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Filtering on: "topics manufacturing"

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Updated FDA Manual Offers Inside Look at Inspection Protocols By Zachary Brennan - Published 18 October 2017

The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations manual on establishment inspections, offering an inside look at how inspections are conducted and what companies should expect.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: FDA inspections, contamination, sterile environments

Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports By Zachary Brennan - Published 16 October 2017

Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes to be documented in annual reports.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: CMC changes, BIO, Sanofi, Pfizer, GSK, AAM

European Commission Adopts Two Acts on GMPs for Medicines By Zachary Brennan - Published 10 October 2017

Last month, the European Commission adopted two legal acts seeking to improve patient safety through good manufacturing practices (GMP) that ensure the highest quality of medicines for investigational and human use.

Categories: News, Europe, EC, Biologics and biotechnology, Drugs, Manufacturing

Tags: good manufacturing practices, implementing directive, delegated regulation, GMPs for investigational medicines

Continuous Manufacturing: Pfizer, Vertex, AstraZeneca and Others Weigh FDA Plans By Zachary Brennan - Published 04 October 2017

The US Food and Drug Administration (FDA) has been encouraging the adoption of continuous manufacturing techniques for years, and several companies recently offered the agency some suggestions to refine its work around the developing technology.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Manufacturing

Tags: continuous manufacturing, Pfizer, AAM, Vertex, AstraZeneca

FDA Warns Korean Drugmaker Over Testing, GMP Issues By Michael Mezher - Published 03 October 2017

The US Food and Drug Administration (FDA) has warned South Korean drugmaker Dasan E&T Co. Ltd. over product testing issues following an inspection of its Gimpo, Kyonggi-do facility in January.

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

Tags: Warning Letter, GMP

FDA Finalizes Guidance on Emerging Manufacturing Tech Program By Michael Mezher - Published 28 September 2017

The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing how drugmakers can participate in the agency's program to advance the use of emerging manufacturing technologies, such as continuous manufacturing or 3D printing.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Manufacturing, Submission and registration

Tags: Emerging Technology, Continuous Manufacturing, Guidance

Asia Regulatory Roundup: TGA Shares Guidance, Tool to Help Companies Navigate GMP Clearance Process (26 September 2017) By Nick Paul Taylor - Published 26 September 2017

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

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Compliance, Drugs, Manufacturing, Submission and registration

Tags: Asia Regulatory Roundup, Regulatory Roundup, Pakistan

FDA Warns Chinese Drugmaker Over Fake Test Results, Blocking Access to Inspectors By Michael Mezher - Published 26 September 2017

The US Food and Drug Administration (FDA) has warned Chinese drugmaker Shandong Vianor Biotech for violating good manufacturing practice (GMP) requirements following an inspection of the firm's Linyi, Shandong facility last May.

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

Tags: Good Manufacturing Practice, GMP, Warning Letter

MedTech Industry Sees Challenges in Restarting Operations, Helping Puerto Rico By Zachary Brennan - Published 25 September 2017

With more than three million Americans in Puerto Rico facing no electricity because of Hurricane Maria, medical device and biopharmaceutical companies are doing what they can to work with the US government to help their employees and restart operations.

Categories: News, US, Drugs, Manufacturing, Medical Devices

Tags: AdvaMed, Department of Commerce, Puerto Rico

Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable' By Zachary Brennan - Published 22 September 2017

A generic drug industry group and several companies have taken issue with recent US Food and Drug Administration (FDA) draft guidance on pre-submission facility correspondence (PFC) that spells out what companies need to do to obtain faster reviews for generic drugs.

Categories: News, US, FDA, Generic drugs, Government affairs, Manufacturing

Tags: Pre-submission facility guidance, FDA draft guidance, priority generic drug reviews

Mistake-Proofing the Workplace By Zachary Sherman, Max Sherman - Published 22 September 2017

This article discusses mistakes, or human errors, made in the pharmaceutical or medical device workplace and provides the definition of a mistake. The authors also present how mistakes are made, whether such errors are the actual "root cause" of defects, the social and company consequences of errors, and what can be done to minimize errors.

Categories: Features, Compliance, Manufacturing, Quality

Tags: Errors, Defects, Quality

FDA Warns Korean, Chinese Drugmakers By Zachary Brennan - Published 19 September 2017

The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent recently to Korea-based Firson Co. and China's Wuxi Medical Instrument Factory detailing the firms' violations.

