Following the previously published Ph. Eur drafts for COC / COP, a new Ph. Eur. chapter 3.1.18. Styrene block copolymers for containers and closures for parenteral preparations and ophthalmic preparations has been proposed in Pharmeuropa.
FDA Warning Letter due to GMP Violations when handling OOS Results
During an inspection, FDA inspectors look closely at how quality control handles analytical data that deviates from the specification. Find out what is important to consider when handling OOS results, verifying test methods and checking electronic data.
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.
EDQM Survey: TOC to replace Test for oxidisable Substances in Sterile WFI
The EDQM has launched a survey on whether the test for oxidisable substances for sterilised water for injection (Sterile WFI) in the European Pharmacopoeia should be changed to a test for total organic carbon (TOC). Read more.
FDA Form 483 due to Delayed Stability Testing at a Sterile Injectable Manufacturing Site
In March 2022, the U.S. Food and Drug Administration (FDA) sent a Form 483 to Cadila Healthcare’s sterile injectable manufacturing site in Jarod, India. Among other observations, it came out that the stability program is not followed to complete the testing within the predefined time frame. Some tests were even delayed by more than 120 days.
Manufacturer of "Magic Heal" Receives FDA Warning Letter
In March 2022, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to an American over-the-counter (OTC) drug product manufacturer due to significant violations of Current Good Manufacturing Practice (CGMP). The violations were related to identity testing, training, calibration, qualification and quality unit oversight.
ICH Guidance Q14 / Q2(R2) - Analytical Method Development/Method Validation Published for Consultation
On March 24, the drafting process of the new ICH Guideline Q14 Analytical Procedure Development and the revised Guideline Q2(R2) Validation of Analytical Procedures reached Step 2, and both were published for consultation by ICH members.
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.