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GMPs/VALIDATION ARTICLES
GMPs for Small-Molecule Drugs in Early Development: Workshop Summary-Part VI
The authors explore and define common industry approaches and practices when applying GMPs in early development.
Using the Guard Band to Determine a Risk-Based Specification
A risk-based guard band surrounds a specification limit and is derived from the uncertainty of the reportable value of the analytical procedure, which includes the uncertainty in the reference standard. The author discusses requirements for generating a reportable value and calculating the associated measurement uncertainty.
Determining Facility Mold Infection
The recovery of an occasional mold does not merit any particular concern. On the other hand, evidence of mold proliferation indicative of infection of facilities or equipment must be taken seriously and requires the prompt implementation of corrective and preventive actions.
A Practical Approach of Implementing GMP for Excipients
Using a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.
Reducing False Out-of-Control Signals
Control charts that are properly constructed and maintained prevent false out-of-control signals and provide a useful method for monitoring a process.
GMPs/VALIDATION NEWS
Aurobindo Pharma USA Recalls One Lot of Gabapentin Capsules
Aurobindo Pharma USA issued a voluntary nationwide recall of Northstar Label Gabapentin Capsules, USP 300 mg, due to complaints of empty capsules.
Baxter Recalls One Lot of Highly Concentrated Potassium Chloride Injection
The Baxter recall in the US of one lot of highly concentrated potassium chloride is due to a mislabeled overpouch.
Hikma Pharmaceuticals Warned About CGMP Violations at Portuguese Facility
An FDA warning letter to Hikma Pharmaceuticals cites violations of CGMP at its plant in Portugal that manufactures finished drugs.
Gerresheimer Introduces Integrated Processes for Mold Qualification
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.
Meggle Receives EXCiPACT Certification
Meggle Group Wasserburg has been granted an EXCiPACT certificate.
GMPs/VALIDATION RESOURCES
Process Validation Strategy Templates
This strategy/validation plan defines what needs to be validation (i.e. equipment, systems, and processes) and how validation needs will be met for a given project.
Example Validation Master Plan
This Validation Master Plan serves as a summary of the overall strategy for the validation of a facility.
Traceability Matrix for Process Validation | IVT
Take a lesson for the CSV group. Add a traceability matrix to your documentation.
CROs Face Issues with Talent Retention
A recent survey shows that talent retention is an issue on industry level for contract research organizations (CROs), particularly for CROs located outside the United States.
Novartis Receives EU Approval for Juvenile Arthritis Treatment
Novartis Ilaris, an interleukin-1 beta inhibitor, treats active system juvenile idiopathic arthritis.
GMPs/VALIDATION EVENTS
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