Transforming India : अब एयरपोर्ट पर भारतीयों को परेशान नहीं करेगा अमेरिका

वॉशिंगटन 

अमेरिका में चुनिंदा एयरपोर्ट पर भारतीयों के प्रवेश को सुगम बनाए जाने को ध्यान में रखते हुए भारत और अमेरिका ने एक समझौता पत्र पर हस्ताक्षर किए हैं ताकि सुरक्षा संबंधी मंजूरी शीघ्र मुहैया कराई जा सके। भारत नौंवा ऐसा देश है जिसके साथ अमेरिका ने इंटरनैशनल एक्स्पीडिटेड ट्रैवलर इनिशिएटिव जिसे वैश्विक प्रवेश कार्यक्रम के रूप में भी जाना जाता है पर समझौता किया है। 

यह दुनिया के दो सबसे बड़े लोकतांत्रिक देशों के बीच मजबूत होते संबंधों का प्रतिबिम्ब है। इसे लागू होने में अभी कुछ महीने लगेंगे और पहले से मंजूरी प्राप्त करने वाले ऐसे भारतीय यात्रियों के लिए अमेरिका में चुनिंदा एयरपोर्ट पर शीघ्र सुरक्षा मंजूरी मुहैया कराई जाएगी जिन्हें लेकर कम जोखिम है। अमेरिका में भारत के राजदूत अरुण के सिंह और अमेरिकी कस्टम्स ऐंड बॉर्डर प्रोटेक्शन के कमिश्नर केविन के मैकेलीनान के बीच समझौता ज्ञापन पर हस्ताक्षर किए गए। 

एक विज्ञप्ति में कहा गया, 'दोनों देशों की संयुक्त जांच एवं मंजूरी के बाद स्वीकृति प्राप्त भारतीय यात्रियों को अमेरिका में चुनिंदा एयरपोर्ट पर स्वचालित बूथों के जरिए अमेरिका में शीघ्र प्रवेश की सुविधा मुहैया कराई जाएगी।' इसमें कहा गया है कि संबंधित प्रक्रिया आगामी महीनों में पूरी होने की उम्मीद है। अरुण के. सिंह ने समझौता पत्र हस्ताक्षर समारोह में कहा, 'इस कार्यक्रम के तहत अमेरिकी एयरपोर्ट पर भारतीय यात्रियों के लिए शीघ्र प्रवेश से पर्यटन संबंधी वातावरण और सहज बनेगा और इसके दोनों देशों के लोगों के बीच सभी प्रकार के आपसी संपर्कों पर सकारात्मक प्रभाव पड़ेगा।' 

सिंह ने कहा कि अमेरिका के साथ द्विपक्षीय संबंध के मामले में प्रधानमंत्री का यह दृष्टिकोण रहा है कि दोनों देशों के लोगों के बीच आपसी संबंध मजबूत बनाए जाए। उन्होंने कहा, 'भारत सरकार ने पिछले दो सालों में कई पहल की हैं ताकि अमेरिका से भारत की यात्रा सुगम बनाई जा सके। इन पहलों में लंबी अवधि के वीजा जारी करना और अमेरिकी नागरिकों के लिए इलेक्ट्रॉनिक-यात्री वीजा मुहैया कराना शामिल है।' 

सिंह ने कहा, 'वैश्विक प्रवेश कार्यक्रम में भारत का प्रवेश दोनों देशों के बीच यात्रा को और सुगम बनाएगा और लोगों के आपसी संबंधों को मजबूत करेगा।' उन्होंने कहा कि अमेरिका में भारतीय मूल के 30 लाख से अधिक लोग रहते हैं जिनके भारत के साथ गहरे संबंध हैं। सिंह ने कहा, 'हम देखते हैं कि पेशेवर, कारोबार, पर्यटन और शिक्षण समेत विभिन्न क्षेत्रों से जुडे हमारे 10 लाख से अधिक नागरिक हर वर्ष दोनों ओर से आ-जा रहे हैं। इस पहल से इन यात्रियों को सीधा लाभ होगा।'

Amendment In ICH GCP Guideline

   The International Conference on Harmonization (ICH) has amended its good clinical practice (GCP) guideline with the aim of helping industry address the increasing scale, complexity and cost of clinica trials.

The evolving use of technology and new risk management processes offer opportunities to increase efficiency, ICH says. The updated guideline is intended to provide a unified standard for the regulatory authorities in the EU, Japan, US, Canada and Switzerland to facilitate the mutual acceptance of clinical data.

"This guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and data integrity," the amended guideline says. "Standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency have also been updated."

