Search Results for Data Integrity

Showing 1 – 25  of 48

FDA Warns Chinese OTC Drugmaker for GMP, Data Integrity Issues By Michael Mezher - Published 24 August 2017

The US Food and Drug Administration (FDA) has warned Chinese over-the-counter (OTC) drug and cosmetics maker Bicooya Cosmetics Limited over poor sanitary conditions and data integrity issues at its Zhejiang, China facility.

Categories: News, China, US, FDA, Over the counter drugs, Manufacturing

Tags: Warning Letter, Inspection, Data Integrity

FDA Warns Chinese API Maker for Data Integrity Issues By Michael Mezher - Published 21 June 2017

The US Food and Drug Administration (FDA) on Monday released a warning letter sent to active pharmaceutical ingredient (API) maker Qinhuangdao Zizhu Pharmaceutical for data integrity issues uncovered during an inspection of its Hebei province facility late last year.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing

Tags: Data Integrity

Asia Regulatory Roundup: CFDA Increases Drug Regulation Budget by 31% (11 April 2017) By Nick Paul Taylor - Published 11 April 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: data integrity, DCGI, pharma manufacturing, DRAP, stents

FDA Warns Two Drugmakers in China and India for Data Integrity Violations By Michael Mezher - Published 21 March 2017

The US Food and Drug Administration (FDA) has warned two drugmakers, USV Private Limited in Daman, India and Jinan Jinda Pharmaceutical Chemistry Co., Ltd. in Zhangqiu City, China, over data integrity and manufacturing issues uncovered during inspections last year.

Categories: News, China, India, US, FDA, APIs, Compliance, Drugs, Manufacturing

Tags: Data Integrity

FDA Warns Wockhardt Subsidiary, Says Seven of Company's Facilities Out of Compliance By Michael Mezher - Published 08 March 2017

The US Food and Drug Administration (FDA) has warned Wockhardt subsidiary Morton Grove Pharmaceuticals over quality control and data integrity issues.

Categories: News, US, FDA, Compliance, Drugs, Manufacturing

Tags: Warning Letter, Data Integrity

FDA Warns Megafine Over Data Integrity Violations at Second Facility By Michael Mezher - Published 07 March 2017

The US Food and Drug Administration (FDA) last month warned Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma Ltd. over data integrity and manufacturing violations at its Gujarat, India facility.

Categories: News, India, US, FDA, APIs, Drugs

Tags: Data Integrity

FDA Warns China API Manufacturer for Data Integrity Violations By Michael Mezher - Published 01 March 2017

The US Food and Drug Administration (FDA) in late February warned Fosun Pharmaceutical subsidiary, the formerly Chinese state-owned Chongqing Pharmaceutical Research Institute (CPRI), over data integrity issues.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs

Tags: Data Integrity

FDA Warns One Japanese, One Chinese Drugmaker By Michael Mezher - Published 18 January 2017

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to Japanese drugmaker Sato Yakuhin Kogyo Co. Ltd. and Chinese drugmaker Suzhou Pharmaceutical Technology Co., Ltd. earlier this month.

Categories: News, China, Japan, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing, Quality

Tags: Warning Letter, Data Integrity, Import Alert

FDA Warns Japanese API Maker Over Data Integrity Issues By Michael Mezher - Published 15 November 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Japanese active pharmaceutical ingredient (API) maker Sekisui Medical Co., Ltd. for a series of data integrity issues at the company's Iwate, Japan site.

Categories: News, Japan, US, FDA, Active pharmaceutical ingredients, APIs, Manufacturing

Tags: Data integrity

FDA Warns Teva’s Banned Hungary Manufacturing Facility By Zachary Brennan - Published 19 October 2016

The US Food and Drug Administration (FDA) has warned Teva’s Gödöllő, Hungary-based manufacturing site, citing deficiencies in manufacturing operations and laboratory controls, as well as the company’s data integrity program.

Categories: News, Europe, FDA, Compliance, Crisis management, Drugs, Government affairs, Manufacturing

Tags: warning letters, Teva, data integrity

'The Rooms Had Never Been Cleaned': Two New FDA Warning Letters for Chinese Manufacturers By Michael Mezher - Published 27 September 2016

The US Food and Drug Administration (FDA) has sent warning letters to two Chinese active pharmaceutical ingredient (API) makers over data integrity and good manufacturing practice (GMP) violations.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, APIs, Compliance, Drugs, Manufacturing

Tags: Data integrity, warning letter

ICH and Pharmaceutical Inspection Co-operation Scheme: No Expectations for China or India to Join By Zachary Brennan - Published 12 September 2016

While China and India continue to supply most of the world with pharmaceuticals (and continue to be plagued by quality and data integrity concerns), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and International Council on Harmonisation (ICH) – two of the largest international pharmaceutical regulatory schemes – say neither China nor India has any plans to join either group in the near future.

Categories: News, Asia, Europe, US, CDSCO, CFDA, FDA, ICH, Compliance, Crisis management, Drugs, Manufacturing

Tags: ICH, PIC/S, data integrity, pharmaceutical guidance, international pharmaceutical harmonization

FDA Warns Pan Over Data Integrity, Sanitation Issues By Michael Mezher - Published 07 September 2016

For the second time in less than a year, the US Food and Drug Administration (FDA) has issued a warning letter to Indian active pharmaceutical ingredient (API) maker Pan Drugs over data integrity and sanitation violations at one of its facilities.

Categories: News, India, US, FDA, Active pharmaceutical ingredients, APIs, Compliance, Drugs, Manufacturing

Tags: Data Integrity, Pan Drugs, Warning Letter

FDA Warns Indian API Maker Unimark for Deviations at Two Facilities By Michael Mezher - Published 24 August 2016

The US Food and Drug Administration (FDA) has issued a warning letter to active pharmaceutical ingredient (API) maker Unimark Remedies Ltd. for poor manufacturing controls and data integrity issues at two of its facilities in India.

