Test Methods

Extraction - Good Manufacturing Practices

Good Manufacturing Practices • Drug product container and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity beyond the official or established requirements. • Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
21CFR211.94(a)(b)