Quality Management

The longest addendum to the guideline is centered on a sponsor's quality management, which includes the efficient design of trial protocols, data collection tools and procedures, and the collection of data essential to decision making.

The broad ICH recommendations call on sponsors to identify processes and data "that are critical to assure human subject protection and the reliability of study results." And as for risks, ICH says they should be considered at both the system level (e.g., facilities, standard operating procedures, computerized systems, personnel, vendors) and clinical trial level (e.g., investigational product, trial design, data collection and recording).

Risks should be evaluated by considering: (a) the likelihood of errors occurring, given existing risk controls; (b) the impact of such errors on human subject protection and data integrity; and (c) the extent to which such errors would be detectable.

Trial Monitoring

In addition to quality management, sponsors should develop a systematic, prioritized, risk-based approach to monitoring clinical trials, ICH says. The group advocates for a flexible approach intended to improve the effectiveness and efficiency of monitoring.

"A combination of on-site and centralized monitoring activities may be appropriate," though sponsors "should document the rationale for the chosen monitoring strategy," ICH says.

As far as why centralized monitoring processes are important, ICH says they can complement and reduce the extent and/or frequency of on-site monitoring by such methods as:  Routine review of submitted data; identification of missing data, inconsistent data, data outliers or unexpected lack  of variability and protocol deviations that may be indicative of systematic or  significant errors in data collection and reporting at a site or across sites;  using statistical analyses to identify data trends such as the range and consistency of data within and across sites; and analyzing site characteristics and performance metrics.

Other Addenda

ICH also updated the guideline, among other topics, on the responsibilities for supervising any delegated or outsourced study tasks conducted at a trial site, as well as how to maintain adequate and accurate source documents and trial records.

Explanatory Note on the Withdrawal of ICH Q1F for the ICH Website

                ICH Q1 F Stability Data Package for Registration Applications in Climatic Zones III and IV defined storage conditions for stability testing in countries located in Climatic Zones III (hot and dry) and IV (hot and humid), i.e. countries not located in the ICH regions and not covered by ICH Q1 A (R2) Stability Testing for New Drug Substances and Drug Products. ICH Q1 F described harmonised global stability testing requirements in order to facilitate access to medicines by reducing the number of different storage conditions. In the course of the discussions which led to the development of the guideline, WHO conducted a survey amongst their member states to find consensus on 30°C/65% RH as the long-term storage conditions for hot and humid regions. As no significant objections were raised in this survey, 30°C/65% RH was defined as the long-term storage condition for Climatic Zone III/IV countries in ICH Q1F. The document was adopted by the ICH Steering Committee in February 2003 and subsequently implemented in the ICH regions.

However, based on new calculations and discussions, some countries in Climatic Zone IV have expressed their wish to include a larger safety margin for medicinal products to be marketed in their region than foreseen in ICH Q1F. As a consequence, several countries and regions have revised their own stability testing guidelines, defining up to 30°C/75 % RH as the long-term storage conditions for hot and humid regions. Due to this divergence in global stability testing requirements, the ICH Steering Committee has decided to withdraw ICH Q1F and to leave definition of storage conditions in Climatic Zones III and IV to the respective regions and WHO.

In assessing the impact of the withdrawal of ICH Q1F on intermediate testing conditions defined in ICH Q1A (R2), the decision was reached to retain 30°C/65%RH. However, regulatory authorities in the ICH regions have agreed that the use of more stringent humidity conditions such as 30°C/75% RH will be acceptable should the applicant decide to use them.

