Elastomers for Pharmaceutical Packaging and Manufacturing
Following the recently adopted USP general chapter <665> for plastic materials used in manufacturing, the USP now published two draft chapters for elastomers for pharmaceutical packaging and manufacturing.
Chapter 5.21 "Chemometric Methods Applied to Analytical Data" to be Published in Ph. Eur. 11.1
During its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of general chapter 5.21. Chemometric methods applied to analytical data to be published in Ph. Eur. Supplement 11.1 and be effective as of 01 April 2023.
EDQM updates List of available Reference Standards
Also in March, the list of available reference standards, which comprises more than 3.000 substances, was revised - and the resulting changes, innovations and updates were listed in the newsroom of the EDQM website.
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: Testing into Compliance using Unvalidated Test Methods
The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to an American drug manufacturer. The company retested failing lots with unvalidated test methods until passing results were obtained. Other deficiencies concern the cleaning validation, the stability program and HPLC data integrity.
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.