Chứng nhận nhà sản xuất và phân phối nguyên liệu mỹ phẩm theo EFfCI (Hiệp hội Quản lý Nguyên liệu Mỹ phẩm Châu Âu). Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
How to apply for COPPs (Certificate of Pharmaceutical Products)?ambitbiomedix12
The certificate of a pharmaceutical products (COPPs) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country. Read More: https://bit.ly/31cfTYl
What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)?Ajay kamboj
CoPP is necessary for exporting medicines and pharmaceutical products from India. The application for grant of WHO GMP Certificate of Pharmaceutical Product shall be made to respective zonal/sub zonal officers appointed by DCGI as per the requirement.
How to apply for COPPs (Certificate of Pharmaceutical Products)?ambitbiomedix12
The certificate of a pharmaceutical products (COPPs) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country. Read More: https://bit.ly/31cfTYl
What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)?Ajay kamboj
CoPP is necessary for exporting medicines and pharmaceutical products from India. The application for grant of WHO GMP Certificate of Pharmaceutical Product shall be made to respective zonal/sub zonal officers appointed by DCGI as per the requirement.
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Malaysian Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO)Vijay Banwala
this ppt covers all quary about the CDSCO ( central drug standard control organisation ,drug controller gernal of india and the organisation strectures
this ppt provides you all detail about the CDSCO
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
Tabular summary of New Drugs & Clinical Trials Rules, 2019 [INDIA]Vikas Dhiman
The slides summarize the changes brought in by the New Drugs & Clinical Trials Rules, 2019. A comparison with previous regulatory requirement is presented in tabular form.
In May 2022, the European In Vitro Diagnostics Regulation (IVDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how manufacturers obtain CE Marking and maintain access to the European market. Many companies have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies. Oliver will present the ‘What will it take? Review IVDR readiness” to help you understand the scope of the new regulations.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
FDA Clarifies The Types Of MDSAP Audits To Be Conducted In The PandemicEMMAIntl
The FDA released an information transmittal to the MDSAP Auditing Organizations on December 31st, 2020 providing further guidance on the expansion of remote MDSAP audits during the period of the public health emergency.
Under this transmittal order, FDA clarifies the difference between the following types of audits and defines when such an audit would be appropriate. Below are the types of audits defined in this order...
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Malaysian Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO)Vijay Banwala
this ppt covers all quary about the CDSCO ( central drug standard control organisation ,drug controller gernal of india and the organisation strectures
this ppt provides you all detail about the CDSCO
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
Tabular summary of New Drugs & Clinical Trials Rules, 2019 [INDIA]Vikas Dhiman
The slides summarize the changes brought in by the New Drugs & Clinical Trials Rules, 2019. A comparison with previous regulatory requirement is presented in tabular form.
In May 2022, the European In Vitro Diagnostics Regulation (IVDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how manufacturers obtain CE Marking and maintain access to the European market. Many companies have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies. Oliver will present the ‘What will it take? Review IVDR readiness” to help you understand the scope of the new regulations.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
FDA Clarifies The Types Of MDSAP Audits To Be Conducted In The PandemicEMMAIntl
The FDA released an information transmittal to the MDSAP Auditing Organizations on December 31st, 2020 providing further guidance on the expansion of remote MDSAP audits during the period of the public health emergency.
Under this transmittal order, FDA clarifies the difference between the following types of audits and defines when such an audit would be appropriate. Below are the types of audits defined in this order...
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS AND POST APPROVAL REQUIREME...Mohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA 201T)
Semester II - Regulatory Aspects of Drugs and Cosmetics (MRA 201T)
Unit V - Regulatory pre-requisites related to Marketing authorization requirements for drugs and post approval requirements in Saudi Arabia
(REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS AND POST APPROVAL REQUIREMENTS IN SAUDI ARABIA)
Drug approval process in Saudi Arabia - Saudi Food & Drug Authority
Learn the key steps your remote audit process must include from FSMA Friday- GFSI's virtual & remote auditing processes. Presented by Rich Simmons, Senior Advisor of Food Safety at The Acheson Group.
This Circular provides for:
1. Principles and requirements of Good Manufacturing Practices (GMP) for health supplements and application of GMP by domestic manufacturers of health supplements.
2. Certificates equivalent to the Certificate of compliance with GMP for imported health supplements.
Post-Market Clinical Follow Up Studies Under EU MDR and IVDREMMAIntl
On May 5, 2017, the Active Implantable Medical Devices Directive (90/385/EEC — AIMD) and the Medical Devices Directive (93/42/EEC — MDD) were replaced by the Medical Device Regulations (MDR) 2017/745, and the In-Vitro Diagnostic Medical Devices Directive (89/79/EC — IVDD) was replaced by the In-Vitro Diagnostic Regulations (IVDR) 2017/746.
