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Implementing an Automated DOE in Twin Screw Wet Granulation
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Parexel Announces CEO Transition
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SCHOTT Pharma Invests $371M in U.S. Prefillable Syringe Mfg. Facility
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The High Five: Key Regulatory Topics for Drug Development in 2024
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Inspections
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Filtration & Purification
GMPs/GCPs
Inspections
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Validation
Inspections
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QA/QC
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Regulatory Affairs
Regulatory Affairs: FDA’s Office of Compliance Issues FY 2023 Annual Report
Issued 170 warning letters and monitored 264 drug recall events during the year.
Bob Pollock, Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc.
02.01.24
Breaking News
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Facilities
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GMPs/GCPs
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Industry News
|
Inspections
|
QA/QC
Crystal Formulations Services Passes EU QP Audit
Crystal Pharmatech’s CDMO business unit poised for global growth.
01.31.24
Inspections
|
Regulatory Affairs
FDA Inspections & Compliance Trends
A look back at 2023 and what 2024 will bring.
Online Exclusives
Ben Locwin , Contributing Writer
01.26.24
Biologics, Proteins, Vaccines
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Breaking News
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cGMP Manufacture
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Industry News
|
Inspections
|
QA/QC
FDA Finds QC Failures at Moderna's Norwood Mfg. Facility
Form 483 report obtained by Reuters notes five separate observations including equipment issues and expired items.
12.18.23
Breaking News
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cGMP Manufacture
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Drug Development
|
Facilities
|
Industry News
|
Inspections
|
QA/QC
WuXi Vaccines Clears First GMP Audit
Resulted in no critical observations and will allow WuXi Vaccines to proceed with GMP manufacturing for the client's projects.
12.13.23
Breaking News
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GMPs/GCPs
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Industry News
|
Inspections
|
QA/QC
Intas Pharmaceuticals Receives Another Warning Letter from FDA
Cites failure to ensure drug products manufactured at Gujarat, India plant comply with cGMP.
12.01.23
Biologics, Proteins, Vaccines
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Breaking News
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cGMP Manufacture
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Drug Development
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Fill/Finish
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GMPs/GCPs
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Industry News
|
Inspections
|
QA/QC
Symbiosis Granted MHRA License Following Expansion
Adds 3,600 ft² of new space, expanding GMP operational footprint at Stirling Innovation Park in Scotland.
11.21.23
Breaking News
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cGMP Manufacture
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Industry News
|
Inspections
Vetter’s Rankweil Site Receives Permanent Manufacturer’s Authorization
Austrian site supports manufacturing and quality control of Human Investigational Medicinal Products.
11.09.23
cGMP Manufacture
|
GMPs/GCPs
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Inspections
Get Ready for a New Approach to cGMP Inspections
ANDAs, Biosimilars, BLA, FDA, Generics, NDA Regulatory Affairs
Bob Kelly, Principal Consultant, Lachman Consultant Services, Inc.
10.27.23
Breaking News
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Drug Development
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Drug Discovery
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Facilities
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Industry News
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Inspections
Dipharma Receives 2nd GMP Certification from Brazilian ANVISA
The Caronno Pertusella site is the second Dipharma facility to receive ANVISA certification.
10.26.23
Breaking News
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cGMP Manufacture
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Drug Development
|
Industry News
|
Inspections
Quotient Sciences Concludes FDA Inspection of UK Facility
For the validation of three bioequivalence studies supporting licensing applications with the FDA.
10.05.23
Breaking News
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cGMP Manufacture
|
Drug Development
|
Facilities
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Industry News
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Inspections
Rentschler Biopharma’s ATMP UK Facility Receives MHRA Approval
Facility offers services from early process and analytical development through cGMP manufacturing for clinical trials.
09.13.23
APIs
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Breaking News
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cGMP Manufacture
|
Facilities
|
Industry News
|
Inspections
Aurisco's Manufacturing Site in China Clears FDA Inspection
Site offers CDMO services and generic APIs.
08.23.23
APIs
|
cGMP Manufacture
|
Facilities
|
Industry News
|
Inspections
|
QA/QC
Understanding the Causes & Impact of Drug Scarcity
The reasons behind drug shortages can range from supply and demand, manufacturing and regulatory issues, to discontinuations.
Online Exclusives
Kristin Brooks, Managing Editor, Contract Pharma
08.08.23
Inspections
|
QA/QC
|
Regulatory Affairs
FDA 2023 Inspection Roadmap: Is “Readiness” in Your Annual Objectives?
Insights from the regulatory experts at Lachman Consultants.
Patrick Day, M.S., Principal Consultant, Lachman Consultants
05.25.23
Inspections
FDA Inspection Preparation
How to get ready for an FDA inspection – important things to know when preparing for an FDA inspection.
Tamil Arasu, Principal Consultant, Lachman Consultants
04.04.23
GMPs/GCPs
|
Inspections
|
QA/QC
|
Regulatory Affairs
Pharmaceutical Recall Trends to Watch in 2023
2022 was a record-breaking year for the number of units recalled, up 114% over 2021.
Online Exclusives
Kristin Brooks, Managing Editor, Contract Pharma
03.31.23
Facilities
|
Inspections
|
Solid Dosage/Creams/Ointments
Lannett CDMO: Delivering on Expectations
The CEO of Lannett Company, Inc., talks about stepping up the visibility of its CDMO organization and showcasing the world-class capabilities supporting it.
Sponsored
released by
Lannett CDMO
03.17.23
Aseptic Processing
|
Breaking News
|
Facilities
|
Industry News
|
Inspections
Grand River Aseptic Manufacturing Receives Zero Observations from FDA Inspection
Aiding in the supply of Bavarian Nordic’s JYNNEOS.
03.17.23
Breaking News
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Industry News
|
Inspections
|
QA/QC
Altasciences Los Angeles Clinical Site Receives CAP Accreditation
The three-year accreditation cycle, includes on-site inspection, desk review, and optional education modules and gap assessment.
11.01.22
Breaking News
AGC Biologics to Manufacture Orchard Therapeutics’ Lenmeldy
Hovione, GEA Advance Continuous Tableting Technology Partnership
Parexel Announces CEO Transition
DifGen Acquires FDA-Registered Manufacturing Facility
Quotient Sciences Makes Executive Leadership Team Appointments
View Breaking News >
CURRENT ISSUE
March 2024
Implementing an Automated DOE in Twin Screw Wet Granulation
Sustainable Pharmaceutical Packaging
Pre-filled Syringe Packaging Trends
Liquid Pharmaceutical Filling: Small, Smaller, Micro Batches
Newsmakers Q&A: BioVectra
Multi-particulate Formulations – Tablets or Capsules?
Manufacturing Equipment Trends
OSD Outsourcing: Savvy CMOs Hone Skills as Complex APIs Fuel Demand
Catalent Acquisition by Novo Holdings: Evolution of the Industry(?)
The Road Ahead for CDMOs in 2024
View More >