1Validation and qualification
Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a)). You failed to ensure that all personnel are qualified for the CGMP operations they perform. For example, your co-owner stated that he is the sole proprietor of the Magic Heal formulation, had full…
2Material and supplier control
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)). Your firm failed to test dimethicone active pharmaceutical ingredients (API) and other components, including neem oil, karanja oil, and lavender, prior to use…
3Documentation and records
Your firm failed to establish and follow written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch. Your firm also failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.186(a) and 211.188). You did not prepare adequate master and batch production records for your drug product, Magic Heal…
4Quality unit oversight
Your firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)). Your firm lacks a quality unit (QU) and approved written procedures defining QU responsibilities and controls. In addition, your firm failed to establish adequate written responsibilities and procedures for: • Batch release •…
5Equipment and facility
Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of and to maintain adequate written records of calibration checks and inspections of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)). You used (b)(4) to manufacture your drug product, Magic Heal. You did not…
