Category: Quality News – ISO Standards

Procedure for submission of cough syrups for Testing

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Mandatory Testing of Cough Syrup before Export – Procedure for submission of cough syrups for Testing

Cough syrup exporters will have to undertake testing of their products at specified Government Laboratories and obtain Production of Certificate of Analysis with effect from June 1 before getting permission for the outbound shipments

Ministry of Commerce & Industry has issued a Notification No.06/2023 dated 22nd May 2023 permiting export of cough syrups, subject to the export sample being tested and production of Certificate of Analysis (COA) issued by any of the Central Government Laboratories and any NABL Accredited State Drug Testing Laboratory.

The specified Central Government labs include Indian Pharmacopoeia Commission, Regional Drug Testing Lab (RDTL – Chandigarh), Central Drugs Lab (CDL – Kolkata), Central Drug Testing Lab (CDTL – Chennai Hyderabad, Mumbai), RDTL (Guwahati)] and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of State Governments

In order to facilitate the process of testing of cough syrups at the said laboratories, the following are the pre-requisite requirements for submission of samples :

  1. Covering letter from the Manufacturer / Exporter on Letterhead addressed to concerned Laboratory
  2. Manufacturing License of the product for Export purpose
  3. Export Order
  4. Representative sample from the export consignment
  5. Thrice the quantity required for performing complete analysis of the sample
  6. Qualitative composition of product including excipients
  7. Certificate of analysis by the manufacturer of the particular batch and method of analysis (STP)
  8. Reference / Working standard (with traceability certificate) and placebo as applicable
Click here to read the Notification

Source: https://www.dgft.gov.in/CP/?opt=notification

EGA 2023 – Application Now Open

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Envirocare Green Awards 2023

Envirocare Green Awards is an initiative by Envirocare Labs started in 2018 with a vision to motivate and empower professionals & organization’s in the field of environment. 

EGA is a non-commercial activity of self-motivated and like-minded people dedicated to making a positive difference to Sustainable Care. 

The objective is to inspire stakeholders to think green & contribute towards a world that is not only progressive but also responsible towards its provider.

The applicants for these awards will be evaluated by an independent international Jury – renowned & respected in their professional fields. The award ceremony would be preceded by keynote speaker sessions.  

The application for this award is online and is open for across the globe under the following categories:

1. Individual / s

2. Private Ltd / LLP / MSME

3. Public Sector / Large Corporates

4. Non Government Organisation NGO / Cooperatives

5. Government Organisation / Municipal

6. Academia

7. Others

To apply please click here for online Google Form:https://forms.gle/ZfWBjSR8PA6W5Bqe7

The short listed applicants will be required to make online presentation for Jury evaluation. The data submitted would be confidential and used only for the purpose of EGA

Application deadline 15th June 2023, Please feel free to reach out to EGA Secretariat Ms Deenal Shah: +91 9167232025 | ega@envirocare.co.in

For regular updates on EGA 2023 , visit  https://lnkd.in/eDiKu3R

Best Practices in Social Sector

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NITI Aayog released the “Best Practices in Social Sector: A Compendium, 2023”

NITI Aayog released the “Best Practices in Social Sector: A Compendium, 2023” in collaboration with the United Nations Development Programme.

To commemorate 75 years of India’s independence and highlight and laud the efforts of Union Ministries and State Governments, this compendium includes 75 case studies cutting across 14 key social sectors. The case studies have been sourced from all States/ Union Territories and 30 Ministries and Departments of the Government of India.

The seventy-five best practices highlight models which are innovative, sustainable, replicable and impactful. The aim of this exercise has been to synthesise lessons for the future to expand, enhance and improve life at the grassroots level. Due care was taken to ensure that the cases identified are spread over diverse themes, including education, health and nutrition, e-governance and digitization, agriculture, women’s empowerment, sports, and financial inclusion, among others.

Click here to read the document

Source: https://niti.gov.in/node/3568

Workshop by IBSC – AMTZ

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Workshop on Indian Medical Device Regulations

IBSC – AMTZ is organising a Workshop on Indian Medical Device Regulations

Indian Medical Device Regulations workshop ensures the safety and effectiveness of medical devices and gives overview of the efficient and safe manufacture of medical devices

LEARNING OBJECTIVE

  • Candidate will get the knowledge on new legal requirements of the Indian Medical Device Regulations (IMDR).
  • Overview of the safe and efficient manufacture of medical devices in accordance with the Indian Medical Device Regulations (MDR).
  • To understand the responsibilities and obligations as a manufacturer, importers, and distributers of medical devices.