Both of these new regulations put a heavy emphasis on post-market surveillance activities for a product. Post-market clinical follow-up studies, or performance studies as called in the IVDR, are an integral part of the post-market surveillance requirements of the newly released regulations. PMCF studies must be initiated by the manufacturer...
Danh mục 37 thuốc sản xuất trong nước được cấp giấy phép lưu hành tại Việt Nam - Đợt 185.
Quyết định được Cục Quản lý Dược Việt Nam ban hành vào tháng 7 năm 2023.
Danh mục 259 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 185.
Danh mục được ban hành bới Cục Quản lý Dược Việt Nam tháng 7 năm 2023.
Ngày 21/06 vừa qua, cục Quản lý Dược vừa ban hành quyết định về việc công bố danh mục thuốc biệt dược gốc - đợt 2 năm 2023.
Ban hành kèm theo quyết định này bao gồm 83 thuốc biệt dược gốc.
Xem thêm các tài liệu khác trên trang của công ty cổ phần Tư vấn thiết kế GMP-EU.
Hướng dẫn thực hành này cung cấp thông tin cho các nhà sản xuất thức ăn có chất sát khuẩn không an toàn do thuốc chuyển sang thức ăn chăn nuôi không chứa thuốc hoặc một loại thức ăn khác. Mục đích của hướng dẫn này:
• “Sản xuất và phân phối thức ăn có chứa thuốc” đề cập đến việc sử dụng thiết bị để sản xuất, chế biến, đóng gói, giữ và phân phối thức ăn.
• “Thức ăn chăn nuôi” được sản xuất có thêm hóa chất bảo quản. Thức ăn cho động vật như vậy có thể được gọi trong hướng dẫn này là “thức ăn có tẩm thuốc” hoặc “thức ăn không có tẩm thuốc”, tùy thuộc vào việc thức ăn đó có được pha chế để chứa một loại thuốc mới dành cho động vật hay không. Để thuận tiện, chúng tôi gọi những loại thuốc mới dành cho động vật này đơn giản là “thuốc”.
• “Thuốc mang theo” đề cập đến sự hiện diện của thuốc trong lô thức ăn chăn nuôi tiếp theo.
• “Ô nhiễm không an toàn”: đề cập đến mức độ nhiễm bẩn, do một loại thuốc được phép sử dụng trong thức ăn chăn nuôi, gây ra rủi ro không thể chấp nhận được đối với sức khỏe con người hoặc động vật.
Nói chung, các tài liệu hướng dẫn của FDA không thiết lập các trách nhiệm có thể thực thi về mặt pháp lý. Thay vào đó nó mô tả Cơ quan về một chủ đề và chỉ nên được xem dưới dạng khuyến nghị, trừ khi các yêu cầu pháp lý hoặc quy định cụ thể được trích dẫn. Việc sử dụng từ nên trong hướng dẫn của Cơ quan có nghĩa là điều gì đó được gợi ý hoặc khuyến nghị, nhưng không bắt buộc.
Xem thêm các tài liệu khác trên trang của công ty cổ phần tư vấn thiết kể GMP EU.
Cục Quản lý Thực phẩm và Dược phẩm Hoa Kỳ đưa ra hướng dẫn cho các nhà sản xuất và phân phối sữa cho trẻ sơ sinh về các yêu cầu ghi nhãn nhất định đối với các sản phẩm này. Hướng dẫn này đặc biệt chú trọng đến số lượng các công thức sữa cho trẻ sơ sinh có bao bì tương tự nhưng khác nhau về thành phần hoặc mục đích sử dụng. Ngày càng nhiều các sản phẩm ghi sai nhãn về hàm lượng chất dinh dưỡng, do vậy hướng dẫn này cung cấp thông tin có thể giúp các nhà sản xuất hiểu và tuân thủ các yêu cầu ghi nhãn liên quan.
Hướng dẫn này không bao gồm đầy đủ tất cả các quy định liên quan đến việc ghi nhãn sữa công thức dành cho trẻ sơ sinh. Vì vậy bạn có thể xem thêm các hướng dẫn khác tại www.fda.gov/FoodGuidances hoặc các tài liệu trên kênh của công ty cổ phần tư vấn thiết kế GMP EU.
Ngày 25/05 vừa qua, Cục quản lý Dược vừa ban hành danh mục 69 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 184.
Theo đó, ban hành kèm theo Quyết định này danh mục 69 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 184, cụ thể:
1. Danh mục 64 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam hiệu lực 05 năm (Phụ lục I kèm theo).
2. Danh mục 05 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam hiệu lực 03 năm (Phụ lục II kèm theo).
Xem thêm các tài liệu khác trên trang của công tư cổ phần tư vấn thiết kế GMP EU.