190-PHARMA ABBREVIATION

190-PHARMA ABBREVIATION

AADA: Abbreviated antibiotic drug application
ADE: Adverse drug event
ADME: Absorption, distribution, metabolism, and excretion
AHU: Air Handling Unit
ANDA: Abbreviated new drug application
ANVISA: Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil)
AP: Applicants Part (of EDMF)
API: Active pharmaceutical ingredient
APR: Annual product review (APQR – Annual product quality
review)
AQL: Acceptable quality level
AR: Analytical Reagent
ASHRAE: American Society of heating, Refrgeration and
Air Conditioning Engineers
ASM: Active Substance Manufacturer
ASMF: Active Substance Master File
AST: Accelerated stability testing
ASTM: American Society for Testing and Materials
BA/BE: Bioavailability/bioequivalence
BCS: Biopharmaceutical classification system
BET: Bacterial Endotoxin Test
BFS: Blow Fill Seal
BI: Biological Indicator
BMR: Batch Manufacturing/Processing Record
BOD: Biological Oxygen Demand
BOM: Bill of Materials
BOPP: Biaxially Oriented Polypropylene
BP: British Pharmacopoeia
BPR: Batch Packaging Record
BRMS: Biologics Regulatory Management System
BSE: Bovine spongiform encephalopathy (mad cow disease)
CAPA: Corrective and preventive action
CBE: Changes being effected
CBER: Center for Biologics Evaluation and Research (FDA)
CCIT: Container closure integrity test
CDER: Center for Drug Evaluation and Research (FDA)
CDSCO: Central drug standard control organization (India)
CEP: Certification of suitability of European Pharmacopoeia monographs
CFR: Code of Federal Regulations
CFU: Colony Forming Unit
cGMP: Current Good Manufacturing Practices
CIP: Clean in place
CMC: Chemistry, manufacturing and controls
CMS: Continuous monitoring system
COA: Certificate of analysis
COS: Certificate of suitability
COPP: Certificate of Pharmaceutical Products
CPP: Critical Process Parameter
CQA: Critical Quality Attribute
CTD: Common technical document
DMF: Drug master file
DOP: Dioctyl Phthalate
DQ: Design Qualification
EDMF: European drug master file
EDQM: European Directorate for the Quality of Medicines
EH&S: Environmental health and safety
EIR: establishment inspection report (FDA)
EMEA: European Medicines Agency (formerly European Medicines Evaluation Agency)
EP: European Pharmacopoeia
EPS: Expanded polystyrene
ETP: Effluent Treatment Plant
EU: Endotoxin unit
EU: European Union
FAT: Factory Acceptance Testing
FBD: Fluid-bed dryer
FDA: Food and Drug Administration,United States
FDC: Fixed Dose Combination
FEFO: First expiry first out
FG: Finished Goods
FIFO: First in first out
FMEA: Failure modes and effect analysis
FOI: Freedom of information
GAMP: Good automated manufacturing practice
GC: Gas Chromatography
GCLP: Good clinical laboratory practice
GCP: Good clinical practice
GDP: Good distribution practice
GEP: Good engineering practice
GGP: good guidance practice
GIT: Gastrointestinal Tract
GLP: Good laboratory practice
GMO: Genetically modified organism
GMP: Good manufacturing practice
GPT: Growth Promotion Test
GRAS/E: Generally recognized as safe and effective
GRP: Good review practice
HACCP: Hazard analysis critical control point
HDPE: High Density Polyethylene
HEPA: High efficiency particulate air (filter)
HPLC: High performance liquid chromatography
HSA: Health Sciences Authority, Singapore
HVAC: Heating, ventilating, and air conditioning
ICAH: International Conference on Harmonisation
IH: In house
IM: Intramuscular
IND: Investigational new drug
INDA: Investigational new drug application
IP: Indian Pharmacopeia
IPA: Isopropyl Alcohol
IPS: In process control
IQ: Installation qualification
IR: Immediate release
ISO: International Organization for Standardization
ISPE: International Society for Pharmaceutical Engineering
IV: Intravenous
JP: Japanese Pharmacopoeia
KOS: Knowledge organization system
LAF: Laminar air flow
LAL: Limulus Amoebocyte Lysate
LD: Lethal dose
LD50: Lethal dose where 50% of the animal population die
LDPE: Low Density Polyethylene
LIMS: Laboratory Information Management System
LIR: Laboratory Investigation Report
LOD: Loss on drying
LOD: Limit of detection
LOQ: Limit of quantification
LR: Laboratory Reagent
LVPs: Large Volume Parenterals
MA: Marketing Authorisation
MAA: Marketing Authorisation Application
MAC: Maximum Allowable Carryover
MCC: Medicines control council (South Africa)
MDD: Maximum daily dose
MFR: Master Formula Record
MEDSAFE: Medicines and medicinal devices safety authority (New zealand)
MHRA: Medicines and Healthcare products Regulatory Agency (UK)
MOA: Method Of Analysis
MSDS: Material Safety Data Sheets
NCE: New chemical entity
NDA: New Drug Application
NF: National Formulary
NIR: Near Infra Red Spectroscopy
NON: Notice of non-compliance (Canada)
ODI: Orally Disintegrating Tablet
OQ: Operation Qualification
OSD: Oral Solid Dosage
OSHA: Occupational Safety And Health Administration
OTC: Over-the-counter
OOS: Out of specification
OOT: Out of trend
PAC: Post-approval changes
PAO: Poly alpha olefin
PAT: Process Analytical technology
PET: Preservative efficacy test
PET: Polyethylene
PIC/S: Pharmaceutical Inspection Co-operation Scheme
PLC: Programmable Logic Control
PQ: Performance Qualification
PVC: Polyvinyl Chloride
PVDC: Polyvinylidene Chloride
PW: Purified Water
QA : Quality Assurance
QC: Quality Control
QbD: Quality by design
QM: Quality Manual
QSD: Quality System Dossier
QSM : Quality System Management
QMS: Quality Management System
RH: Relative humidity
RLAF: Reverse laminar air flow
RLD: Reference listed drug
RM: Raw material
RO: Reverse Osmosis
ROPP: Roll On Pilfer Proof
RS: Related Substance
SAL: Sterility Assurance Level
SAT: Site Acceptance Testing
SDN: Screening Deficiency Notice (Canada)
SIP: Sterilization in place/Steam in place
SLS: Sodium Lauryl Sulphate
SMF: Site master file
SOP: Standard operating procedure
SPE: Society for Pharmaceutical Engineering
SUPAC: Scale-up and post approval changes
SVP: Small Volume Parenteral
TC: Thermocouple
TDS: Total Dissolved Solids
TGA: Therapeutics goods administration (Australia)
TOC: Total organic carbon
TSE: Transmissible spongiform encephalopathy
USFDA: United states foods and drugs administration
USP: United States Pharmacopeia
USP-NF: United States Pharmacopeia-National Formulary
URS: User Requirement Specification
VAI: Voluntary action indicated
VMP: Validation Master Plan
WFI: Water for injection
WHO: World Health Organisation
WL: Warning letter

