Interpretation of 21 CFR 211.67 Cleaning of Equipment
The US-American GMP regulations for medicinal products are laid down in 21 CFR 211. Section 21 CFR 211.67 requires the establishment of and adherence to written instructions regarding the cleaning and maintenance of equipment. What is exactly meant by this?
FDA Warning Letters for Products Containing CBD and Delta-8 THC
The FDA issued several Warning Letters to companies for illegally selling CBD products and products labeled as containing delta-8 THC. Violations include the marketing of unapproved new drugs, misbranding, and adding delta-8 THC to food products.
Recently, the CMDh has added a recommendation for the classification of a proposed packaging change to the list of unforeseen variations ("Article 5 Recommendations"). What is the recommended category for a change of the “total thickness” for a blister foil?
The FDA finalized the guidance on voluntary recalls to help industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco products.
Brexit: Legal Proposals adopted on the Supply of Medicines in Northern Ireland, Cyprus, Ireland and Malta
The European Parliament and Council agree to proposals from the EU Commission to ensure the continued supply of medicines to Northern Ireland, Cyprus, Ireland and Malta. Both a directive and a regulation are now in place.
Currently there are no compendial standards available for metal packaging systems for pharmaceutical use. Thus any other guidance providing information on metal components like the revised EDQM technical guide “Metals and alloys used in food contact materials and articles” can be useful.
FDA Warning Letter: No Quality Unit, No Thorough Investigations and No Stability Program
The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a Californian firm that utilizes Contract Manufacturing Organizations (CMOs) to manufacture nasal spray products. The FDA criticises the lack of a quality unit (QU), an insufficient investigation into microbial contamination and an inadequate stability program.