Search Results for cGMP

Showing 1 – 25  of 66

Compounding: FDA Details Policy Priorities for 2018, Finalizes Guidance By Michael Mezher - Published 18 January 2018

The US Food and Drug Administration (FDA) on Thursday released its priorities for addressing compounded drugs in 2018 after years of developing policies to improve its oversight.

Categories: News, US, FDA, Manufacturing

Tags: Compounding, Outsourcing Facilities, cGMP, Good Manufacturing Practice, Drug Quality and Security Act, DQSA

FDA Warns 5 Drugmakers in China, Australia and Austria By Zachary Brennan - Published 18 January 2018

The five warning letters sent from the US Food and Drug Administration (FDA) in December and January deal with violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals and active pharmaceutical ingredients (APIs).

Categories: News, US, CDER, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing

Tags: warning letter, cGMP violations

Numerous Complaints, Repeat Observations Fill FDA Warning Letter for Indoco By Zachary Brennan - Published 12 April 2017

Goa, India-based contract manufacturer Indoco Remedies received a US Food and Drug Administration (FDA) warning letter late last month after the agency said its failure to comply with current good manufacture practices (CGMP) may significantly affect the quality, safety and efficacy of the drugs it manufactures.

Categories: News, US, FDA, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: FDA warning letter, Indoco Remedies, cGMP

FDA Offers Final Guidance on CGMP Requirements for Combo Products By Zachary Brennan - Published 10 January 2017

The US Food and Drug Administration (FDA) on Tuesday released final guidance describing and explaining the current good manufacturing practice (CGMP) requirements for combination products, first released in January 2013.

Categories: News, US, FDA, Combination products, Regulatory intelligence, Regulatory strategy

Tags: CGMP, combo products, FDA guidance

FDA Warns Wockhardt for Destroying CGMP Documents, Other Violations By Zachary Brennan - Published 03 January 2017

The beleaguered Indian drug manufacturer Wockhardt is in trouble again with the US Food and Drug Administration (FDA), this time for destroying current good manufacturing practice (CGMP) documents, among a list of other major violations.

Categories: News, Asia, FDA, Active pharmaceutical ingredients, Compliance, Crisis management, Drugs, Due Diligence, Manufacturing

Tags: warning letter, Wockhardt, CGMP

FDA Warns Taiwanese Drug Manufacturer Over Significant cGMP Violations By Zachary Brennan - Published 07 June 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter for Taiwanese drug and contract manufacturer Ko Da Pharmaceutical over four specific violations.

Categories: News, China, FDA, Compliance, Drugs, Government affairs, Manufacturing

Tags: Taiwan drug manufacturing, cGMP violations, FDA warning letters

Data Integrity in cGMP Drug Manufacturing: FDA Offers New Draft Guidance By Zachary Brennan - Published 14 April 2016

The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance on Thursday to help the pharmaceutical industry ensure data is consistent and accurate.

Categories: News, Asia, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Compliance, Drugs, Manufacturing, Quality

Tags: data integrity, pharma manufacturing data, cGMP manufacturing pharmaceuticals

FDA Expresses Desire to Work With Industry on CGMPs for Combo Products By Zachary Brousseau - Published 15 April 2015

FDA officials and industry representatives discussed the agency’s draft guidance on current Good Manufacturing Practice (CGMP) for combination products during a workshop on the topic presented by RAPS and the Combination Products Coalition.

Categories: HTML, Video, Articles, Under RAPS, RAPS Events, US, FDA, RAPS, Combination products, Manufacturing

Tags: Food and Drug Administration, FDA, Weiner, combination products, combo products, CGMP, workshop, webcast, Combination Products Coalition

Drug Manufacturer Lacked Adequate Controls Over Manufacturing, FDA Warns By Alexander Gaffney, RAC - Published 11 March 2015

A Thailand-based active pharmaceutical ingredient (API) manufacturer has been warned by the US Food and Drug Administration (FDA) for failing to ensure that its manufacturing data could not be altered or falsified—claims similar to those levied against many Indian pharmaceutical companies.

Categories: News, US, CDER, Active pharmaceutical ingredients, Compliance, Manufacturing

Tags: Thailand, Data Integrity, CGMP

How do you Ensure the Proper Manufacture of a Combination Product? FDA Explains By Alexander Gaffney, RAC - Published 26 January 2015

New guidance issued by the US Food and Drug Administration (FDA) offers an extensive set of recommendations on how members of the pharmaceutical industry can comply with a rule regarding the proper manufacture of combination products.

Categories: News, US, FDA, Combination products, Manufacturing, Quality

Tags: Combination Products, CGMP, Quality, Guidance, Draft Guidance

FDA Warns Indian Generics Manufacturer Cadila Over Data Integrity Issues By Alexander Gaffney, RAC - Published 11 November 2014

The US Food and Drug Administration (FDA) has issued a stern warning to the Indian pharmaceutical manufacturer Cadila regarding various deficiencies at its drug production facility in Ahmedabad, including serious problems with the systems needed to ensure testing data isn't falsified.