Ngày 25/05 vừa qua, Cục quản lý Dược đã ban hành quyết định số 352/QĐ-QLD về việc ban hành danh mục 231 thuốc nước ngoài được cấp, gia hạn giấy đăng ký lưu hành tại Việt Nam - Đợt 184.
Theo đề nghị của Trưởng phòng Đăng ký thuốc, Cục Quản lý Dược quyết định:
Ban hành kèm theo Quyết định này danh mục 231 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 184, cụ thể:
1. Danh mục 172 thuốc sản xuất trong nước được gia hạn giấy đăng ký lưu hành hiệu lực 05 năm (Phụ lục I kèm theo).
2. Danh mục 52 thuốc sản xuất trong nước được gia hạn giấy đăng ký lưu hành hiệu lực 03 năm (Phụ lục II kèm theo).
3. Danh mục 07 thuốc sản xuất trong nước được gia hạn đăng ký lưu hành đến 31/12/2025 (Phụ lục III kèm theo).
Xem thêm các tài liệu khác trên trang của công ty cổ phần Tư vấn thiết kế GMP EU.
Ngày 26/05 vừa qua, Cục Quản lý Dược đã ban hành quyết định số 371/QĐ-QLD về việc công bố danh mục thuốc biệt dược gốc Đợt 1 - năm 2023.
Theo đề nghị của Trưởng phòng Đăng ký thuốc - Cục Quản lý Dược, quyết định:
Công bố Danh mục 56 thuốc Biệt dược gốc Đợt 1 - Năm 2023 tại Phụ lục kèm theo Quyết định này.
Xem thêm các tài liệu khác trên trang của công ty cổ phần Tư vấn thiết kế GMP EU.
Ngày 26/05 vừa qua, Cục Quản lý Dược vừa ra quyết định số 370/QĐ-QLD về việc ban hành danh mục 50 thuốc nước ngoài được cấp, gia hạn giấy đăng ký lưu hành tại Việt Nam - Đợt 111 bổ sung.
Theo đề nghị của Trưởng phòng Đăng ký thuốc - Cục Quản lý Dược quyết định:
Ban hành kèm theo Quyết định này danh mục 50 thuốc nước ngoài được cấp, gia hạn giấy đăng ký lưu hành tại Việt Nam - Đợt 111 bổ sung, bao gồm:
1. Danh mục 41 thuốc nước ngoài được cấp giấy đăng ký lưu hành hiệu lực 05 năm - Đợt 111 bổ sung (tại Phụ lục I kèm theo).
2. Danh mục 01 thuốc nước ngoài được cấp giấy đăng ký lưu hành hiệu lực 03 năm - Đợt 111 bổ sung (tại Phụ lục II kèm theo).
3. Danh mục 07 thuốc nước ngoài được gia hạn giấy đăng ký lưu hành hiệu lực 05 năm - Đợt 111 bổ sung (tại Phụ lục III kèm theo).
4. Danh mục 01 thuốc nước ngoài được gia hạn giấy đăng ký lưu hành đến 31/12/2025 - Đợt 111 bổ sung (tại Phụ lục IV kèm theo).
Ngày 24/05 vừa qua, Bộ Y tế vừa ban hành quyết định về việc công bố danh mục thuốc có chứng minh tương đương sinh học đợt 2 - năm 2023.
Theo đề nghị của Trưởng phòng Đăng ký thuốc - Cục quản lý Dược, quyết định:
Công bố Danh mục 28 thuốc có chứng minh tương đương sinh học Đợt 2 - Năm 2023 tại Phụ lục kèm theo Quyết định này.
Xem thêm các tài liệu khác của Công ty cổ phần Tư vấn thiết kế GMP EU.
More from Công ty Cổ phần Tư vấn Thiết kế GMP EU (20)
Struggling with intense fears that disrupt your life? At Renew Life Hypnosis, we offer specialized hypnosis to overcome fear. Phobias are exaggerated fears, often stemming from past traumas or learned behaviors. Hypnotherapy addresses these deep-seated fears by accessing the subconscious mind, helping you change your reactions to phobic triggers. Our expert therapists guide you into a state of deep relaxation, allowing you to transform your responses and reduce anxiety. Experience increased confidence and freedom from phobias with our personalized approach. Ready to live a fear-free life? Visit us at Renew Life Hypnosis..
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Welcome to Secret Tantric, London’s finest VIP Massage agency. Since we first opened our doors, we have provided the ultimate erotic massage experience to innumerable clients, each one searching for the very best sensual massage in London. We come by this reputation honestly with a dynamic team of the city’s most beautiful masseuses.
