FDA Warning Letters in Fiscal Year 2021: Deficient Stability Tests Reason for most frequent Complaints
During an FDA inspection, the area of quality control is always closely investigated. This is reflected in the citations in the Warning Letters of the past fiscal year. Find out where the most frequent GMP violations occurred and what the FDA inspectors had to complain about with regard to stability tests on active ingredients and finished medicinal products.
ECA comments on FDA Guideline on Visual Inspection
In December 2021, the FDA published its long-awaited Draft Guideline on 100% Visual Inspection of Parenterals. Comments were accepted until mid-February 2022. Members of the Advisory Board of the ECA Visual Inspection Group took advantage of this opportunity and submitted numerous comments.
Proposal for Slightly Revised USP Chapter <711> Dissolution Published
In the Pharmacopeial Forum, PF 48(2), a proposal for a slightly revised Chapter <711> Dissolution was published. The purpose of the revision is to include an option of using a new USP Reference Standard, USP Dissolution Performance Verification Standard-Prednisone RS, to qualify the Dissolution Apparatus 1 and Apparatus 2.
USP: Second Stimuli Article on Instrument Qualification published for Comments
In the beginning of March 2022, the stimuli document "Measurement Uncertainty Evaluation Relevant to Analytical Instrument and System (AIS) Qualification - The Role of Measurement Uncertainty Concepts within the AIS - PF 48(2)" has been published on the USP Pharmacopeial Forum website for comment.
USP: Proposed Addition to Chapter <1236> Solubility Measurements
It is proposed to add the porcine simulated gastric and intestinal fluids in the subchapter on solubility measurements in biorelevant media. The new version of the chapter has now been published in the Pharmacopeial Forum, PF 48(2) for public comments.
Plastic Components Used in Manufacturing: USP extends Official Date for <665>
To address inquires and to give USP more time to engage with stakeholders regarding the suitability of making <665> an applicable general chapter, the USP intends to extend the official date for <665> to May 1, 2026.
WHO publishes Draft Working Document on Chromatography
The World Health Organization (WHO) has published a proposal for a new chapter 1.14.1 Chromatography for inclusion in The International Pharmacopoeia. Comments on this draft working document can be submitted until 25 March 2022.
The U.S. Food and Drug Administration (FDA) has published a Draft Guidance for Industry entitled Collecting and Providing 702(b) Portions of FDA Official Samples. The draft guidance is intended to assist FDA staff and industry with issues and questions related to the requirements for FDA to collect and provide portions of official samples under section 702(b) of the Federal Food, Drug, & Cosmetic Act (FD&C Act).
FDA Warning Letter: Combination of Returned Capsules from Various Lots into New Batches
The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a Californian drug manufacturer. During an inspection, it was observed that the firm combined returned capsules from various lots into new batches, resulting in new lots with no uniform character and quality. The FDA also criticizes the firm’s stability programme and validation activities.
Dissolution Testing in Pharmaceutical Analysis (Part 3)
The dissolution test is a key test parameter for assessing the performance of solid and semi-solid dosage forms in both drug development and quality control. This article provides a brief overview about the automation in dissolution testing.
USP: Analytical Instrument Qualification Stimuli published for Comments
Since the beginning of 2022, the stimuli document "Analytical Instrument and System (AIS) Qualification, to support Analytical Procedure Validation over the Life Cycle- PF 48(1)" has been published for comment on the USP Pharmacopeial Forum website.
Proposal for New General USP Chapter on Quality Attributes of Starting Materials for the Chemical Synthesis of Therapeutic Peptides
In the Pharmacopeial Forum, PF 48(1), a proposal for a new general chapter <1504> was published. According to the Expert Committee, the aim of the new chapter is to provide an overview of the minimum quality attributes required for starting materials used in the manufacture of synthetic therapeutic peptides.
Approved USP Chapters on Plastic Components used in Manufacturing
The new USP general chapters <665> and <1665> have now finally been approved. Chapter <665> establishes a baseline for the qualification of plastic components used in the manufacturing of pharmaceutical and / or biopharmaceutical drugs.