Ensuring the accuracy, reliability and consistency of analytical data in laboratories

Ensuring the accuracy, reliability and consistency of analytical data in laboratories

The basic reason for which analytical methods and procedures need to be validated is to ensure that analytical data have consistency, accuracy and reliability. This becomes possible when laboratories employ proper scientific methods and procedures and validate analytical methods and procedures. This is the only means to ensure that the analytical data are reliable, consistent and accurate.

The aim of doing so is to substantiate the suitability of intended use of a particular test. It also confirms that the quality, purity, identity and strength parameters required for a product produced in the laboratory are fulfilled in the required and set measure.

The acute need for validation of analytical data

A number of reasons can be ascribed for why analytical data has to be validated for the criteria described above:

  • The quality of the data is best indicated and assessed by validation;
  • This is a means to ensure the trustworthiness of the analytical data;
  • All these steps – validation, verification and transfer of analytical methods -are set out by regulatory the different regulatory bodies such as the FDA and the EMA, and standards such as the USP and ICH requirements, and are thus part of regulatory requirements.

Method validation and compendial methods

Ensuring the accuracy, reliability and consistency of analytical data in laboratories3

Lately, regulatory agencies and industry task forces have been taking a more than cursory interest in method validation. The FDA, as well as the EMA, have recently come up with guidelines on method validation and transfer. Also, USP has proposed new chapters for approaches to the following important areas:

  • Integrated validation
  • Verification and transfer of analytical procedures
  • Equivalency testing and for statistical evaluation.

Compendial methods

That compendial methods are verified needs to be demonstrated in two aspects:

  • The suitability of laboratories to successfully run the method, and
  • To demonstrate through testing that transfer of methods, when carried on between laboratories, is successful. When a laboratory intends to use an alternative method in place of a compendial method, verification of compendial measures should establish the equivalency of the alternative method.

Complete learning on validation, verification and transfer of analytical methods

Ensuring the accuracy, reliability and consistency of analytical data in laboratories1

All the issues relating to validation, verification and transfer of analytical methods will be taught during a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. Ludwig Huber, the director and editor of Labcompliance, the global online resource for validation and compliance and highly respected author of several books on compliance, will be Director at this seminar.

Interested in gaining complete knowledge of all areas relating to validation, verification and transfer of analytical methods? Then, please register for this seminar by visiting Ensuring the accuracy, reliability and consistency of analytical data in laboratories.

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Meaningful learning over two days

Ensuring the accuracy, reliability and consistency of analytical data in laboratories4

Dr. Huber will familiarize participants of this event with the background needed for getting a proper understanding of the requirements that need to go into validation, verification and transfer of analytical methods. The strategies needed for this, which he will explain, will constitute an even more significant learning.

The Director of this seminar will provide tools to implement most critical requirements, along with templates and examples for developing inspection-ready documentation. At this highly interactive seminar, Dr. Huber will augment the workshop with exercises into and between the presentations. Around half of the total time will be dedicated to practical sessions with real life examples.

Participants will also be offered a variety of tools that the Director of this seminar will offer them, such as SOPs, validation examples and checklists. All of these will be made readily available on a dedicated website, and can be used to easily implement the learning gained in the course.

 

Ensuring the accuracy, reliability and consistency of analytical data in laboratories

Ensuring the accuracy, reliability and consistency of analytical data in laboratoriesThe basic reason for which analytical methods and procedures need to be validated is to ensure that analytical data have consistency, accuracy and reliability. This becomes possible when laboratories employ proper scientific methods and procedures and validate analytical methods and procedures. This is the only means to ensure that the analytical data are reliable, consistent and accurate.

The aim of doing so is to substantiate the suitability of intended use of a particular test. It also confirms that the quality, purity, identity and strength parameters required for a product produced in the laboratory are fulfilled in the required and set measure.

The acute need for validation of analytical data

Ensuring the accuracy, reliability and consistency of analytical data in laboratories3

A number of reasons can be ascribed for why analytical data has to be validated for the criteria described above:

  • The quality of the data is best indicated and assessed by validation;
  • This is a means to ensure the trustworthiness of the analytical data;
  • All these steps – validation, verification and transfer of analytical methods -are set out by regulatory the different regulatory bodies such as the FDA and the EMA, and standards such as the USP and ICH requirements, and are thus part of regulatory requirements.

Method validation and compendial methods

Lately, regulatory agencies and industry task forces have been taking a more than cursory interest in method validation. The FDA, as well as the EMA, have recently come up with guidelines on method validation and transfer. Also, USP has proposed new chapters for approaches to the following important areas:

  • Integrated validation
  • Verification and transfer of analytical procedures
  • Equivalency testing and for statistical evaluation.

Compendial methods

That compendial methods are verified needs to be demonstrated in two aspects:

  • The suitability of laboratories to successfully run the method, and
  • To demonstrate through testing that transfer of methods, when carried on between laboratories, is successful. When a laboratory intends to use an alternative method in place of a compendial method, verification of compendial measures should establish the equivalency of the alternative method.

Complete learning on validation, verification and transfer of analytical methods

All the issues relating to validation, verification and transfer of analytical methods will be taught during a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. Ludwig Huber, the director and editor of Labcompliance, the global online resource for validation and compliance and highly respected author of several books on compliance, will be Director at this seminar.

Interested in gaining complete knowledge of all areas relating to validation, verification and transfer of analytical methods? Then, please register for this seminar by visiting Ensuring the accuracy, reliability and consistency of analytical data in laboratories.

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Meaningful learning over two days

Ensuring the accuracy, reliability and consistency of analytical data in laboratories1

Dr. Huber will familiarize participants of this event with the background needed for getting a proper understanding of the requirements that need to go into validation, verification and transfer of analytical methods. The strategies needed for this, which he will explain, will constitute an even more significant learning.

The Director of this seminar will provide tools to implement most critical requirements, along with templates and examples for developing inspection-ready documentation. At this highly interactive seminar, Dr. Huber will augment the workshop with exercises into and between the presentations. Around half of the total time will be dedicated to practical sessions with real life examples.

Participants will also be offered a variety of tools that the Director of this seminar will offer them, such as SOPs, validation examples and checklists. All of these will be made readily available on a dedicated website, and can be used to easily implement the learning gained in the course.

 

RPS says pharmacists must always be present in pharmacies

The three RPS national boards have jointly called for legal guarantees that a pharmacist will always undertake a clinical assessment or check, and that there must be no legal loopholes that can bypass this requirement.

pharmacy counter patient pharmacist al 17

Source: Alamy.com

The leaked document, prepared by a working group of the Department of Health’s Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board, suggested that current legislation could be changed to allow a registered pharmacy professional, which could include a technician, to take responsibility for the sale and supply of pharmacy and prescription-only medicines.

The Royal Pharmaceutical Society (RPS) has said it believes a pharmacist should always be present in a pharmacy, apart from occasional short periods of time.

Responding to a leaked document produced for the Department of Health (DH) on the issue of whether pharmacy technicians should be allowed to supervise pharmacies, the RPS has issued an eight-point position statement on the role of registered technicians supervising the sale and supply of medicines.

Read More: http://snip.ly/3pujp#http://www.pharmaceutical-journal.com/news-and-analysis/news/rps-says-pharmacists-must-always-be-present-in-pharmacies/20203609.article

Pharmacist in deadly meningitis outbreak heading to trial

Pharmacist in deadl

After watching his mother die from meningitis in a nationwide outbreak caused by contaminated steroids, Scott Shaw is determined to make sure something like that never happens again.

A stiff punishment for the Massachusetts pharmacist Shaw believes is partially responsible may help, he says.

“I believe as surely as I’m talking to you right now that if something isn’t done, we will repeat this again,” the North Carolina man said.

Glenn Chin, the supervisory pharmacist at the now-closed New England Compounding Center in Framingham, about 22 miles (35 kilometers) west of Boston, is to go on trial Tuesday for his role in the 2012 fungal meningitis outbreak that killed 76 people and sickened hundreds of others.

Chin faces up to life in prison if convicted of all counts of second-degree murder under federal racketeering law.

Experts, and Chin’s defense attorney, believe prosecutors have a stronger case against Chin than they did against the co-founder of the compounding pharmacy, Barry Cadden. Cadden was sentenced in June to nine years in prison after being acquitted of second-degree murder charges but convicted on conspiracy and fraud charges.

Chin ran the so-called clean rooms where steroid injections were made. He is accused of failing to properly sterilize the drugs, among other things. Chin also faces conspiracy, mail fraud and other charges.

“I’m just a little concerned that the judge and the jury might be a little more harsh on Glenn Chin because he was doing the work in the clean room,” Chin’s attorney, Stephen Weymouth, said.

Throughout Cadden’s trial, the co-founder’s lawyers tried to push the blame onto Chin. Chin intends to point the finger back at Cadden.

Weymouth said he will argue that Chin was essentially a “puppet” for Cadden, who made working in the clean rooms so difficult that “mistakes might have been made.” Cadden was the one calling the shots and pushing the orders to line his own pockets, Weymouth said.

 

Read More: http://snip.ly/kx5et#http://abcnews.go.com/US/wireStory/pharmacist-deadly-meningitis-outbreak-heading-trial-49907214

Pharmaceutical companies gave $12m to doctors, nurses and pharmacists

Pharmaceutical companies gave $12m to doctors, nurses and pharmacists.jpg

Pharmaceutical companies gave Australian doctors, nurses and pharmacists almost $12m in fees and expenses to attend conferences and give talks between November 2016 and April 2017.

The payments comprised more than $6.5m for travel expenses and accommodation; more than $4.2m in speaking and consultancy fees; and more than $700,000 to cover registration at medical conferences and events.

The drug companies Bristol-Myers Squibb and Amgen both spent more than $1m over the six months and one doctor received more than $39,000.

Health economists Prof Philip Clarke from the University of Melbourne and Dr Barbara de Graaff from the Menzies Institute for Medical Research in Tasmania conducted an analysis for Guardian Australia on the $11,667,253 in pharmaceutical payments made to healthcare professionals.

Under the updated Medicines Australia code of conduct, pharmaceutical companies were required to disclose all payments made to healthcare professionals by 29 August. Previously, this disclosure required the consent of the health practitioners, which in many cases

 

Read More information: http://snip.ly/mulqf#https://www.theguardian.com/australia-news/2017/sep/12/pharmaceutical-companies-gave-12m-to-doctors-nurses-and-pharmacists

CURE Pharmaceutical Launches New Academic Partnership Program Providing the Company’s Proprietary CureFilm™ for More Humane and Effective Animal Research

OXNARD, Calif., Sept. 06, 2017 (GLOBE NEWSWIRE) — CURE Pharmaceutical (OTCQB:CURR), (“CURE”), a leading disruptive drug delivery technology company, today announced the launch of a new academic partnership program, CureDotsTM. Under the CureDotsTMprogram, academic institutions may access the Company’s patented, multilayer oral thin film (OTF), CureFilm Oral™, for more humane and effective animal research and testing. CureDotsTM are punch-hole dot size versions of CureFilm Oral™ appropriate for pre-clinical testing with smaller animals such as mice.

Translation of a drug to human clinical trials requires that safety and efficacy studies be performed in animal models using the intended clinical route of administration, which is the oral route for many drugs. Oral gavage is the standard method for consistent and precise delivery of an investigational agent to an animal. However, oral gavage is often not well tolerated by the animal causing stress, which can jeopardize the integrity of the experiment.

According to published research by the University of Southern California School of Pharmacy, “Utilizing an Orally Dissolving Strip for Pharmacological and Toxicological Studies: A Simple and Humane Alternative to Oral Gavage for Animals,” preclinical, oral drug delivery using the CureDotsTM represents a safe, convenient, and humane alternative to oral gavage for repetitive pharmacological and toxicological testing performed on animals.

 

Read More: http://snip.ly/sp598#http://markets.businessinsider.com/news/stocks/CURE-Pharmaceutical-Launches-New-Academic-Partnership-Program-Providing-the-Company-s-Proprietary-CureFilm-for-More-Humane-and-Effective-Animal-Research-1002345676

US pharmaceutical company expands Dublin presence

US pharmaceutical company expands Dublin presence

PTC Therapeutics, a US pharmaceutical company, plans to expand its European headquarters in Dublin to 40 staff.

The Dublin site of the company is responsible for finance, quality assurance, legal and a raft of other back office roles.

“We currently employ 30 people in the Dublin office and this will increase to a total of 40 sustainable jobs in this office within a short period of time,” said Adrian Haigh, who heads up the company’s international operations.

PTC focuses on the discovery and commercialisation of novel medicines. It has been working on the development of a drug called Translarna for almost 20 years. The drug is the only protein restoration therapy for the treatment of nonsense mutation Duchenne Muscular Dystrophy – a genetic disorder characterised by progressive muscle degeneration.

 

Read More: http://snip.ly/qmou7#https://www.irishtimes.com/business/health-pharma/us-pharmaceutical-company-expands-dublin-presence-1.3212652