GMPs/GCPs

Breaking News | GMPs/GCPs | Industry News

TATAA Biocenter Awarded GLP Accreditation

The company can now support clients through all development stages and regulatory filings.

04.16.24

Analytical Services | GMPs/GCPs | Laboratory Testing | QA/QC

Never Assume!

Analytical insights from the NIR Professor.

Online Exclusives Emil W. Ciurczak, Contributing Writer 03.04.24

Crystal Formulations Services Passes EU QP Audit

Crystal Pharmatech’s CDMO business unit poised for global growth.

01.31.24

Breaking News | GMPs/GCPs | Industry News

Thermo Fisher’s Monza Mfg. Facility Receives GMP Approval

Italian Medicines Agency certification allows the company to manufacture RNA-based therapies and vaccines.

01.19.24

Crystal Pharmatech's CDMO Unit Obtains GMP/GDP Certification

Meets requirements in technical capabilities, quality management systems, compliance, and facility construction.

12.06.23

Breaking News | GMPs/GCPs | 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

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

cGMP Manufacture | GMPs/GCPs | 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 | Drug Development | Formulation Development | GMPs/GCPs | Industry News

Crystal Pharmatech's CDMO Business Unit Receives China Drug Product Manufacturing License

The license marks an important milestone in expanding and upgrading the company's service capabilities.

04.19.23

Breaking News | Cytotoxics and High Potency Manufacturing | Fill/Finish | GMPs/GCPs | Industry News

Ajinomoto Bio-Pharma Services Gets FDA Approval for High Potency Fill Line

The company has six fill-finish lines that offer a range of configurations, including prefilled syringes, cartridges, and vials.

04.19.23

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

Bio News | Breaking News | GMPs/GCPs | Industry News

ExoCoBio Obtains 2 GMP Licenses for Exosome Biopharmaceuticals

Advanced biopharmaceutical manufacturing license was obtained from Korean and Brazilian regulators.

03.03.23

Biologics, Proteins, Vaccines | Breaking News | GMPs/GCPs | Industry News

Polyplus Strengthens CGT Production Capabilities

Announces GMP accreditation for DNA production at Xpress Biologics’ Belgian facility.

03.01.23

Breaking News | Clinical Trials | Drug Development | GMPs/GCPs | Trials & Filings

Pfizer, Valneva Drop Half of Participants in Phase III Lyme Disease Vax Trial

Participants in the trial are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites.

02.21.23

Chime Biologics Receives Commercial Manufacturing License

GMP commercial manufacturing license authorized by the China's NMPA demonstrates capabilities in large scale commercial production.

08.02.22

WuXi Vaccines Receives GMP Certificate from HPRA

Marks the first GMP certificate for its QC potency lab from Ireland’s drug manufacturing regulator.

07.18.22

Drug Development | GMPs/GCPs | Regulatory Affairs

Why is Big Pharma Increasingly Adopting 505(b)(2)?

USFDA 505(b)(2) pathway submissions (“(b)(2)s”) can be advantageous because they offer the potential for the accelerated approval of patient-centric medicines.

06.16.22

Clinical Trial Materials | Cold Chain Management | GMPs/GCPs | Supply Chain

Sentry Biopharma Services: Protecting Pharmaceutical Integrity

Sentry Biopharma Services protects the integrity of temperature sensitive biopharmaceutical products during the clinical and commercial phases of development.

Videos06.13.22

cGMP Manufacture | GMPs/GCPs