Categories: News, India, FDA, Active pharmaceutical ingredients, APIs, Manufacturing

Tags: Unimark Remedies, Data Integrity, Lizard

Data Integrity: New Draft Guidance and Q&A By Zachary Brennan - Published 11 August 2016

The European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on Thursday released new draft guidance and a question and answer document to help ensure that data integrity is maintained during the process of testing, manufacturing, packaging, distributing and monitoring medicines.

Categories: News, Africa, Asia, Canada, Europe, Middle East, Oceania, US, EMA, FDA, Active pharmaceutical ingredients, Business Skills, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: PIC/S, data integrity of medicines during manufacturing, pharmaceutical manufacturing, GMP drug manufacturing

FDA Warns Two Chinese Drugmakers for Data Integrity Violations By Michael Mezher - Published 30 June 2016

The US Food and Drug Administration (FDA) has issued warning letters to two Chinese drugmakers over manufacturing and data integrity issues, including backdated tests and falsified records.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, APIs, Compliance, Drugs, Manufacturing, Quality

Tags: Data integrity, Warning letter

FDA Warns CMO’s Italy Site, Banned Indian API Manufacturer Over GMP Deficiencies By Zachary Brennan - Published 31 May 2016

Contract manufacturing organization (CMO) Corden Pharma’s Sermoneta, Italy-based site and Megafine’s active pharmaceutical ingredient (API) manufacturing site in Nashik, India, both received warning letters from the US Food and Drug Administration (FDA), which were released Tuesday.

Categories: News, India, Europe, US, FDA, Active pharmaceutical ingredients, Audit, Crisis management, Drugs, Manufacturing

Tags: FDA warning letter, Corden Pharma, Megafine, pharmaceutical data integrity

CDSCO Offers Risk-Based Checklist for Indian Pharma Manufacturing Inspections By Zachary Brennan - Published 26 May 2016

India’s Central Drugs Standards Control Organization (CDSCO) on Thursday released a new draft checklist and evaluation tool for pharmaceutical inspectors of manufacturing sites in India.

Categories: News, Asia, CDSCO, FDA, Active pharmaceutical ingredients, Compliance, Crisis management, Drugs, Government affairs, Manufacturing

Tags: Indian drug manufacturing, API manufacturing, data integrity

EMA Reviewing Indian CRO Semler After FDA Warns of Data Integrity Issues By Michael Mezher - Published 29 April 2016

The European Medicines Agency (EMA) on Friday announced it is reviewing all EU-authorized drugs that relied on studies conducted by contract research organization (CRO) Semler Research after recent inspections uncovered serious data integrity violations at its Bangalore, India facility.

Categories: News, India, Europe, EMA, FDA, WHO, Clinical, Generic drugs, Ethics, Preclinical, Submission and registration

Tags: Data integrity, Notice of Concern, Semler

FDA to Pharma Companies: Indian CRO’s Clinical and Bioanalytical Studies are Unacceptable By Zachary Brennan - Published 20 April 2016

Another day, another issue with data integrity. This time, however, the US Food and Drug Administration (FDA) is taking the issue one step further and notifying sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that clinical and bioanalytical studies conducted by Bangalore, India-based contract research organization (CRO) Semler Research are not acceptable as a result of data integrity concerns and need to be repeated.

Categories: News, India, US, FDA, Active pharmaceutical ingredients, Clinical, Compliance, Crisis management, Drugs

Tags: Indian data integrity, India CRO, FDA and India drug inspections

Another FDA Warning Letter for an Indian Drugmaker: More Data Integrity Violations By Zachary Brennan - Published 19 April 2016

The US Food and Drug Administration’s (FDA) interest in rooting out data integrity deficiencies among Indian pharmaceutical manufacturers continued this month with a warning letter issued to Hyderabad-based Sri Krishna Pharmaceuticals.

Categories: News, India, US, FDA, Compliance, Crisis management, Drugs, Manufacturing

Tags: data integrity, pharmaceutical drug manufacturing data, Indian drug manufacturing

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

EMA Assesses Concerns With Indian Generic Firm’s Clinical Data By Zachary Brennan - Published 06 April 2016

The European Medicines Agency (EMA) has begun a review of medicines for which studies have been conducted at Alkem Laboratories’s site in Taloja, India due to data integrity concerns.

Categories: News, India, Europe, US, EC, EMA, FDA, MHRA, Active pharmaceutical ingredients, Clinical, Compliance, Generic drugs, Due Diligence, Government affairs, Manufacturing, Research and development

Tags: data integrity, EMA review of clinical trials, Alkem Laboratories, GCP inspection

Asia Regulatory Roundup: China Looks to Protect Clinical Data Integrity (5 April 2016) By Nick Paul Taylor - Published 05 April 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, China, India, CDSCO, CFDA, MFDS, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs, Medical Devices, Postmarket surveillance

Tags: Asia Regulatory Roundup, clinical trial data integrity, compulsory licenses, FSSAI

MHRA Restricts GMP Certificate for Indian Pharma Company Over Data Integrity By Zachary Brennan - Published 18 March 2016

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) on Friday announced that because of more data integrity concerns, Marksans Pharma’s Goa, India-based facility will have a "Restricted GMP Certificate," allowing the company to only continue manufacturing and marketing products critical for the UK.

Categories: News, India, Europe, MHRA, Compliance, Drugs, Manufacturing

Tags: pharma data integrity, Indian drug manufacturing, Viagra generic