India's NRA for medicines is lauded by WHO

J P Nadda, Union Minister for Health & Family Welfare

In a letter to J P Nadda, Union Minister for Health & Family Welfare, the WHO applauded the country's NRA, declaring it "functional' with a maturity level of 4 -- the highest level as per currently evolved definitions in respect of 5 functions -- and maturity level 3 in respect of 4 functions. While, maturity level 4 indicates good results and sustained improvement trends, maturity level 3 reflects systematic process based approach, early stage of systematic improvements, data availability regarding conformance to objectives and existence of improvement trends.

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Global health leaders meet in Sri Lanka to discuss and reset the agenda on Migrant Health & World Health Organization (WHO)

Feb 22, Colombo: Global health leaders meet in Colombo, Sri Lanka, this week to discuss the migrant health and reset the agenda on migrant health based on the current trends of global migration.

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What is the ICMRA?

The ICMRA is a venue for heads of national regulatory authorities around the world to enable a shared strategic leadership to address current and emerging global regulatory challenges and to better leverage resources in ways that expand global regulatory reach.

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India’s measles-rubella vaccination campaign a big step towards reducing childhood mortality, addressing birth defects

WHO NEWS

By Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia

World Health Organization congratulates India for launching one of the world’s largest vaccination campaign against measles, a major childhood killer disease, and congenital rubella syndrome (CRS), responsible for irreversible birth defects.

The campaign launched today to vaccinate more than 35 million children in the age group of nine months to 15 years with MR (measles and rubella) vaccine, once again demonstrates India’s commitment to improve health and well-being of its people by protecting children against vaccine preventable diseases.

The first phase of the campaign is significant as it is expected to accelerate the country’s efforts to eliminate measles which affects an estimated 2.5 million children every year, killing nearly 49 000 of them. The campaign also marks the introduction of rubella vaccine in India’s childhood immunization programme to address CRS which causes birth defects such as irreversible deafness and blindness in nearly 40 000 children every year.

India has made important efforts and gains against measles in recent years. Measles deaths have declined by 51% from an estimated 100 000 in the year 2000 to 49 000 in 2015. This has been possible by significantly increasing the reach of the first dose of measles vaccine, given at the age of nine months under routine immunization programme, from 56% in 2000 to 87% in 2015. In 2010 India introduced the second dose of measles-containing vaccine in routine immunization programme to close the immunity gap and accelerate measles elimination. Nearly 118 million children aged nine months to 10 years were vaccinated during mass measles vaccination campaigns between 2010 and 2013 in select states of India.

Today’s campaign, the first in the series to cover a total of 410 million children across the country over the next 2 years, is a truly remarkable, world-beating effort. Apart from improving the life-chances of millions of children in India, the campaign is expected to have a substantial effect on global measles mortality and rubella control target as India accounts for 37% of global measles deaths.

For the MR campaign to be effective, it is important that throughout its duration, and in routine immunization thereafter, no child is left behind.

Simultaneously, India continues to further strengthen surveillance for measles and rubella, an important learning from India’s polio eradication programme that helped to identify infected and vulnerable areas and populations and enabled the programme adopt appropriate strategies to eradicate the disease.

India has already beaten smallpox, polio, maternal and neonatal tetanus and, very recently, yaws. Further gains in the battle against measles will help achieve a number of other public health priorities.

A regional flagship of WHO in South-East Asia, elimination of measles will contribute to achieving Sustainable Development Goal’s target 3.2 which, among others, aims to end preventable deaths of newborns and children under five years of age by 2030

Source: WHO
Published under: Health News

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Attention: WHO new quality projects list for review please comment on respective guideline

• Current projects
  
  
  Attention: WHO new quality projects list for review please comment on respective guideline 
  
  
  The following list of items represents the work that is currently underway within the Quality Assurance team:
  
  
  New texts under review for medicines quality assurance
  
  
  Should you have any comments thereon please send these as requested in the box on the first page of each document. You will need to use a downloaded/copied version of the table for comments.
  ·         Table for comments
  doc, 51kb
  ·         Table example
  pdf, 48kb
  
  
  ·         Guidelines
  
  
  ·         Good pharmacopoeial practices. Glossary (QAS/16.677) pdf, 652kb
  
  
  ·         Guidelines on validation - appendix 6: validation on qualification of systems, utilities and equipment QAS/16.673)
  
  
  
  
  ·         Equilibrium solubility experiments for the purpose of classification of active pharmaceutical ingredients according to the biopharmaceutics classification system (QAS/16.672)
  
  ·         Guidelines on validation - Appendix 4: Analytical method validation (QAS/16.671)
  
  ·         Guidelines on validation - appendix 5: validation of computerized systems (QAS/16.667)
  
  Guidelines on validation (QAS/16.666)
  
  WHO global model regulatory framework for medical devices including IVDs (QAS/16.664/Rev.1)
  
  Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by un agencies (QAS/16.656/Rev.1)
  
  
  Proposal for update
  ·         Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (QAS/15.639/Rev.1)
  
