EMA's document on the implementation of ICH Q3D for already marketed products contains essential recommendations for marketing authorisation holders. Learn why risk assessments with regard to elemental impurities for existing marketed products are so important and how to decide about the necessity of a variation procedure.
To maintain the qualified state of a pharmaceutical water system, a reliable maintenance plan is necessary. This is an official requirement, though it does also make sense from an operational viewpoint. Maintenance intervals based on the criticality of individual components are usually defined during qualification. But what is the rule here?
The current edition of the Swissmedic Journal 05/2017 and the Technical Interpretation I-SMI.TI.17 specify the requirements with regard to the independence and the obligation of presence of the Swiss QP.
The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) updated the Guidance for Industry "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)".
In March 2017, the FDA published another Warning Letter to an Indian pharmaceutical manufacturer due to GMP violations. The letter describes findings with regard to complaint handling, leaking of sterile products and the corresponding CAPA processing as well as on the non-compliance with quality agreements.
Incorrect sampling has led to an FDA Warning Letter for an API manufacturer in China. The FDA inspectors criticised that around 10% of the API batches manufactured exceeded the impurity limit set. Read more about this FDA Warning Letter.
A recent FDA Warning Letter cited a lack of scientifically sound and appropriate sampling plans for inspection. It stated that the company had no scientific justification for the number of reserve samples selected for the yearly visual examination aimed at identifying any evidence of drug product deterioration. Similarly, the company lacked appropriate statistical sampling plans for the inspection of paper label rolls.
Even 17 years after the publication of the ICH Q7 Guideline, some companies still manufacture without complying with the most important binding GMP instructions and recordings. Read more about what minimal GMP requirements FDA inspectors expected but couldn't find at Changzhou Jintan Qianyao.
To avoid a supply shortage, batches of a lyophilisate manufactured by the company Jazz Pharmaceuticals which possibly contain visible particules are to be visually checked before administration and additionally filtered through a 5 µm strainer.
The Indian company Sal Pharma has received a Warning Letter due to serious deficiencies with regard to the procurement and storage of APIs, their distribution and disguising information. Read more about what makes the non-transparency of the API supply chain and the procedures highly suspect for the FDA inspectors.
A manufacturer of sterile ophthalmics in Singapore has recently received a Warning Letter of the US FDA. Container leaks and the associated risk of microbial contamination were the main points of criticism.
The USP proposes two new general chapters <665> and <1665> to address the qualification of polymeric components used in the manufacture of pharmaceutical and biopharmaceutical APIs and drug products. Chapter <665> was previously published as Plastic Components and Systems Used in Pharmaceutical Manufacturing <661.3>. Read more about the proposals for Polymeric Components and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products and Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products.
Because of various severe GMP violations, the FDA issued a warning letter to an American manufacturer of wound disinfactants. The authority especially criticised deviations in monitoring of microbiological environments. Read the more about the Warning Letter to Aplicare from December 2016.
An article from April reported about the publication of inspection results by the British MHRA for 2016. Amongst other things, this publication addresses deficiencies concerning validation/qualification.
Revised USP general chapters <660> and <1660> have been published for comment in the Pharmacopeial Forum. Read more about the drafts for Containers-Glass and Evaluation of the Inner Surface Durability of Glass Containers.
During an FDA inspection at the Kansas-based company Hospira in mid 2016, the FDA encountered several GMP violations which resulted in a Warning Letter. The GMP deficiencies concerning visual inspection as well as the handling of distributed batches which were contaminated with particles even lead to the assertion that the company's process of manufacturing injectable products was out of control.
In the course of an FDA inspection at a Brazilian manufacturer of antibiotics, the inspector observed a few serious GMP violations which led ultimately to a Warning Letter. Read more about the FDA Warning Letter issued to the company Antibioticos Do Brasil Ltda.