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
Chứng nhận nhà sản xuất và phân phối nguyên liệu mỹ phẩm theo EFfCI
1. Dr. Peter Ungeheuer
Secretary General
Mainzer Landstrasse 55
D - 60329 Frankfurt
EFfCI Head Office: Avenue Louise 489, B-1050 Brussels
Phone: +49-69-25 5613 41
E-mail: Ungeheuer@effci.com
Fax: +49-69-25 56 1342
HTTP://WWW.EFFCI.COM
EFfCI is registered as AISBL, No 0840.955.059 EFfCI-VAT number: BE 0840.955.059
EFfCI GMP for Cosmetic Ingredients – Annex to 2017 Edition
Cosmetic Ingredientmanufacturer anddistributor certification;
Application of remote audits
Frankfurt, January 14th
, 2021
Purpose and Objectives:
Conducting an EFfCI GMP audit may be impossible in the very exceptional situation where
countries are in lockdown as a result of the COVID-19 pandemic crisis. The safety of people
that conduct and receive audits is top priority for EFfCI and we support those governmental
regulations which are aimed at reducing the impact of this virus. Even if travel was possible
then company policies may mean many personnel are working from home and operational
activities reduced or even halted. All these factors will have consequences with regards to
EFfCI GMP Audits.
The goal of this document is to describe alternative options where a physical audit is not
permitted, to maintain or to renew the GMP Certification of Cosmetic Ingredient manufacturers
and distributors. It indicates the conditions and time-periods which are acceptable to postpone
a re-certification or surveillance audit or to replace it by a remote audit.
It will be communicated to each EFfCI Registered Certification Body for implementation in their
internal procedures.
Supporting documents:
- EFfCI GMP for Cosmetic Ingredients 2017
- EFfCI Position Paper: Cosmetic Ingredient manufacturer and distributor certification
with regards to the COVID-19 outbreak (13 March 2020)
- IAF ID3 2011 Guidance: International Accreditation Forum (IAF) Informative Document
for Management of Extraordinary Events or Circumstances Affecting Accreditation
Bodies, Certifying [Assessment] Bodies and Certified Organisations
https://www.iaf.nu/articles/Informative_Documents_/32
1. Scope
This document should be followed by EFfCI Registered Certification Bodies, when a
scheduled audit is affected by an extraordinary circumstance such as a government-
imposed travel ban, or other restrictions applied externally to the Cosmetic Ingredient
manufacturer and/or supplier which are beyond their control.
The annex applies to EFfCI GMP re-certification or surveillance audits and the first part of
an initial Certification audit (Stage-1) audit. However, the full on-site initial Certification
audit (Stage 2 audit) has to completed with a physical on-site audit.
These requirements are valid while the COVID-19 pandemic containment measures are in
place in the affected countries. It should remain valid until local or national travel
restrictions are suspended, and physical (on-site) audits can return to normal.
2. Dr. Peter Ungeheuer
Secretary General
Mainzer Landstrasse 55
D - 60329 Frankfurt
EFfCI Head Office: Avenue Louise 489, B-1050 Brussels
Phone: +49-69-25 5613 41
E-mail: Ungeheuer@effci.com
Fax: +49-69-25 56 1342
HTTP://WWW.EFFCI.COM
EFfCI is registered as AISBL, No 0840.955.059 EFfCI-VAT number: BE 0840.955.059
2. Definitions
Extraordinary event or circumstance: A circumstance beyond the control of the certified
company, commonly referred to as “Force Majeure” or “act of God”. Examples are
war, strike, riot, political instability, geopolitical tension, terrorism, crime, pandemic, flooding,
earthquake, malicious computer hacking, other natural or man-made disasters.
3. Responsibilities
It is the responsibility of the Certification Body to implement these requirements in its own
system of procedures for communication to its team of auditors. The Certification Body
shall also communicate these requirements to their impacted Cosmetic Ingredient Suppliers
in case a certification audit cannot be performed for the above reason.
It is the responsibility of the Certification Body to inform EFfCI aisbl (ungeheuer@effci.com)
about the decision to either postpone or to perform a remote certification audit, before the
audit is completed.
4. Procedure: conditions for postponement or remote audit
4.1. Initial Certification Audit
When a new supplier of a Cosmetic Ingredient is willing to be certified with reference to the
EFfCI GMP, the Stage 1 audit may be performed remotely. However, a Stage 2 audit
cannot be conducted remotely. The Stage 2 certification audit shall be made no later than 6
months after the Stage 1 audit. If such conditions cannot be fulfilled, the best solution would
be to wait until an on-site Stage 1 and Stage 2 certification audit can be completed.