Categories: News, India, US, CDER, Audit, Compliance, Drugs, Ethics, Manufacturing

Tags: Data Integrity, Cadila, CGMP, GMP, Warning Letter

India’s CDSCO Issues Guidance on How to Conduct GMP Inspections By Louise Zornoza, RegLink News - Published 08 August 2014

India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on 6 August 2014 to all local State Drugs Controllers setting forth uniform procedures on how to conduct good manufacturing practice (GMP) inspections of local pharmaceutical manufacturing facilities.

Categories: News, India, CDSCO, Biologics and biotechnology, Compliance, Drugs, Manufacturing, Quality

Tags: CGMP, GMP, Inspections

After Six-Month Dry Spell, FDA Finally Sends Warning Letter to Chinese Company By Alexander Gaffney, RAC - Published 18 June 2014

Unless you've been paying close attention, you'd be forgiven for missing one of the biggest stories at the US Food and Drug Administration (FDA) this year. While the agency has been sending letter after letter to manufacturers in India, until this week the agency hadn't sent a single Warning Letter to a company in China—a curious trend following the 38 sent to Chinese companies since 2008 and the six it sent to them last year alone.

Categories: News, China, US, CDER, Active pharmaceutical ingredients, Audit, Compliance, Manufacturing, Quality

Tags: Warning Letter, Inspection, CGMP

Regulators Again Find Data Integrity Problems at Indian Manufacturing Site By Alexander Gaffney, RAC - Published 17 June 2014

Nearly three months after Canadian generics firm Apotex was put on import alert by the US Food and Drug Administration (FDA), the agency has released the text of a Warning Letter issued to the company, highlighting alleged practices that led to some of the firm's products being banned from the US.

Categories: News, US, CDER, Active pharmaceutical ingredients, Ethics

Tags: Data Integrity, India, CGMP, Warning Letter

Sterility Concerns Lead to Warning Letter, Import Alert for German Pharmaceutical Manufacturer By Alexander Gaffney, RAC - Published 20 May 2014

The US Food and Drug Administration (FDA) has sent a Warning Letter to German-based pharmaceutical manufacturer SANUM-Kehlbeck GMbH & Co alleging that it violated current good manufacturing practices (CGMP) at its Hoya, Germany facility.

Categories: News, US, CDER, Audit, Compliance, Drugs, Manufacturing, Quality

Tags: FDA, Drug, Pharmaceutical, Penicillin, CGMP, Registration

Warning Letter to Allergy Manufacturer Cites Insects, Unapproved 'Custom Mixes' By Alexander Gaffney, RAC - Published 06 May 2014

Categories: US, FDA

Tags: warning letter, Insect, BLA, Latest News, cGMP

"Our Lady's Tears" Brings Warning Letter to Supplement Maker By Alexander Gaffney, RAC - Published 16 April 2014

Categories: US, FDA, Labeling

Tags: 21 CFR 101.4(h), Dietary Supplement, warning letter, Latest News, cGMP

Brazil Expedites Device Imports By Louise Zornoza, RegLink - Published 15 April 2014

Categories: Regulatory Update, Anvisa

Tags: Medical Device Single Audit Program, MDSAP, CBPF, Import, brazil, cGMP, medical device

FDA Warning Letter Hits GSK for Contaminated API, Reproducibility Challenges By Alexander Gaffney, RAC - Published 01 April 2014

Categories: US, FDA

Tags: GSK, warning letter, Contamination, Latest News, cGMP

FDA Finds 'Significant' Problems at API Manufacturer By Alexander Gaffney, RAC - Published 12 February 2014

Categories: US, FDA

Tags: warning letter, Latest News, Excipient, cGMP, API

Woodcock to Legislators: FDA Has Limited Role to Play in Advancing Manufacturing By Alexander Gaffney, RF News Editor - Published 13 December 2013

Categories: US, FDA, Manufacturing

Tags: Janet Woodcock, Latest News, pharmaceutical, cGMP, drug

Paintbrush, Cardboard and Black Residue Earn Supplement CMO a Warning Letter By Alexander Gaffney, RF News Editor - Published 24 October 2013

Categories: US, FDA

Tags: Dietary Supplement, warning letter, cGMP

Trust but Verify: Supplement Manufacturer's Reliance on Trust not Sufficient to Meet CGMPs, Says FDA By Alexander Gaffney, RF News Editor - Published 11 September 2013

Categories: US, FDA

Tags: Dietary Supplement, warning letter, trust, cGMP

After Trio of Disastrous Inspections, Company Enters into Consent Decree with FDA, DOJ By Alexander Gaffney, RF News Editor - Published 27 August 2013

Categories: US, DOJ, FDA

Tags: Sterile, Lawsuit, Consent Decree, Latest News, cGMP

New Warning Letters to Indian Manufacturers Again Find CGMP Violations, Falsified Test Results By Alexander Gaffney, RF News Editor - Published 20 August 2013

Categories: India, US, FDA

Tags: warning letter, manufacturer, testing, cGMP, records