  Recommendations on the content of a survey protocol for surveys of the quality of medicines (QAS/14.590)
  
  General background on the list of international comparator pharmaceutical products (QAS/14/586/Rev.4)
  
  
  ·         Draft international comparator list
  
  Good pharmacopoeial practices concept paper on purpose and benefits (working document QAS/13.518/Rev.1)
  
  Proposal for a procedure on sampling and market surveillance survey (QAS/12.510)
  
• 
  
• 
  

World Health Organization
Essential medicines and health products
20 Avenue Appia
1211 Geneva 27
Switzerland 
empinfo@who.int

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WHO Draft on Analytical Method Validation

GMP News WHO Draft on Analytical Method Validation In June 2016 the World Health Organization (WHO) published a draft document "Guidelines on Validation - Appendix 4 Analytical Method Validation". Comments on the text should be sent to WHO until July 30, 2016. The appendix 4 of the published Supplementary guidelines on good manufacturing practices: validation (WHO Technical Report Series, No. 937, 2006, Annex 4) has been revised in view of current trends in validation. The appendix presents some information on the characteristics that should be considered during validation of analytical methods. Approaches other than those specified in the Appendix may be followed and may be acceptable. The new Appendix 4 is structured as follows (New and revised): 1. Principle (revised): ·         1.5 The recommendations as provided for in good laboratory practices and guidelines for transfer of technology (WHO Technical Report Series, No. 961, 2011, Annex 7) should be considered, where applicable, when analytical method validation is organized and planned.  2. General (revised): 2.6 The procedure should become part of a continuous verification procedure to demonstrate that it meets the predefined criteria over the life of the procedure. 2.7 Trend analysis and risk assessments should be considered at intervals to ensure that the method is appropriate for its intended application. 2.8 Changes to methods should be managed in accordance with the authorized change control procedure. 2.9 The scope of verification or degree of revalidation depend on the nature of the change(s) and the outcome of risk assessment. 2.11 The data obtained during method validation and verification should be considered covered by good anything practices (GxP) requirements and are expected to follow the principles of good data and record management practices. Their associated metadata are also expected to be retained and subjected to good data and record management practices (WHO Technical Report Series, No. 996, 2016, Annex 5). 2.12 When computerized systems are used to obtain and process data relating to method validation and verification, they should comply to the principles enunciated in Appendix 5 – Validation of computerized systems. 2.13 Adequate attention should be paid to the method of sample preparation. (...) 3. Pharmacopoeial methods 4. Non-pharmacopoeial methods 5. Method validation 6. Method verification (New): 6.1 Method verification should be performed for already validated analytical methods, for example, when it is used on a product for the first time (e.g. in case of a change in API supplier, change in method of synthesis or after reformulation of a drug product). 6.2 Method verification may include only the validation characteristics of relevance to the particular change. (...) 7. Method revalidation (New): 7.1 Methods should be maintained in a validated state over the life of the method. Revalidation (see also ICH Q2) should be considered whenever there are changes made to the analytical method (e.g. changes to mobile phase, column, column temperature, detector). 7.2 In case of repeated SST failures or when obtaining of doubtful results. In such cases an investigation of the root cause should be performed, the appropriate changes made and the method revalidated. 7.3 Periodic revalidation of analytical methods should be considered according to a period that is scientifically justifiable. (...) 8. Method transfer  (New) 8.1 During method transfer, documented evidence should be established to prove that a method has equivalent performance when used in a laboratory different from that where it has been originally validated. (...) 8.3 The two sets of results should be statistically compared and the differences between the two sets of test results should be within an acceptable range. 8.4 Method transfer should be performed before testing of samples for obtaining critical data for a dossier, such as process validation or stability studies or applied for routine use. (...) 9. Characteristics of analytical procedures (revised), 9.3 System suitability testing: 9.3.1 The suitability of the entire system should be confirmed prior to and during method validation tests as well as during the test of samples. 9.3.2 System suitability runs should include only established standards or reference materials of known concentration to provide an appropriate comparator for the potential variability of the instrument. 9.3.3 Where a sample is used for system suitability or a trial run, written procedures should be established and followed and the results of all such trial runs be included in the results and data review process. A sample can be used only if it is a well characterized material. Characterization in such a case should be performed prior to the use of this sample as part of system suitability testing. The sample material or product under test should not be used for trial run purposes or to evaluate suitability of the system (see WHO guidelines on good data and record management practices). The revised version of appendix 4 parallels certain considerations of the current USP lifecycle approach for analytical method validation. However, QbD concepts and the Analytical Target Profile (ATP) - which is equivalent to the Quality Target Product Profile (QTPP) - have not yet been introduced in the WHO draft. According to WHO the draft of Appendix 4 will also be placed on the WHO Medicines website under "Current projects". Members of the ECA Academy are able to access the new WHO Guidelines on Validation - Appendix 4 Analytical Method Validation in the ECA Members Area. Source: GMP news ww.gmpviolations.com (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed.)

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