As data integrity violations continue to be found in Form 483s and warning letters, the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme (PIC/S) released a 52-page draft guidance outlining how an inspector should inspect facilities that must adhere to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. The guidance, which will be open for consultation until 28 February 2019, was directed by the Australian an...

Sichuan, China-based Yibin Lihao Bio-technology Co. earlier this month received a statement of noncompliance with good manufacturing practices (GMP) from the Italian Medicines Agency. The statement followed an inspection at the firm’s crude heparin manufacturing site on 31 October 2018. The extraction of substance from animal sources, certain physical processing and packaging steps and biological testing were found to be noncompliant. The inspection identified 24 GMP...

A recently issued US Food and Drug Administration (FDA) warning letter escalated previously observed issues around quality control at Mylan Pharmaceuticals’ manufacturing facility in Morgantown, WV, to significant violations of good manufacturing practices (GMP).   The warning letter posted on Tuesday took issue with the firm’s May response to the 13 inspectional citations outlined in a Form 483, following an inspection conducted by FDA investigators between March an...

American Contract Systems provided “unacceptable” timelines to correct US Food and Drug Administration (FDA) inspectional citations, according to a new FDA warning letter.   The Pennsylvania-based manufacturer of surgical trays and kits indicated for hospital use drew a total of five significant violations, following the quick turnaround on the warning letter. FDA investigators inspected the firm’s manufacturing facility in Zelienople over the course of two weeks from ...

South Korea-based Hanlim Pharm Co. drew a US Food and Drug Administration (FDA) warning letter over poor aseptic practices and inadequate processes for documentation, among other violations of good manufacturing practice (GMP). The FDA inspection of the company’s drug manufacturing facility in Gyeonggi-do earlier this year concluded that similar GMP violations had been observed during FDA visits to the site in 2014 and 2016. The repeat observations underscore a need for ...

The European Commission on Wednesday launched a three-month public consultation ahead of its planned revision to good manufacturing practice (GMP) rules for sterile medicinal products contained in Annex 1 of Eudralex Volume 4 . The Commission says the revision was developed in cooperation with the World Health Organization (WHO) and the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), and is meant to add clarity to Annex 1, which has been updated numerous times si...

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) found Apotex Research Private Limited's Bangalore, India-based manufacturing site to be noncompliant. A statement of non-compliance with good manufacturing practice (GMP) requirements highlighted the site’s non-complaint operations related to non-sterile products, packaging and quality control testing. "Due to the nature of the issues identified, batches not released to market are included in the ...

The US Food and Drug Administration (FDA) earlier this month warned Indian drugmaker Lupin Limited for good manufacturing practice (GMP) deficiencies at its facilities in Goa and Indore, India. Lupin acknowledged receiving the warning letter in a Bombay Stock Exchange filing on 7 November, saying it had responded to nine observations stemming from FDA's inspections and that it will work to address the concerns raised in the warning letter. The warning letter says Lupi...

The US Food and Drug Administration (FDA) on Tuesday announced that beginning on Wednesday, the agency will recognize eight EU drug regulators – from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The announcement follows the creation of a mutual recognition agreement between the US and EU last March as part of a more collaborative approach to drug ma...

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. In a warning letter released on Monday, FDA says the company failed to adequately test its raw materials and finished products to ensure they conformed to appropriate specifications. "Your firm failed to analyze glycerin raw material from your supplier prior to the quality unit re...

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. According to FDA, the firm's management admitted to falsifying analytical test results used to release a lot of its products to the US. In another instance, FDA says the firm reported that a batch of one of its products was within specification ...

Editor's note: this article has been updated with a statement from FDA clarifying that the agency must sign a confidentiality agreement with each EU country before unredacted inspection reports may be shared. 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 soon share non-public and commercially confidential information, including trade secret information. The a...