New Approach for Dissolution or Disintegration Tests in Ph. Eur. Monographs to be Published in Supplement 10.6.
A new policy for dissolution and disintegration testing in European Pharmacopoeia (Ph. Eur.) monographs has been adopted at the 168th session of the European Pharmacopoeia Commission (November 2020). A dissolution or disintegration test will be included in each medicinal product monograph on an immediate-release solid dosage form.
FDA Warning Letter: No Adequate Quality Unit, Laboratory Controls, Sampling Plans, and Stability Program
The U.S. Food and Drug Administration (FDA) recently sent a warning letter to a US over-the-counter (OTC) drug manufacturer due to significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
The United Nations (UN) Commission on Narcotic Drugs (CND) has decided to reclassify cannabis. With this, the Commission followed the WHO recommendation of 2019.
Will Cannabidiol be controlled as a narcotic in the future? This question is currently intensively discussed. The European Court of Justice recently released their opinion.
FDA Warning Letter for not Adequately Testing Components prior to Use in the Manufacture
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Mexican manufacturer. According to the FDA, the firm did not adequately validate the process and qualify the equipment used to manufacture the drug products. Furthermore, the company did not adequately test components prior to use in the manufacture of drug products destined for the US market.
Updated version of APIC's "How to do"- Document on GMPs for APIs
The updated version of the paperback "ICH Q7 Side-by-Side Comparison", which lists and compares the "ICH Q7 Guideline - GMP for Active Pharmaceutical Ingredients" with the "How to do"- Document - Interpretation of ICH Q7 Guide and "Review form" on GMPs for APIs, is now available.
Can Cannabis be Imported into the EU without GMP Certification?
The answer to this question is: It depends. Recently, medical cannabis grown in a non-EU-GMP-certified facility in Uruguay became available on the German market.
The requirement for a "written GACP declaration" is contained in the current draft of the EMA HMPC Guidance Document "Quality of Herbal Medicinal Products". However, some questions remain: Who creates the declaration and what does it look like?
Nitrosamine Impurities in Medicinal Products and APIs - the New FDA Guidance
The new FDA Guidance for industry reflects the current state of knowledge regarding nitrosamine impurities. Read more here about what measures the FDA expects from medicinal products and API manufacturers to take to mitigate the risk of nitrosamine contamination.
The US Food & Drug Administration (FDA) explicitly explains the deficiencies in the area of quality control in its Warning Letter for the company "Signa SA de CV".
FDA Warning Letter to Homeopathic Product Manufacturers due to Quality Issues
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Washington Homeopathic Products, Inc. due to specific violations of CGMP regulations. These violations include failure to establish an adequate quality control unit, failure to conduct at least one test to verify the identity of each component of a drug product, and failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods.
Once again, the lack of laboratory data integrity, beside other observations, caused the issuance of a US-American FDA Warning Letter and resulted in deficiencies mainly focused on the solvent recovery processes.
The Good Distribution Practice for Active Substances Guidance on interpretation and implementation has been published as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute.