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A quick and comprehensive overview of the complex world of GMP.

 

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More than 650 typical questions related to audits and inspections.

 

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News about GMP/cGMP

2017-04-21

Following the introduction of ICH Q8, Q9 and Q10, the European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) launched a joint pilot program for the parallel assessment of applications containing Quality by Design (QbD) in 2011. To facilitate the exchange of information between the two agencies the program was laid down under US-EU Confidentiality Arrangements. Both agencies have now issued a report that addresses the outcome of the 5-year-program so far.

 
2017-04-21

This month the FDA has updated its yearly list of the new and revised draft guidances CDER is planning to publish in 2017. Compared to the list published in January 2017 (we reported) no changes were identified for the three categories

  • Biosimilarity
  • Pharmaceutical Quality/Manufacturing Standards (CGMP)
  • Pharmaceutical Quality/CMC.

 
2017-04-04

Anaheim, Ca.  April 3, 2017 – A press release by Walt Morris, Senior Director of Publishing at PDA (Parenteral Drug Association)

The Parenteral Drug Association (PDA) today announced that it has been approved by the Executive Standards Council (ExSC) of the American National Standards Institute (ANSI) as an Accredited Standard Developer (ASD). The announcement was made during the opening session of PDA’s Annual Meeting at the Anaheim Marriott.

 
2017-03-31

In July 2015, US FDA released a draft guidance on quality metrics. The intention behind the introduction of quality metrics was described as a measure to improve drug quality and to encourage the implementation of a modern, risk-based pharmaceutical quality assessment system. The document aroused a storm of criticism by the pharmaceutical industry and its organisations as soon as it appeared.

 
2017-03-29

In 2017, the US FDA has already listed the impressing number of 73 Warning Letters on its website. One topic that emerges again and again is the violation of data integrity, with rising tendency. Remarkably often, those violations are found in China and India. This time, the following pharmaceutical manufacturers are involved:

  • USV Private Limited, Daman, India
  • Jinan Jinda Pharmaceutical Chemistry Co., Zhangqiu City, China.
 
2017-03-29

The European Medicines Agency (EMA) has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India. Bioequivalence studies are usually the basis for approval of generic medicines. The suspensions can be lifted once alternative data establishing bioequivalence are provided.

 
2017-03-21

Last week the EMA (European Medicines Agency) published a concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V) which addresses the need to update and revise the guidance which originally went into effect on 1st June 2002.

 
2017-03-15

In a letter to the European Commission that was published this week, PIC/S (The Pharma Inspection Co-operation Scheme) strongly criticized the Commission’s development of its proposed stand-alone Advanced Therapy Medicinal Products (ATMP) GMP Guidelines.

 
2017-03-14

During its February Meeting in Switzerland, which was attended by representatives of 37 of its regulatory authorities, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) unveiled a new road map for the next two years.

 
2017-03-03

Following a three-year-process, the United States (represented by the US FDA) and the European Union (represented by the European Commission) have now finally announced their agreement to mutually recognise each other's GMP inspections of pharmaceutical facilities.

 
2017-02-28

This news summarizes the latest regulatory changes for medical devices in China and the newly issued five year-plan of the CFDA (China Food and Drug Administration).

 
2017-02-24

The ICH (International Council for Harmonisation) has developed a training presentation on the ICH Q11 Q&A document Selection & Justification of Starting Materials. Therein the Expert Working Group gives answers to the following questions:

 
2017-02-21
 
2017-02-14

The ICH has now published the Meeting Minutes of the ICH Assembly meeting which was held in Osaka, Japan in November 2016. Following you will find the key points on guidance progress in the area of GMP and on new members and observers in brief:

 
2017-01-31

The US Food and Drug Administration (FDA) already issued 7 Warning Letters in 2017, one of which went to Porton Biopharma Limited in Salisbury, United Kingdom. The UK-government owned manufacturer of biopharmaceutical products was inspected from March 7 to 18, 2016 and previously on January 12 to 23, 2015. Both inspections resulted in similar violations and a Form 483.

 
 
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