COURSE AGENDA

  • Contents and Fundamentals of the Indian Medical Device Regulation (IMDR)
  • Classification of Medical Devices
  • Basic Requirements
  • Content Requirements for Technical Documentation
  • Validity of Conformity Assessment and Certification, Transition Periods
  • Requirements for Manufacturers, Importers, Distributors and Service Partners

TARGET AUDIENCE

  • Medical device manufacturers
  • Consultants 
  • Regulatory Affairs Specialists
  • Expert advisors in medical devices regulatory affairs
  • Working biomedical engineers / medical device professionals
  • Pursuing Students are also eligible

Fee: INR 3,540 including 18% GST

CANDIDATES WILL BE PROVIDED WITH IBSC CERTIFICATE


LAST DATE FOR REGISTRATION: 30th May 2023 


TRAINING DURATION: 2 DAYS (9th & 10th June 2023)


LOCATION: Faculty of Pharmacy, MS Ramaiah University of Applied Sciences, Bangalore 

For more information, please contact

Mr. Nitturi Naresh Kumar
Mobile: +91-8897330990 | +91-7075737284
WhatsApp Link: https://wa.me/918897330990
WhatsApp Link: https://wa.me/917075737284
trainings@amtz.in

Source: https://ibsc-amtz.in/coursedetails/25

NABH – LATEST NOTIFICATIONS

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Latest Notifications Issued by NABH on Hospital Accreditation Standards

NOTIFICATION FOR SMALL HEALTH CARE ORGANIZATIONS

NABH has started implementation of 3rdedition accreditation standards for SHCOs w.e.f. 1st March 2023.

In view of multiple representations received from various stakeholders and our endeavour to continue conducting comprehensive assessments of SHCOs, NABH has decided to increase number of man-days for conducting the mid-term surveillance assessments of SHCOs under 3rd edition, from current 1*1 (1 assessor for 1 day) to 2* 2 (2 assessors for 2 days) with immediate effect.

There shall be no change in the number of man-days for final and re-assessments of SHCOs.

Source: https://nabh.co/Announcement/Notification%20for%20Change%20in%20Man-days%20for%20Surveillance%20assessment%20of%20SHCOs.pdf

NOTIFICATION FOR FEEDBACK ON 5th EDITION ACCREDITATION STANDARDS FOR HOSPITALS

NABH will soon be initiating drafting of 6th edition of Hospital Accreditation Standards in accordance with ISQua EEA Guidelines. You are requested to give feedback on the current NABH Standards i.e. 5th Edition. Your feedback/ inputs will add value in developing new edition of Hospitals standards.

The comments are invited on the following link.

Feedback form: https://forms.gle/5TXp5PsymacUR3Mu8

The last date for receiving feedback is 15th May, 2023.

Source: https://nabh.co/Announcement/Notification%20for%20Feedback%20on%205th%20Edition%20Standard.pdf

NABH Notification

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NABH – DIGITAL HEALTH ACCREDITATION STANDARDS – (DRAFT)

NABH has released the Draft standard – Digital Health Accreditation Standards – 1st Edition.

NABH invites comments, suggestions and feedback in the draft document from public at large, including the stakeholders like hospitals the other clinical establishments, industry, consumer groups etc.

The comments may be shared on the form within 20 days of publication of this notice on the website.

Click here to read the Draft standard

Please find the Link for google form link to submit the feedback.

https://forms.gle/wSCKTJnfbDwvnase7

The last date for receiving comments is 2nd May 2023

Source:https://nabh.co/Announcement/Public%20Notice%20for%20Digital%20Health%20Standard%201st%20Edition.pdf

QCI’s Virtual Trainings

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QCI’s Virtual Trainings on NABCB Accreditation – ISO/IEC 17020, ISO/IEC 17065 & ISO/IEC 17021

Quality Council of India (QCI) is an autonomous body under the Department for Promotion of Industry & Internal Trade (DPIIT), Ministry of Commerce & Industry, Government of India. QCI is the apex national body and provides accreditation and other related services through its constituent Boards viz. National Accreditation Board for Certification Bodies (NABCB), National Accreditation Board for Testing and Calibration Laboratories (NABL), National Accreditation Board for Hospitals (NABH), National Accreditation Board for Education and Training (NABET), National Board for Quality Promotion (NBQP).  