It is the decision of the Lead Auditor and of the Certification Body to accept a Stage 1
remote audit instead of on-site audit. Such a decision should consider the previous
knowledge of the client, the scope of the certification, the size of the site, the number of
products to be included in the assessment and the complexity of the production processes.
The Lead Auditor should also take into consideration the probability for performing a Stage
2 on-site audit within a 6 months’ time period, before performing a remote Stage 1 audit.
It is acknowledged that it may not be possible to perform a physical audit for Stage 2, and
this may mean the application has to lapse. At this point EFfCI does not believe that this
physical audit can be omitted without seriously compromising the reputation and value of
the Certification Scheme to cosmetic manufacturers.
4.2. SurveillanceAudit
a) When a Surveillance Audit 1 (SA-1) cannot be performed within one year after the Initial
Certification Audit, or when a Surveillance Audit 2 (SA-2) cannot be performed within
two years after the Initial Certification Audit, the physical audit can be delayed for a
maximum of 6 months after the initial scheduled date. The initial scheduled date must
be considered as the last day of the initial certification audit plus 12 or 24 months.
Therefore, SA-1 should be conducted maximum 18 months after the initial certification
audit and SA-2 should be conducted maximum 30 months after the initial certification
audit date.
The normal window which is applied to all scheduled audits should be respected based
on the revised date.
3. Dr. Peter Ungeheuer
Secretary General
Mainzer Landstrasse 55
D - 60329 Frankfurt
EFfCI Head Office: Avenue Louise 489, B-1050 Brussels
Phone: +49-69-25 5613 41
E-mail: Ungeheuer@effci.com
Fax: +49-69-25 56 1342
HTTP://WWW.EFFCI.COM
EFfCI is registered as AISBL, No 0840.955.059 EFfCI-VAT number: BE 0840.955.059
b) If such an on-site audit is not possible for the reasons in the purpose and objectives, it
may be acceptable to perform a remote audit in place of physical audit. This should be
completed within the 6 month period after the initially scheduled audit date.
The Certification Body shall as a first step perform a quality risk assessment considering
the conditions mentioned in section 5.2 “Quality Risk Assessment for allowing a remote
audit”. If the conclusion is that risk is low or moderate, the Certification Body can
propose to the Supplier that a remote audit according to the procedure described in
Section 5 can be conducted. The remote audit will then replace the on-site audit. If the
SA-1 was already performed using remote means, then the SA-2 can also be a remote
audit if the risk assessment is reviewed, revised and has a favorable conclusion (it is
now permitted that there can be two successive remote surveillance audits).
c) If the quality risk assessment concludes a remote audit is not acceptable, or if for any
other reason a remote audit cannot be performed, then the EFfCI Certification shall be
suspended for a maximum 6 months period and be withdrawn immediately after 6
months.
d) In any case, the Certification Body should inform EFfCI aisbl at ungeheuer@effci.com
about the audit’s postponement or the completion of a remote audit or a certification
suspension, before the decision is implemented.
4.3. Re-certification Audit
One of the following three options may be adopted:
a) If a re-certification audit (RCA) cannot be performed within the normal window following
the third anniversary of the Initial Certification Audit, the audit can be delayed for a
maximum of 6 months after the third anniversary date.
Therefore, an RCA should be conducted no later than 42 months after the initial
certification audit date. In this case, there should be an extension of the expiry date of
the certificate.
b) If an on-site audit is not possible for the reasons in the purpose and objectives, it may
be acceptable to perform a remote audit, in accordance with Section 5, in order to
replace an on-site physical audit and to avoid certification suspension. That is the
recertification audit in its entirety can be replaced by a remote audit.
The Certification Body shall initially perform a quality risk assessment considering the
conditions mentioned in Section 5.2 “Quality Risk Assessment for allowing a remote
audit”. If the conclusion is that risk is low or moderate, the Certification Body can
propose a remote audit according to the procedure described in Section 5.
If the quality risk assessment is favorable, the remote audit shall be conducted within 6
months of the original planned RCA date, i.e., not more than 42 months after the initial
certification audit (to allow time for planning and organizing the remote audit). In such an
option, the remote audit shall also be confirmed by an on-site audit within the 6 month
period after the date of the remote audit. In this case, there should be an extension of
the expiry date of the certificate to the date of the remote audit. This means the physical
audit will fall within the next audit cycle for the Certificate, but it should be an exceptional
one off circumstance. This on-site audit duration can be shorter as the documentation
was already assessed during the remote audit.
c) If the quality risk assessment concludes a remote audit is not acceptable, or if no
physical audit is possible within the 6 month extension in section a) then the EFfCI
4. Dr. Peter Ungeheuer
Secretary General
Mainzer Landstrasse 55
D - 60329 Frankfurt
EFfCI Head Office: Avenue Louise 489, B-1050 Brussels
Phone: +49-69-25 5613 41
E-mail: Ungeheuer@effci.com
Fax: +49-69-25 56 1342
HTTP://WWW.EFFCI.COM
EFfCI is registered as AISBL, No 0840.955.059 EFfCI-VAT number: BE 0840.955.059
Certification shall be suspended for a maximum 6 months period from the date of the
original scheduled RCA and withdrawn immediately after.
