The Pharma Solution

CLEANING VALIDATION SAMPLING PROCEDURE The cleaning validation is to verify the effectiveness of the cleaning procedure for removal of product residues, preservatives, excipients and cleaning agents so that the analytical monitoring may be reduced to a minimum in the routine phase. In addition one need to ensure there is no risk associated with cross contamination of active ingredients. Cleaning validation is intended to address special consideration and issues pertaining to validation cleaning procedures for equipment used in the manufactured of pharmaceutical products, radiopharmaceuticals, and biological drugs. The document is also intended to establish inspection consistency and uniformity with respect to equipment cleaning procedures. SAMPLING PROCEDURE In order to evaluate a cleaning method it is necessary to sample the product contact surfaces of the equipment and establish the level of residuals present. i) Swabs and Wipes Method Swabbing is the most wid...

21 Code of Federal Regulations Parts 211 Subpart K-Returned and Salvaged Drug Products § 211.204 Returned drug products. Returned drug products shall be identified as such and held. If the conditions under which returned drug products have been held, stored, or shipped before or during their return, or if the condition of the drug product, its container, carton, or labeling, as a result of storage or shipping, casts doubt on the safety, identity, strength, quality or purity of the drug product, the returned drug product shall be destroyed unless examination, testing, or other investigations prove the drug product meets appropriate standards of safety, identity, strength, quality, or purity. A drug product may be reprocessed provided the subsequent drug product meets appropriate standards, specifications, and characteristics. Records of returned drug products shall be maintained and shall include the name and label potency of the drug product dosage form, lot number (or co...

21 Code of Federal Regulations Parts 211 Subpart J-Records and Reports § 211.180 General requirements. (a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under § 211.137 , 3 years after distribution of the batch. (b) Records shall be maintained for all components, drug product containers, closures, and labeling for at least 1 year after the expiration date or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under § 211.137 , 3 years after distribution of the last lot of drug product incorporating the component or using the container, closure, or labeling. (c) All records required under th...