Process Validation

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.

The new sizes follow the 2014 launch of the company’s fully disposable purifier.

An ISPE guidance document, four years in the making, brings risk-based thinking, statistics, and Lean Six Sigma to cleaning validation.

The new column features Natrix’s signature macroporous hydrogel.

Presenters at IVT's Microbiology Week discussed best practices and recent guidance publications for microbial control in sterile and non-sterile pharmaceutical processes.

Pharmaceutical Technology spoke with Tim Kearns, pharmaceutical and medical devices manager at Videojet.

Medicago's new production facility will make plant-based vaccines and therapeutics.

The author reports results of evaluations and concludes that a disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.

At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.

The document serves as guidance for the pharmaceutical industry in data integrity issues and complements existing EU GMP relating to APIs and dosage forms.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

Industry awaits the final revision of USP General Chapter and the impact it will have on the evaluation of sterile product package integrity.

Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.

The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the manufacturing process following a change in the manufacturer.

McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.

The all-synthetic 3M Emphaze AEX Hybrid Purifier contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.

Working with biological matrices and understanding the intended use are crucial.

This article gives an overview of the concept and contents of the revised guidance and outlines how it has changed from the previous version.

New guidelines and best practices may lead to improved quality and reduced recalls due to visual defects.

Aurobindo Pharma USA issued a voluntary nationwide recall of Northstar Label Gabapentin Capsules, USP 300 mg, due to complaints of empty capsules.

The Baxter recall in the US of one lot of highly concentrated potassium chloride is due to a mislabeled overpouch.

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

An FDA warning letter to Hikma Pharmaceuticals cites violations of CGMP at its plant in Portugal that manufactures finished drugs.

Gerresheimer, a company with expertise in pharmaceutical and medical technology, announced that it is applying an integrated mold qualification and validation concept for a fast and cost-efficient time-to-market. The company notes that this approach provides process windows for reliable large-scale production and offers options for different deployment scenarios and qualification levels.

Understanding how to identify, remediate, and prevent facility infection is crucial for product quality.

Meggle Group Wasserburg has been granted an EXCiPACT certificate.

FDA found violations of cGMP at finished-drug manufacturer in India.

Baxter investigates root cause of cellulosic fibers and/or plastics in four lots of IV solutions.

Sun Pharma, Forest Pharmaceuticals and West-Ward Pharmaceuticals issue recalls over dissolution issues.