5. Dr. Peter Ungeheuer
Secretary General
Mainzer Landstrasse 55
D - 60329 Frankfurt
EFfCI Head Office: Avenue Louise 489, B-1050 Brussels
Phone: +49-69-25 5613 41
E-mail: Ungeheuer@effci.com
Fax: +49-69-25 56 1342
HTTP://WWW.EFFCI.COM
EFfCI is registered as AISBL, No 0840.955.059 EFfCI-VAT number: BE 0840.955.059
d) In all cases, the Certification Body should inform EFfCI at ungeheuer@effci.com about
the audit’s postponement, application of a remote audit or certification suspension,
before the decision is implemented in order for this to be updated on the EFfCI website.
4.4. Certification Scope Changes
Where an organization requires an additional location to be added to the scope of
certification, then a physical audit of that location is required. If this cannot be completed
then no change to the certification scope can be completed.
4.5. Certificate Validity
The recertification date on Certificates will be retained as originally established. This means
that if an audit is delayed under these rules and a new one issued the validity period of the
new certificate will be the third year of the anniversary of the end of the validity of the
previous certificate. That is, any delay to the audit will not increase the period of validity of
the certificate.
5. Procedure: Organization ofa Remote audit
A remote audit is an audit which is performed under a confidential disclosure agreement by
remote tools (e.g.: phone, e-mails, Skype, WhatsApp, Zoom), with exchange of electronic
documents using internet-cloud system when the size of document cannot be transferred by
direct mails (e.g.: WeTransfer, Dropbox). The auditor may also be granted temporary
access to the client’s IT systems to observe information directly.
A remote audit is different from a questionnaire assessment as there should be a direct
discussion between the auditor and the auditee, and the use of a video-conferencing
system is essential.
A remote audit is also different from a simple teleconference as the auditor shall have the
opportunity to read and assess written audit evidence which is displayed on screen.
At the end of the remote audit, it should be considered that, as far as audited topics are
concerned, the Lead Auditor shall be able to provide a recommendation about the audit
outcome with the same degree of confidence as after a physical audit. A remote audit does
not have to include an on-site visit and audit of workshops, laboratories and warehouses
but any visual evidence of these locations that can be provided is to be considered.
5.1. Confidentiality agreement
The realisation of a remote audit will require some exchange of documents and
photographs prior to the audit. Therefore, the existing confidentiality agreement may need
to be revised and strengthened. The method of information exchange should be agreed in
advance including the storage, processing, retaining and disposal of the shared information.
There should be a prior commitment to keep confidential any information shared before and
during the audit, and to not to copy or archive any photograph or document unless formally
agreed by the auditee.
5.2. Quality Risk Assessment for allowing a remote audit
A quality risk assessment should be performed by the Certification Body, with input from the
client, before deciding if a remote audit can be conducted. EFfCI should be consulted if
there is any doubt about the risk assessment outcome. The conclusion of the risk
6. Dr. Peter Ungeheuer
Secretary General
Mainzer Landstrasse 55
D - 60329 Frankfurt
EFfCI Head Office: Avenue Louise 489, B-1050 Brussels
Phone: +49-69-25 5613 41
E-mail: Ungeheuer@effci.com
Fax: +49-69-25 56 1342
HTTP://WWW.EFFCI.COM
EFfCI is registered as AISBL, No 0840.955.059 EFfCI-VAT number: BE 0840.955.059
assessment should be based on knowledge of the client, any publicly available information
about their quality systems, and preliminary information provided by the client.
7. Dr. Peter Ungeheuer
Secretary General
Mainzer Landstrasse 55
D - 60329 Frankfurt
EFfCI Head Office: Avenue Louise 489, B-1050 Brussels
Phone: +49-69-25 5613 41
E-mail: Ungeheuer@effci.com
Fax: +49-69-25 56 1342
HTTP://WWW.EFFCI.COM
EFfCI is registered as AISBL, No 0840.955.059 EFfCI-VAT number: BE 0840.955.059
The risk assessment for determining whether to permit a remote audit, shall be
documented. The risk assessment and the fact the audit was conducted remotely shall be
clearly and prominently stated in the audit report.
