Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron To meet the requirements of the iron regulations, manufacturers and packagers must determine an appropriate expiration date for the drug products in unit-dose packages. Accelerated stability testing may be impractical because drug products containing iron, especially multivitamin products, often do not perform well under the artificially stressful conditions of accelerated studies. As a result, real-time stability testing may be the only method to determine an appropriate expiration date. However, the final iron regulations were published only six months before they were to take effect; therefore, there may be insufficient time for some manufacturers of solid oral drug products containing 30 mg or more of iron per dosage unit to perform real-time stability testing on their products. To minimize the burden faced by those manufacturers who have made good faith efforts to comply with
CLEANING VALIDATION (ACCEPTANCE CRITERIA) Introduction Companies must demonstrate during validation that the cleaning procedure routinely employed for a piece of equipment limits potential carryover to an acceptable level. That limit established must be calculated based on sound scientific rational. Methods of Calculating Acceptance Criteria Acceptancecriteria using health-based data PermittedDaily Exposure (PDE) The procedure proposed in this document for determination of health based exposure limits for a residual active substance is based on the method for establishing the so-called Permitted Daily Exposure (PDE) as described in Appendix 3 of ICH Q3C (R4) “Impurities: Guideline for Residual Solvents” and Appendix 3 of VICH GL 18 on “residual solvents in new veterinary medicinal products, active substances and excipients (Revision)”. The PDE represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed a