is dedicated equipment required? Investigation did not show any obvious causes. What could be the source of contamination? They conducted their media fills using TSB (tryptic soy broth) prepared by filtration through a 0.2 micron sterilizing filter. Is there a list of CDER-approved drug manufacturing equipment?Ĭan Total Organic Carbon (TOC) be an acceptable method for detecting residues of contaminants in evaluating cleaning effectiveness?Ī firm has multiple media fill failures.
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