The risk assessment shall at a minimum consider the following items:
- Changes to the certification scope (automatic high risk factor)
- Changes to the production site address or major changes to the production facilities
(e.g. new plant installed, new manufacturing process) (automatic high risk factor)
- Changes to the types of Products manufactured in the same plant or using the same
production equipment (automatic high risk factor)
- Quality Complaint(s) communicated the Certification Body, concerning a Supplier
Quality System deficiency (automatic high risk factor)
- The number of major non-conformities at any or each of the previous two audits (more
than three would be a high risk factor)
- The history of closure of actions on the previous three audits
- The numbers of all other observations (all types) in the previous three audits
- Changes to the quality and or site management team since the last audit
5.3. Preparation and duration ofa remote audit
The success of a remote audit will depend on the possibility for both the auditor and the
auditee to have direct exchange concerning the quality matters that are not limited to a
review of documentation only. The use of videoconference instead of a voice-only
teleconference may facilitate such exchanges. It is also very important that auditor has a
direct view of a requested document and the opportunity to ask questions and to receive
immediate answers during the review.
The time for connection with the attendees should be carefully managed, as well as the
access to documents in the interviews.
During the audit preparation phase the communication tools to be used shall be agreed. It is
recommended these be tested, including the ability to exchange documents a few days
before the audit.
A list of documents which the auditor needs to see shall be communicated in advance, with
the audit schedule. Additional documented evidence may be requested during the audit.
In case translation is needed between the auditor and the auditee, the parties should agree
prior to the audit how this will be managed.
The total audit duration should be not less than the one defined for the original on-site
physical audit. For instance, if a surveillance audit is defined to last one day, the remote
surveillance audit should last not less than 8 hours. It is recommended to organise the
remote audit agenda into several sections. This will allow named auditee’ employees to be
present to discuss relevant concerns, and the auditor to have time to assess documents on
their own. The remote audit may be organised over several days, with only a few hours per
day for the interview.
An example agenda corresponding to remote audit organisation is proposed in the
Appendix.
5.4. Realisation of a remote audit
The remote audit shall follow the same basic steps as a physical audit:
- Audit program (the audit program should mention that it is a remote audit)
8. Dr. Peter Ungeheuer
Secretary General
Mainzer Landstrasse 55
D - 60329 Frankfurt
EFfCI Head Office: Avenue Louise 489, B-1050 Brussels
Phone: +49-69-25 5613 41
E-mail: Ungeheuer@effci.com
Fax: +49-69-25 56 1342
HTTP://WWW.EFFCI.COM
EFfCI is registered as AISBL, No 0840.955.059 EFfCI-VAT number: BE 0840.955.059
- Receipt of documents prior to the interview and study of them
9. Dr. Peter Ungeheuer
Secretary General
Mainzer Landstrasse 55
D - 60329 Frankfurt
EFfCI Head Office: Avenue Louise 489, B-1050 Brussels
Phone: +49-69-25 5613 41
E-mail: Ungeheuer@effci.com
Fax: +49-69-25 56 1342
HTTP://WWW.EFFCI.COM
EFfCI is registered as AISBL, No 0840.955.059 EFfCI-VAT number: BE 0840.955.059
- Opening meeting
- Interview of Cosmetic Ingredient supplier teams
- Assembly of objective evidence
- Closing meeting
- Audit Report issuance (The audit report should mention it is a remote audit which
was justified based on a documented risk assessment.)
- Supplier’s commitment for improvement – CAPA plan assessment
- Final auditor recommendation regarding EFfCI GMP Certification status
- Certification Body Certification decision
- Communication of the certification conclusion
If there is no remote visual visit to the plant (for example because of safety concerns such
as explosive zoning), the auditor may request specific photographs of e.g., the production
area and utilities. The auditor may also request raw data using a shared screen in case of
electronic data or using webcam pictures of paper documentation.
The organisation of such a remote audit should ensure when auditee representatives for
each topic and each function are available in a timely manner.
5.5. Contentof the remote audit: Items to be audited
The remote audit shall consider the key items listed in the EFfCI GMP Standard for
Cosmetic Ingredients (non- exhaustive list):
a) CAPA from the previous audit:
Any previous preventive and corrective action plan should be reviewed, and evidence
obtained (e.g. pictures and/or documents) to demonstrate action closure. This evidence
may be requested during the audit preparation phase.
b) List of Changes implemented since the previous audit:
New equipment, new products, change of process, new activity within the site, change
of organisation.
For each change, an impact assessment should be available. Such change should be
considered as of minor importance with regards to quality of manufactured Cosmetic
Ingredient, otherwise a remote audit cannot replace an on-site audit.
c) Annual Management Review:
Performance of manufacturing operations and the quality system (e.g. Number of
batches manufactured, number of batches rejected, customer complaints, recalls)
Customer satisfaction assessment.
