Tuesday, 19 January 2021

EDQM webinars

EDQM (European Directorate for the Quality of Medicines and Healthcare) is all set for the two webinars in order to enhance the knowledge of the audience. They have always given quality driven and essential information. 

A guest post by Aparna Rane

1) Nitrosamines

Its all about Nitrosamines. This webinar will provide users and stakeholders with an update on the different activities related to nitrosamine impurities, including a detailed overview of the new general chapter. It will also include a recap of the Ph. Eur. approach to keeping the monographs aligned with the latest regulatory decisions.

The webinar will take place on 21 January 2021, from 1 p.m. to 2:30 p.m. (Paris, France)

N-Nitrosamine impurities: Latest update on the Ph. Eur. Approach

See: https://www.edqm.eu/en/events/new-webinar-n-nitrosamine-impurities-latest-update-ph-eur-approach



2) Data protection in Blood sector

Its all about the needed data protection for the Blood establishments. The webinar will focus on data protection in the blood sector, the impact and challenges faced by European blood establishments.

The webinar will take place on 17 February 2021, from 2 p.m. to 5 p.m. (Paris, France).

Data Protection in the Blood Sector: Impact and Challenges for Blood Establishments’

See: https://www.edqm.eu/en/events/new-webinar-data-protection-blood-sector-impact-and-challenges-blood-establishments 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Monday, 18 January 2021

Integrating Good Distribution Practice Into The QMS

Good Distribution Practice (GDP) concerns the distribution processes for pharmaceutical products that results in medics and patients obtaining access to the medications required. For the pharmaceutical organization, the distribution process occurs both upstream and downstream. Upstream are the suppliers who create goods and services used in a manufacturer’s own operations, such as raw components or materials.

The downstream supply chain efficiently distributes a company’s products or services to its customers. Each stage, both upstream and downstream, needs to be proactively risk assessed. With these endeavours, the use of digital technology can be of great benefit.

Tim Sandle has written a new article on the complexities of modern GDP systems and challenges.

The reference is:

Sandle, T. (2020) Integrating Good Distribution Practice Into The QMS, Journal of GXP Compliance, 24 (5): 11-20: https://www.ivtnetwork.com/article/integrating-good-distribution-practice-qms

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Sunday, 17 January 2021

Useful FDA links

The following links relating to the U.S. Food and Drug Administration (FDA) may be of interest to readers.


FDA Home Page: http://www.fda.gov/default.htm


FDA GMP Regulations (CFR21): http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr211_ 01.html


FDA Inspections Operation Manual: http://www.fda.gov/ICECI/Inspections/IOM/default.htm  


FDA Inspection Guides: http://www.fda.gov/ora/inspect_ref/igs/iglist.html  


FDA CBER Guidance / Guidelines / Points to Consider: http://www.fda.gov/cber/guidelines.htm  


FDA Guidance on Drugs:  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInfor mation/Guidances/default.htm

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Saturday, 16 January 2021

Antiseptic handrubs (FDA)

The U.S. Food and Drug Administration (FDA) has provided a question and answer document about antiseptic handrubs. This relates to over-the-counter consumer antiseptic rub products. This means those products described as t rubs, leave-on products, or hand sanitizers.

The Consumer Antiseptic Rub Federal Regulation has established that 28 active ingredients used in non-prescription consumer antiseptic rub products are not eligible for evaluation under FDA’s ongoing rulemaking to evaluate the safety and effectiveness of OTC drug products marketed in the United States on or before May 1972, which is known as the OTC Drug Review.

The ingredients not permitted are:
  • Benzalkonium cetyl phosphate 
  • Benzethonium chloride 
  • Cetylpyridinium chloride 
  • Chloroxylenol 
  • Chlorhexidine gluconate
  • Cloflucarban 
  • Combination of potassium vegetable oil solution, phosphate sequestering agent, and triethanolamine
  • Fluorosalan 
  • Hexachlorophene 
  • Hexylresorcinol
  • Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate) 
  • Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol) 
  • Methylbenzethonium chloride
  • Nonylphenoxypoly (ethyleneoxy) ethanoliodine
  • Phenol (equal to or less than 1.5 percent or greater than 1.5 percent)
  • Poloxamer iodine complex 
  • Polyhexamethylene biguanide
  • Povidone-iodine (5 to 10 percent)  
  • Salicylic acid 
  • Secondary amyltricresols 
  • Sodium hypochlorite
  • Sodium oxychlorosene 
  • Tea Tree Oil
  • Tribromsalan 
  • Triclocarban 
  • Triclosan 
  • Triple dye 
  • Undecoylium chloride iodine complex 


Drug products containing these active ingredients will require approval under a new drug application (NDA) or an abbreviated new drug application (ANDA) before they can be marketed.