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First in the world Bharat Biotech to develop Zika virus vaccine

Hyderabad-based Bharat Biotech is developing world's first vaccine for Zika virus, which has beeOrganisation.n declared as public health emergency by the World Health 

The vaccines and bio-therapeutic manufacturer on Wednesday announced that it is working on ZIKAVAC vaccines for Zika infection.

The company, which claims to be working on the vaccine for one-and-half years, has informed both the World Health Organisation (WHO) and the government of India about the status of its project.

Krishna Ella, chairman and managing director, Bharat Biotech, told reporters that the pre-clinical trials for the vaccine will start in a week or two.

The company has filed global patents for both inactivated and recombinant vaccines.

He said the company was ready to partner with Latin American countries like Brazil for the vaccine development. Some Latin American companies have already shown interest in partnering with it for human trials.

"It depends on the regulatory system in the country," he said when asked how long it would take for the vaccine to hit the market in India. Ella said that if the government declares Zika as a national emergency and takes an aggressive stand, the vaccine can be developed in less than two years.

Sumathy, director, research and development, Bharat Biotech, who is heading the vaccine development, said they started the work on this along with the development of vaccine for Chikungunya but the work was progressing at a slow pace.

She said with the virus spreading fast to Latin America and the WHO declaring it public health emergency, they will now speed up the project.

The inactivated vaccine has reached the stage of pre-clinical testing in animals. The pre-clinical trials may take two to five months while human trials will take another four to five months.

Ella pointed out that Zika is now present in 23 countries. Brazil, the hardest-hit country, has reported around 3,530 cases of the devastating birth defect called microcephaly in 2015 that are strongly suspected to be related to Zika.

The Zika virus is spread by mosquitoes of the Aedes genus, which can breed in a pool of water as small as a bottle cap and usually bite during the day. The mosquito-transmitted infection is related to Dengue, Yellow Fever and West Nile virus.

Bharat Biotech has invested over $150 million since inception to build its portfolio of vaccines including ROTAVAC, the first vaccine from the developing world

It has successfully commercialised Typbar TCV, typhoid conjugate vaccine. Chikungunya Vaccine will be entering phase 1 trials shortly. IANS

EU GMP Revised Annex 16 on QP Certification and Batch Release Effective from 15 April 2016

EU GMP Revised Annex 16 on QP Certification and Batch Release Effective from 15 April 2016







The European Commission has published the final version of the revised EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release". Deadline for coming into operation is 15 April 2016.

As one important topic, it has been pointed out that the major task of a Qualified Person (QP) is the certification of a batch for its release. In this context, the QP must personally ensure the responsibilities listed in chapter 1.6 are fulfilled.  In chapter 1.7 a lot of additional responsibilities are listed which need to be secured by the QP. The work can be delegated and the QP can rely on the respective Quality Management Systems. However "the QP should have on-going assurance that this reliance is well founded" (1.7). Amongst these twenty-one tasks are for example:

Starting materials comply and the supply chain is secured, including GMP assessments by third parties

The necessary audits have been performed and the audit reports are available

Manufacturing and testing performance are compliant with the MA

Manufacturing and testing processes are validated

Changes have been evaluated and investigations completed

It is important to mention in this context that "the ultimate responsibility for the performance of an authorised medicinal product over its lifetime; its safety, quality and efficacy lies with the marketing authorisation holder (MAH). However "the QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force (…), in accordance with the requirements of the marketing authorisation (MA) and with Good Manufacturing Practice (GMP)" (see General Principles).