Training and Capacity Building (TCB), an independent Cell under the ambit of QCI has been regularly conducting trainings for the laboratories, TIC Sector, and industries

Latest training program details of TCB are given below:

Source: https://tcb.qcin.org/

Launch of Healthcare textiles processing facility certification Scheme

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Healthcare Textiles Processing Facility Certification Scheme Launched in India

On the occasion of World Health Day on 7 April, the triple A partnership of AMTZ LTD, Association of Healthcare Providers – AHPI (India) and Association of Indian Medical Device Industry – Aimed India, launched Healthcare Textiles Processing Facility Certification Scheme (HTPFCS) to ensure the quality of healthcare textiles, including personal protective equipment (PPE), by certifying the facilities or laundries that process them for reuse

While the Covid-19 pandemic has highlighted the importance of healthcare textiles and PPE in protecting healthcare workers and patients from infection, the quality of these products depends not only on the materials used but also on the processing facilities where they are sterilized, cleaned, and packaged.

The Healthcare Textiles Processing Facility Certification Scheme will help ensure that these facilities meet international standards for quality and safety. It aligns with international standards and guidelines, including those of the World Health Organization (WHO) and the International Organization for Standardization (ISO).

Under the scheme, healthcare textiles processing facilities can apply for certification by undergoing a rigorous evaluation process that includes site visits, documentation reviews, and testing of samples.The certification will be valid for three years, after which the facility will need to undergo a recertification process.

The Certification would be carried out by independent third party certifying agencies to be accredited as per applicable international standard, ISO 17065, and approved by AMTZ to assure their competence, impartiality and consistent implementation of certification process.

The Healthcare Textiles Processing Facility Certification Scheme is open for applications from healthcare textiles processing facilities in India and abroad.

source:http://www.pharmabiz.com/NewsDetails.aspx?aid=157437&sid=1#:~:text=The%20Healthcare%20Textiles%20Processing%20Facility%20Certification%20Scheme%20is%20a%20welcome,of%20healthcare%20textiles%20and%20PPE.

IAF CertSearch

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IAF CertSearch Team Identifies 20,000 Fake or Fraudulent ISO QMS Certs

As of 2023, more than 27,000 medical device QMS certificates have been issued worldwide

On Feb. 13, 2023, 33 nations sent their medical device regulators to Riyadh, Saudi Arabia, to participate in the Global Harmonization Working Party. The GHWP is a nonprofit organization that studies and recommends ways to harmonize global medical device regulations

The IAF was asked to participate and provide an update on the IAF CertSearch database, a global database where users can search and validate the status of accredited certificates issued by a certification body that has itself been accredited by an IAF-recognized accreditation body. The IAF presentation was provided by Nigel Johnston, who developed the database.

The presentation given to the GHWP members focused attention on the use of ISO 13485 and how the IAF CertSearch database is helping regulators to verify the credibility of these certificates. Johnston’s presentation raised alarms. He noted that the IAF CertSearch team had identified 20,000 fake or fraudulent certificates in the last year alone.

Although it isn’t fully populated (the database represents about 44% of all ISO QMS certificates included in the ISO Survey), it is now mandatory that accredited certification bodies upload them. Because of this requirement, this percentage is expected to increase significantly.

Source: https://www.qualitydigest.com/inside/fda-compliance-article/iaf-certsearch-team-identifies-20000-fake-or-fraudulent-iso-qms-certs

One Person Company (OPC)

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NABL accepts the “One Person Company (OPC)” as a legal entity of CAB

NABL accepts the “One Person Company (OPC)” as a legal entity of CAB under the Companies Act 2013.

An OPC has features of a Company along with the benefits of a Sole Proprietorship.

An OPC can have just one single member and one Director. The Director and member can also be the same person. OPC of sole-proprietor and company form of business has been provided with concessional /relaxed requirements under the Companies Act, 2013.

The accredited CABS which are under Proprietorship are given a transition period till 31.12.2023 to align with any one of the legal entities specified in the Notification

click here to read the Notification

Source: https://nabl-india.org/

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