Quality and GMP Objectives and Targets and the results of any previous ones
d) Batch Record:
At least one production and quality control batch record should be assessed by the
auditor. The auditor should be able to select the batch record to be audited.
A specific focus should be made on the testing, release and shipment process.
e) Quality Control:
Organisation of the QC, role and responsibilities.
Audit of an actual analytical batch record with specific focus on raw data traceability
Number of out-of-specification results recorded since previous audit.
Issuance of Certificate of Analysis or Certificate of Conformity.
f) Certification and Inspections
10. Dr. Peter Ungeheuer
Secretary General
Mainzer Landstrasse 55
D - 60329 Frankfurt
EFfCI Head Office: Avenue Louise 489, B-1050 Brussels
Phone: +49-69-25 5613 41
E-mail: Ungeheuer@effci.com
Fax: +49-69-25 56 1342
HTTP://WWW.EFFCI.COM
EFfCI is registered as AISBL, No 0840.955.059 EFfCI-VAT number: BE 0840.955.059
ISO 9001 audits and outcomes if those audits are performed separately to the EFfCI
GMP audit.
11. Dr. Peter Ungeheuer
Secretary General
Mainzer Landstrasse 55
D - 60329 Frankfurt
EFfCI Head Office: Avenue Louise 489, B-1050 Brussels
Phone: +49-69-25 5613 41
E-mail: Ungeheuer@effci.com
Fax: +49-69-25 56 1342
HTTP://WWW.EFFCI.COM
EFfCI is registered as AISBL, No 0840.955.059 EFfCI-VAT number: BE 0840.955.059
g) Internal Audits
Annual program, list and duration of the audits performed, process review
Processes covered by the internal audit program since previous audit.
h) Suppliers’ and Contractors’ Management
New suppliers, monitoring of approved suppliers, audit of contractors, qualification
evidence.
i) Organisation roles and Responsibilities
Number of employees (changes since previous audit), percentage of temporary
employees.
Organisation chart and corresponding job descriptions.
j) Personnel Qualification
GMP training program and realization
Reference to EFfCI standards
Example of training program traceability
Management of consultants and temporary employees, if any
k) Infrastructure and Working Environment Risk Assessments
Changes to these documents resulting in new controls being applied to utilities,
infrastructure and the working environment.
6. DocumentHistory
1 17th
April 2020 First Issue
2 6th
October 2020 Second edition with updates (in red text)
3 14th
January 2021 Addition of Section 4.4 and 4.5 and editorial corrections
12. Dr. Peter Ungeheuer
Secretary General
Mainzer Landstrasse 55
D - 60329 Frankfurt
EFfCI Head Office: Avenue Louise 489, B-1050 Brussels
Phone: +49-69-25 5613 41
E-mail: Ungeheuer@effci.com
Fax: +49-69-25 56 1342
HTTP://WWW.EFFCI.COM
EFfCI is registered as AISBL, No 0840.955.059 EFfCI-VAT number: BE 0840.955.059
7. APPENDIX: Example ofRemote Audit Agenda
Day Time Participant Topic to be audited Technical tool
D-1
08:30 All Opening Meeting – roundtable, test of
connection, scope – objectives
Videoconference
09:15 concerned
managers
Discussion of CAPA from previous
audit (based on document provided
prior the audit)
Videoconference
10:00 Break
10:15 Team 1
(e.g.: HR +
QA)
Topic 1
(e.g.: Training & personal qualification)
webcam &
shared screen
10:45 Team 2 Topic 2 webcam &
shared screen
11:10 Team 3 Topic 3 webcam &
shared screen
11:30 Auditee Team
Leader
Request for additional documentation e-Mail, Cloud
transfer
11:45 Break
12:00
12:30
Auditee’s
team
Preliminary feedback after Day 1,
documents to be prepared for Day 2
Videoconference
D-1
Afternoon
Auditor only Review documentation, request for
additional evidence, communication to
the auditee’s team leader
Mail, phone,
office work
D-2
08:30 Auditee’s
team
Day-2 introduction meeting
Program of the 2nd
day
Availability of Company representatives
webcam &
shared screen
09:00 Team 4 Topic 4 webcam &
shared screen
09:20 Team 5 Topic 5 webcam &
shared screen
09:40 Team 6 Topic 6 webcam &
shared screen
10:00 Auditee’s
team
Auditor ask for documents,
photographs, other evidence
webcam &
shared screen
10:05 Break
10:20 Ad-hoc team Last item(s) to be audited,
last questions about provided
documentation
webcam &
shared screen
11:15
Auditor time
Room / Tool
change
11:45 All Audit Conclusion meeting
List of non-conformities and
observations
Videoconference
12:30 End of the audit