In the case that the QP has to rely on the correct functioning of the quality management system of other sites, the QP "should ensure that a written final assessment and approval of third party audit reports has been made". The QP should also "be aware of the outcome of an audit with critical impact on the product quality before certifying the relevant batches."

Another important section clarifies the role of the QP when it comes to deviations, implementing main features of the EMA Position Paper on QP Discretion (which was issued in February 2006 and updated January 2008). Chapter 3 of the draft describes the "handling of unexpected deviations". A batch with an unexpected deviation from details contained within the Marketing Authorisation and/or GMP may be certified if a risk assessment is performed, evaluating a "potential impact of the deviation on quality, safety or efficacy of the batch(es) concerned and conclusion that the impact is negligible." Depending on the outcome of the investigation and the root cause, the submission of a variation to the MA for the continued manufacture of the product might be required.

During the consultation phase, stakeholders expressed their concerns regarding the sampling of imported products. Now the new annex is clear on this: "Samples may either be taken after arrival in the EU, or be taken at the manufacturing site in the third country in accordance with a technically justified approach which is documented within the company's quality system. (…) Any samples taken outside the EU should be shipped under equivalent transport conditions as the batch that they represent."

The new annex is rather short on other importation requirements. These requirements will probably be defined in the new Annex 21.

GSK joins with research councils in UK and South Africa to tackle non-communicable diseases

GSK has announced a £5m collaboration with the UK and South African Medical Research Councils, to support much-needed research into non-communicable diseases (NCDs) in Africa, as part of GSK's Africa NCD Open Lab initiative.

The funding was pledged today by the UK Foreign Office Minister responsible for Africa, James Duddridge, and South Africa's Minister for Science and Technology, Naledi Pandor, at an event in Cape Town, South Africa, as part of a broader collaboration between the two countries on scientific research. It will be used to support researchers from South African institutions conducting research projects in NCDs, aligned with the objectives of GSK's Africa NCD Open Lab.

£2.5m will be provided by the UK MRC, via the UK Newton Fund - a government fund established in 2013 to develop science and innovation partnerships that promote the economic development and welfare of developing countries - and approximately £1.5m will come from the South African Medical Research Council. GSK will provide an additional £1m, together with a commitment of internal R&D expertise, to support projects within South Africa. As the first initiative to receive support from the UK / South Africa Newton Fund, this is significant external endorsement for GSK's open approach to NCD research in Africa.

Alongside the funding confirmed today for South African research proposals, GSK will also commit a further £4m to support successful proposals for NCD research from selected countries elsewhere in sub-Saharan Africa. The call for proposals from these countries will launch later in 2014.

The Africa NCD Open Lab was established by GSK earlier this year as part of a series of strategic investments in sub-Saharan Africa. In this region, and across developing countries, non-communicable diseases, such as cancer and diabetes, pose an increasing threat, and more needs to be done to understand the specific variations of disease in this setting. The Africa NCD Open Lab aims to address this through the creation of an innovative research network that will see GSK scientists collaborate with researchers across Africa on high quality epidemiological, genetic and interventional research, from its hub at GSK's Stevenage R&D facility in the UK. The aim is that this will help build local expertise, creating a new generation of African NCD experts, while instilling a deep vein of "African thinking" within GSK's own R&D organisation.

This builds on the success of GSK’s Open Lab in Tres Cantos, Spain, which was established in 2010 to give independent researchers access to GSK facilities, resources and knowledge, to help them advance their own projects in to diseases of the developing world, such as malaria, tuberculosis and leishmaniasis. Since the Tres Cantos Open Lab was established, 14 projects from world class institutions have completed, progressing much needed research into diseases of the developing world.

Patrick Vallance, President of Pharmaceutical R&D at GSK, said: "The funding announced today is a great endorsement of GSK's open research philosophy, and signifies growing agreement among the scientific community that collaboration is key to defeating some of the world's biggest health problems.

"We believe that by providing support to African institutions as they carry out their own research in to the chronic disease variants that most affect the African people, the NCD Open Lab will play a key role in helping to tackle disease in this area."

An official call for proposals, seeking interest from researchers from South Africa and wider sub-Saharan Africa, will be launched later in 2014, to begin in the second quarter of 2015.

GSK - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.