Article archive

Good manufacturing practice: data integrity definitions by MHRA

23/01/2015 22:37
Medicines and Healthcare products Regulatory Agency (MHRA) good manufacturing practice data integrity expectations for the pharmaceutical industry.Document: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/397853/Data_integrity_definitions_and_expectations_v3_4__ack.pdfThis...

ISO 9001: 2008 Quality Management Systems – Requirements

23/01/2015 20:58
ISO 9001:2008

USFDA 483s Published in 2014 by USFDA

23/01/2015 20:41
The ORA (Office ofRegulatory Affairs) ElectronicReading Room displays FDA 483's copies. USFDA is making these records publiclyavailable either (1) proactively at USFDA's discretion or (2) because they are"frequently requested" per the Electronic Freedom of Information ActAmendments of 1996. Some...

GMP Non-compliance reports (North China Pharmaceutical Group Semisyntech Co., Ltd, China) Published by EMA

23/01/2015 20:36
Non-compliance report of North China Pharmaceutical Group Semisyntech Co., Ltd by French National Agency for Medicines and Health Products Safety...

GMP Non-compliance reports (AGEPHA, Austria) Published by EMA

23/01/2015 20:32
The recent 'GMP non-compliance report' issued and published by...

USFDA Inspections/483s Dashboard

04/01/2015 01:07
FDAzilla's Inspections Database and 483 Listings have been merged as of November 2013.  Form 483s are issued out of inspections and raw numbers mean less when ratios tell a more important story.  Below is a bar chart of inspections by month; the height of the bar represents the number of...

USFDA Warning Letter to Novacyl Wuxi Pharmaceutical Co., Ltd. 12/19/14

04/01/2015 00:53
USFDA issued warning letter to Novacyl Wuxi Pharmaceutical Co., Ltd., an API & FinishedProduct manufacturer in China and let us assess our existing controls againstthese cGMP deviations/ violations.Summary of cGMP Violations:API: CGMP DEVIATION1.    Failure to...

Delegated Regulation on GMP for APIs published in the Official Journal of the EU

04/01/2015 00:16
Article 47 of Directive 2001/83/EC (Community code relating to medicinalproducts for human use) requires that the EU Commission enforces principles andguidelines of good manufacturing practice for medicinal products and APIs. Thelatter should be adopted in the form of a delegated act (wording of...

Elemental impurities: ICH Q3D has reached step 4 (final guideline)

04/01/2015 00:04
Elemental impurities (=heavy metals) play a key role in the update of the ICH Q3X series of regulations. ICH Q3D, which is aiming to control the level of metal impurities in medicinal products, has now reached step 4 (final guideline) after step 2b was entered in July 2013. The guideline consists...

Seetharam Kandarpa Receives ASQ Quality Auditor

03/01/2015 22:40
Milwaukee, Wis., 12/06/2014 - The Certification Board of ASQ (American Society for Quality) is pleased to announce that Seetharam Kandarpa has completed the requirements to be named an ASQ-Certified Quality Auditor, or ASQ CQA.As such, Seetharam Kandarpa has reached a significant level of...
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