The Consumer Antiseptic Rub FR also established that three active ingredients used in consumer antiseptic rub products— benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are eligible for evaluation under the OTC Drug Review.


See: https://www.fda.gov/media/144833/download

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Friday, 15 January 2021

Good Distribution Practice - new guidance

The MHRA has issued a new blog post about Good Distribution Practice (GDP), dated January 2021. The blog emphasises that qualification and re-qualification of suppliers and customers is one of GDPs highest risk areas.

It states that the MHRA expects organisations to have qualification and re-qualification procedures implemented as part of a quality management system. Online resources provide a certain degree of confidence for conducting independent checks on licence details, such as company name, company number, site name, site address, authorised licensable activities, authorised categories of products to be handled on site and contact information.


The blog notes that inspectors often see stakeholders relying on this information available in the public domain to establish the legitimacy of a business partner. MHRA expects companies to adopt practices that incorporate independent checks as part of procedures.

It says that when verifying your business partners, it is crucial that you consider your sources of information and who else may potentially have the same access.


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Thursday, 14 January 2021

PharmaFlow vows to inject transformational strategy into biopharmaceutical value-chains


Industry-leading biopharmaceutical supply-chain management consultancy PharmaFlow has today repositioned itself in the market with the launch of a brand-new website and business proposition.

Aimed at drug developers, manufacturers, service providers and suppliers, PharmaFlow are transforming biopharmaceutical value-chains through the provision of strategically tailored action plans to profitably leverage opportunities and address challenges.

Founded in 2005 by Hedley Rees, managing consultant, PharmaFlow has established itself as the ‘go-to’ consultancy for strategic, unconflicted advice across all areas of the biopharmaceutical value-chain. PharamaFlow’s unrivalled client service will remain unchallengeable in its suite of new services founded on consultancy and client education programmes.

Complementing Hedley’s decades of experience in the industry are a variety of expert subject matter consultants, including:

·         Chris Morgan, Advanced Therapy Manufacturing and Quality

·         Michael Stewart, Pharmacy and Medical Writing

·         Adele Sanders, Management Systems and Compliance

·         Gareth Morris-Stiff, Clinical Development and Patient Experience

In addition, for wider scope projects, PharmaFlow has an extensive network of collaborators, including:

·         Ed Narke, Principal and Regulatory Managing Director – DSI Informatics

·         Jenny Murray, Managing Director of Life Science Group Ltd

·         Tim Sandle, Editor, GMP Review

·         Alan Kennedy, Director, TEAM Poseidon

·         Linda Kim, Founder & CEO, Cold Chain Platform

PharmaFlow client Chris Pollard, co-founder, director, and former CEO of TOWER Cold Chain Solutions, commented:

“2020 saw PharmaFlow undertake two commissions for TOWER. The first was to conduct a broad market appraisal to assess strategic objectives for TOWER’s reusable, passive, refrigerated shipping containers, and the second was to look at market prospects for a range of smaller (sub 100 litre) containers.

In each case PharmaFlow executed the project efficiently and on time, exhibiting valuable market knowledge and insights, and referencing an impressive range of relevant industry contacts. There is little doubt that TOWER will be turning to PharmaFlow again in 2021.”

Emphasising the benefits PharmaFlow can bring to stakeholders in the industry, Hedley said:

“We help organisations in biopharmaceutical value-chains build strategies to help them grow and prosper. In the post COVID-19 world, those strategies have to be based on integration, collaboration and patient-focussed innovation”.

For more information on PharmaFlow, click here, or contact Hedley on +447734 961726.

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