Pharma Journal

03/07/2025

https://youtu.be/xbSjzSy4vu0?si=RYhorpVqr0yNHpAH

FDA on Quality Matrices and Quality culture

Tara Gooen from CDER’s Office of Pharmaceutical Quality discusses a set of quality metrics which may be useful for manufacturers without a current quality me...

02/11/2023

22/10/2023

22/10/2023

Pharma player Granules India has inked a memorandum of understanding (MoU) with ..

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Medicine: This CoE will focus on crucial areas such as exploring plant-based excipients, advancements in polymer-free pharmaceutical formulations, innovative methods in producing directly compressible crystals, promotion of solvent-free pharmaceutical processes, and the development of resource-effic...

21/10/2023

Nector Lifesciences unit at Himachal Pradesh Plant has received untitled letter from FDA for repeated GMP violations.

The untitled letter, published by the FDA on Wednesday, reveals that some observations had been previously noted during an inspection back in January 2014, with inspectors noting that “repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

Indian API manufacturer Nectar Lifesciences late last month received an untitled letter from the FDA over repeat GMP violations, the FDA said, following a seven-day inspection at its Unit VI site in Himachal Pradesh, India, last March. During the inspections, the FDA uncovered improper aseptic manuf...

13/10/2023

Science News: On Thursday, Dr. Reddy's Laboratories, a prominent pharmaceutical company, disclosed to the stock exchanges that it has been issued a Form 483 contain

13/10/2023

FDA Publishes Draft Guidance on Quality Considerations for Topical Ophthalmic Drug Products
FDA is announcing a new draft guidance for industry, Quality Considerations for Topical Ophthalmic Drug Products. Ophthalmic drug products refer to any FDA-regulated drug products that are used for topical delivery around the eye such as solutions, suspensions, emulsions, gels, ointments or creams.

This draft guidance articulates important quality considerations for ophthalmic topical drug products, including:

approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products;
use of in vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms;
recommendations for design and delivery dispensing features of container closure systems; and
recommendations for stability studies.

The guidance applies to ophthalmic drug products approved under new drug applications, abbreviated new drug applications, biologics license applications, as well as to over-the-counter monograph drugs.

To read the guidance and for more information on how to submit comments to the docket, visit the guidance page.

Quality Considerations for Topical Ophthalmic Drug Products

12/10/2023

Continued Process Verification (CPV) was introduced roughly 12 years ago by the FDA as a third stage in the guidance on the process validation life cycle.

In addition to being a mandatory requirement for the pharmaceutical industry, CPV can also provide valuable information to improve the quality and consistency of products. There may be limited data available when a process is designed and validated that was used for deriving different parameters, including control limits.

As more process data gets generated, implementation of the CPV will provide insights into the variability of the characteristics and potential causes for it, which are crucial to maintaining product quality.

For more such updates, follow the channel.

12/10/2023

Spectrum Laboratories is the new API manufacturer hit with FDA form 483.

The form 483 has 14 deficiencies. Of the 14 observations noted, six are attributed to manufacturing process deficiencies and five are related to documentation issues.

The other observations noted problems in addressing customer complaints, lack of sufficient employee training and failure to investigate or resolve any “critical deviations,” such as freezer temperature issues.

Manufacturing issues included risks of cross-contamination of APIs and non-APIs when repackaging products as well as failures to validate cleaning processes, microbiological and analytical test methods.

Spectrum Laboratory Products is the latest API manufacturer to receive an FDA Form 483 following an inspection. The 483 includes 14 deficiencies from seven inspections between February and March of this year. The 13-page document, published October 5, details how the FDA carried out four inspections...