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

Tags: FDA warning letters, Wuxi Medical, Firson

ICH Advances Q&A on Drug and Biologic Starting Materials By Michael Mezher - Published 07 September 2017

The International Council for Harmonisation (ICH) on Wednesday advanced a questions and answers guideline aimed at clarifying expectations for selecting and justifying starting materials for drug and biologic manufacturing.

Categories: News, ICH, Biologics and biotechnology, Drugs, Manufacturing

CDRH Releases 8 Warning Letters for Foreign, US Device Manufacturers By Zachary Brennan - Published 06 September 2017

About a week after the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) was criticized for sending a historically low number of warning letters so far in 2017, a flood of new letters were released Wednesday.

Categories: News, Asia, Europe, US, CDRH, Manufacturing, Medical Devices

Tags: warning letters, medical device warnings

FDA Warns Indian Contract Manufacturer Hetero Labs By Zachary Brennan - Published 29 August 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to India-based contract manufacturer Hetero Labs’ manufacturing site on the outskirts of Hyderabad for significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

Categories: News, India, FDA, Drugs, Due Diligence, Manufacturing

Tags: Hetero Labs, FDA warning letters

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

EMA and FDA to Begin Sharing Commercially Confidential Information By Zachary Brennan - Published 23 August 2017

As part of a landmark agreement forged in March, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) said Wednesday that they will now share non-public and commercially confidential information, including trade secret information.

Categories: News, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Regulatory strategy

Tags: EMA and FDA agreement, mutual recognition agreement, GMP inspection reports

ICH Details Pilot Training Programs for 2017 By Michael Mezher - Published 16 August 2017

The International Council for Harmonization (ICH) has released details for five upcoming training programs in the US, Germany and Japan.

Categories: News, Japan, Europe, US, ICH, Clinical, Drugs, Manufacturing, Submission and registration

Tags: ICH, Training, eCTD, GMP, GCP

EMA’s CHMP Adopts Updated Guideline on Manufacture of Finished Dosage Form By Zachary Brennan - Published 14 August 2017

The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) on Monday adopted an updated guideline on what manufacturing process information should be included in the marketing authorization application (MAA).

Categories: News, Europe, EC, EMA, Drugs, Manufacturing, Regulatory intelligence

Tags: CHMP, finished dosage form, pharmaceutical manufacturing

German Regulators Slam Dr. Reddy's Plant for Critical, Major Deficiencies By Zachary Brennan - Published 10 August 2017

Regulators working for the Central Authority for Supervision of Medicinal Products in Bavaria have published a statement of non-compliance with good manufacturing practices (GMP) following an August inspection of a Hyderabad, India-based manufacturing site run by Dr. Reddy's Laboratories.

Categories: News, Asia, Europe, EC, FDA, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Dr. Reddy's, competent authorities, EudraGMDP

FDA Warns of Bacterial Contamination in PharmaTech Liquid Drugs By Michael Mezher - Published 09 August 2017

The US Food and Drug Administration (FDA) on Wednesday warned patients and health care professionals not to use liquid drugs made by Florida-based contract manufacturing organization (CMO) PharmaTech LLC due to possible bacterial contamination.

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

Tags: PharmaTech, Burkholderia cepacia, B. cepacia, Recall

FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics By Zachary Brennan - Published 08 August 2017

As the number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Postmarket surveillance

Tags: BLA, CMC changes, postapproval manufacturing changes, FDA draft guidance

FDA Warns Italian Drugmaker for GMP Violations By Michael Mezher - Published 31 July 2017

The US Food and Drug Administration (FDA) earlier this month warned Italian ophthalmic drugmaker Tubilux Pharma for manufacturing and testing issues at its facility in Rome, Italy.

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

Tags: Warning Letter

Asia Regulatory Roundup: India Seeks Feedback on Medical Device Safety and Performance Principles (25 July 2017) By Nick Paul Taylor - Published 25 July 2017

India has released draft guidance on the safety and performance of medical devices. The text gives companies flexibility in how they meet the design and manufacturing requirements officials see as essential to the safe, effective functioning of medical devices.

Categories: News, India, Oceania, CDSCO, TGA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup

FDA Inspections and Outcomes for Oral Solid Dosage (OSD) Manufacturing Facilities By Sharry Arora - Published 14 July 2017

The article discusses various types of current Good Manufacturing Practice (CGMP) inspections conducted by the US Food and Drug Administration (FDA) at oral solid dosage forms manufacturing facilities. It also elaborates on types of inspections, approaches to investigations, limitations of these inspections and major inspection outcomes in the event of deficiencies, including 483s, Warning Letters and Establishment Investigation Reports (EIRs).

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

Tags: Oral Solid Dosage, OSD, Inspections